Pharmaceutical & Cosmetic Review September 2021 by New Media B2B

SEPTEMBER 2021 Volume 48 | Number 9

years www.pharmacos.co.za

Investing in new technology today

to be future-ready tomorrow PHARMA FOCUS

New developments in tablet coatings & equipment

SERIALISE, TRACK & TRACE

How to succeed in securing your supply chain

HOME CARE

Multifunctional, high-performing & sustainable ingredients

OUR BATTLE

IN A BOTTLE DISCOVER MARCHESINI GROUP’S PACKAGING LINES FOR VACCINES

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SEPTEMBER 2021

Contents

years

Volume 48 | Number 9 www.pharmacos.co.za

27 46 Association News Coschem’s sun care seminar review

19 6 News Beautyworld Middle East collaborates with Iberchem The Body Shop commits to being 100% vegan certified by 2023 Italian packaging machinery sales return to 2019 levels

12 Contract Manufacturing & Packing Hersol takes a future view with new high-speed suite Pfizer and BioNTech sign thirdparty agreement with Biovac

16 Industry Talk Omron explores data storage options and advantages

44 18 Pharma Focus: Tablet Coating & Equipment

34 Home Care Sustainable technologies for effective cleaning

New sports nutrition solutions from Gelita

Probiotics and enzymes to enhance cleaning products

Glatt makes improvements to its GC Smart series

Pigments and dyes for home care formulations

Quantum Colours explores the evolution of tablet coatings

40 Ethnic Care

Romaco Tecpharm launches TP R Optima perforated coating pan

Lucas Meyer Cosmetics launches Dendriclear

Study data on Kollicoat Smartseal’s taste-masking functionality

BASF inaugurates care evaluation salon in Nigeria

27 Packaging: Serialise, Track & Trace

Insights into innovation drivers in Africa’s beauty industry

Serialisation: what cosmetics can learn from pharmaceuticals

Solvay launches Restorative formulations for textured hair

Symrise shares new in vivo data on Crinipan PMC

Vision systems for a safer supply chain The role of serialisation in sustainable development

he cover On tHersol invests in a high-speed manufacturing suite

"The adoption of emerging technologies is essential to improving product quality and manufacturing efficiency"

Using data to build trust in SA’s vaccination efforts

WWW.PHARMACOS.CO.ZA // SEPTEMBER 2021

FROM THE EDITOR

Improving manufacturing performance in SA

conomic data by Stats SA released at the beginning of the year shows that manufacturing production fell by 11% and total sales declined by 9.9% in 2020, compared to the previous year. This is largely as a result of the COVID-19 pandemic, which experts say has had a devastating effect on the manufacturing sector. In the personal care industry, many manufacturers say their volumes are down. For example, shampoo and conditioner products have been particularly affected by social distancing and working from home, because people are washing their hair less frequently. Pharmaceutical manufacturing volumes appear to be more promising with the 2019 Footprint Study conducted by the Innovative Pharmaceutical Association South Africa revealing that the South African Health Products Regulatory Authority licensed 276 local companies to manufacture, import, export and distribute pharmaceuticals. There has also been significant investment in new technology and equipment in the pharma industry to keep up with the growing demand for pharmaceutical and nutraceutical products. Featured on our cover this month, Hersol Manufacturing Labs continues to transform itself to ensure its customers and employees benefit from increased efficiency, supply chain agility and better asset utilisation. Turn to page 12 to read more about the contract manufacturer’s future-ready strategy, which Hersol has implemented to achieve and exceed its goals for years to come. In the pharma focus on tablet coating and equipment, we explore improvements in

technology and formulation ingredients, which have seen coatings progress from an art of earlier years to techno-advanced and controlled processes that are centred on compliance and GMP. Turn to page 18 to read about how Glatt has improved its GC Smart tablet coating series, the process optimisation and flexibility benefits offered by Romaco Tecpharm’s new tablet coater – the TP R Optima – and new data from BASF on the impact of Kollicoat Smartseal formulation concepts on taste-masking functionality. This edition of P&C Review also features serialisation and track and trace solutions in the packaging section (page 27) to help you succeed in securing your supply chain and your products. On page 34, we explore sustainable solutions and market trends in the home care segment and, on page 40, we highlight new formulation ingredients aimed at meeting the needs of the ethnic care segment. Also featured in the section on ethnic care, contract manufacturer KAS Africa shares interesting insights into the forces driving innovation in Africa’s beauty and cosmetics industry. Stay safe and enjoy the read!

Consultant, Cosmetic Solutions

CEO of the Generic and Biosimilar Medicines of Southern Africa

Professor Emeritus, Faculty of Health Sciences, Nelson Mandela University

P C Review is affiliated with:

CTFA - The Cosmetic, Toiletry & Fragrance Association of South Africa GBM - Generic and Biosimilar Medicines of Southern Africa

SEPTEMBER 2021 // WWW.PHARMACOS.CO.ZA

EDITOR: Abby Vorster +27 (0)71 359 4519 abby.vorster@newmedia.co.za LAYOUT & DESIGN: Andipha Nkoloti, David Kyslinger SUB-EDITOR: Katrien Smit CONTRIBUTORS: Lonsdale O’Donovan, Jordi Carrera, Ivan Bogaerts, Leslie van Eeckhout, Frederik Detobel, Andrea Beck, Florian Bang, Nils Rottmann, Glynis Stark, Mervyn George

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EDITORIAL

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The team

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COSCHEM - The Society of Cosmetic Chemists of South Africa HPA - The Health Products Association of Southern Africa AMA - T he Aerosol Manufacturers’ Association of South Africa

Pharmaceutical & Cosmetic Review is published by New Media 11 times a year and circulates to manufacturers, packers and distributors of pharmaceuticals, health products, cosmetics, detergents, soaps, toiletries and allied products. The journal is an up-to-date source of reference for company directors, factory and production managers, marketing executives, engineers, import agents, buyers and research personnel. While precautions have been taken to ensure the accuracy of its contents and information given to readers, neither the editor, publisher, or its agents can accept responsibility for damages or injury which may arise therefrom. All rights reserved. © Pharmaceutical & Cosmetic Review. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, photocopying, electronic, mechanical or otherwise without the prior written permission of the copyright owners. Pharmaceutical & Cosmetic Review is printed and bound by CTP Printers - Cape Town Copyright: all rights reserved. ISSN 0257-8719

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NEWS

Masslift Africa makes a difference on Nelson Mandela Day

Beautyworld Middle East collaborates with Iberchem For the 2021 edition of Beautyworld Middle East, taking place from 5 to 7 October at the Dubai World Trade Centre, exhibition organisers are collaborating with Iberchem on a new olfactory experience, known as a world of scents, for visitors and participants to enjoy. Curated by Iberchem team, a world of scents will take place in different locations throughout the show, such as the premium lounge, the quintessence zone and during the Beautyworld Middle East Awards ceremony, taking place at the Dubai Ritz Carlton on 5 October. “A World of Scents” was developed as a unique way for visitors to discover, the beauty and benefits of scents beyond the stands

Making a positive impact remains one of Masslift Africa’s fundamental driving forces, whether through enabling businesses to scale up their operations or directly creating job opportunities. As a purpose-driven organisation, Masslift Africa is acutely aware of its role in contributing to a more equitable and sustainable society. To this end, the distributor of Mitsubishi forklifts recently supported two initiatives geared towards reducing suffering and hardship among the most vulnerable in South Africa. For its Nelson Mandela Day initiative this year, Masslift Africa contributed to the Nelson Mandela Children’s Hospital via Jacaranda FM’s Good Morning Angels. The company pledged R60 000, which translates into treatment for two children in need of medical care. “This is a very worthy cause. Investing in our children is investing in the future,” says Masslift Africa’s chief financial officer, Thembi Mazibuko. In addition to its donation to the hospital, its Cape Town branch supported the Durbanville Children’s Home on Nelson Mandela Day. This children’s home is dedicated to the care, development and rehabilitation of emotionally traumatised children between the ages of two and 18. Masslift Africa supported the home through its “adopt a baby in a box” initiative. “As a company operating in South Africa, it is more than required of us to play our part not only to ensure the stability of the economy, but also the stability of the people living in our country. We believe in helping where we can,” Mazibuko concludes.

of the fragrance brands and companies. The concept will feature interactive installations and innovative concepts to delight visitors. It is the first time that the show has offered such an experience to its audience.

"We are thrilled to present this new fragrance experience at Beautyworld Middle East" “We are thrilled to present this new fragrance experience at Beautyworld Middle East,” says Guillaume Audy, corporate communications director at Iberchem. “We feel incredibly honoured by all the trust the team at Beautyworld has placed in us to create this tailor-made experience. Year after year, Iberchem has brought innovative fragrance concepts to the show and this year, the creativity of our team will be featured at a whole new level. The fragrance industry has so much to offer, and it is our pleasure to contribute to spreading the word diffusion.” Elaine O’Connell, show director of Beautyworld Middle East, adds: “A world of scents will offer trade buyers, beauty professionals, retailers and distributors at Beautyworld Middle East the opportunity to elevate their typical trade fair visit by taking them on an olfactory journey through the show. Creating scents is not only about chemistry, but also creative vision, living, dreaming and experiencing smells through memory, music, shapes and colours. A world of scents will embody this artistic journey and we’re delighted to partner with Iberchem in bringing this unique initiative to our 2021 show.” Beautyworld Middle East will be celebrating its 25th anniversary edition this year. It is the region’s largest international trade fair for the beauty industry. The upcoming show will host exhibitors from 54 countries and 17 dedicated country pavilions, making it the first truly international beauty event of the year.

SEPTEMBER 2021 // WWW.PHARMACOS.CO.ZA

Goods donated to the Durbanville Children’s Home on Nelson Mandela Day

Integrated diaphragm monitoring bridges the gap between digitalisation and process reliability Wika’s new DMSU21SA diaphragm monitoring system fulfils the increasing need for process monitoring on plants for sanitary applications. With the Hart protocol, both the measuring signal and the status of the integrated diaphragm monitoring can be transmitted, as required, to the process control. The system architecture with integrated diaphragm monitoring bridges the gap between digitalisation and process reliability. With the patented diaphragm monitoring, a monitoring element is mainly used for electrical/digital signal transmission of the diaphragm condition. In addition, the diaphragm condition is displayed on a dial with red/green areas. In the event of a diaphragm rupture, a second internal diaphragm ensures the reliable separation of the environment and the process. A fluid inside the system, which is explicitly chosen to suit the particular measuring requirement, hydraulically transmits the pressure to the pressure measuring instrument. Depending on the application, the system fill fluid is both FDA and USP compliant. The diaphragm monitoring system can be supplied with all common process connections for sanitary applications and fulfils the applicable standards, such as EHEDG, 3-A and ASME BPE. Contact Wika Instruments for more information or visit www.wika.co.za The DMSU21SA diaphragm monitoring system from Wika Instruments

NEWS

The Body Shop commits to being 100% vegan certified by 2023 The Body Shop recently announced that by the

800 stores in 14 markets, by the end

end of 2023 its entire product formulations

of 2021. Lionel Thoreau, global brand director,

have all its product formulas certified by The Vegan

portfolio* will be certified by The Vegan Society

The Body Shop says: “Going 100% vegan is a

Society. It is possible that old formulations which

and will carry its Vegan Trademark. The Body

natural progression for us and vegan beauty

have not been certified by The Vegan Society may

Shop was also the first cosmetics company to

is a critical next step in our sustainability and

still be present in the market at that point, as those

campaign against animal testing in cosmetics

environmental endeavours. This, along with our

products are being sold through.

in 1989, with a fundamental belief that animals

global refill and in-store recycling programmes

should not be harmed in the pursuit of beauty.

makes The Body Shop a destination for

The Vegan Society represents the global gold standard in vegan certification and takes

ethically-minded customers.” Chantelle Adkins, director of business

an extremely thorough approach to this,

development at The Vegan Society comments:

scrutinising every supplier and manufacturer of

“Body Shop’s ambition to achieve 100% Vegan

raw materials.

Trademark certification across their substantial

For The Body Shop, that’s over 3 700

portfolio of formulations demonstrates their

raw materials. Currently 60% of The Body

solid commitment to deliver the very best in

Shop products are vegan. The company also

efficacious and planet-loving products.”

announced the launch of an ambitious global

* By December 2023, The Body Shop aims to

Commenting on the refill initiative, Thoreau

rollout of refill stations across 500 stores this

added: “We want refills to become mainstream

year, and a further 300 stores in 2022. The

– easy and accessible to everyone. This is just

Body Shop will also extend its in-store recycling

our first step in a five-year plan to roll out refill

scheme ‘Return, Recycle and Repeat’, across

stations across the globe.”

A new refill station in The Body Shop which will be rolled out globally across 500 stores in 2021 and a further 300 stores in 2022

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WWW.PHARMACOS.CO.ZA // SEPTEMBER 2021

NEWS

Symrise Cosmetic Ingredients and Kobo enter into a strategic partnership Kobo Products, a powder and dispersion

leader in the beauty solutions market.

specialist for the beauty industry, will sell

The group is capitalising on over 100

off 25% of its business to Symrise as part

years of experience in developing and

of a strategic investment to expand the

marketing cosmetic ingredients and the

activities of the fragrances & flavours

ability to intertwine the best of nature with

producer into inorganic UV filters and

science and skin and hair biology. With a

decorative cosmetics.

portfolio ranging from advanced actives

“With this investment, we fast-track our

and botanicals to market-leading product

strategic plan to expand into decorative

protection solutions and a broad range

cosmetics. It enables us to stay at the

of sun care filters to high-performance

forefront of consumer trends by bridging

functionals and special colour solutions,

colour and skin care cosmetics,” says

Symrise sees a wide range of possibilities

Dr Jörn Andreas, president of cosmetic

to jointly explore growth prospects with

ingredients division at Symrise. “We will

Kobo. Both groups will, for example,

combine Kobo’s broad range of market-

cooperate in the distribution of UV filters

leading product lines in surface-treated

and Kobo can capitalise on Symrise’s

pigments, sun care and colour dispersions

global sales infrastructure.

with our decades long experience in

President of Kobo since inception,

manufacturing and marketing high-quality

David Schlossman says: “Joining forces

cosmetic ingredients. Our customers

with Symrise offers us an opportunity

will benefit from an unmatched range of

to further develop our colour and sun

UV filter products and a full spectrum of

businesses. Both companies share similar

formulations and integrated solutions.”

values regarding employee health and

Incorporated in New Jersey, USA in 1987

well-being. Symrise’s resources and

and headquartered in South Plainfield,

expertise in organic UV filters combined

USA, Kobo Products is a pigment and

with ours in inorganic UV filters will create

powder specialist, providing innovative,

an organisation with the capacity to

technology-based raw materials to the

analyse and develop novel ingredients

cosmetics industry. Kobo has a very large

and formulations, which provide broad-

portfolio of surface-treated pigments

spectrum protection, are safer for the

and dispersions to meet market demands

environment and help minimise carbon

for makeup products for a wide range of

emissions. Together, we will do the

skin tones. It is a market leader in mineral

necessary research to create technical

sunscreen technologies to create high

colour and sun care products that are

protection formulations with broad-

responsive to the needs of customers,

spectrum protection, microspheres for

regulators and other stakeholders around

enhanced textures and materials that

the world.”

are derived of natural origin. Symrise’s Cosmetic Ingredients division is a global

The financial details of the investments were not disclosed.

Together, Symrise and Kobo will explore R&D activities to create technical colour and sun care products that are responsive to market needs

SEPTEMBER 2021 // WWW.PHARMACOS.CO.ZA

Growth in online pharmacy sales puts pressure on UK pharma and logistics The UK e-commerce market is the fourth largest in the world with an estimated revenue of £77bn in 2020, placing the country ahead of Germany but behind Japan. Unprecedented growth in online business in general is placed squarely on the shoulders of the COVID-19 pandemic, and in pharmaceuticals, the frequency of product shipping and timed deliveries is skyrocketing. Dispensing volumes of e-commerce pharmacies grew by 45% in 2020 (www.statista.com), resulting in additional pressure on pharmaceutical warehousing and logistics facilities. Increased demand for storage space brought home just how important choosing a reputable, flexible and innovative storage and logistics partner is for your business. “During the pandemic, pharmacies have had to quickly adopt an online approach to handling the ever-growing demand for medicines and goods. According to Statista, it is estimated that there are over 390 ‘distance selling’ pharmacies active in the UK today alone,” says Marcus Sanders, executive director at Clarity Pharma, a UK pharma and healthcare consultancy and logistics provider. “Clarity has been approached by more online pharmacies than ever before, which highlights the popularity of online pharma products. Disruptions in the shipping industry, marked by tight capacity and upward pricing pressure, is forcing pharmaceutical shippers to implement more agile and effective means of distribution and to provide additional capacity in authorised facilities.” Shipping pharmaceuticals involves the transportation of high-value medications and requires fully compliant, premium warehousing and logistics facilities that offer ambient and chilled storage conditions, as well as Home Office and Medical Healthcare Regulatory Agency approvals for controlled drugs; all critical in an industry beset by product fraud. “In the pharma industry, one of the most important take-outs from 2020 was the need for more agile and efficient pharma distribution partners that could cope with the demands of the new e-pharmacy growth and unexpected supply chain issues. Clarity Pharma is ideally positioned to offer solutions to these challenges and is seeing an increase in demand from the e-commerce pharmacy sector as a result,” Sanders confirms. With its recent Home Office Controlled Drugs Licence approval, Clarity now boasts an impressive warehousing capacity, which includes a state-of-the-art controlled drug vault and 578 feet of controlled drugs space. As online purchases in the healthcare market grow, so does prescription fraud and a host of illegitimate e-pharmacies. Examples of pharmaceutical fraud include the issuing of fake COVID medication and false cures for other illnesses. Many distributors in this fraudulent market are from less regulated countries, where medications are often easily accessible online.

NEWS

Clariant acquires remaining 70% in Beraca to seize full control Clariant has signed an agreement to acquire the remaining 70% in Brazilian personal care specialities company, Beraca from the founding Sabará family. Clariant has held a 30% stake in the company since 2015. The purchase price will not be disclosed. The acquisition is subject to regulatory approvals and is expected to close in Q4 2021. Beraca is one of the key manufacturers of natural ingredients for the personal care sector offering fats, oils and botanicals, which are all collected and extracted using environmentally sustainable production processes. Located in the Amazon region, Beraca promotes the development of communities, making them part of the personal care business on a global scale while simultaneously being strongly committed to sustainability and fair-trade processes. In more than 30 years since its foundation, it has received several awards and recognition from customers and institutions as a leading company in ethical sourcing aspects for personal care ingredients. Since 2015, Beraca has invested significant resources in expanding research and innovation and has steadily increased production capacity. With around 90 employees, the familyrun company generated sales of $15m in 2020. “With its focus on sustainable products and processes, Beraca fits perfectly into Clariant’s portfolio,” emphasizes Conrad Keijzer, CEO of Clariant. “The acquisition gives us valuable access to natural materials based on the biodiversity of the Brazilian rainforest. This opens up great opportunities for high-quality growth for our care chemicals business.” Christian Vang, head of business unit industrial & consumer specialties: “There is an increasing demand for ethically produced products on the world market, which we can meet even better with this acquisition.” Welcoming the Beraca team, Vang adds: “The excellent and highly-creative team has written an extraordinary success story over the past five years, which we now want to continue and further develop under the Clariant umbrella.” The acquisition of the remaining 70% in Beraca is a relevant building block in the strategy of further strengthening individual core business areas through targeted acquisitions. Beraca’s business will be integrated into the care chemicals business area.

Wolf Plastics supplies SMEs and international key accounts in the construction, chemical and food industries with buckets, canisters and bottles

Packaging manufacturer, Alpla acquires Wolf Plastics The Alpla Group, a global packaging solutions and recycling specialist, is purchasing the Wolf Plastics Group to expand its product portfolio in central and south-eastern Europe where it sees growth potential. By acquiring 100% of the shares of Wolf Plastics, which is based in Kammern, Austria, Alpla intends to use the company’s expertise, in particular in the manufacture of plastic buckets and canisters, to expand its product portfolio. With its three

New ISO 22000-approved pharma processing cleaner

production facilities in Austria, Hungary and Romania, Wolf Plastics is the market leader in its line of business in central and south-eastern Europe. The Austrian and Romanian competition authorities are currently examining the proposal. Closure of the

Fuchs Lubricants has launched a heavy duty water-

deal is subject to regulatory approval.

based cleaner concentrate for pharmaceutical and food

Wolf Plastics was founded in Kammern in the Austrian federal

processing which is solvent free, readily biodegradable and

state of Styria in 1973. It supplies SMEs and international key

environmentally friendly.

accounts in the construction, chemical and food industries with

Bio Clean assists facilities with meeting the highest standards

buckets, canisters and bottles.

in both the pharma and food industries, especially HACCP and ISO 22000. Bio

It currently has a workforce of approximately 210 employees

Clean and the premix are also NSF registered.

across its three sites while its product range consists of around

“While the product’s reputation originated in the food industry, it has

400 products.

been embraced by the commercial and mining sectors, and is suitable for

“Wolf Plastics has decades of experience in product areas

all environments,” explained Giles Cutter, Lubritech divisional manager,

in which we want to increase our representation in order to

Fuchs Lubricants South Africa. “As a solvent-free industrial cleaner for

expand our portfolio and grow in key regions,” says Alpla CEO

both commercial and industrial cleaning, it works especially well on

Philipp Lehner.

greasy surfaces. It can be used diluted or in

Alpla regional manager, Rainer Widmar adds: “Sustainability

concentrated form without significant loss

is also becoming more and more important in the market

of cleaning power. For the lower volume

segments covered by Wolf Plastics. This is precisely where we

commercial and retail sectors it also comes in

at Alpla can apply our expertise and market position.”

a pre-diluted version.”

The contracting parties have agreed not to disclose the

Bio Clean has approval from NSF non-food

purchase price or any of the details involved. The acquisition

compound listing-A1 (133135) and is SANHA

deal was signed on 29 July 2021. The acquisition is subject

HALAAL approved.

to the legal and regulatory approval of the competent

Bio Clean assists facilities with meeting the highest standards in both the pharma and food industries

competition authorities.

WWW.PHARMACOS.CO.ZA // SEPTEMBER 2021

NEWS

Italian packaging machinery sales return to 2019 levels year that saw year-end sales in excess of

the number of companies in business (635 in

€8bn). This performance was the combined

total, 3.1%) and in the number of employees,

result of 9.2% growth in the first quarter and

which grew by 7% to 35 630.

an even higher 29.4% growth in the second

In line with 2019, export sales accounted

quarter, compared to the same period the

for 78% of the total (€6.08bn) but fell by

previous year.

4.1%. The European Union remained the

The growth is similar in the domestic

main target market for Italian packaging

market (34%) and in the export market (28.4%),

machinery and accounted for 41% of total

compared to the previous year. The UCIMA-

turnover (€2.087m) including sales in Italy,

Mecs Research Centre published data on

followed in second place by Asia with a

The automatic packaging machinery

orders, which were up by 10.9% in the second

value of €985.8m and a 19.4% share and

industry recorded robust 21% growth in the

quarter and 10.7% over the entire first half

North America in third place with €733.1m

first half of 2021 compared to the same

of the year. It also reported the results for

(14.4%). North America is the only macro

period in 2020. In the period from January

2020 in the ninth national statistical survey,

region that saw growth in turnover (+5.9%)

to June, exports were 19.3% higher than in

which every year provides an overview of the

with respect to 2019, a year when exports

the first half of 2020 and domestic sales

sector’s performance.

dropped to €691.9m. Next came non-

THE

Buyer’sguide

up 31.2%.

Last year the Italian automatic packaging

According to UCIMA, the Italian

EU Europe (8.6% or €439.7m), Africa and

machinery manufacturers essentially

Oceania (8.4%) and Central and South

Packaging Machinery Manufacturers

maintained the previous year’s turnover levels.

America (8.2%).

Association, with these figures the entire

Following the record figures of 2019, the

industry has returned to pre-pandemic

sector saw a modest year-on-year decline of

positive trend seen in recent years with

levels, with a difference of just 1.8%

2.9% to €7.81bn, in line with the result of 2018

sales up 1.9% year-on-year in 2020 to

compared to the first half of 2019 (a record

(€7.9bn). Last year also saw an increase in both

€1.72bn.

2017/2018

The domestic market continued the

THE

Buyer’sguide

2020/2021

The directory for manufacturers of food, beverages, pharmaceuticals, cosmetics, toiletries, packaging and the printing industry

Available online: www.thebuyersguide.co.za 10

Buyers Guide 2018.indd 1

SEPTEMBER 2021 // WWW.PHARMACOS.CO.ZA

2018/05/07 3:09 PM

What’s on in 2021

DIARY

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basan Cleanroom Forum 3 to 4 November (new dates) Monte Casino, Joburg www.basan.co.za

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WWW.PHARMACOS.CO.ZA // SEPTEMBER 2021

CONTRACT MANUFACTURING & PACKING

Agile, optimised and ready for the future When a manufacturing business successfully transforms itself, customers and employees benefit from increased efficiency, agility of supply chain planning and asset utilisation. This is the case at Hersol, which has established a future-ready strategy to achieve and exceed its goals for years to come. By Abby Vorster

rom rapid advances in technology to ever-increasing consumer demands, every industry, including

manufacturing, is trying to stay abreast of the pace of change while reinventing processes for a more sustainable future. Pharmaceutical manufacturing is one of the industries heavily affected by technology advances, with the adoption of emerging technologies essential to improving product quality and manufacturing efficiency. Hersol Manufacturing Laboratories (Hersol) is a contract manufacturer that specialises in developing and producing nutritional supplements and complementary medicines (CAMs). In addition to improving its operational efficiencies, the company has advanced its strategic value and embraced cultural change. Hersol has extensive high-tech facilities to manufacture and pack most dosage forms including tablets, capsules, liquids, powders, creams, ointments and gels. The company operates a GMP-approved facility in central Johannesburg, South Africa and all

Did you know? Hersol’s R&D department is an important contributor of new ideas and concepts, which add value to its customers’ businesses.

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products produced on site are manufactured according to pharmaceutical standards and legislation as prescribed by the relevant

population and an increased focus wellness have affected market demands. Experts believe that vitamins, minerals and

governing authorities, such as SAHPRA, the SA Pharmacy Council and US FDA.

CAMs are an efficient and affordable solution to improve optimal immune function in consumers to protect them against viruses and diseases. Furthermore, immunity-boosting supplements are popular thanks to the role they play in supporting physical and mental health. These trends have resulted in an everincreasing demand for vitamins, minerals and health supplements, requiring manufacturers to mass produce tonics, tablets, capsules etc. at faster speeds than ever before.

A BOOMING MARKET According to Market Research Future, the global vitamin and mineral supplements market is expected to register a CAGR of 6.70%, reaching $108.14bn by 2025. During the forecast period, the market is poised to achieve significant growth as a result of the increasing emphasis on preventive healthcare. Factors such as changing health conditions, an ageing

CONTRACT MANUFACTURING & PACKING New manufacturing equipment to be installed in Hersol’s high-speed suite, will ensure that the contract manufacturer continues to meet customers’ needs for increased volumes

LEADERSHIP WITH A FRESH PERSPECTIVE Thanks to its forward-thinking management team, Hersol has taken a future view to ensure the long-term sustainability of the business. The contract manufacturer recently made several new appointments to its management team. These employees bring a fresh approach and new energy to the traditional way of doing things. We asked the new faces at Hersol what inspires them to give of their best, daily: 1. The Hersol team is excited and happy that Kevin van Wyngaardt has accepted the appointment of managing director and responsible pharmacist as of 1 March 2021. He is well suited to the position and brings with him with years of pharmaceutical manufacturing and business experience. His goals and vision to take the company into the future align perfectly with management and the leadership of Hersol. The business has every confidence in Van Wyngaardt’s ability going forward.

NEW HIGH-SPEED SUITE Over the years, Hersol has established extensive analytical, manufacturing, packing and warehouse facilities to keep up with rising and changing demands in the market. Its investments in these areas have been ongoing with the most recent being the installation of UPS technology in its fully-equipped analytical laboratory and microbiological laboratory to ensure these facilities are unaffected by loadshedding. Hersol has also acquired new laboratory equipment in the form of an HPLC and FTIR to improve efficiencies in testing and to ensure the quality and consistency of all raw materials and finished products. The company’s manufacturing plant is home to modern production areas used for granulation, compression, encapsulation and coating, which put the company in the upper ranks of pharmaceutical production in South Africa. The latest enhancement to Hersol’s manufacturing capacity is a high-speed high-volume production and packing suite, which is currently being built on-site at the Jeppestown plant and is scheduled to be completed by January 2022. The new highspeed suite will ensure that Hersol continues to meet the need for increased volumes in areas where specialised equipment and controlled conditions are required. As manufacturing remains critically important to job creation and boosting the South African economy, Hersol will continue to invest in its plant and its people to remain competitive. • Hersol – www.hersol.co.za

2. Vera Terentieva, quality manager: “I have more than 25 years’ experience in quality management and global experience in the pharmaceutical industry. My responsibilities include establishing and maintaining a total quality system encompassing management review, document control, training, customer feedback and complaints, internal audits, process improvement, and corrective/preventative action activities in compliance with cGMP and the latest SAHPRA guidelines. My main goal is to increase quality awareness and the quality mindset across Hersol. I enjoy the teamwork and Hersol’s diversity. Our quality strategy receives great support from executive management which helps us strive for improvement and customer recognition. 3. Tumelo Langa, production manager: “I have a distinct passion for efficient manufacturing processes, employee motivation and excellent customer service. My primary responsibility is to oversee all manufacturing processes and ensure that all products are manufactured to the highest quality standard. The challenging and yet exciting environment provided by Hersol keeps me on my toes and offers a rewarding job experience and an opportunity to do something new daily. Hersol’s production efficiency and customer service are expected to improve significantly with the company’s investment in the new high speed suite.” 4. Christopher Briscoe, production pharmacist and HOD of compression and granulation: “If I were to describe my most inspirational moment at Hersol, I simply could not isolate one thing. Each day provides me with a different challenge, and each is bigger than the next, yet with the amazing Hersol support system it feels like there is no challenge that cannot be overcome. The most satisfying feeling is finding a solution to a seemingly unsolvable situation. I am a big believer in growth and development, and I am super excited about the new high-speed suite. This growth will bring Hersol, as a company, into a whole new league of pharmaceutical manufacturing.” 5. Erwin Prozesky, technical associate, R&D and regulatory: “I come from a research background and I have many years’ experience in CAMs quality control, new product development and regulatory requirements. I have an analytical mind and ensure great attention to technical detail. These areas of expertise have come perfectly together in my current role. I am excited to use my technical abilities and CAMs knowledge to make a contribution in ensuring quality new and current products. My passions include R&D, herbal medicine, people’s health and ensuring quality products.

WWW.PHARMACOS.CO.ZA // SEPTEMBER 2021

CONTRACT MANUFACTURING & PACKING

mRNA vaccine manufacturing partnership a first in Africa Pfizer and BioNTech have signed a letter of intent with Biovac, a Cape Town-based biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 vaccine for distribution within the African Union.

he Biovac Institute (Biovac) will perform manufacturing and distribution activities within Pfizer’s and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network, which will now span three continents and include more than 20 manufacturing facilities. To facilitate Biovac’s involvement in the process, technical transfer and onsite development activities as well as the installation of dedicated equipment related to mRNA technology will begin immediately. Pfizer and BioNTech expect that Biovac’s Cape Town facility will be incorporated into the vaccine supply chain by the end of 2021. Biovac will obtain drug substance from facilities in Europe and manufacturing of finished doses will commence in 2022. At full operational Dr Morena Makhoana, capacity, the annual CEO of Biovac production will exceed 100m finished doses. All doses will exclusively be distributed within the 55 member states that make up the African Union.

COLLABORATION TO INCREASE VACCINE ACCESS “From day one, our goal has been to provide fair and equitable access to the Pfizer-

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Biovac’s manufacturing facility is located in Cape Town, Western Cape

BioNTech COVID-19 vaccine to everyone, everywhere,” said Albert Bourla, chairman and CEO of Pfizer. “Our latest collaboration with Biovac is a shining example of the tireless work being done, in this instance to

benefit Africa. We will continue to explore and pursue opportunities to bring new partners into our supply chain network, including in Latin America, to further accelerate access to COVID-19 vaccines.”

CONTRACT MANUFACTURING & PACKING

Ugur Sahin, CEO and co-founder of BioNTech, added, “We aim to enable people on all continents to manufacture and distribute our vaccine while ensuring the quality of the manufacturing process and the doses. We believe that our mRNA technology can also be used to develop vaccine candidates

"Establishing strategic partnerships is at the centre of Biovac’s success in building manufacturing capacity in Africa for vaccines and biologicals" addressing other diseases. This is why we will continue to evaluate sustainable approaches that will support the development and production of mRNA vaccines on the African continent.”

A LEADING LOCAL CONTRACT MANUFACTURER “We are thrilled to collaborate with Pfizer and BioNTech to produce and distribute the Pfizer-BioNTech COVID-19 vaccine within Africa. This is testament to the long-standing relationship we have had with Pfizer through the Prevenar 13 vaccine,” commented Dr Morena Makhoana, CEO of Biovac. “This is a critical step forward in strengthening sustainable access to a vaccine in the fight against this tragic, worldwide pandemic. We believe this collaboration will create opportunity to more broadly distribute vaccine doses to people in harder-to-reach communities, especially those on the African continent.” Pfizer and BioNTech select contract manufacturers using a rigorous selection process based on the following factors: • quality • compliance • safety track record • technical capability • capacity availability • highly trained workforce • project management abilities • prior working relationship • commitment to working with flexibility through a fast-paced programme. Pfizer and Biovac have worked together since 2015 on the sterile formulation, fill, finish and distribution of the Prevenar 13

Biovac subscribes to current Good Manufacturing Practices

Did you know? Africa imports in excess of a billion doses of vaccines per year but the manufacturing contribution is less than 1% of that. With less than five vaccine manufacturers on the continent and none in southern Africa before Biovac was established in 2003, it was imperative to develop manufacturing capacity in the country. Biovac started its journey of building manufacturing capability by following a reverse integration approach wherein it has been importing, exporting, packaging, testing and supplying vaccines.

vaccine. Biovac also had an agreement with Sanofi to locally manufacture another very complex paediatric vaccine. According to Biovac, this latest deal with Pfizer is the first on the African continent and the first in the Southern Hemisphere for production of an mRNA vaccine. This shows that South Africa has the capacity and expertise to become a manufacturing hub for complex biological pharmaceutical products. Establishing strategic partnerships is at the centre of Biovac’s success in building manufacturing capacity in Africa for vaccines and biologicals. The manufacturer says it is open to

collaboration with local and overseas organisations and scientists on vaccine development projects that are relevant to Africa and other developing countries.

COMMITTED TO ACTIVE COLLABORATION To date, Pfizer and BioNTech have shipped more than 1bn COVID-19 vaccine doses to more than 100 countries or territories in every region of the world. The companies are firmly committed to working towards equitable and affordable access to COVID-19 vaccines for all people around the world, actively collaborating with governments and health partners with the aim to provide 2bn doses to low- and middle-income countries in 2021 and 2022 – 1bn each year. This includes an agreement to supply 500m doses to the US government at a not-for-profit price, to be donated to the African Union and COVAX 92 Advanced Market Commitment (AMC) countries, as well as a direct supply agreement with the COVAX facility for 40m doses. •

Biovac – www.biovac.co.za

WWW.PHARMACOS.CO.ZA // SEPTEMBER 2021

INDUSTRY TALK

Data storage – on the edge or in the cloud

There is a buzz around the idea of digitalisation – for its ability to deliver the benefits of greater visualisation and analysis of data and to gain a greater understanding of the root causes of unexpected downtime and production bottlenecks. But what are the options and how can they best be employed?

ne advantage of digitalisation – in addition to offering greater connectivity of devices at plant level – is its potential to escalate data to other systems and to make it possible to monitor plants remotely, in more depth, over wider distances and longer periods than was ever possible in the past. Manufacturing traceability, for example, would traditionally have been achieved via paper-based batch recording, while product level traceability would not have been achievable without digital technology. Predictive maintenance could be achieved, but only via periodic monitoring of devices. Digitalisation brings with it a host of valuable new functions which make use of the data that probably already existed on a production line but was stranded in disparate systems. At its most simplistic, digitalisation is about integrating devices to gain information that helps to rectify problems. The potential goes much further, and the benefits of digitising will be widespread, right across an enterprise. Visualisation can give greater insight into the productivity and efficiencies within an entire manufacturing plant.

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BARRIERS TO ADOPTION Operational technology (OT) was traditionally designed around the need for machine optimisation, employing architectures and networks that provide optimal performance for machines. Because the success of any digitalisation project relies on the amalgamation of IT and OT, there has been a need for OT to evolve to allow for its seamless integration with the wider world. As a result, modern machine control solutions now incorporate IT functionality.

" Data is opening up horizons for many manufacturers as they start to understand what it can achieve" Omron’s Sysmac controller includes direct SQL database connectivity and can be provided with OPC-UA, as well as MQTT. These provide solutions to achieve a simple and seamless method of escalating

operational information from machine level to the IT environment and vice versa. Middleware solutions are also available and can act as a gateway to connect legacy devices to the IT world, where necessary.

DATA HANDLING SOLUTIONS On-premises servers can offer a good data handling solution for applications that need fast access to data. When it comes to connecting the OT environment to the rest of the world, security is often a concern. However, if the intention is to analyse and

INDUSTRY TALK

Did you know? It is possible to work with the same data in more than one place, first using it at the edge for real-time processing requirements and then escalating it for post-processing purposes. This is possible because data is time-stamped, so it can be referenced and synchronised in different applications.

store data in an on-premises IT server, security should already be provided by the factory firewall or existing security infrastructure. Because any connection point may be a potential security threat, some security measures should always be considered. Omron has addressed this issue through the use of trusted certificates – a recognised IT security measure. The trusted certification is unique to the OT device on which it resides and can be easily identified by the IT server. The downside of on-premises servers is that they are not able to store infinite amounts of data. If an application requires huge amounts of data to be processed, a better solution would be to use a cloudbased server. This will, however, require more stringent security considerations. The cloud can provide a scalable data storage solution that is not limited by capacity and requires no architecture changes if the storage solution needs to be updated. The downside of cloud-based servers is that they cannot provide a real-time

connection. There will always be some latency when it comes to processing and reacting to data. When it comes to data storage platforms, different solutions offer benefits in various applications. Tasks such as production visualisation lend themselves well to the use of on-premises servers because less data need to be stored, and less data processing is required. Predictive maintenance requires huge amounts of data and processing power, so it lends itself to the cloud to churn the data to get meaningful outcomes. Manufacturing traceability probably also lends itself best to the cloud as it requires vast amounts of information to be stored. Likewise, product quality improvement projects are also suited to the cloud as realtime access is not required.

MOVING TO THE EDGE Operators are also seeing the benefit of processing data at the edge – close to the device itself – making it possible to gain realtime operational benefits. Once again, using the example of Omron’s Sysmac controller, an integral artificial intelligence (AI) engine allows data to be analysed in real-time, allowing for fast reactions to the information at the point of its creation. This enables real-time predictive analysis. However, the limitation of edge technology is that it cannot handle large amounts of data.

The best data management approach is often a hybrid solution, which allows OT and IT environments to maximise the use of data created and that sees data processed at the edge and then escalated for storage with further analysis in on-premises or cloud-based servers to gain the most benefit. For added data security, it is also helpful to employ controllers that can spool data. In the event of a connection or data corruption issue, there will always be a backup – a particularly important consideration in FMCG sectors where compliance and product traceability are such a high priority. For most manufacturers, the on-premises server solution will offer the best first step on the digitalisation ladder, as it is usually the easiest function to achieve. Indeed, many manufacturers will already have some degree of IT infrastructure installed on the factory floor, so placing data on the premises gives easy access to data. It is also possible to achieve such a solution more cost-effectively if you already have a controller that has the capability to escalate data. Once there, it can be analysed using a range of low-cost software solutions.

DON’T JUST STORE DATA – USE IT Data is opening up horizons for many manufacturers as they start to understand what it can achieve and what traditional processing issues can now be solved. When it comes to storage and processing options, there are a variety of platforms available – edge, on-premises or cloud-based servers – to suit the needs of all applications. However, bear in mind that storing data for the sake of it is a costly exercise, so make sure that you use the data and do not let the data use you! For engineers, it is reassuring to know that digitalisation does not require a fundamental shift in the method of manufacturing – its purpose is simply to gather and handle data. Engineers should consider digitalisation as another tool that can give them greater insight into their processes to help improve efficiencies. • Omron – www.industrial.omron.co.za

WWW.PHARMACOS.CO.ZA // SEPTEMBER 2021

PHARMA FOCUS: TABLET COATING & EQUIPMENT

Sports nutrition solutions for winning teams

Gelita is taking part in the Vitafoods Europe exhibition from 5 to 7 October. This year’s show will be showcasing exhibitors from across four industry sectors, including ingredients and raw materials, branded and finished products, contract manufacturing and private label, and services and equipment.

GLOBAL EXPERT IN GELATINE, COLLAGEN PEPTIDES AND COLLAGEN

uring the event, Gelita will present solutions to strengthen sports teams. Attendees to the exhibition are encouraged to challenge Gelita’s experts, either on site or within the virtual event, about the specific advantages of Bioactive Collagen Peptides. To deliver performance benefits at the right time and in the right place, the Gelita controlled release portfolio comes into play. Specific gelatines allow softgels to release their fill either immediately in the stomach or enterically in the intestine – depending on a product’s “game plan”.

Gelita is a leader in manufacturing and marketing collagen proteins. Coordinated from its headquarters in Eberbach, Germany, the company provides customers around the world with products of the highest standard coupled with comprehensive technical expertise and sophisticated solutions. Gelita’s more than 20 sites and its global expert network ensure that state-of-the-art know-how is always available to customers. This is supported by the company’s experience in the field of collagen proteins which spans more than 135 years.

NOVEL COLLAGEN PEPTIDES Collagen continues to be highly sought after for sports nutrition formulations. Gelita’s Bioactive Collagen Peptides promise to help keep players healthy by addressing condition-specific needs. These collagen peptides are clinically substantiated for: • keeping ligaments and tendons healthy and flexible (Tendoforte) • supporting joint health and mobility (Fortigel) • improving bone mass density and supporting bone stability and flexibility (Fortibone) • body toning and muscle strength (Bodybalance).

IMMUNE SYSTEM SUPPORT Gelita recently added Immupept to its portfolio. This was subsequent to the

Did you know? Gelita Health offers finished product, shelf-ready solutions. All product development is based on bioactive collagen peptides. Customers are provided with individually-developed products under their own private label or under a Gelita Health label. They can choose their favourite application format, whether it’s a powder, liquid, gummy or even a bar format.

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discovery that collagen peptides support the immune system. The bioactive collagen peptides in Immupept optimally stimulate the collagen-rich tissues, which play a supporting role in the immune system. Immupept is also supported by productspecific immune-modulatory data. The Bioactive Collagen Peptides in Immupept are selected based on their strongest potential in benefiting collagen-rich tissues that are recognised for their role in supporting a wellfunctioning immune system, such as the skin, extracellular matrix and bone marrow. Product-specific trials also show Immupept’s potential for immunemodulatory effects.

Within its range of collagen proteins, the company supplies collagen peptides with proven body-stimulating capabilities, tailor-made gelatines and nonor partly-water soluble collagens. This holistic range of products, in combination with its vast experience in developing solutions for different applications, makes Gelita a first choice for customers. CONTROLLED FILL RELEASE Softgels are a preferred delivery format for many nutrients and active ingredients. With the right type of gelatine from Gelita’s controlled release portfolio, manufacturers are equipped to meet the current and future needs of consumer as well as regulatory requirements. When there is a demand for fast or delayed release, or long shelf life, Gelita RXL R², Gelita EC and Gelita RXL offer an ideal solution. • Gelita – www.gelita.com

PHARMA FOCUS: TABLET COATING & EQUIPMENT

Coating technology improvements deliver outstanding value for money

The coating process should produce smooth, uniform and taste-masked tablets, capsules, or pellets with a defined degree of solubility. In a manufacturing environment, these results need to be reproducible and the process time short. These results are achievable with Glatt’s GC Smart tablet coating series, which was recently improved.

he drum coating method is truly classic and often used in the production of solid materials. As an absolutely indispensable production process, it represents the procedure of choice for coatings containing sugar, those with aqueous and organic solvents, and coatings with a delayed release. About 40 years ago, Glatt developed the very first drum coater with a fully perforated drum. Now, its experts have revised the proven GC Smart with various finely tuned adjustments to further increase coating speed and productivity. The air guidance system and handling have been improved considerably in response to pharmaceutical industry demands for quick and reproducible processes, allowing manufacturers to achieve a coating time of just one hour from charging to coating and discharging.

EXCELLENT TECHNICAL IMPROVEMENTS Glatt’s developers invested heavily in completely overhauling the coater’s air guidance system (inlet and exhaust air). One of the goals was to simplify cleaning and inspection by removing the need for time-consuming processes, such as integrating an exhaust air chamber in the coater housing. The distance between the spray arm and the tablet bed can be varied, and the angles of the spray arm itself can be manually adjusted across five axes based on the degree of charging, so the spray nozzles are always positioned at exactly the right distance from the tablet bed. The degree of charging can be varied between 100% and 10%. A guide plate can also be used for filling volumes of less than 30% to ensure that the air guidance and the filling level are perfectly matched.

Sophisticated coating is achieved with the unique Glatt spray nozzles

The discharge channel is another new feature. It is now firmly integrated in the housing, ensuring tablets are transported to the collection hopper both quickly and gently. These features demonstrate the immense work of developers to improve a whole range of aspects on the coater, making it possible to significantly reduce processing times even further. • Glatt – www.glatt.com

THE FASTEST TABLET COATING TECHNOLOGY IN THE WORLD

WWW.PHARMACOS.CO.ZA // SEPTEMBER 2021

PHARMA FOCUS: TABLET COATING & EQUIPMENT

Technological advancements in tablet coatings Applied to various oral dosage forms such as particles, powders, granules, crystals, pellets and tablets, coatings have advanced from an art of earlier years to technologically advanced and controlled processes centred around compliance and good manufacturing practices. Lonsdale O’Donovan of Quantum Colours explores the evolution of tablet coatings.

raditionally, tablets were sugarcoated. Yet sugar coating is a long and tedious process of building layer upon layer, followed by polishing, with some variable results in certain cases. The advantage of this process is the fact that the equipment is simple and inexpensive and yields an attractive appearance.

REASONS WHY TABLETS ARE COATED:

1. A tablet coating gives brand recognition to a tablet by adding colour. 2. A coating can mask an unpleasant taste or smell, such as that of a B-complex tablet, which can be masked with a flavoured coating. 3. A coating acts as a moisture barrier, protecting active ingredients against oxidisation. 4. Coatings protect the core against light. 5. They can be used to separate incompatible materials. 6. A coating is used to hide discolouration of the core over time. 7. By using polymers that are pH specific, a coating can modify drug release. 8. A coating adds structural strength to the core and can increase the hardness of the core by about 60N.

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Did you know? Research and Markets projects the value of the tablet coatings market will reach $969m by 2025 rising from $739m in 2020, at a CAGR of 5.6% during the forecast period. Based on end users, the market is segmented into the pharmaceutical and nutraceutical industries with the latter projected to witness the highest growth during the forecast period. The rising demand for nutraceutical products to prevent the occurrence of lifestyleassociated diseases is supporting the growth of this segment.

Subsequent to sugar coating, film coating became the preferred way of coating tablets. This involved solvents (alcohol or methylene chloride) used with solids. The process was easy but posed a flammable hazard and the equipment had to be flame-proof. Finished tablets also had an undesirable solvent or

" The incorrect selection of an enteric coating can account for an 80% loss in availability of calcium and magnesium"

chemical-like smell. In most instances the solvent process was replaced with aqueous-based film coating, which is more challenging to use as the coating has to be applied to tablets without wetting and affecting their integrity.

SELECTING THE RIGHT COATING Depending on its required functionality – be it moisture, taste barrier, controlled sustained release or enteric – a film coating is generally based on a powder blend of different low viscosity, film-forming polymers (PVA) or cellulose (HPMC), plasticisers, pigments, fillers and flow agents etc. This powder base is then mixed with reverse osmosis water or a solvent base, depending on the physical properties of the tablet. It is critical that the correct type of coating is selected. Solvents are used when rapid drying is required, especially when hygroscopic material is used in the tablet core like some calcium/magnesium (Ca/Mg) preparations. For a Ca/Mg preparation that absorbs moisture from the atmosphere, one should not select an enteric coating as this will compromise the absorptivity as the calcium and magnesium needs to be exposed to the acidic medium of the stomach in

PHARMA FOCUS: TABLET COATING & EQUIPMENT

"...it’s critical to obtain the recommended weight gain on the cores to achieve the desired efficacy of the functional coating" order to activate the minerals to become more bioavailable. The incorrect selection of an enteric coating can account for an 80% loss in availability of calcium and magnesium and should not be the first choice.

POLYMER-BASED COATINGS Film coatings based on high molecular weight polymers are safe to use as these cannot be absorbed into tissue. They have no physical action at the recommended dosage and are non-toxic. Polymer-based coatings yield a smooth, glossy finish on tablets which is easy to swallow and compatible with most active ingredients. Enteric coatings can be based on methacrylic acid copolymers type A, B and C, which are pH specific. The delivery systems can be specific to the jejunum (pH 6.0), colon (pH7.0) and duodenum (pH5.5). Enteric preparations can be used for targeted-specific drug delivery, or to protect the active ingredients in the tablet against the acid medium of the stomach. HPMC-based coatings yield a matte finish and are not as smooth as polymerbased coatings, though HPMC-based coatings give good moisture protection.

THE COATING PROCESS Because the coating process has many variables, everything needs to be controlled and correctly done in order to obtain the desired result of an aesthetically pleasing tablet to the functionality of the actual coating. Some critical parameters begin with the integrity of the raw materials used to manufacture the cores through to the manufacturing process of the tablets and on to the processing and coating of the tablets. Remember, it’s critical to obtain the recommended weight gain on the cores to achieve the desired efficacy of the functional coating. To identify and resolve defects associated with the coating process, readers are invited to request a complimentary trouble-shooting guide poster from Quantum Colours, by sending an email to sales2@quantumcolours.com. This detailed poster covers issues such as orange peel, film peeling, picking, twinning, film cracking, logo erosion, film chipping, colour variation, logo bridging and logo infilling. •

Quantum Colours – www.quantumcolours.com

WWW.PHARMACOS.CO.ZA // SEPTEMBER 2021

PHARMA FOCUS: TABLET COATING & EQUIPMENT

Smart coating technology that

automatically adapts to batch ratio

The TP R Optima perforated coating pan provides fully automatic adjustment of all parameters during the coating process for an impressive batch size range from 10% to 100% filling volume with one and the same drum. Jordi Carrera, sales director of Romaco Tecpharm, explores the process optimisation benefits and flexibility of this new tablet coater.

oatings are applied to tablets for different purposes. Amongst other things, they make tablets easier to swallow; protect them from light, air and moisture; or mask an unpleasant taste when they are taken. Film coatings are additionally used to control the release of the active ingredient in the human body. When it comes to the application, pharma manufacturers have their sights set on two main goals. First is maximum batch size variability as a condition of responding quickly and flexibly to changing customer requirements and market trends. As much automation as possible is the second goal to ensure consistently high product quality coupled with shorter processing times. Previous generations of tablet coaters were only able to offer variable batch sizes by exchanging the drum – a timeconsuming task. Subsequently, larger batch size ranges have become possible with a single drum. Having said that, quite a few technologies require manual intervention to achieve good results. The GMP-compliant in-wall design of the TP R Optima tablet coater provides for a strict separation between technical and production area.

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CONTINUOUS MONITORING OF PARAMETERS The newly developed TP R Optima coater enables tablet coatings of all kinds to be produced in a fully automated process for a wide range of batch sizes. The machine operator can access the formulation with the predefined process parameters via the HMI, which then runs automatically. This eliminates the need for parameters such as the spray distance and angle or exhaust air flows having to be adjusted (or re-adjusted) manually.

"The coating suspension is accurately applied to the product for any batch volume between 10% and 100%" All parameters are monitored continuously during the coating process. The system automatically adapts them to the formulation, which means the operator is no longer required to be present throughout the coating process, freeing them up to attend to other tasks.

Automatic extendable spray arm with selfadjusting movable spray nozzles allows for variable batch sizes from 10% to 100%.

This highly automated coater delivers absolutely reproducible results. Optimal process control is guaranteed, because all manual intervention during the coating process is eliminated. For example, sampling can take place directly without having to stop coating and open the machine.

INTELLIGENT SONAR SYSTEM The key to the TP R Optima tablet coater’s ability to automatically adjust the parameters during the coating process lies in a sonar. Acoustic wave sensors continuously measure the complete tablet bed and use the data to determine batch volume. The tablet bed inclination, which varies according to the turning speed of the drum, is measured in the same way. Therefore, the new perforated coating pan from Romaco Tecpharm allows for the ultra-precise application of the spray liquids over the entire batch size range from 10% to 100%. This is achieved as a result of the interaction between the sonar’s real-time data and a newly developed nozzle arm with a three-point extension mechanism, which automatically adjusts the spray angle and distance without interrupting the coating

PHARMA FOCUS: TABLET COATING & EQUIPMENT

Peripherical systems of the TP R Optima tablet coater for inlet and exhaust air as well as for cleaning.

Blocked spray nozzles are automatically detected and cleared on the spot.

process. The long reach of the nozzle arm ensures that the suspension is applied to the tablets exactly as per the formulation, even with very small batch sizes.

SHORTER PROCESSING TIMES Drying is a particularly important step in the tablet coating process, which begins while the spray liquid suspension is being applied. The inlet and exhaust air temperature and flow rate are crucial to the efficiency of the spraying and drying processes, as is correct air flow behaviour in relation to the batch size. Near loss-free application of the suspension and rapid drying will otherwise be impossible. It is also extremely important to adjust the drying air to prevent the product in the coater from becoming too moist, causing individual tablets to stick together. The TP R Optima tablet coater uses a bypass to adjust the supply of process air. The vacuum that is created inside the drum can be varied according to the batch size; it stabilises the air flow and diverts the air towards the automatic air exhaust flaps. These flaps can be opened individually and continuously in a controlled manner, so that the process air is directly guided through the product. The coater’s high spraying and drying efficiency is reflected in the short processing times – generally between one and three hours depending on the product – as well as the reduced energy usage. With the precise control of the air flow inside the drum, the coating suspension is accurately applied to the product for any batch volume between 10% and 100%. In other words, the system prevents the liquid from simply running over the tablets or from being

Did you know? Romaco Tecpharm’s TP R Optima spray arm and its three-point extension mechanism are patented.

discharged without being applied. Together with the high spray accuracy, this results in a significantly lower consumption of the coating suspension and a material saving of up to 60% compared to other coating methods, depending on the application.

CLEARING CLOGGED SPRAY NOZZLES The newly developed coating technology includes a system for automatically detecting and clearing clogged spray nozzles. The risk of such blockages occurring is actually very low in practice, but it increases as the suspension’s viscosity increases. Directly downstream of the peristaltic pump, the newly developed coating pan has a load cell that measures the amount of spray liquid being pumped. If the load cell registers that liquid is no longer exiting from one of the nozzles, the coater initially attempts to unclog that particular nozzle by building up maximum pressure. If this is not possible, an individually configurable mechanism takes over – depending on the product being processed, either the coating process continues and the system simply issues an alert, or the process is immediately interrupted. In this way, the coating pan’s response to nozzle blockages can be fine-tuned to the product in question.

GMP-COMPLIANT IN-WALL DESIGN The TP R Optima tablet coater was designed in conformity with the standards of Good Manufacturing Practices (GMP). All productcontacted parts on the inside of the coater are readily accessible and easy to clean using wash-

in-place (WIP) procedures, so that cleaning validation is totally straightforward. There are no dead spaces where product residues could accumulate, leading to crosscontamination. The design of the spray arm particularly rules out such critical spaces due to its extendable and retractable mechanism. Furthermore, the tablet coater’s in-wall design enables strict separation between the ‘grey area’ and the production area in the cleanroom. If servicing is required, the technician can carry out the necessary work without having to enter the cleanroom, eliminating the need to decontaminate the area after servicing. What is more, is the batch being processed does not necessarily need to be disposed of following a service assignment in the ‘grey area’ and can be processed further once the work is completed.

NEXT-LEVEL PROCESSING AUTOMATION Romaco Tecpharm’s new perforated coating pan combines very high flexibility with premium product quality and a previously unattainable level of automation in tablet coating. Nevertheless, the system still allows individual parameters to be adjusted manually, if required. The TP R Optima tablet coater, which is available in seven different sizes and sourced through Romaco’s local agent PMD Packaging, is equally suited for product development with laboratory-scale batch sizes and for scale-ups to larger production volumes. The machine is also ideal for suppliers producing under contract which need to run a wide range of batch sizes on one line and often face ‘last-batch challenges’, especially during campaign manufacturing. • PMD Packaging – pmdpackaging.co.za Romaco Tecpharm – www.romaco.com

WWW.PHARMACOS.CO.ZA // SEPTEMBER 2021

PHARMA FOCUS: TABLET COATING & EQUIPMENT

The impact of Kollicoat Smartseal formulation concepts on taste-masking functionality Taste is a crucial factor that determines the palatability of oral solid dosage forms. Using tastemasking techniques, pharmaceutical manufacturers may not only improve the taste of bitter pills but also patient compliance. In this article, a team of experts from BASF and GEA Process Engineering investigate the impact of three different Kollicoat Smartseal formulation concepts on taste-masking functionality. By Ivan Bogaerts, Leslie van Eeckhout and Frederik Detobel of GEA Process Engineering, and Andrea Beck, Florian Bang and Nils Rottmann of BASF

aste-masking is used to overcome the bitter or unpleasant taste of an active pharmaceutical ingredient (API), leading to improved patient compliance and product acceptability. Different techniques are available to obtain taste-masking functionality. An effective method is to cover the surface of the individual oral solid dosage form with a functional film coat. This separates components with an unfavourable taste from the patient’s tongue, thereby avoiding an unpleasant taste sensation. BASF’s cationic polymer Kollicoat Smartseal is designed for taste-masking applications. It is insoluble in water at neutral or basic pH values to ensure effective taste-masking in the saliva. At pH values below 5.5 (e.g. in the patient’s stomach) it dissolves readily, allowing for the immediate release of the API.1 To investigate the impact of Kollicoat Smartseal-based film coatings on tastemasking functionality, three distinctly different formulation strategies were included in a study. The three formulations contained the following: 1. Kollicoat Smartseal 30 D (aqueous dispersion) 2. Kollicoat Smartseal 100 P (spray-dried powder-grade, redispersed in water)

3. an organic solution of Kollicoat Smartseal 100 P. A GEA ConsiGma coater was used for all three coating strategies.

MATERIALS AND METHODS The tablets used for the coating trials were composed of 74% Ludipress LCE (co-processed lactose and povidone), 5% Kollidon CL-F (crospovidone, type B), 5% Kollidon VA 64 (copovidone) (all BASF products), 15.5% caffeine anhydrous 0.2 to 0.5 (Siegfried) and 0.5% magnesium stearate (Baerlocher). A taste-masking functionality was to be delivered by different grades of Kollicoat Smartseal: • Kollicoat Smartseal 30 D is a low viscous aqueous dispersion of a methyl methacrylate (MMA) and diethylaminoethyl methacrylate (DEAEMA) copolymer (see Figure 1) • Kollicoat Smartseal 100 P represents a spray-dried powder-grade of the polymer. The slightly alkaline, milky white dispersion of Kollicoat Smartseal 30 D was directly formulated with additional excipients (see Table 1) and applied onto the caffeine tablets. In contrast, the powder-grade Kollicoat Smartseal

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Figure 1: Structure of Kollicoat Smartseal (MMA and DEAEMA copolymer)

"BASF’s cationic polymer Kollicoat Smartseal is designed for tastemasking applications" 100 P had to be redispersed in water, by adding an organic acid (e.g. succinic acid) before use. All aqueous formulations required a plasticiser to reduce the minimum filmforming temperature (MFFT) of the polymer (~57°C) and to decrease the brittleness of the film formed. When selecting a plasticiser, it is important to consider that

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PHARMA FOCUS: TABLET COATING & EQUIPMENT

Table 1: Composition of different coating formulations

Ingredient

Quantity (%)

Kollicoat Smartseal 30 D

Kollicoat Smartseal 100 P Succinic Acid

57.8

42.0

10.0

6.3

14.3

57.8 12.4

0.3

Ponceau 4R HC 70% E124

0.4

Buthylene Hydroxy Toluene (BHT) 4 Tributyl O-Acetylcitrate (ATBC)5

2.3

Talc6

0.4

0.3

0.2 0.2

1.6

2.3

0.8

5.0

2.1

2.5

Aceton7

45.0

2.1

Isopropanol

45.0

2.1

Water 1

39.5

50.7

80.0

39.6

BASF SE, 2 Bernd Kraft, 3 Fiorio Colori, 4 Lanxess, 5 Jungbuzler, 6 Sigma Aldrich, 7 VWR Chemicals

Figure 2: Design of the ConsiGma coater, which was used in this case study

some options, such as citric acid esters, are prone to hydrolysis in alkaline aqueous environments and may cause the formation of free acid, counteracting the functionality of the cationic polymer. 2 In view of this and due to its wide acceptance in the pharma industry, tributyl O-acetylcitrate (ATBC) was selected as the plasticiser for this case study.

The lipophilic antioxidant butylated hydroxytoluene (BHT) was used to stabilise the amino ester moiety of the polymer and to avoid potential yellowing of the film on the tablets. Further excipients such as anti-tacking agents (talc) or colourants (Ponceau 4R HC) were used as listed in Table 1. Organic solutions of Kollicoat Smartseal 100 P were prepared with an acetone-isopropanol mixture (1:1). As the film-forming mechanism of a polymer dispersed in water and the filmforming mechanism of dissolved polymer are fundamentally different, the need for a plasticiser and other additives had to be tested. Organic Kollicoat Smartseal solutions were tested with the formulations (F5 to F7). All seven formulations were applied with a solid matter content (SMC) of 20%. The aqueous formulations were additionally coated with a SMC of 30%. The respective film-coating formulations were coated onto the 9mm, round, biconvex tablets in a GEA ConsiGma coater

(see Figure 2), which can be an integral part of a continuous manufacturing line or used as a standalone system as in this case study. Three kilograms of uncoated tablets were fed into the fully-perforated coating wheel. Due to centrifugal forces at a wheel speed of 115rpm, the tablets were moved towards the wall of the wheel. Two ‘air knifes’ situated outside the perforated wheel caused a cascade in which the tablets were moved into a state of free fall. The coating formulations were applied within the cascade using a spray nozzle positioned in the centre of the wheel, spraying upwards into the cascade. Due to the unique concept of the ConsiGma coater, the tablets were coated during the free fall phase, allowing the coating liquids to be distributed evenly over the complete surface around the individual tablets. This allowed for a remarkably uniform tablet coating to be achieved, even at the critical edges of the tablet cores. Several spray rates between 45g/minute and 120g/minute were applied, at inlet air temperatures ranging between 45°C and 70°C and at inlet air volumes of between 200m³/hour and 250m³/hour. Samples of the caffeine tablets were taken at 1mg/ cm², 2mg/cm², 3mg/cm², 4mg/cm², 5mg/ cm², 6mg/cm², 7mg/cm² and 8 mg/cm² coating level. A standard USP dissolution apparatus 2 (paddle) from Erweka, equipped with continuous on-line UV measuring (Agilent 8453), was used for the dissolution testing. Since taste-masking functionality is to be delivered in the saliva of the oral cavity, a phosphate buffer (pH 6.8) was used as dissolution media (700mL ±1%, 37°C ±0.5 K, n=3). Hereby, the criterion

WWW.PHARMACOS.CO.ZA // SEPTEMBER 2021

PHARMA FOCUS: TABLET COATING & EQUIPMENT

Figure 3: The amount of drug released after 30 minutes in the phosphate buffer (pH 6.8), depending on formulation concept and coating level: • Kollicoat Smartseal 30 D (F2) • redispersed aqueous Kollicoat Smartseal 100 P (F3) • an organic Kollicoat Smartseal formulation (F5) (mean value [n=3])

In contrast, a redispersed Kollicoat Smartseal 100 P formulation (such as F3) required a distinctively higher coating level to meet the same criterion. This effect was expected, as Kollicoat Smartseal 100 P needs to be partially neutralised to be redispersed. Succinic acid used for the partial neutralisation slightly increased the hydrophilicity respective solubility of the cationic polymer due to salt formation with the cationic polymer. Organic solutions of Kollicoat Smartseal 100 P provided tastemasking functionality at a coating level of less than 3mg/cm², outperforming both the other formulation concepts. This may be the preferred formulation concept for moisture sensitive APIs. Both aqueous formulations were sprayed with 20% and 30% SMC, enabling the collation of the two formulation approaches at different SMCs. A difference in functionality between 20% and 30% SMC was hardly seen within each aqueous formulation concept (see Figure 4 and Figure 5). Consistently, the process could be further optimised by selecting higher SMCs.

Figure 4: Dissolution profiles of tablets, bearing a Kollicoat Smartseal 30 D (F2) film coat, applied with: a) 20% SMC b) 30% SMC (mean value [n=3], ± abs. SD)

Figure 6: Dissolution profiles of tablets coated with an organic Kollicoat Smartseal 100 P solution: a) without plasticiser (F5) b) with plasticiser (F7) (mean value [n=3], ± SD)

for a functional coat was that no drug release was detected for a period of >30 minutes. HCl buffer (pH 1.1) was used to test the immediate release character of the taste-masked tablets (700mL ±1%, 37°C ±0.5 K, n=3).

When comparing the dissolution profiles of organic formulations, coated with and without a plasticiser, no differences could be seen (see Figure 6). Though potential differences may occur during stability tests of the respective formulations, which were not included in this case study.

RESULTS AND DISCUSSION

CONCLUSION

Both the aqueous and organic-based Kollicoat Smartseal formulations could be processed without problems in the ConsiGma coater. In a setup with just a single spray nozzle, process cycles of less than 10 minutes were achieved for the coating of a 3kg batch with up to 8mg/cm² coating level. Such exceptionally short coating process cycles that don’t compromise on coating quality are a prerequisite in continuous manufacturing installations. All formulations tested were able to deliver taste-masking functionality as per the predefined criterion of >30 minutes coating stability in phosphate buffer (pH 6.8). However, differences in performance were seen among the three formulation concepts, particularly with respect to the amount of coating required. A Kollicoat Smartseal 30 D-based formulation (such as F2) required a coating level of about 4mg/cm² to deliver full taste-masking functionality over more than 30 minutes (see Figure 3).

Organic solutions of Kollicoat Smartseal 100 P showed the full tastemasking performance at a coating level of less than 3mg/cm². Hence organic coating formulations can be recommended if a minimum coating level is desired, without compromising on taste-masking performance. Where organic coating is not an option, due to safety or equipment constraints, the aqueous dispersion Kollicoat Smartseal 30 D offers an appropriate alternative, delivering the same functionality at a slightly higher coating level. Partially neutralised, redispersed Kollicoat Smartseal 100 P needs a markedly higher coating level to deliver the same taste-masking performance when compared with the dispersion or organic solution. Depending on the required delay of release in the saliva and on the amount of applied coating, the aqueous formulations of the powder-grade may still be considered. An influence of the SMC on the taste-masking functionality was not seen. SMCs of 30% can be applied to allow for the most economic processing method. • REFERENCES: 1. Kolter, K.; Guth, F.; Angel, M.; Physicochemical characteristics of a new aqueous polymer; AAPS Annual Meeting and Exposition, November 14 – 18, 2010, New Orleans, Louisiana, USA.

Figure 5: Dissolution profiles of tablets, bearing a Kollicoat Smartseal 100 P (F3) film coat, applied with: a) 20% SMC b) 30% SMC (mean value [n=3], ± SD)

SEPTEMBER 2021 // WWW.PHARMACOS.CO.ZA

2. Bang, F.; Broicher, C.; Cech, T.; Haberecht, M.; Rillmann, T.; Evaluating the different characteristics of plasticisers used in cationic polymer-based film-coating applications; 3rd Conference on Innovation in Drug Delivery, September 22-25, 2013, Pisa, Italy.

BASF – www.basf.com GEA Process Engineering – www.gea.com

PACKAGING: SERIALISE, TRACK & TRACE

Serialisation: what cosmetics can learn from pharmaceuticals

Chanel No. 5 and Cool Water by Davidoff are among the top-selling fragrances. This popularity also puts them at the top of the list of products most counterfeited. If cosmetics companies want to avoid economic disadvantages and loss of reputation in times of globalisation and growing online trade, they must act now. Solutions already exist within the pharma industry which could be advantageous to cosmetics.

ood counterfeits of cosmetics no longer stand out based on insufficient imprints on inadequate packaging or as cheap copies. And with e-commerce clearly competing with brick-and-mortar stores, product piracy is becoming an increasingly lucrative business. VKE-Cosmetics, Germany’s association of cosmetics producers, has demanded that certain consumer protection measures be implemented on internet trading platforms and that traffic safety obligations be introduced.1 If this becomes official and corporations want to better protect their brands, safety standards will have to improve.

LEARNING FROM PHARMA Since clever drug counterfeiters have proven that encodings and holograms are conditionally forgery-proof, the cosmetics industry needs to follow suit. The fake mafia has shown that they can imitate everything from security codes that are invisible to the naked eye to micromarkings. These imitations are so good that it is no longer possible to expose false codes using smartphones and apps. The same applies to laser-gloss technology, a laminated reusable special film that makes markings safer.

Did you know? Serialisation stands for safety – at every point in the manufacturing and distribution chain – regardless of package contents, product sizes and batches.

Luckily, the high-volume cosmetics industry has a trump card – the new serialisation policy for pharmaceuticals, which became mandatory at the beginning of 2021. Cosmetics industry players need only glance over and adapt pharma serialisation technologies for the production of their products.

BRAND PROTECTION If cosmetics companies pay too little attention to the issue of product piracy, it can be costly. The associated risks include reputational damage and concomitant loss of sales. These consequences can be far more expensive than an equipment upgrade to include serialisation solutions. Technically, it makes little difference whether a serialisation solution is aimed at protecting a biologic packaged in a forgery-proof vial or a fragrance in a glass bottle. The follow-up and solutions are what counts. For beauty giants this means enhanced brand protection and security for their brands

and their customers, because every single product that comes off the production line can be identified beyond doubt. Retailers, both online and brick-and-mortar stores, are already familiar with the place and date of manufacture of skin creams and hair products. The next logical step is serialised beauty products.

A NEED FOR INNOVATIVE CONSUMER PROTECTION Fake cosmetics pose serious health risks, especially since it is not only a bad scent that lingers when counterfeits enter legitimate supply chains. For example, if a sunscreen claiming SPF50 does not deliver on its promise, consumers are likely to become sunburnt and could suffer a skin irritation resulting in them losing confidence in the legitimate brand. In view of increasing globalisation and the growing customisation of products to different target markets, solid serialisation measures and their communication with the end user create trust. This makes counterfeiting of cosmetics obsolete, as the business model is no longer lucrative. Wipotec, represented locally by USS Pactech, has years of expertise in developing serialisation solutions for pharmaceutical products. It is irrelevant whether these are very small batches or large units and what material is used for primary and secondary packaging. Serialisation secures the valuable products – from the formulation of creams and perfumes to retail shelves of brick-and-mortar stores or the storage location of the online retailer. Solutions from Wipotec represent a very meaningful investment in the future, in which experts predict not only more acceleration and increased online commerce, but also further growth of the cosmetics industry. •

REFERENCE: 1. www.presseportal.de/pm/42679/3918882

Serialisation technology from Wipotec offers enhanced brand protection and security for beauty brands and consumers, because every product that comes off the production line can be identified

USS Pactech – www.usspactech.co.za Wipotec – www.wipotec-ocs.com/en

WWW.PHARMACOS.CO.ZA // SEPTEMBER 2021

PACKAGING: SERIALISE, TRACK & TRACE

Vision systems for a safer supply chain With the use of machine vision technology, manufacturers, regulators and consumers can ensure that counterfeit pharmaceutical products and medical devices are identified and removed from the supply chain before they cause any harm. TracePack offers customised, innovative solutions for every application.

ccording to the World Health Organization, 5% to 10% of global pharmaceuticals are counterfeit. The number of counterfeit medicines is also increasing by 6% to 8% per year. To fight this problem, regulators around the world are in the process of establishing stricter regulations for pharma manufacturers, co-manufacturers and packers, distributors and retailers to prevent counterfeit drugs from making their way into the hands of consumers. Unfortunately, this effort creates

Barcode inspection technology from TracePack verifies the quality of required elements on packaging, such as logos and date/lot information

significant challenges for drug manufacturers, which require inspection and identification solutions for new products.

AUTOMATED VISION SYSTEMS Life science, biotech, pharmaceutical and medical device manufacturers face regulatory requirements that affect the compliance of their vision and labelling systems. These include FDA 21 CFR Part 11, digital records submitted electronically for regulated FDA filings and Unique Device Identifier (UDI) requirements for device labels and packages. Similar versions of these regulations apply in the US and the EU. TracePack’s vision systems support 21 CFR Part 11-compliance and integrated label management across supply chains required by UDI. Production and distribution of only perfectly identified products at plant level can be achieved with the help of vision systems, allowing counterfeits to be more easily removed. These systems also help validate

Tamper seal inspection on pharmaceutical products

"Unlike manual inspection, machine vision delivers error-free checks on the fastest production lines" the presence, accuracy and readability of various pharma products to safeguard package integrity in all areas of the supply chain. Unlike manual inspection, machine vision delivers error-free checks on the fastest production lines. This ensures that complying with regulations and standards does not impact production levels or cause bottlenecks in the supply chain.

ANTI-COUNTERFEITING PROTECTION A major business driver of pharma and bio-science product manufacturers is the need to cost-effectively comply with patient safety and traceability requirements. Whether inspecting package integrity, tracking serialised products from manufacture to a patient, or checking label accuracy with barcode and text verification, TracePack’s deep learning, vision and barcode-reading solutions add value every step of the way to improve quality, prevent defects, increase yield, boost productivity and achieve compliance. In this regard, overall equipment effectiveness (OEE) improvements are increasingly important. Cognex vision and ID products help with three traditional OEE drivers: • material handling efficiency and flexibility • product quality and yield • package safety and integrity.

BRAND PROTECTION AND COMPLIANCE As compliance with global traceability requirements and transition from batch to item-level serialisation are prepared for, it is important to remember that compliance requires much more than simply reading a code on a label or part. For mass serialisation to support traceability, it is essential to first verify code quality and validate that all the encoded data is accurate and correctly formatted.

SEPTEMBER 2021 // WWW.PHARMACOS.CO.ZA

PACKAGING: SERIALISE, TRACK & TRACE

TracePack’s trademarked track-and-trace solution works with networked In-Sight vision systems to create a complete identification and data verification solution for serialised labels on pharmaceutical packaging.

DIGITAL AND PHYSICAL ENCRYPTION TECHNOLOGY When the origin and authenticity of an item cannot be verified, it can become susceptible to counterfeiting. As a result, manufacturers are turning to item-level serialisation to combat the distribution of falsified, mislabeled and potentially hazardous products. DataMatrix codes allow for detailed information about the manufacturer, product ID, expiration date and a unique serial number to be marked on individual finished goods and packaging. These codes make commonly counterfeited goods traceable and authenticable at multiple stages of handling and the point of sale. By embedding critical product information in codes, companies can take serialisation one step further by using digital and physical encryption. TracePack helps to isolate the source and extent of safety, quality and counterfeiting

A system that reads and detects label errors is ideal for enhacing product security

control problems with authentication technologies that are compatible through all supply chain stages. UV codes can be added without compromising the aesthetics of highend packaging. Track-and-trace solutions from TracePack authenticate and verify products along the supply chain. Image-based barcode readers read codes, even ultra-small codes, quickly and

accurately to maximise throughput. They can capture and store images of no-reads or string validation failures to fight counterfeiting. For UV codes, barcode readers using a UV lighting module and lens filter illuminate and quickly decipher the code using high-performance decoding algorithms. • TracePack – www.tracepack.co.za

Anticounterfeiting protection in the pharmaceutical industry According to the World Health Organization, 5-10% of global pharmaceuticals are counterfeit and the number of counterfeit medicines is increasing by 6% to 8% per year.

PACKAGE SAFETY & INTEGRITY

Production and distribution of only perfectly identified products at the plant level can be achieved by drug manufacturers with the help of vision systems, allowing counterfeits to be more easily removed. It also helps validate the various drug labels’ presence, accuracy, and readability to safeguard package integrity in all areas of the supply chain.

BRAND PROTECTION & COMPLIANCE

PRODUCT QUALITY & YIELD

DIGITAL & PHYSICAL ENCRYPTION REDUCE DIVERSION & COUNTERFEITING

Contact TracePack today: +27 10 020 7221 | sales@tracepack.co.za | www.tracepack.co.za

WWW.PHARMACOS.CO.ZA // SEPTEMBER 2021

PACKAGING: SERIALISE, TRACK & TRACE

The role of serialisation in sustainable development As customers and consumers become increasingly aware of and concerned about climate change and economic and social inequality, they are looking for ways of influencing and effecting change. One of the ways they can achieve this is through their consumption decisions and purchasing actions, writes Glynis Stark of Adept Pharma.

ustomers expect that the products they purchase and consume will have been produced in a way that not only has the lowest impact on the environment, but also positively contributes to its restoration. This expectation extends to improving the lives of the people involved in providing raw materials and ingredients and in manufacturing and distribution of the product. One way of assessing this is through the widely accepted metric of a company’s contribution to the achievement of the United Nation’s 17 Sustainable Development Goals (SDGs). This means that manufacturers of both ingredients and finished products need to not only consider these aspects when making business decisions, but will also need to be able to demonstrate that this is the case. Brand image and history will no longer be enough. This is where serialisation across the product supply chain can assist with developing and maintaining records as well as providing the necessary audit trail in case of queries (about quality or ingredients).

Jekson Vision equipment and systems add value at all five serialisation levels

THE CONFIDENCE FACTOR

UN SDGS APPLICABLE TO MANUFACTURING INDUSTRIES • Goal 5: Gender equality • Goal 8: Decent work and economic growth • Goal 10: Reduced inequality • Goal 11: Sustainable cities and communities • Goal 12: Responsible consumption and production • Goal 13: Climate action • Goal 14: Life below water • Goal 15: Life on land Source: sdgs.un.org/goals

SEPTEMBER 2021 // WWW.PHARMACOS.CO.ZA

Serialisation has the ability to provide consumers with the confidence that producers are in fact doing what they claim to be doing, through the secure, detailed and accurate aggregation of information related to a product’s origin. It has application in the manufacture, packaging and repackaging of: • pharmaceuticals • cosmetics • personal care products • complementary medicines • health products • food • veterinary pharmaceuticals • animal feed. Adept Pharma is a Southern African company providing engineering and

project services to meet serialisation needs in manufacturing industries. In addition, Adept Pharma is the regional representative of Jekson Vision. Jekson Vision, established in 2001 in New Jersey in the US and now with offices in India, Germany, Russia and Singapore, has developed visual inspection equipment and systems which enable serialisation (trackand-trace) systems. The equipment and systems have the advantage of flexibility in that they can be added as the final stage on existing production lines, as well as offering a number of semi-automated and manual handling systems. Jekson Vision operates a 24hour customer care desk to support its customers.

PACKAGING: SERIALISE, TRACK & TRACE

Did you know? ESG refers to environment, social and governance. These non-financial factors are increasingly being applied by customers (and investors) in their decision-making processes.

SECURE, USER-FRIENDLY AND CONFIGURABLE The serialisation systems can also interface with existing production and enterprise management systems at all hierarchy levels, including regulatory authority platforms. Solutions have been developed to interface with several widely-used ERP systems including SAP, Tracelink and rfXcel. Jekson Vision has the capability to develop other bespoke interfaces where necessary. The serialisation system known as Reetrak is compliant with the global GS1 standard and can accept barcodes generated by third-party systems as well as generating its own, depending on the requirement and current system configuration.

Reetrak offers a secure, user-friendly and configurable solution. With Reetrak, manufacturers and brand owners will be optimally equipped to meet current and future market demands with respect to counterfeit protection and production.

FLEXIBLE, MODULAR SOLUTIONS Jekson Vision, through Adept Pharma, offers a variety of serialisation machines that are fully equipped with the advanced Reetrak system. The S120, ST220, Bottle 360, Pallet 200 and ST100 are best-suited to meet the needs of the South African market in terms of their flexibility and modularity which facilitates integration into existing production lines. The S120 is the world’s most compact serialisation machine. Despite its compact size, it can host up to four printing heads and accommodates a huge variety of carton format sizes at very high speeds. The latest version within Jekson Vision’s ST200 series is the ST220.

It is one of the most efficient tamperevident labelling machines on the market, and generates, prints and scans unique serialised numbers at item level. To examine the top, bottom and sides of bottles, Bottle 360 is an ideal inspection system for pharmaceutical bottling lines. Its advanced features include 360° label orientation of barcodes, pharma codes and data matrix decoding as well as highly accurate optical character recognition. For repacking and warehouse operations, Pallet200 is easily moveable and highly effective in meeting scanning, printing and labelling needs at case and pallet level. ST 100 is Jekson Vision’s standalone module for tamper-evident label application and the positive verification of labels applied on cartons. It offers high-accuracy printing and excellent labelling quality, running at up to 250 cartons per minute. • Adept Pharma – glynis@adeptpharma.co.za Jekson Vision – jeksonvision.com

• Engineering and project services • REEVIEW visual inspection equipment for production and packing lines • REETRAK adaptive track and trace serialisation solutions Flexible – REEVIEW can be installed as the final stage on existing production and packing lines Bespoke – REETRAK with custom software interfaces for ERP systems

Contact enquiries@adeptpharma.co.za

WWW.PHARMACOS.CO.ZA // SEPTEMBER 2021

PACKAGING: SERIALISE, TRACK & TRACE

The critical role of data in building trust in SA’s vaccination efforts

As the African country hardest hit by the coronavirus, South Africa has been regrettably slow with its vaccine rollout, with only 12 million of its 59 million citizens having received a vaccine dose at the time of publishing this article. The vaccination of the South African population against SARS-CoV-2 is the most ambitious and far-reaching healthcare initiative in the country’s history and continues to stretch the limits of our healthcare sector writes Mervyn George, executive advisor: strategic engagements at SAP Africa.

uch has been said about the slow pace of vaccine procurement and challenges with convincing parts of the population to vaccinate – thanks in no small part to the extraordinary disinformation campaigns flourishing on social media. However, one somewhat forgotten aspect risks being lost: the importance of data, and the protection thereof, in building trust in the process.

OPTIMAL USAGE AND PROTECTION OF PATIENT DATA Personal health data represents a particular challenge in terms of data security as a failure

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to protect such data could severely harm people and expose them to discrimination. For example, inadvertently sharing sensitive personal health data of a person living with a dread disease could affect their job prospects and livelihoods. A mix-up in personal health data could lead to someone receiving the incorrect diagnosis or, even worse, the wrong treatment. This can be lifethreatening under some circumstances. The Protection of Personal Information Act (POPIA), which was finally implemented in full force in 2020, aims to give citizens greater control over how their personal data is stored, processed and used.

While all businesses that work with private data – including that of organisations and other juristic persons – are affected, it is arguably the healthcare sector that is under most pressure due to the ongoing pandemic and the unprecedented vaccine rollout effort.

WHERE IS MY DATA ANYWAY? The vaccine rollout in particular poses an immense challenge in terms of data security and privacy protection. Any clinic, hospital, private or public healthcare practitioner, medical aid or medicines firm needs to ensure they protect the personal healthcare data processed during the course of business.

PACKAGING: SERIALISE, TRACK & TRACE

MAJOR VACCINE PRODUCERS RUN SAP Today, 18 of the world’s 20 major vaccine producers are already running their production on SAP solutions, which cover their end-to-end processes, from manufacturing and controlled distribution to administration and post-vaccine monitoring. Moderna, which began shipping its COVID-19 vaccine in January, is relying on SAP to help distribute hundreds of millions of vaccine doses. The company is running digital supply chain solutions to help with serialisation and distribution. SAP advanced track and trace for pharmaceuticals is helping Moderna to comply with international legislation intended to prevent counterfeit drugs from reaching patients. The application provides a corporate serialisation repository, serial number management and regulatory reporting capabilities. Similar tools are in use at AstraZeneca, Sanofi, GlaxoSmithKline and Pfizer, all of which are working on COVID-19 vaccines. Here are just a few examples: • Over 90% of global revenue from GSK’s pharmaceutical and vaccine businesses is managed with SAP software, enabling the company to leverage the data it collects and develop insights from that information to improve operations. GSK also uses SAP Ariba to help procure the raw materials that make up its vaccine formulas. • AstraZeneca uses SAP Work Manager to oversee its manufacturing equipment and help managers predict when machines require maintenance. This has resulted in a 6% to 8% increase in worker efficiency, according to Michael Zboray, lead business analyst at AstraZeneca.

While government has taken steps to centralise the scheduling and rollout of vaccinations via its electronic vaccination data system (EVDS) portal and requires that all citizens wishing to be vaccinated register on EVDS. The intention is that, as each population group (over-60s, teachers, healthcare workers, etc.) registers, each person receives communication with the time, date and location of their scheduled vaccination appointment.

"The vaccine rollout in particular poses an immense challenge in terms of data security and privacy protection" However, the system is often unreliable, and many people simply get no confirmation of where they need to go or when. There is also little communication over the status of an application for vaccination. Compounding the problem is that actual vaccination sites are run by a combination of public and private sector organisations, and in many cases are open to walk-ins who may not have received confirmation of their appointments. How is the data of walk-ins, for example, collected, stored, processed and managed? Who is overseeing the full end-to-end process to ensure it is fully POPIA compliant? In the case of manual data entries, how is quality maintained to ensure data integrity? And how is this data secured from the rising tide of cyberattacks besieging South African organisations?

THE ROLE OF TECHNOLOGY Public and private sector healthcare organisations should lean heavily on

• Sanofi, a French drug manufacturer, introduced SAP S/4HANA in 2017 to help standardise and harmonise processes, support the development of standard solutions and improve efficiency.

technology to assist with both the protection of vaccine patient data as well as better supporting the end-to-end vaccination process. A patient experience management tool can give healthcare decision-makers insights into underperforming or misaligned aspects of the vaccination process – for example, insufficient communication around vaccination appointments – and help ensure a seamless process from start to finish. A cloud-based analytics tool can help integrate healthcare data from public and private sector role-players and highlight critical insights that can point to trends, risks, opportunities and areas for improvement while maintaining data integrity throughout. Equipped with accurate and complete data, government and other decision-makers will be able to determine the most effective healthcare response and potentially save lives. In addition, any vaccine rollout strategy should include a comprehensive customer data strategy, which helps to safeguard the longevity of each organisation involved in the vaccination value chain. Such a strategy should include relevant digital platforms that can ease or enable the process of managing patient profiles and help manage access and authorisation to systems that provide selfservice options for activities such as booking vaccination appointments or tests. In terms of POPIA compliance, all organisations should have taken steps by now to ensure they meet the requirements of the Act, especially since the grace period for sanction and fines for non-compliance expired at the end of June. Implementing an effective cloud-based customer relationship management tool enables healthcare providers to have a unified view of each vaccinated patient and gives them the power to limit how that information is used or even delete it (in line with the requirements of POPIA) if needed. Critically, the customer data strategy should provide individuals with the power of consent to subscribe or unsubscribe to correspondence, manage their preferences for ongoing communication, and afford them the right to be forgotten. • Mervyn George SAP – www.sap.com

WWW.PHARMACOS.CO.ZA // SEPTEMBER 2021

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Sustainable technologies for effective cleaning

The Innospec home care line, available in South Africa from AECI Specialty Chemicals, offers a wide selection of surfactants, additives and patented high-performance formulations for everyday cleaning products. Natural as well as synthetic substances can be found in a variety of products, from laundry liquids and pods to powders and multipurpose cleaners.

nnovations from Innospec are used in various applications, with the latest releases being 100% vegetable derived launched in line with the sustainability movement. Epicol LV 840 is a sodium caprylyl sulfate which is vegetable derived, has excellent wetting properties and is stable in high electrolyte systems. It reduces spotting and streaking on dishes and glassware by promoting drainage. Its low foaming properties allow it to be used in automatic dishwashing products and cleaning systems. A green label accompanies this ingredient. The excellent compatibility of Empicol LV 840 with high pH levels and electrolyte levels paired with the foam-boosting properties of Empigen OD ensure excellent overall performance in terms of wetting, detergency, flash foam and foam stability. When packaged with a suitable pump spray nozzle, a multi-surface cleaner formulated with Empicol LV 840 produces a very thick and durable mousse, which also sticks to vertical surfaces.

Viscosisty Profile vs NaCL Added (25°C, Brookfield RVT, Spindle 3, Speed 20-2,5RPM) 3 50 00

V iscosity (cP)

3 00 00 2 50 00 2 00 00 1 50 00 1 00 00 5 00 0 0 0

0 ,25

0 ,5

0 ,75

1 ,25

1 ,5

1 ,75

2 ,25

2 ,5

2 ,75

Table: Major differences between dyes and pigments

Ingredients

% w/w

NaOH

6.90

NaClO

52.63

Nansa PC 38/F Empigen OD Empicol LV 840

2.07 11.40 27

INCI Sodium Hydroxide Sodium Hypochlorite Potassium cocoate Alkyl Dimethylamine Oxide Sodium Caprylyl Sulfate

COCONUT-BASED AMPHOTERIC SURFACTANT Also from Innospec, Empigen BS/H50 C is a coconut-based concentrated amphoteric surfactant that can be used in a wide range of formulations. It is compatible with anionic, non-ionic and cationic surfactants. Empigen BS/H50 C is Ecocert-certified, with a 66% vegetable-derived base. It is also sulfate-free and has foam-enhancing and viscosityboosting properties. This ingredient is suitable for surfaces cleaners, toilet blocks, laundry detergents and laundry pre-treatments. In a standard SLES/CAPB formulation, Empigen BS/ H50 C shows a quicker viscosity response than a fatty acid based-CAPB at 30% and a coconut oil-based concentrated CAPB. See Figure 1. •

NaCl added (%) Bas ed on E mpig en BS/H5 0

Bas ed on BS/FA

Bas ed on D eyto n P K 45

Figure 1: Comparative viscosity profiles in a standard SLES/CAPB formulation

AECI Specialty Chemicals – charmaine.dupreez@aeciworld.com Innospec – innospec.com

EMPICOL® LV 840 – a Sodium Caprylyl Sulfate 100% vegetable derived EMPIGEN® BS/H50 C – a coconut-based concentrated amphoteric surfactant EMPIGEN® BAC – Benzalkonium Chloride Product Manager Charmaine Du Preez – Charmaine.dupreez@aeciworld.com Technical Manager Jacques Strydom – jacques.strydom@aeciworld.com

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At IMCD, we help our customers facilitate cleaning and sanitising wherever people gather: at home, at work, and in our public institutions. In 2020, our Home Care and Industrial & Institutional Cleaning Business Group rose to the challenge as demand for hygiene and cleaning solutions suddenly skyrocketed.

Tel: 011-570-4260 Web: www.imcdgroup.com

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Probiotics and enzymes

to enhance cleaning products IMCD home care and I&I has been exploring the latest industry trends and consumer behaviours to create an insightful and detailed guide for brand owners and manufacturers. Featuring an expert interview with business and technical contributors from IMCD, this article provides an analysis of key trends such as the quest for ultimate efficiency, and cleaning for fun.

MCD home care and industrial & institutional (I&I) has six global laboratories with interconnected teams of experts who pride themselves on offering a deep understanding of formulation development alongside insights into global and regional market trends. This business group develops smarter, more appealing formulations for cleaning, hygiene and disinfection, working with customers to create tailor-made solutions for end users. In 2020, the group’s home care and I&I cleaning business rose to the challenge to meet the demand for hygiene and cleaning solutions which suddenly skyrocketed. Supported by industry-leading technical expertise and market knowledge, it has helped its partners get to market fast with solutions that meet the growing and evolving demands of their customers. Now, the business group is sharing insights into what comes next on the home care and I&I landscape along with the trends that are shaping this segment.

THE NEW SUSTAINABLE STANDARD As our lives keep getting busier, the pressure is on to achieve as much as we can in as little time as possible, and with the least amount of effort. This is especially true when it comes to the routine tasks of cleaning and disinfection.

"As manufacturers innovate to meet the need for efficiency, they are increasingly drawn to the magic of “multi-function” According to Mintel, in Brazil as many as 93% of adults use a multi-purpose cleaning product at least once a week. In commercial spaces, there’s a different kind

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of pressure. As employees return to work and places of business let the public through their doors once again, the transition needs to be as What do you do to smooth as possible in have order fun to during your help people feelfree safetime? while Several more yearsintensive ago, few managing of us would have said cleaning routines. “cleaning thetime, house”. At the same But the cannot way webe see efficiency at the our cleaning routines expense of sustainability. is changing. Home care and I&I brands are expected to pursue At first glance, the social the highest environmental media platform TikTok seems and standards without anethical unlikely place to host a compromising on ease of use, hygiene revolution. According to convenience and efficacy. the blog Apartment Therapy, since

MEET THE ‘CLEANFLUENCERS’

the start of the pandemic, TikTok has FORMULATING FORincrease EFFICIENCY reported a massive in users Assearching home carefor and I&I manufacturers cleaning content, with innovate meet theofneed for efficiency, close toto4bn uses the hashtag they are increasingly to the magic #cleaning recordeddrawn by October 2020. ofFurthermore, “multi-function”. The versatile and #cleanup, #cleaninghack cost-effective solutions which catch their and #cleanthatup trailed closely behind with a few hundred eyes include formulations thatmillion control both tagshardness each. water and metal ions in waterTikTok has become home to loads of short video cleaning tutorials and aspirational before-and-after clips that create a sense of satisfaction, even for those who don’t usually do any cleaning themselves. As with any social media trend, influencers are at the fore. Leading figures such as UK-based Instagrammer Sophie Hinchcliffe and American YouTuber Melissa Maker have acquired followers in the millions. Check out some of the influencers’ cleaning-related content here: • Sophie Hinchcliffe –

www.instagram.com/mrshinchhome

• Melissa Maker –

https://bit.ly/3DhsTQ3

based systems, while maintaining a good ecological profile. This can be achieved through the use of ingredients such as biodegradable chelates with superior environmental and (eco) toxicological properties. These enhance both the experience and efficiency of the product by reducing the detrimental effects of metal catalysts. The rise of more sustainable processes, such as the use of naturally-derived raw materials, avoidance of solvents and greater industrial water recycling have one unintended downside – an increased risk of microbial deterioration. This is why biocides have an important role to play in safeguarding our standard of living and realising a more sustainable future. When IMCD’s customers were looking for a highly efficient biocide for disinfectant and preservative applications, the supplier turned to a less traditional fatty aminebased biocide to uncover a solution. Not only does this product provide a broad spectrum of efficiency, but it also has the additional benefits of being nonsensitising and free from aldehydes,

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materials or create packaging that can be re-used? It’s also important to seek out raw materials that are cleaner or more ethically sourced, and which provide the same levels of efficiency as their harsher counterparts. It’s here that probiotics and enzymes, for example, have a big role to play. Please elaborate on the role of probiotics and enzymes in cleaning applications? Jaeglé: Enzymes enable dish and laundry formulations in particular to achieve excellent performance, depending on their profile, at a low temperature, sensible pH, in concentrated formulations and in short time cycles. Enzymes break down different types of dirt into smaller particles, making it easier for surfactants to remove dirt from hard surfaces and fabrics. Pohl: Probiotics are typically used in hard surface and drain cleaning. Microorganisms multiply on a surface, producing enzymes that break down the organic soilage present so that probiotics can use it as an energy source. They can therefore continue to grow while producing further enzymes as long as soilage is present. In this way, probiotics enable a cleaning solution with a long-lasting effect and positive impact on the malodour caused by organic soilage, in the bathroom for example. Moreover, when spread on a surface they will enable better disinfection.

WHAT’S NEXT?

"It’s important to seek out raw materials that are cleaner or more ethically sourced” halogens and quats. IMCD works closely with its customers to bring them the most value from this solution, offering technical expertise to optimise product performance and cost in use.

ASSISTANCE FROM INDUSTRY EXPERTS Thorsten Pohl, market manager, home care and I&I at IMCD Germany, and Fanélie Jaeglé, global marketing and technical director, home care and I&I at IMCD, share their expert advice on formulating for efficiency and how to find that perfect balance in product development. How can manufacturers optimise efficiency while maintaining high standards in sustainability?

Pohl: Saving energy and water is essential, so it’s important that manufacturers explore formulations that enable this. Packaging is also a critical consideration. According to Mintel, in Germany 72% of adults who clean want to switch to cleaning products that use less packaging. Jaeglé: Manufacturers should ask if it’s possible to do more with less. Can they include less water in the formulation itself, or less packaging for the same number of washes, for example? Could they use renewable

IMCD never stops asking, “what’s next” – for the group, its partners and for those who use, live and work with the products that IMCD helps to create. This drives the group’s passion to uncover the trends shaping future communities – from the broadest global level down to the smallest local scale. IMCD is excited to co-create with its partners to bring those trends to life – supported by 25 years’ expertise, consumer insight and market-leading technical capabilities. To download a copy of IMCD’s Tomorrow’s Cleaner Living trends commentary and to find out more about its home care and industrial & institutional cleaning business group, visit https://bit.ly/2WqAGKq. • IMCD – www.imcdgroup.com

WWW.PHARMACOS.CO.ZA // SEPTEMBER 2021

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Effective colour formulation technologies Today’s sophisticated formulations, together with the demand for transparent packaging, make it increasingly challenging to combine an attractive appearance with clearly recognisable branding. Colours are an important criterion for the sensory appeal of a product. Colours, as well as scents and overall design, suggest and stimulate emotions, thereby influencing buying decisions.

rands and manufacturers use colours to support a product’s positioning and promote product recognition. They are therefore essential to the commercial success of a formulation. Colours in the home and personal care industry usually follow fashion trends dictated by the textile and automotive industries. Aesthetics and visual aspects convey symbolic messages to the consumer which emphasise specific product properties as well as brand image. A product’s colour stability throughout its life cycle is therefore as important as its application properties. Colours must be carefully selected to meet marketing requirements and to ensure product compatibility and high storage stability without discolouration. In addition to suitable colour selection for the respective medium, stabilisers can be used to provide protection against UV radiation, oxidants and radicals. Since colour selection is often the last step in product development, any problems arising, such as incompatibility, inhomogeneity and pH or light instability, are especially critical.

COLOURANT PROPERTIES AND CLASSIFICATION A basic understanding of the properties of colourants and their classification can assist

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in finding the optimum colour selection, helping to ensure cost-efficient, storage stable, homogeneous colouration and a longlasting attractive appearance. Such expertise can also assist manufacturers in ascertaining without loss of time whether, and if so which, stabilisers are required.

"Colours must be carefully selected to meet marketing requirements" Colour index numbers and the chromophores on which they are based allow properties such as the shade and stability of a colourant to be determined. Knowledge of dye types (acid, alkaline, etc.) provides an idea of their solubility and compatibility in a formulation. This information can also be useful during screening, to make sure that a wide range of chromophores, and thus colours, can be included. Regulations, such as those set out by the FDA, EU Cosmetics Directive or individual countries, must be taken into account and adhered to.

APPLICATION RECOMMENDATIONS Based on the chemical properties of a dye or pigment, the following colourant classes are recommended for coloured home and personal care applications:

• liquid products such as liquid detergents, rinse conditioners, shower gels and shampoos • acid dyes • aqueous pigment dispersions • toilet bar soaps and laundry detergent soaps • aqueous pigment dispersions • pigment powders • dyes • powder products and granules such as powder detergents and bath products • dyes • aqueous pigment dispersions • pigment powders.

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Table: Major differences between dyes and pigments

Properties

Dye

Pigment

Colour strength

+ very high

- mostly moderate

Transparency

+ very high

- low

Opacity

- low

+ very high

Solubility (water)

+ completely soluble

- insoluble

Light stability

- poor to moderate

+ moderate – very good

pH stability

(+) varies

+ good – very good

Bleach stability

- limited colours

+ moderate – good

CHARACTERISTICS OF COLOURANTS AND THEIR PROPERTIES The globally accepted colour index, originally created by the textile dyes industry, classifies colourants in the following categories: • dyes (soluble) • pigments (insoluble) • lakes (insoluble salt of a dye). In addition, Halal and Kosher certified products are becoming globally more important.

DYES Dyes are colouring substances that are soluble in the application medium. Soluble dyes are further classified according to their (textile) application. Acid dyes (anionic, water-soluble dyes) are the most relevant in home and personal care applications. Dyes are distinguished particularly by their high transparency, together with their excellent colour purity and brilliance. In addition

to colouring ability, solubility is the most important property of dyes. Thanks to their high and rapid solubility, incorporating dyes into aqueous systems is very simple and unproblematic. However, dyes are not as lightfast as pigments. The pH stability of individual dyes can also vary widely. Dyes should therefore be tested separately in each formulation. Liquid dye formulations, which permit easier dosage than powder dyes, are being used on an increasing scale. Different liquid dyes can be simply mixed to produce almost all colours. However, their significantly reduced shelf life in comparison to powder dyes can be a disadvantage.

PIGMENTS AND PIGMENT PREPARATIONS A pigment is a colouring substance consisting of particles that are practically insoluble in the application medium. Due to the scattering of the pigment particles, pigments are opaquer than

dyes. For this reason, completely transparent formulations cannot be achieved. Due to the insoluble nature of pigments, it is often easier working with pigment preparations, where the pigment powder has already been optimally dispersed into a liquid form. Liquid pigment preparations are used wherever outstanding durability is required, simple stirring is desired and work- and costintensive dispersing and production need to be avoided. Liquid products also have the advantage of optimum colour strength combined with consistent quality as a result of their excellent dispersion and stabilisation properties. Pigments and pigment preparations are generally not suitable for low-viscosity liquid formulations, because sedimentation and the associated discolouration cannot be completely excluded.

LAKES Lakes are formed by precipitation of water-soluble dyestuffs with suitable precipitants. For example, acid dyes can be converted into insoluble metal salts by using various water-soluble metal salts as precipitating agents. This process gives them similar properties to those of pigments. Manufacturers of detergents, cleaning agents and personal care products face significant challenges. These include rapidly changing market trends, increasingly complex formulations and tougher global regulatory requirements. AECI Specialty Chemicals can assist with efficient colour management. •

AECI Specialty Chemicals – karen.meyer@aeciworld.com

WWW.PHARMACOS.CO.ZA // SEPTEMBER 2021

ETHNIC CARE

Rebalance the “acnebiome” for healthy, blemish-free skin

In a warm and humid climate skin is more prone to acne regardless of skin type and ethnicity. Most finished products on the market address the signs of acne by reducing the production of sebum, though sebum is important to maintain healthy skin. Considering this, Dendriclear is a one-of-a-kind active ingredient that works against acne, breaking the rules of the existing mechanisms of action.

ecreasing the quantity of Cutibacterium acnes (C.acnes) is no longer key to clearing acne, yet rebalancing its distribution between acneic and non-acneic strains is. Although the causes of acne are multifactorial, the involvement of microbiota is undeniable, particularly with regard to the role played by C. acnes. Knowledge of this bacterium has recently evolved to include a new understanding of its mode of action, which offers a fresh strategic perspective in the battle against acne. Using advanced metagenomic technology, C. acnes genome revealed that this bacterium forms a large family with several sub-groups, called phylotypes and ribotypes including acneic and non-acneic strains. C. acnes over-proliferation has long been thought to contribute to the development of acne, yet recent studies now say that excess C. acnes colonisation might not be an important factor, as a very small difference in the comparative amount of these bacteria in individuals with and without acne has been reported. However, healthy skin and acneic skin have a different C. acnes strain distribution profile.

THE “ACNEBIOME” At the phylotype level, the acne-prone skin, or “acnebiome”, is characterised by the dominance of phylotype IA1 (acneic strains) whereas phylotype II (non-acneic strains) is more abundant in healthy skin. A decrease in acnebiome (microbiome related to acne)

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phylotype diversity is also observed for acne-prone skin, attesting to a decrease in acnebiome health. At the ribotype level, some ribotypes like RT4 and RT5 (acneic strains) are prevalent on acne-prone skin compared to healthy skin. On the contrary, some other ribotypes like RT6 (non-acneic strain) are only found in healthy skin. With this recent update on acne science, Lucas Meyer Cosmetics challenged the existing mechanisms of action to rethink the battle against acne.

in order to recover a healthier microbiota. It regulates sebum overproduction and reduces the appearance of acne lesions and blemishes for clear and flawless skin. With this breakthrough microbiotafriendly mechanism of action perfectly aligned with the increasing microbiome trend, Dendriclear is the next generation of active ingredients in the battle against acne. It is also a gentle alternative with no undesired side effects, unlike some traditional acne-prone skin solutions.

DENDRIMER INNOVATION MICROBIOTA-FRIENDLY MECHANISM OF ACTION Composed of a unique patented lysine dendrimer, Dendriclear is able to selectively weaken acneic C. acnes strains and their biofilm to favour growth of nonacneic strains. The recovery of acnebiome homeostasis decreases skin bacterial aggression and reduces the induced immuno-inflammatory response attested by a decrease in the production of inflammatory mediators. It also prevents hyper-keratinisation and maintains healthy skin structure. Clinically proven, Dendriclear gently rebalances the acnebiome of acne-prone skin

Did you know? Dendriclear is China-compliant, preservative free and its content is of 99.95% natural origin (ISO 16128).

For the first time, a cosmetic ingredient has been developed which uses dendrimer technology. Dendrimers are dendritic polymers characterised by a threedimensional branched molecular structure, for a higher efficacy compared to linear chain structures. Synthetised from naturally-derived lysine amino acids using a green chemistry process that involves safer solvents and lower energy usage compared to standard processes, Dendriclear answers Lucas Meyer Cosmetics’ sustainability strategy. It also has an excellent safety profile in terms of toxicology and ecotoxicology (it is biodegradable and doesn’t impact the water ecosystem). Dendriclear is available in South Africa from Azelis. • Azelis – www.azelis.com/en Lucas Meyer Cosmetics – www.lucasmeyercosmetics.com/en

ETHNIC CARE

BASF inaugurates care evaluation salon in Nigeria BASF’s Care Creations has opened a state-of-the-art evaluation salon for personal care at its site in Lagos, Nigeria. The new facilities will enable in vivo sensory and performance testing of ethnic skin and hair care formulations on volunteers, helping customers to develop finished products with high relevance and consumer acceptance in the sub-Saharan African market.

osin Dania, technical manager personal care sub-Saharan Africa, comments: “To develop successful formulations and ingredients for ethnic personal care products, it is essential to have a deep understanding of African consumers’ preferences and pain points, their skin and hair characteristics, as well as how ingredients affect them. The BASF care evaluation salon combines market empathy, scientific excellence and formulation expertise, allowing us to share this understanding and benefit with our customers across the region.”

FACILITATING SUSTAINABLE GROWTH This new in-house salon is the first of its kind launched by a personal care ingredient

"This new in-house salon is the first of its kind launched by a personal care ingredient supplier in Nigeria" BASF’s Care Creations’ new state-of-the-art evaluation salon in Lagos, Nigeria

supplier in Nigeria. It complements BASF’s application technology laboratory inaugurated in February 2019. “This expansion is another example of our commitment to this growing and important market. With our strong competency in the region, we aim to drive the evolution of the personal care industry in sub-Saharan Africa towards more global

competitiveness,” says Jason McAlpine, vice president personal care – EMEA. The salon and laboratory facility will be open for collaboration with academic institutions on research topics in cosmetic science. By partnering with academic researchers, BASF aims to advance technical expertise in the region and support the training of the next generation of cosmetic scientists. • BASF – www.basf.com

Tel 011 608 4944 Fax 011 608 4948 Email sales@sensetek.biz

Sensetek.indd 1

2017/03/02 11:50 AM

WWW.PHARMACOS.CO.ZA // SEPTEMBER 2021

ETHNIC CARE

New in vivo data underlines efficacy of next-gen dandruff control active Until now, anti-dandruff products relied on three effective actives to utilise in their formulations: zinc pyrithione; climbazole and piroctone olamine. But with Crinipan PMC green from Symrise, the industry now has access to a 100% bio-based solution with a novel mechanism of action and which shows comparable results to established actives.

GREEN INGREDIENTS AND SUSTAINABLE SOLUTIONS Developing products like Crinipan PMC green is in line with the Symrise corporate sustainability strategy. Sustainability considerations are at the heart of the company’s new developments and are directing its daily work, from advancing ingredients and formulations to optimising the most resourceand energy-efficient processes, technologies and supply chains.

n a current in vivo study, Symrise has found further proof that the performance of Crinipan PMC green (INCI: Propanediol Caprylate) is equal to that of conventional systems. The application of the ingredient compared to piroctone olamine on two groups of test subjects with dandruff resulted in a significant reduction of flaking with no difference between the two groups. A shampoo study at an external institute yielded this result. It evaluated the degree of dandruff before and after a 28-day application of test shampoo on greasy scalp. Previously, Symrise had already reported that Crinipan PMC green can reduce dandruff significantly versus a

Did you know? Crinipan PMC green is an awardwinning active ingredient. It won first prize at the BSB Innovation Awards 2020 in the category Most Innovative Active Ingredient/Scalp, Barrier, Redness, and received the SEPAWA Innovation Award 2020.

SEPTEMBER 2021 // WWW.PHARMACOS.CO.ZA

By developing sustainable solutions, Symrise is able to secure and strengthen its future as well as the future of its customers’ businesses and the world around us. According to Symrise, all its product development adheres to strict sustainability criteria, not only maximising the value of its products to customers, but also the social and ecological value. The company’s future developments are built on commitments to: • eco-friendly chemistry • resource-efficient production • new technology and digitisation opportunities. placebo and works as effectively as the established active ingredient climbazole. Current data from a shampoo study carried out at an external institute further emphasises the effectiveness of the new product. As part of the test, dermatologists compared Crinipan PMC green to the established anti-dandruff active ingredient piroctone olamine and applied identical shampoo formulas containing either one of the ingredients on the two groups of people with greasy scalp.

To help Symrise achieve its goals, it has developed a product sustainability scorecard, which is an independently certified procedure that allows it to record the environmental impact of raw materials and products in a systematic manner. Ultimately, this allows Symrise and its customers to select the most environmentallyfriendly product options when it comes to product development.

ETHNIC CARE PLANT-BASED, ECO-FRIENDLY SOLUTION

"Crinipan PMC green provides formulators with a unique ecofriendly ingredient" Both test shampoos reduced dandruff significantly compared to the base values during a 28-day study.

SUPPORT FOR A HEALTHY SCALP MICROBIOME Crinipan PMC green stands out with its innovative micro-activated mode of action that targets dandruff. The yeast malassezia, known as one of the main causes of dandruff on scalp, activates the ingredient with its enzymes. Symrise previously demonstrated the effectiveness of Crinipan PMC green in several in vivo studies. Next to its ability to reduce flaking on scalp, the active ingredient has also been shown to support a healthy scalp

microbiome and could improve sensorial parameters for the hair fibre, thus increasing the acceptance of hair and scalp care cosmetics by consumers. “I find it exciting to see our innovation performing equal to those strong benchmarks,” says Dr Steffen Nordzieke, manager microbiology in the global innovation cosmetic ingredients division at Symrise. “Seeing theory confirmed in real life always serves as a strong motivation to look for alternative ways of solving old problems.”

Crinipan PMC green provides formulators with a unique eco-friendly ingredient. Made from 100% renewable raw materials using green chemistry, the readily biodegradable cosmetic ingredient fulfils consumer demand for cosmetics featuring natural derived ingredients which deliver effectiveness on par with conventional products. “For long, manufacturers of antidandruff shampoos have relied on the efficacy of conventional active ingredients like zinc pyrithione, piroctone olamine or climbazole. Looking at the upcoming ban of zinc pyrithione in European cosmetics in 2022, we find it reassuring to see once again that Crinipan PMC green goes head-tohead with conventional systems, offering the market an entirely new eco-friendly alternative,” adds Dr Florian Genrich, senior global product manager, cosmetic ingredients division at Symrise. •

Symrise – www.symrise.com

Hair Actives

AMAZING HAIR INSIDE OUT

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WWW.PHARMACOS.CO.ZA // SEPTEMBER 2021

ETHNIC CARE

Forces driving innovation in Africa’s beauty and cosmetics industry With technology advancing at a rapid rate and consumer behaviours changing fast – accelerated by the impact of the COVID-19 pandemic – health, personal care and beauty manufacturers in Africa are coming under pressure to innovate. For those that get it right, there is a significant opportunity to take advantage of growing export and domestic markets.

inny Perumal, CEO of KAS Africa, a contract manufacturer of personal, home, baby and oral care FMCG products, says the personal care industry is experiencing a dramatic shakeup. This is creating opportunities for innovative new brands to carve out more market share and grow their businesses. “Following a difficult year-anda-half for our industry, we’re starting to see the shape it will take in the post-pandemic world,” says Perumal. “There is a shift towards the localisation of production to reduce emissions Vinny Perumal, CEO and increase agility to respond of KAS Africa to changing consumer tastes. In addition, the rise of Generation Z consumers, the global focus on diversity and the growing African middle class are reshaping expectations. New technologies, too, are changing the game, whether it’s the impact of digital technology on the consumer experience, automation in factories, or the impact of new materials.”

NEW INGREDIENTS AND FORMULATIONS Over the past 20 years, the science behind beauty and cosmetics has advanced at a blistering pace. Multinational FMCG

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"There is a shift towards the localisation of production to reduce emissions and increase agility to respond to c hanging consumer tastes" manufacturers are using nanotechnology and stem cell research to deliver innovations such as skin care products that address skin at the molecular level. Manufacturers worldwide are returning to nature to create clean, sustainable products based on organic ingredients. “To keep up with the global competition, local manufacturers are also needing to be creative about the ingredients and formulations they use,” says Perumal. “African manufacturers, too, are looking at how they can innovate using locally-sourced, natural ingredients. The boom in cannabis-based products is just one example.”

DIVERSITY IN DEMAND It’s consumer demand that ultimately drives beauty and personal care brands to invest in innovation. What do today’s consumers want? They want brands that cater for different ages

and diverse hair and skin types – they expect to find products that will help them look their best no matter who they are. “Diversity isn’t just about race and ethnicity these days, though it remains important to create products for underserved markets,” she explains. “We’re seeing new categories such as genderless makeup and men’s makeup emerge in the global market. What’s more, the beauty industry is moving away from the narrative of seeing conditions like acne, thinning hair and eczema as abnormalities.”

SUSTAINABILITY IN FOCUS With growing alarm about climate change, environmental, social and governance factors are of foremost concern for beauty and cosmetics manufacturers. Consumers and regulators alike want to know that products are made with sustainability and ethics in mind. “Like most industries, FMCG manufacturers are under pressure to reduce their carbon emissions,” Perumal comments. “This affects the supply chain end-to-end – from the sourcing of raw materials and the manufacturing of products to the disposal of waste, transportation and packaging. It’s no longer enough to green-wash with label claims like ‘natural’, ‘organic’ or ‘friendly to the planet’ – brands need to walk the talk. The most

ETHNIC CARE

successful brands of the future will be those that do more than the minimum required by legislation and regulations.”

THE FOURTH INDUSTRIAL REVOLUTION To compete on the world stage and meet global quality standards, African manufacturers need to invest in digital transformation. Industry 4.0 technologies such as the Internet of Things, artificial intelligence, additive manufacturing, big data and robotics will be key in driving higher levels of efficiency in the years to come. These technologies will not only help to reduce costs and improve productivity, but also transform the consumer experience. They can help brands to come to market fast with highly-tailored products for different customer segments. There are some start-ups already doing exciting work – like Proven, a US-based brand which combines AI, big data and academic research to create personalised skin care products.

Restorative routine introduced for textured hair

With a complete routine of 10 products designed to clean, care and style curly and textured hair, Solvay is helping consumers embrace their natural hair one wash at a time.

THE PANDEMIC’S AFTERMATH As was the case in many other industries, the pandemic has accelerated changes in some consumer behaviours and disrupted many of their traditional behaviours and beliefs, perhaps for good. Whereas beauty products were once a category where buying

p to 75% of the world’s population has textured hair and natural hairstyles are increasingly seen as an element of personal identity. Yet, there is still a notable gap in high-end shampoos, conditioners and other hair care products made for these unique hair types. Solvay is working to change this with ready-to-use formulations designed to help textured hair consumers embrace their natural hair. “One of my closest friends has textured hair and she described how challenging it was for her to find the right products to style and care for her hair. I knew that I could make a difference with my work at Solvay,” says Stephanie Neplaz, global marketing innovation director for hair care at Solvay. “When the opportunity came to work with R&D to create a textured hair routine, I knew we could make incredible products that would have a real impact on consumers worldwide.”

EXPERT PARTNERSHIP BENEFITS THE MARKET Based in the US, Proven uses AI, big data and academic research to create personalised skin care products

was about seeing and experiencing products in real-world shops, e-commerce is rapidly on the rise. “Companies that sell makeup, skin care and hair care products are therefore needing to find creative ways to sell and market. Salons still have a key role to play, but we’re also seeing social media, especially influencers and tutorials, driving much of the customer experience. In future, augmented or virtual reality could offer interesting try-before-you-buy experiences,” she explains. The pandemic has also influenced what consumers buy from the health and beauty section of the store – during hard lockdowns, for example, they started focusing more on skin health than on cosmetics. Many of these buying patterns could stay in place as work-from-home and periodic lockdowns remain part of the foreseeable future. • KAS Africa – kasafrica.com

Acknowledging the many different types of hair is just the first step in creating hair care solutions formulated for textured hair. In partnership with the textured hair stylists and models at Studio Ana’e, Solvay’s scientists were able to evaluate and validate each of the products when used in realworld situations. “As curls are becoming a huge part of the hair care industry and hairstyling market, we are often asked to share our expertise in the field,” comments Aude Livoreil-Djampou, founder of Studio Ana’e. “We particularly enjoyed this partnership because the Solvay team was totally dedicated to understanding the needs of curly haired women and men.” In addition to providing highly specialised benefits for textured hair consumers, many of Solvay’s formulations are developed with eco-friendly ingredients that help customers care for the planet and themselves. Click on the link to learn more about the restorative textured hair routine from Solvay and to download the supplier’s complementary e-book: https://bit.ly/3Dutkqw. •

Solvay – www.solvay.com

WWW.PHARMACOS.CO.ZA // SEPTEMBER 2021

ASSOCIATION NEWS

Sun care – from seasonal to an everyday staple

Coschem has been hard at work connecting its members virtually. A total of five seminars have been hosted online this year with the final seminar scheduled for 19 and 20 October, on packaging sustainability and solutions. The focus for August was sun care. This article provides an overview of the comprehensive programme from the sun care seminar and the array of local and international presenters who shared their expertise with the attendees. VEGAN AND ORGANIC SUN PROTECTION Natural vegetable-derived materials have been found to provide UV protection, but are not approved as UV filters, hence they cannot be used as sunscreen actives. Inorganic sunscreens (zinc oxide and titanium dioxide) are derived from mineral sources and tend to be regarded as more natural and are therefore excellent replacements for synthetic organic UV filters. This was the focus of the presentation by Helen Playdon of The Care Co. Zinc oxide is a great choice as it provides broad spectrum UVA/UVB protection with the added benefits of less risk of skin sensitisation, increased safety, pigmentation protection, and wound healing properties. It is also an obvious choice for daily use skin care products and makeup. Zinc oxide uncoated powder is transparent and non-whitening. A choice of dispersions of zinc oxide provide the benefits of transparent non-whitening, non-nano, broad-spectrum UVA/UVB protection. These dispersions are suitable for all skin types, whilst being easy to handle. A natural sun protection factor (SPF) booster oil such as the emollient Pongamia glabra, is a powerful natural antioxidant rich in flavonoids. It absorbs UVB, hence the increasing photo-

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protection activity. Calophyllum inophyllum has healing activity and reduces oxidative stress, preventing UV-induced DNA damage.

" The maximum SPF value that can be claimed for cosmetics in South Africa is SPF 50+" Modern day natural sun care needs to provide an offering in terms of efficacy, pleasant sensory and an interesting texture to keep the consumer excited in terms of trying the product. Poloxamer-338-PPG-12/SMDI copolymer is a smart thermosensitive polymer with filmforming properties to improve the homogeneity of UV filter distribution on the skin, improving the SPF and sensory effects which providing transformative textures – such as liquid to gel. Dextrin palmitate is a thickener/stabiliser that increases the viscosity of oil and is a texture enhancer. It is ideal for oil sprays and water-like textures.

A REGULATORY OVERVIEW According to Carina Dewar of CTFA, the industry has the responsibility to place sunscreen

products on the market that are efficacious and safe for consumer use and to create a compliant industry. The South African National Standard is SANS 1557:2019 – Sunscreen Products, which specifies the requirements for sunscreen products including product categories, product claims, as well as the testing methods required for claim substantiation and warning statement requirements. Sunscreen products are classified as providing low, medium, high and very high protection. One can claim this on the packaging provided the SPF value is within the specified limits. The maximum SPF value that can be claimed for cosmetics in South Africa is SPF 50+ and a product with a SPF value lower than 6 is not classified as a sunscreen. Claim substantiation includes the testing of the mean SPF value as well as the UVA factor. The UVA factor should be at least a third of the labelled SPF, measured above the critical wavelength of 370nm after irradiation, when this is the case, one can make a broad-spectrum claim provided the minimum SPF value is 15. There are certain claims that are not allowed – a sunscreen product shall not imply that a single application can provide all-day protection, or that it is “sweat resistant” or “waterproof”. Claims shall not be made to imply 100% protection and claims should not be misleading

ASSOCIATION NEWS

to consumers. It is vital to have certain warning statements on the packaging to help keep consumers safe, such as, “products should be re-applied frequently”, “do not stay in the sun too long even when using a sunscreen” and “over-exposure to the sun is a serious health threat”.

BOOSTING SPF PERFORMANCE Caroline Mabille of Solvay France and Barry Zhang of Solvay China discussed a multifunctional rheology modifier that enables formulators to bring high sun protection to daily wear skin care products. Consumers are increasingly aware of the damaging effects of sun exposure. As a consequence, there is a growing demand for more protection from daily UV exposure. However, high SPF formulas are usually expensive and come with sensory negatives, limiting the penetration of high SPF products in daily wear applications. Solvay has developed and patented a unique multi-functional hydrophobically modified alkali swellable acrylic emulsion (HASE) polymer (INCI: Acrylates/Beheneth-25 Methacrylate Copolymer), which delivers excellent SPF boosting effect when formulated with organic, or combination of organic and inorganic UV filters, in addition to its excellent rheology and emulsification benefits. In vivo studies indicate a SPF increase of as much as 2.5 times the estimated SPF value, enabling the formulation of high SPF products with a significantly reduced dosage of sunscreens. Because of this, this multi-functional rheology modifier enables the formulation of affordable and aestheticallypleasing daily wear products with high SPF value (>30).

CHALLENGES IN SUNSCREEN PRESERVATION Sunscreen products are known to be challenging when it comes to preservation. Israel Weisser of Sharon Labs addressed the influence of the sunscreen formulations on the preservation system used and on the risk of microbiological

contamination. Weisser showed how features such as high oil versus water ratio, as well as the presence of specific UV blockers, introduce much complexity to the preservation process. He also demonstrated solutions to overcome these obstacles including a maltol-based preservative system combined with a cationic surfactant, which provides a high efficacy at low levels of use to broad microbiological spectrum natural-like protection.

ECO-FRIENDLY PROTECTION The impact of some UV filters on coral reefs has been discussed in several publications, despite the fact that there is no standardised procedure available to test the impact of chemicals on corals. The discussions have resulted in the ban of some UV filters in certain markets and in significant reformulation activities of sunscreens in Europe. According to Marcel Schnyder of BASF, there is a clear trend that B3, EHMC and OCR is being removed from sunscreen formulations. Based on the environmental data of the individual UV filters, BASF developed EcoSun Pass to calculate the environmental safety of UV filter combinations taking into account SPF and UVA-PF as well as the UV filter concentration required. The removal of liquid UV filters like EHMC and OCR brings new challenges into spotlight, such as the photostability of the UV filter combination or the solubility capacity of the oil phase. These aspects have to be taken into account when developing environmentallyenhanced sunscreen formulations.

INSIGHT INTO FORMULATION DEVELOPMENT Ana da Costa of IMCD South Africa reminded seminar attendees of various important things to consider during sun care development. These include organic and inorganic UV filters and the specific country regulations pertaining to them, patent infringements, product performance, photostability, reducing costs by using SPF boosters, the use of anti-oxidants, anti-inflammatories, the counter effects of

IR-A and aesthetics of the final formulation. She also provided formulation tips to influence the stability of the final product.

CLAIM SUBSTANTIATION VERSUS TESTING Heibrie le Roux of Future Cosmetics presented on the topic of market claim substantiation versus testing. She provided an overview of the electromagnetic light spectrum and focused on the newer generation claims and testing areas such as infrared (IR) and high energy visible light (HEV). Le Roux also highlighted the importance of the SPF golden standard (ISO 24444:2019) versus the legislative standard (SANS1557:2019). She further discussed key new requirements such as volunteer ITA values, new visual evaluation requirements for erythema and discussed dry as well as water resistant testing changes within the new standards. Deviations from acceptable claims substantiation not covered by the mandatory standards were also pinpointed. Le Roux summarised the key issues by explaining interesting claims found on SPF products in the South African market – not covered by the local standard – and how these should be addressed through innovative claim substantiation efficacy studies.

LOCAL RELEVANCE OF CRITICAL WAVELENGTH Highly effective mineral UV filter dispersions yield high critical wavelengths and subsequently high SPF values, which are required to protect all skin types including skin types 4 to 6. In her presentation, Karin Barends of Afrisil Speciality Ingredients highlighted pre-dispersed mineral UV-filters composed of ultrafine TiO2 and ZnO2 dispersed in hydrogenated vegetable oil, vegetable squalene and hydrogenated polydecene. These UV-filters offer photostabilty and are available in various particle sizes for different applications. The applications range from transparent to slightly opaque with very low dosage levels.

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ASSOCIATION NEWS

Importantly, the dispersions do not penetrate the skin and offer highly-stable emulsions.

SUN, SEA AND SAND WITH SILICONES The sun brings new vitality and boosts your well-being. It tells you that summer has arrived and represents freedom. Today’s consumers demand sun care products that not only provide protection, but also care benefits and an even tan. For any application, Wacker offers reliable, market-oriented additives: silicone resins for water resistance or elastomer gels as rheology modifiers – with dual benefits of protection and care. Kirsten Scott, sales manager for consumer care, Wacker Chemicals Middle East, provided an overview on how to use silicones to modify sun care products for extra-ordinary sensorial benefits as well as SPF boosting.

UV filters, formulators are able to address environmental concerns and evaluate the eco-friendliness of formulations at the beginning of a project. This is a step into the right direction. We, as the industry, need to consciously and pro-actively move towards more eco-friendly SPF products, mastering trade-offs.

SUSTAINABLE SOLUTIONS The importance of sustainability and preserving our planet for future generations cannot be overstated. In order to fulfil AECI’s corporate social responsibility, Charmaine du Preez of AECI Specialty Chemicals, says the company delivers products to the consumer which are safe for people and the planet.

SAFE AND SUSTAINABLE UV PROTECTION Dr Rob Sayer and Aline Souza of Croda UK discussed an innovative range of ZnO powders and dispersions based on patented, platelet-shaped structures of zinc oxide particles. These dispersions are large enough to be suitable for natural and COSMOS-approved formulations, whilst being transparent on skin. This level of transparency makes them extremely versatile and suitable for a wide range of applications and skin phototypes.

"Trends like blue light protection as well as sustainability and natural ingredients are gaining traction"

ECO-PROFILING TOOL Conscious beauty is a major trend. Consumers are looking for products that are good for them and the environment. Yet there is currently no validated standard method available to evaluate the impact of UV filters on the environment, which was highlighted by Aeysha Jakoet of Chempure. These ecological concerns are resulting in fewer and fewer ingredient options in the sun care category. Luckily, with some of the online tools available which have built in data about the biodegradation, bioaccumulation and toxicity of all current

Local and international delegates and presenters who attended Coschem’s sun care seminar

Global warming is a reality and the changing temperatures make sun care very prevalent in South Africa. Sunburn, which can lead to melasma and cancer, can be avoided by educating people and providing them solutions to help protect their skin against harmful UV rays. Sun care can include emollients, UV filters, actives, botanicals, silicones that are sustainable, film formers, and boosters. It is imperative that the formulations we develop for topical applications adhere to the regulations, to ensure coral reef safety and non-animal testing. Other requirements include natural, eco-certified, COSMOScertified, non-GMO, mass balance and safe for topical use. Trends like blue light protection as well as sustainability and natural ingredients are gaining traction. There are several factors that make a sunscreen effective: even coverage, non-whitening effects, easy application, and sufficient SPF. As new ingredients are launched on the market, access to sustainable alternatives to silicones, dispersions, film formers, boosters and actives is increased. The pandemic has also had a significant impact on the sun care category. Over the past 18 months, consumers have been largely confined to their homes and continue to spend most of their time indoors, resulting in a decrease in sun care product sales. In 2023 and onwards, sales are expected to improve in this category. Innovations surfacing in sun care include CBD-infused sun care products, protective hand care, sea breeze scented candles, tattoo products, and self-tanners. As part of sun care packaging innovations, there was the launch of a board-based tube with 45% less plastic and a sugarcane tube produced using minimal plastic. •

Coschem – www.coschem.co.za

SEPTEMBER 2021 // WWW.PHARMACOS.CO.ZA

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ONLINE

INDUSTRY WEB REVIEW ESSENTIAL SPECIALISED PRODUCTS

COSCHEM

Supplier of cosmetic and personal care ingredients.

Visitors to the Society of Cosmetic Chemists’ website will find information on membership, educational programmes (specific details pertaining to the Cosmetic Science Training), as well as the society’s objectives of promoting professionalism and higher technical skills in the personal care industry.

Ingredients include; Bioferments, Botanical Extracts, Delivery Systems, Enzymes, Functional Actives, Silicones, Emollients, Emulsifiers, Meadowfoam Seed Oil & Derivatives, Abyssinian and other Oils, Shea and other Butters, Aliphatic Hydrocarbons, Lanolin & Derivatives

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accredited facility, licenced by the Medicine Control Council (MCC) & endorsed by the World Health Organisation (WHO). Our schedule of accreditation can be viewed via www.sanas.co.za Phone: +27 (0) 11 661 7914 Cell: +27 (0) 81 399 9737 E-mail: peter.moopeloa@bureauveritas.com

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Pharmaceutical & Cosmetic Review September 2021

Articles inside

Probiotics and enzymes to enhance cleaning products

The critical role of data in building trust in SA’s vaccination efforts

The role of serialisation in sustainable development

Vision systems for a safer supply chain

Smart coating technology that automatically adapts to batch ratio

Coating technology improvements deliver outstanding value for money

mRNA vaccine manufacturing partnership a first in Africa

Agile, optimised and ready for the future