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Vol - 16 / Issue - 1 / April - May 2021

A U T O M AT I O N i n

PACKAGING EVOLUTION TO REVOLUTION

PACKAGING-The Passionate Profession My Best 6-Pack Slides

Evolution of Pharmaceutical Packaging & Dispensing Solid Dosage Packaging & Dispensing – Overseas v/s US

Need of Lean, Agile & Smart Pharmaceutical Manufacturing


PM&T_OCT-NOV.-2020


machines & technology

Vol - 16 Issue - 1 April - May 2021 PUBLISHER & EDITOR Harjit Singh Dhaul

Dear Pharma Pals, As you all know, our country is reeling under a deadly second wave of the pandemic, recording world's sharpest spike, and the political and financial capitals New Delhi and Mumbai are running out of hospital beds, oxygen and medicines. Given the situation, what's the way out for our industry?

Editorial Office Global Vision 26-B, Rebellow Cottage, Gaon Devi Road, Poinsur (E), Kandivli 400 101 E-mail:info@pharmamachines.com

During this public health related pandemic situation, and when social distancing is of prime importance, automation and digitalization, along with the wireless communication system are the best rescuing tools for the manufacturing and supply chain system, says Prabir K Das, a veteran pharmaceutical packaging professional, in our exclusive on automation in packaging.

Advertisement/Circulation/ Subscription enquiries: Mobile: +91 93 24 577012 +91 77 15 957717 E-mail:info@pharmamachines.com Website: www.pharmamachines.com All rights reserved. Reproduction in any manner is prohibited. PHARMA Machines & Technology takes no responsibility for validity of claims in advertisement and articles published. Printed & Published by: Harjit Singh Dhaul on behalf of Global Vision and printed at Hariom Printers, C/70, Akurli Industrial Estate, Akurli Road, Kandivali East, Mumbai 400 101, and published at 26-B, Rebellow Cottage, Gaon Devi Road, Poinsur (E), Kandivli 400 101. Editor Harjit Singh Dhaul.

DEPUTY EDITOR Byju Bhaskaran EDITORIAL ASSISTANT Ravlin Kaur

These can well support supply of essentials, including medicines and other healthcare products. They can smoothly deliver with minimum human intervention and with minimum variability in quality. They can also support to maximize outputs and optimize supply chain efficiency. Entire network system can be digitally connected to get best result, including handling, storage and distribution of the goods. Our second exclusive, by Masih Jaigirdar, a pharmaceutical scientist and senior quality reviewer, discusses the evolution of pharmaceutical packaging and dispensing, and how the year-old practice and stubborn attitude in the US population of having the medication (solid dosage) packaged, supplied, and dispensed will ultimately compromise it quality and efficacy as opposed to the overseas packaging system used for the solid dosage medication in blister package. In today's time, to meet customer demand and keep the cost of goods at lowest, there is an ever-increasing need for biopharmaceutical organizations and professionals to adopt lean six sigma methodology, showcase agile mindsets, and move towards digitalization, says Bhavesh V Agarwal, a certified Six Sigma Black Belt and Lean manufacturing professional, in his article in this issue. Harjit Singh Dhaul

CONTENTS

Publisher & Editor

Evolution of Pharmaceutical Packaging & Dispensing Exclusives

Solid Dosage Packaging & Dispensing – Overseas v/s US

A U T O M AT I O N i n

PACKAGING

18

34

Exclusive articles by Prabir K Das, a veteran pharmaceutical packaging professional

26

Sustainable Packaging: A hot topic in Asia The innovative WEBCAST series from KOCH Pac-Systeme GmbH

44

TECHNEWS

53

Pharmaceutical Scientist and Senior Quality Reviewer Masih Jaigirdar writes

EVOLUTION TO REVOLUTION

PACKAGING-The Passionate Profession My Best 6-Pack Slides

In focus

Need of Lean, Agile & Smart Pharmaceutical Manufacturing Article by Bhavesh V Agarwal, a certified Six Sigma Black Belt and Lean manufacturing professional

48

Regulars INDIA PHARMA 8 GLOBAL PHARMA 10 DID YOU KNOW? 12


India Pharma

News & Updates

Retail giant to support India's Covid-19 battle 'Clevira' repurposed as supportive treatment Clevira, an antiviral drug, primarily developed to treat dengue, has been repurposed as supportive treatment for mild to moderate Covid-19 cases. Manufactured by the Chennai-based Apex Laboratories Private Limited, the drug is effective when taken orally and the dosage is one tablet twice daily after food for 14 days. The drug has also proved to be safe on liver and kidney parameters. After rigorous scrutiny and deliberations, the drug got approval by the Ministry of AYUSH regulators, a first-ofits-kind approval in India through various stages of scrutiny at the Central Council for Research in Ayurvedic Sciences (CCRAS) and the Interdisciplinary Technical Review Committee (ITRC).

Covid-19 best practice guidelines book

Retail giant Walmart has said that it is mobilising its global resources to further expand support for Covid-19 relief efforts in India, which is reeling under a deadly second wave of the pandemic. Walmart, the Walmart Foundation, Flipkart and PhonePe, along with Walmart's Global Technology and Sourcing hubs, are collaborating to counter oxygen shortages, support the national vaccination drive and donate to organizations. This includes a Rs 14.82 crore donation from the Walmart Foundation to support various NGOs in India. Walmart will donate up to 20 oxygengenerating plants and 20 cryogenic containers for oxygen storage and transportation, as well as more than 3,000 oxygen concentrators and 500 oxygen cylinders for delivering oxygen therapy to patients at home or in hospital.

India's leading healthcare provider, Apollo Hospitals has come out with a book with best practice guidelines for hospitals, nursing homes and healthcare workers amid the Covid-19 pandemic.

Pharma firm to donate Rs 100 cr to families of deceased

The Covid-19 Red Book summarises evidence-based best practice guidelines to support big and small healthcare institutions in making quick and timely decisions for diagnosis, treatment and management of Covid and non-Covid cases during the pandemic.

Mankind Pharma has announced that it will donate Rs 100 crore to the families of deceased doctors, police officers, pharmacists, and other healthcare workers who have lost their lives fighting the pandemic.

The book also includes guidelines for non-clinical processes, policies and protocols to improve efficiency and ensure a sound working environment.

The company plans to start releasing the money with immediate effect and hopes to complete it within three months, Mankind Pharma said in a statement.

The guidelines will empower the healthcare institutions and the medical fraternity to react with agility to the evolving situation brought about by the second wave of the Covid pandemic, the healthcare provider noted. The Red Book is the culmination of Apollo's over 38 years of expertise in healthcare combined with experience of being at the forefront in battling Covid-19.

As the country continues to grapple with the second wave of coronavirus pandemic, healthcare and frontline workers are racing against time to contain its spread. Many dedicated heroes have lost their lives in the process, it added.


India Pharma

News & Updates

Pandemic may peak at 33-35 lakh active cases

Pharmexcil appeals to China to clear bottlenecks

According to a mathematical module devised by IIT scientists, the ongoing second wave of the Covid-19 pandemic in India may peak between May 11-15 with 33-35 lakh total 'active' cases and decline steeply by the end of May.

Pharmaceuticals Export Promotion Council of India (Pharmexcil), the country's nodal agency for exports of pharmaceuticals has appealed to the Indian Ambassador in China to immediately intervene in clearing bottlenecks on import of key raw materials from China amid serious supply chain disruptions.

In predicting that the active cases would go up by about 10 lakh by mid-May before sliding, scientists from the Indian Institute of Technology in Kanpur and Hyderabad applied the 'Susceptible, Undetected, Tested (positive), and Removed Approach' (SUTRA) model. The scientists said there are several novel features in the SUTRA model. Whereas previous papers divided the patient population into asymptomatic and Infected, the new model also accounts for the fact that some fraction of asymptomatic patients could also be detected due to contact tracing and other such protocols. The SUTRA model's prediction of the new peak is sensitive to the daily new infections data.

Coronavirus care centres for employees As India's daily Covid-19 cases inch towards the 4 lakh mark, corporates in the country have stepped up to support Covid-hit employees by providing them with access to isolation/quarantine centres. Companies such as Tata Consultancy Services, Amazon, ITC, Capgemini, RPG Group, HDFC Bank and Cognizant have set up Covid-care centres either on their own, or through tie-ups with hotels or hospitals. Employees at these centres will have access to nurses and doctors, even oxygen, while for more serious cases, the necessary medical help/hospitalisation will be arranged as available. These centres, meant largely for mildly symptomatic/asymptomatic cases, are especially useful for people who live alone or in small homes with family.

The Pharmexcil director-general Ravi Uday Bhaskar wrote to Indian Ambassador in China Vikram Misri for an immediate intervention in the backdrop of the decision of the Chinese state-owned Sichuan Airlines to suspend its cargo services to India for 15 days following the second wave of Covid-19.

Covaxin found to neutralise 617 variant White House chief medical adviser Anthony Fauci Covaxin has said that the Covid-19 vaccine produced by Hyderabad-based Bharat Biotech has been found to neutralise the B.1.617 variant. This variant is said to be driving the surge in infections across the country. “Now, this is something where we're still gaining data on a daily basis. But the most recent data was looking at convalescent sera of Covid-19 cases in people who received the vaccine used in India, the Covaxin--and it was found to neutralise the 617 variant,” he was cited telling reporters. The World Health Organisation (WHO) has said that the B.1.617 variant is likely to be contributing to the Covid spike in India and has been detected so far in at least 17 countries.


Global Pharma

Licensing deals with Indian firms for Oral Covid-19 drug Merck has entered non-exclusive voluntary licensing agreements with five leading Indian generics manufacturers for oral Covid-19 drug molnupiravir (EIDD-2801/MK-4482). The agreements have been signed with Cipla, Dr Reddy's Laboratories, Emcure Pharmaceuticals, Hetero Labs and Sun Pharmaceutical Industries which have WHO prequalified manufacturing facilities and capability as key suppliers to global and key low and middle-income countries. Being developed by the company in partnership with Ridgeback Biotherapeutics, molnupiravir is an investigational, orally bioavailable form of a potent ribonucleoside analogue that hinders the replication of various RNA viruses, including SARS-CoV-2. According to the agreements, these manufacturers will receive licenses to supply molnupiravir to India and over 100 low and middle-income countries.

UK's first nationwide life sciences ecosystem Three companies have merged to form the UK's first nationwide life sciences ecosystem, boosting R&D and drug discovery capacity in the country and giving early-stage companies access to much-needed investment and facilities. US real estate investment company Harrison Street and UK real estate group Trinity Investment Management has announced their joint acquisition of Nottingham-based science business incubator BioCity. The £120m deal will see BioCity merge with Knowledge Factory, Trinity's network of science parks, to become We Are Pioneer Group (WAPG).

News & Updates

BioCity was founded in 2002 at the University of Nottingham and Nottingham Trent University, and has invested in 29 early-stage companies to date. WAPG says the merger will create a £450m business operating across ten science parks in England, Scotland and Wales, amounting to 2.6 million square feet of labs and offices, and will host 650 high-growth businesses – an impressive 10% of the UK's life sciences sector. The direct management of labs by real estate investors is rare in Europe, but is common practice in the US. As the first nationwide business to combine education, investment and business support with the development and asset management of lab space, WAPG hopes to become the UK's leading hub for science and innovation.

Anvisa rejects import of Russia's Covid-19 vaccine The Brazilian National Health Surveillance Agency (Anvisa) has rejected the import of the Russian Covid-19 vaccine, Sputnik V, citing a lack of consistent and reliable data. Anvisa's five-strong board voted unanimously against the Russian vaccine approval as technical staff had emphasised 'inherent risks' and 'serious' defects, pointing out the lack of data ensuring the safety, quality and effectiveness of the shot Anvisa's five-strong board voted unanimously against the Russian vaccine approval as technical staff had emphasised 'inherent risks' and 'serious' defects, pointing out the lack of data ensuring the safety, quality and effectiveness of the shot. The EU also had expressed similar concern and has not approved the vaccine so far as it required more data on the tests and manufacturing methods. Currently, Sputnik V is approved in many countries across the globe.


Global Pharma

Partnership to develop gene-editing treatments Vertex Pharmaceuticals (VRTX) and Obsidian Therapeutics have entered a strategic research partnership and licensing agreement to discover and develop novel therapies that regulate gene editing for treating serious diseases. In this collaboration, Obsidian's cytoDRiVE technology will be used to develop novel regulated gene-editing therapy candidates whose therapeutic activity can be accurately controlled using small molecules. The established scientific and clinical expertise of Vertex in small molecule, cell and genetic therapies will aid in swiftly delivering these approaches to patients. Vertex holds the exclusive option to licence worldwide rights to candidates developed under the partnership.The company will oversee the future preclinical and clinical development and commercialisation of the products.

Blockchain technology can play a crucial role The decentralised nature of blockchain technology can bring unprecedented transparency and security to the pharmaceutical supply chain, eliminating the scope for tampering, counterfeiting or diversion of drug products. Pharmaceutical giants such as Novartis and Merck have embraced blockchain technology to prevent drug counterfeiting and improve their supply security. The management of existing pharmaceutical supply chains has issues such as lack of modernisation and involvement of intermediaries. Blockchain technology can help in the modernisation and digitisation of the supply chain, although it involves high implementation costs and has limited storage capabilities, according to GlobalData, a data and analytics firm.

News & Updates

Blockchain technology along with artificial intelligence (AI), machine learning (ML) and other digital tools can also support the research and development process through the secure transfer of large data and its analysis across a wide network. Further, manufacturing of highly complex personalised product, technology transfer between academia and industry, and patient data management can be improved through the use of blockchain technology. The COVID-19 pandemic, however, could be a headwind for the future implementation of blockchain technology as the crisis pushed back the technology in the priority list of the healthcare industry, adds GlobalData.

Antibody therapy for Covid-19 treatment The National Institutes of Health (NIH) has commenced subject enrolment in a Phase II/III ACTIV-2 trial of a new fully human polyclonal antibody therapeutic called SAB-185 for treating Covid-19 in non-hospitalised individuals with mild or moderate disease. Developed by SAB Biotherapeutics, SAB-185 has shown to neutralise live SARS-CoV-2 at titers higher than convalescent plasma in preclinical studies. Funded by the NIH unit National Institute of Allergy and Infectious Diseases, ACTIV-2 is a master protocol to assess various investigational agents in people with mild-to-moderate Covid-19 who do not require hospitalisation. Other therapeutics being analysed in the trial are Brii Biosciences' experimental antibodies, BRII-196 and BRII-198, Synairgen's SNG001, AstraZeneca's AZD7442, and Sagent Pharmaceuticals' Camostat mesilate. NIH has announced plans to fund the Phase III ACTIV-6 clinical trial to analyse various prescription and over-the-counter medications that are currently available for self-administration to treat Covid-19 symptoms.


DYK

Facts & Figures

DID YOU KNOW? Bridging trial is a study conducted in a new region or country that builds on clinical data from another region. Sputnik V was the first Covid-19 vaccine to be registered globally and has been approved for use in 55 countries. Sputnik V was developed by the Gamaleya National Research Centre for Epidemiology and Microbiology in Moscow with backing from Russian Direct Investment Fund. India is likely to get a fourth Covid-19 vaccine in August from Hyderabad-based biopharmaceutical company, Biological E. Biological E is the largest manufacturer of tetanus vaccines and snake venom antidotes in India. It will manufacture 1 billion doses of Covid-19 vaccines including the Johnson & Johnson vaccine under the Quad Vaccine Partnership. Mumbai-based VAV Lifesciences is the only domestic firm in the COVID-19 vaccine supply chain to supply phospholipids, a crucial ingredient. Phospholipids are crucial biomolecules used in manufacturing of mRNA-based COVID19 vaccines of Pfizer and Moderna. Covaxin has received Emergency Use Authorizations (EUAs) for COVID-19 treatment in India and in several countries across the globe with another 60 in the process. Matrix-M vaccine, developed by the University of Oxford's Jenner Institute, is the first candidate vaccine for malaria to surpass a target set by WHO for researchers to create a jab of 75 percent efficacy by 2030. The vaccines against Covid-19 were approved rapidly while the first trials for one against malaria date all the way back to the 1940s. Malaria kills some 400,000 people each year around the globe. It is one of the leading causes of childhood mortality in Africa. Oxford-Astra-Zeneca vaccine is called Covishield in India and Vaxzevria abroad. Inactivated vaccines, while highly safe, are extremely complex and expensive to manufacture, resulting in lower yields when compared to live virus vaccines. Johnson & Johnson's Janssen COVID-19 vaccine is a single-dose jab and can be stored for up to three months in a temperature between 2 and 8 degrees Celsius. Two firms had filed application for registration of trademark 'Covishield'. Cutis Biotech for sanitiser, liquid antiseptic and disinfectant on April 29, 2020, and Serum Institute for vaccine on June 6, 2020.


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Exclusive

Packaging

AUTOMATION in

PACKAGING

In our daily life we see and use many products since leaving the bed in the morning, till we take the bed again at night. All these products reach to us with the help of packaging for custom-made uses with appropriate quality and adequate quantity. Our life cannot be imagined without packaging. How the packaging works for variety of products (essentials and non-essentials), how the products are distributed and delivered to our doorsteps at each corner of the country, is a mysterious cycle of operations to many of the users. How mass scale manufacturing happens for most of these products and how do they get packed to our convenience, how the quality and quantity is ensured for each unit, how efciently they are handled, stored and transported to various destinations – The answer to all these queries is Automation.

Evolution turned into revolution with the help of automation. It accelerated the growth of civilization multi-fold. We cannot imagine development without automation, just like we cannot imagine product without packaging. Similarly, packaging and labelling are complement to each other, just like automation and digitalization. The other major contributors are communication and wireless connectivity, which have further fuelled rapid exchange of mass scale data and information. Altogether our development and growth are now fully indebted to these. Coming to packaging and labelling, we can

By Prabir K Das say from design and development to distribution and delivery, all are now well managed with the help of automation and digitalization. From labscale to production scale, from primary packaging to palletization, from testing and release of incoming materials to testing and release of finished goods, all are happening through different degree of automation and digitalization. Packaging design options and labelling contents are finalized in compliance to all regulatory and customer requirements and are now digitally being processed across the industry. Automation and digitalization also helped to add many valueadded features in packaging and labelling for customer safety and supply chain security, apart from brand protection and brand promotion. During this public health related pandemic situation, and when social distancing is of prime importance, automation and digitalization, along with the wireless communication system are the best rescuing tools for the manufacturing and supply chain system. These can well support supply of essentials, including medicines and other healthcare products. They can smoothly deliver with minimum human intervention and with minimum variability in quality. They can also support to maximize outputs and optimize supply chain efficiency. Entire network system can be digitally connected to get best result, including handling, storage and distribution of the goods.

Automation – Impact on Product Shelf life and Quality Let me define the terminologies – Automation, Shelf Life and Quality. Automation: Simply known, automation is a tool or process to increase the level of output and


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scale reproducibility or replication of an operation with predefined parameters to produce consistent output. It is an inevitable and adaptable change, which helps business to Scale up, Survive and Sustain in global competition. Shelf Life: It is the maximum intended life span of a product within which it maintains its originality inside a pack before it is dispensed and used. Quality: It is a set of parameters with respect to a product's physical, chemical, biological and organoleptic properties, infused during its development and manufacturing and is retained throughout its shelf life.

Why Automation needed – Choice for scalability – Support to sustainability – Minimize human interference – Optimize output variability – Minimize consumer complaints – Compliance to regulatory guidelines – Inclusion of value-added features All these are evolving essentially to support lifestyle transformation due to rapid consumerization and globalization. Packaging automation is applicable in every sector of manufacturing where it is an integral part of product and its processing.

Where Automation needed Primary packaging: The first layer of enclosure which is in direct contact with the product is the primary packaging. Product feeding / filling, labelling, variable data printing, are part of primary packaging operations and mostly these are accomplished through automation for large scale operations.

Packaging

primary packs are further packed in another level of packaging. These are mostly printed with fixed and variable data. Many of the processes like labelling, cartoning, etc. are also automated in secondary packaging area. Collation, banding and bundling are also accomplished through automation. Tertiary packaging: Mostly it is the distribution or shipment pack where more units of primary packs or secondary packs are put together in an outer box, generally known as shippers. These may or may not be printed but have proper labelling with fixed and variable data. Automation is also largely deployed here and popularly known as end-of-theline automation. Automation also facilitates material handling, palletization, warehousing, logistics and distribution and data management at all stages of operation. Sampling / testing / release of product and packaging are also automated for many of their parameters.

Understanding the basics of Product and its Packaging Packaging provides basic identity to a product. Every product has a cost - packaging adds value to it. Packaging effectively connects the products with the people. Package means pack should not age till the end usage of the product. Packaging takes as much care for the product as a mother takes for her child. Product-packaging relationship is like man-woman – complement to each other. The definition of good packaging is: Pack which prevents aging of the product inside it. While packaging is the last operation at manufacturing, it is the first impression at selling. Packaging boosts both – smooth selling of the product as well as smooth sailing of the brand. In a civilized society, packaging is to a product as


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Packaging

What all we need to do for Automation and ensure availability?

which are facilitated predominantly through automationfor quantity / quality enhancement.

– Techno-Commercial feasibility studies

– Strip Pack -> Thermoform Blister -> Tropical Blister and Cold-form Blister -> Customized userfriendly design (calendar pack, compliance pack, etc.)

– Product characteristics and process flow – Smooth flow of process inputs to the operations –

Preferably a unidirectional flow of operations

Standardization of component specifications

Harmonization of all associated processes

Synchronization with other support functions

Strong coordination between user and vendor

Qualification, Validation and Documentation

Training and skill development of people

Risk Assessment and Mitigation plan

What all we need to know and understand? Product Characteristics: Sensitivity, Machinability, Dispensability. Degradation: Thermal, Hydrolytic, Oxidative, Photolytic degradation. Container-Closure System: Product requirement, Market requirement. Material Options: Availability, Compatibility, Machinability, Stability. Packaging Area: Qualification & Control, Handling & Storage System. Feeding / Filling mechanism: Feasibility and ease of automation. Sealing / Closing mechanism: Manual / automatic, impulse / induction. Labelling / Coding option: Migration, Presence of leachables, legibility. Packaging Design: Smooth machinability and ease in dispensability. Process Design: URS / FAT / SAT, qualification, validation, process control. Subsequent protection at secondary and tertiary packaging stages.

Journey through Automation

– Glass Bottle -> Plastic Bottle -> Flexible Sachet and Pouch packs. – Glass Ampoule or Vial -> Blow-Fill-Seal container and Prefilled Syringe – Aluminium Tubes -> Plastic or Laminated Tube Packs – Metal Closures -> Plastic Closures with induction sealing provision, child resistant and tamper proof feature, Closure with in-built desiccant option – Conventional Closure -> Single dose and Metered dose dispensers. – Conventional glass or metal container -> Aerosol containers. – Cut Label or Pre-gummed label -> PS Sticker label and Shrink label – Manual inclusion of desiccant / filler / plugs / measure cup / dropper -> Automated dispensing of ancillary items. Product feeding/lling: This is the most critical initial step, which sets the tone of packaging line. Manual to automated systems like brush box feeder, disc feeder, count filler, specially designed feeder like simtap, transfer roller, channel feeding, vibratory feeding, electronic weigh filling, volumetric filling, gravity filling, cup filler, piston and pump filler, screw and auger filler, pick and place system, vacuum filling, inert gas purging, modified and controlled atmosphere packaging, etc. Process control improvements: Pin hole detection for primary packaging, Leak testing of the filled packs, Metal detection, Non-fill detection, Vision inspection, Check weighing, Image comparison, Metal stereo coding, Hot foil stamping, Inkjet printing, Thermal transfer printing, Laser printing,


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Packaging

features included in packaging and labelling for various intended benefits. These cannot be easily achieved without automation. – Special purpose Dispensing Features – Child-resistant (CR) & Senior-friendly (SF) Features – Authentication Features – Tamper Evidence Feature – Anti-counterfeiting Features – Track & Trace system – Data Management Advantages of Automation: It converts evolution to revolution. It brings disciplined culture at workplace. It helps civilization to progress. Other advantages are – Minimized human interface – Large scale production output – Minimized variation on output – Assurance on safety and quality – Regulatory and Quality compliance – Inclusion of value-added features – Ease in data retrieval and recovery – Enhancement of packaging standard Limitations & Challenges: Even though automation brings lot of value addition, there are many factors which require advance analysis to adopt it successfully. Else the purpose of automation will not bring the intended benefits. – Space – Availability – Finance – Affordability – Workforce – Adaptability – Process Flow – Simplicity – Support Functions – Strength

Few examples of transformation through automation

of functions. Cross-functional interactions are must to exchange ideas for smooth implementation with harmonised thoughts. – Packaging component and process design – Production, Planning and Scheduling – Procurement and Service providers – Engineering and Maintenance – Quality and Validation – IT & Communication The standing instructions forautomation: Even though automation brings lot of advantages, there are few areas, which need attention to achieve the best out of it. – Precision process design with linear configuration as much as possible. – Practicing highest level of discipline without bypassing any control. – Perioding training of the people involved in the process. – Fine tuning the parameters and upgrading the controls. – Periodic maintenance of each of the line equipment.

– Branding Benefits – Awareness – Vendor Selection – Backward Integration – Market Dynamics – Evolving Technologies – Business Intelligence – Complete SWOT

Design & Development

Discussion & Decision

Deployment & Delegation


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Packaging

PACKAGING The Passionate Profession By Prabir K Das While choosing Packaging as career 34 years back (1985), I was not fully aware about its role and importance in our life. The concept of globalization and consumerization was nascent in this part of the world. But after completion of the course I soon realized that it is a subject where science, arts and commerce are homogeneously blended to make it a technology driven and application-oriented subject with immense potential in coming days. All types of materials and technologies are involved in packaging, directly or indirectly. Because of this wide material options, many different conversion processes are also involved, which covers a large section of the industry. The technology world suddenly started looking wider than the real world. A large range of packaging materials, designs and processes are available for adoption, depending on the nature of product, intended end use and mode of

distribution. It ensures the product retains the same quality through its assigned shelf life. It takes as much care for the product as a mother takes for her child. Very silently, it establishes the connectivity between the product and the people. Now I can proudly claim that the growth and success of globalization and consumerization is triumph of packaging with its valuable contribution. I feel proud to be associated with the healthcare industry for last 28 years where packaging is regarded as complement to the product and instrumental in maintaining the efcacy of the product throughout the shelf life. The profession and the industry have helped me to establish in the society and evolve as a person with multiple qualities. The most signicant learning is timely service to the distressed and deserving people who are struggling to live a healthy life.


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Ergonomic designs coupled with tamper-proof protections is part of our manufacturing excellence. 21CFR and other such regulations are complied with.

Each of these can be inserted along with a leaflet as well. And all at high speeds too.

Not just this, we offer bundlers and other end-of-line automations from our own range. Integrated technology means seamless operations and minimum downtime.

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Packaging

Secondary Functions & Value Added Features

organization and this we call as consumerization.

I have observed, apart from primary functions of packaging in protecting and preserving the product, there are many secondary functions emerged due to consumerization and globalization. Many value added features started getting embedded on packaging and labelling to comply with various regulatory, quality and patient compliance to sustain and survive in the industry.

Convenient and smart packaging

While some of these features are for consumer convenience, tamper evidence, authentication, others are for product positioning, safety and security across the supply chain. With all these primary and secondary functions, packaging has now become responsible and accountable for brand building for the product and trust building with the people. The socio-ecological drive also prompted packaging to be smart and environment friendly to promote the campaign on reduce, reuse and recycle program and to promote disposability and biodegradability. Awareness building in the industry The awareness building in the industry, academy and media has also taken new shape with changing scenario. Now, the subject packaging has grown up, exceptionally and exponentially. However, still there are unexplored opportunities prevailing at different levels and sectors of the industry. While big players at top layer understood its importance, medium and small sectors are yet to recognize its full potential. They are hesitant to take risk and realize the return. It is experienced that a good product may fail to get success with a bad packaging, but a poor product can achieve it with a good packaging. Packaging demands equal attention and passion as the product needs. With a balanced and compliant feature embedded in

Over the years, it has been observed a trend change from conventional pack style to convenient and smart packaging, efficiently backed up by operational changes from manual to semi-automatic or fully automatic packaging lines, not only to scale it up for volume, but also to reduce variability and improve consistency in quality and compliance. Various technologies started blending to assist automation through standardization and harmonization of packaging designs and systems. On line processes designed to ensure stronger controls and compliances. Combination of mechanical-electrical-optical engineering and introduction of digital electronics brought technological revolution in various conversion industries, including packaging. All these technologies adopted and adapted to ensure improvement in productivity, quality, stability, safety and security. With this rapid unconventional growth of the industry, a parallel threat also grown proportionately to tarnish the trust of people on successful products / brands. Many value added features then appeared and embedded in packaging to prevent tampering, theft, duplication, diversion, etc. On compliance front, there came child-resistant features, senior friendly features, punctuality compliant features, easy dispensing features, age-band specific designs, and many other features based on dynamic regulatory and customer compliance needs. Growth rate of technology faster than overall growth However, the growth rate of technology was much faster than the overall growth of the industry. Only bigger progressive players could afford and adopt


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players also left behind due to lack of foresight and reluctance in investment risk. A few faced limited infrastructure for extension or expansion of packaging facilities to embrace changes and challenges. Newer compliance challenges emanating from statutory and regulatory guidelines from local and global agencies further brought high investment and larger space requirements to sustain and survive in the industry. Such challenges often end up with either finding the loopholes in the law or strong lobbying to bend the rulings. Such situation sometimes creates chaotic business cases, obliterating all the innovative solutions to support control and compliance. Challenges and threats There are many challenges to keep pace with this regulatory and technology driven environment. The key challenges are harmonization of regulations from different geographies, integration of different technologies, training and skill development of people, simultaneous development of product and packaging, strong and reliable supply chain network, backward integration of raw material and conversion industries, academy-industry-regulators networking, awareness building among the people through seminars / conferences, etc. People need to understand that a consumer gets the product in their hand only with its packaging

Packaging

communicates and transfers the value of the product silently. We have a long way to travel with many more challenges and threats in coming days. Digitization and communication will be two major drivers in all sectors from development to distribution. Services will be equally important as goods and consumer expectation will be as dynamic as ever along with regulations to safeguard public health. All layers of the industry need to get true professional to channelize the resources for critical functions and allocate sufficient provision to adapt quick changes. Unfortunately, packaging today is still considered as a noncritical service function in many organizations, which need a prompt resolution. The other factor is variation of packaging standards. While the importance and valuation of packaging differ within an industry from large scale (global) organization to small scale (local) organization, it also varies across the industry. People from healthcare sector evaluate packaging on a different scale compared to FMCG sector. It also varies across geographies based on demographic conditions and practices therein. But flexibility with material and design options made it possible to meet all such variances within affordable reach of people. This is where science, arts and commerce

Conclusion In conclusion, what I learnt is – packaging connects the product with the people. So, it is important to understand the product, understand what people want and understand the process, how people can easily access the product and how can packaging function help to facilitate it by applying knowledge on material and technology, rules and regulations, logistics and distribution, economy and environment.


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ABOUT THE AUTHOR

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Prabir K Das, is one of the rst batch alumni (1985 – 87) from Indian Institute of Packaging, Mumbai (India), and a 30+ years-experienced pharmaceutical packaging professional, currently taking care of the Indian operations for one of the large and renowned global pharmaceutical service providers based in the US. He is actively involved in development, execution and post commercialisation life cycle management which involves technology transfer, new product-pack launch, packaging validation, change management, quality and COGS improvement projects, automation, standardization and harmonization projects, track and trace project, and any kind of innovative packaging development project considering patient safety and compliance.


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This article discusses the evolution of pharmaceutical packaging and dispensing, and how the year-old practice and stubborn attitude in the US population of having the medication (solid dosage) packaged, supplied, and dispensed will ultimately compromise it quality and efcacy as opposed to the overseas packaging system used for the solid dosage medication in blister package. Unlike overseas, in the US it is still use of bottles for the solid dosage packaging. This practice of pharmaceutical packing and supply for the US market is century old and due to the prejudice and un-scientic mind of the population. To me this packaging system has many disadvantages. My humble suggestion is: the academia should think about it and make some scientic studies to determine, come up and publish what is needed to be done?

Packaging

Evolution of Pharmaceutical Packaging & Dispensing by- Prabir K Das

By Masih Jaigirdar

I, Masih Jaigirdar, by education am a Pharmacist and by profession a Pharmaceutical Scientist started my professional career in the early 70s. In my boyhood in mid 50s when I used to go to the pharmacy or the medical college hospital dispensary to get the prescribed medication, they used to dispense the tablets either in a paper package or amber colour glass bottle. However, over the years it changed into different mode of dispensing, especially when the capsule medication was made available in the sixties; then the packaging was usually done by the pharma industry making strip packaging putting individual tablet or capsule into a pocket created between

through two heated rollers in a machine (e.g. Hasia or others). However, with my retirement, before I go into relaxation and hibernation mode, thought to bring as food for thought on certain pharmaceutical cum medical issues that I have come across over my career of about 50 years. I still remember after my graduation of Pharmacy joined the then E.R.Squibb & Sons, in the early 70s in their pharmaceutical plant in Bangladesh. At that time we have used Hasia Strip Packaging Machine for tablets and capsules packaging. We have packaged their Theragran-M multivitamin tablets and others with this strip packaging machine.


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Medicine packer bottles pharmaceutical grade

Packaging

Hasia strip packaging machine

Packaging of Solid Dosage (Individual unit) overseas In the early 70s when I started my career in Squibb, BD, it was “Aluminum-foil Strip packaging”, putting a single unit tablet/capsule within a pocket created between two polymer laminated aluminum foil passing through two heated knurled rollers with circular/elliptical cavities/sockets drawing the tablet/capsule from the hopper through a chute by a strip packaging machine with regulated temperature melting the polymer at the knurling area of the roller to seal the strip for the each individual unit of the dosage. A cutting knife was employed to cut the strip based on required number of units of dosage. An in-process test was done for the sealing check by performing a leak-test in a beaker/device with water, and putting one of such sealed strip with tablets/capsules and exerting vacuum. If there would be some leakage in the one of the pocket or many pockets of the strip (mostly at the beginning of the operation) air bubbles will come. Then after thoroughly wiping this strip undergone for the leakage test with towel or dry tissue, the strip was opened carefully to find which pocket tablet/capsule had actual wetness. This procedure was employed for both initial setting of the machine as well as an in-process test for the packaging process. In mid-80s when I went to Sweden for training at the then ASTRA at Sodertalje, Sweden, to take the position of Head of the Process Technique for their newly built pharmaceutical plant in the M.E; it was pre-pocket formed “Blister” packaging. Now it was initial or simultaneous pockets created in a

Individual unit tablet/capsule is put inside the pre-formed pocket and then closing and sealing mostly with a thin aluminum foil laminated with polymer, by either a single unit strips packaging or continuous striping packaging machine. Initial testing and inprocess testing were somewhat similar to that of aluminum foil strip packaging.

The user or the patient would open only one unit dosage from any of this system of packaging for intake. Hence, both of these above systems/procedures of packaging will not only provide protection against product stability towards its shelf-life but also any pilferage, contamination and/or physical manipulation for

Images of medication in blister strip

Packaging of Solid Dosage (Individual unit) in the US However, unlike overseas, in the US it is still use of bottles for the solid dosage packaging. These are packaged/supplied in bottles of High Density Poly Ethylene (HDPE) of counts for 30s, 90s or 500s up to 5000s unit with pilfer proof caps either child resistance (CRC) or non-CRC, aluminum foil induction liner, with or without dunnage and with or without desiccant supplies for use by the patient taking medicine or as commercial package for repackaging in the pharmacy. This practice of pharmaceutical packing and supply for the US market is century old and due to the prejudice and un-scientific mind of the population. To me this packaging system has many disadvantages for the following reasons: Product Stability: Pharmaceutical companies for its solid dosage drug products would put into a


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Packaging

configurations depending on number of units to fill-in and its stability requirement: a) singlewalled, double-walled, with dunnage (polyester) or no-dunnage, no or canisters of different sizes, desiccant (for moisture protection), odour absorption (activated charcoal) or both depending on the requirements. I myself as a product development formulator at various phase of product development, used to put in bare petri-dish and intended/planned product containers for the above stated sizes and configurations and requirements at the following stability conditions i) Controlled Room Temperature (CRT) using shelving cabinet ii) Stress stability condition 50°C / 2-3 Weeks iii) Accelerated Stability Condition (40°C / 75% RH) for 1, 2 and 3 months; and Long Term Stability

The commercial supplier warehouse and/or the pharmacy will receive in such packaged conditions ensured by the pharmaceutical manufacturer for their drug products. However, these drug products would again undergo the following stages of handling by the pharmacy or the patient during the dispensing or actual usage (intake) steps that may have impact on the stability of the product. At dispensing stage in the pharmacy: The pharmacy for 90 days supplies to the patient, generally will dispense these 90 counts of the dosage units tablet/capsule from a bulk container of at least more than 100 to 5000 count bottles and take into a tray for counting and filling into their own clear amber colour bottle and close with a cap and label it with all required information. The concern here is; there are two types of compromising:

Pharma HDPE CRC bottle (US)

Prescription pharmacy CRC vials-Amber (US)

Generally during the product development stage for the packaging stability testing, the following critical process parameters are maintained:

1) How the stability of the remaining dosage units in the bulk container is maintained once it is being opened. Thus firm given/maintained required stability condition is lost. If there were desiccant it will ultimately absorb the room humidity of the pharmacy storage. 2) When the pharmacist/technician is spreading the dosage units on a dispensing tray they are exposed not only to the room temperature, humidity conditions but also other in-borne particulate of the room air supply. Thus

P.S: With this studied the acceptability stability was determined and accordingly the required packaging conguration and CCPs are established and nalized.


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An Example of Packaging System Used in the Pharmaceutical Industry (Generic)

Packaging


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Point of concern and suggestion: What is the CGMP regulatory guideline and the current cGMP practice for the pharmacy environmental control of monitoring and recording all required CPPs i.e., temperature, humidity and personnel hygiene for dispensing and secondary packaging. Otherwise all those precautions required during the packaging of pharmaceutical unit dosage at the industry would be lost and the quality of the DP would be lost. At actual patient use stage: Generally at home, be it for 30s or 90s, the patient or his/her care taker will place this above stated dispensed drug product tablet/capsule in a medicine cabinet most likely within the vicinity of the bath-room where there is possibility of highhumidity and in winter temperature conditions and being opened at least for 30 to 90 times based on supplied format. Thus further exposing the medication at such stability compromised conditions. Comments and Suggestions: Here, my concern is without performing actual studies on these factual exposures of the drug product what would be their final stability, i.e., assay, impurity and/or pharmacological effectiveness? My humble suggestion is: the academia should think about it and make some scientific studies to determine, come up and publish what is needed to be done? Otherwise due to this years old practice and stubborn attitude in the US population of having the medication (solid dosage) packaged, supplied, and dispensed will ultimately compromise it quality and efficacy as opposed to the overseas packaging system used for the solid dosage medication in blister package. For such studies the college of pharmacy pharmaceutics with the collaboration of the agency (FDA) can do by simulating the conditions such as: I. For the pharmacy condition: Simulating the

units DP (Tablet or capsule) dosage X number of such numbers of opening and closing simulating in that prevailing environmental condition of the pharmacy dispensing area (temperature and humidity). Do all analytics including, assay, dissolution and impurity to find if the last dosage has maintained these quality integrity. II. For the at actual patient use stage: Simulating the opening of the dispensed container where it is supplied in an Prescription Pharmacy CRC VialsAmber in 30s or 90s for one month or three months supplies; for the worst scenario for 90 units DP (Tablet or capsule) dosage X number of such numbers of opening and closing simulating in that prevailing environmental condition at home in a medicine cabinet most likely within the vicinity of the bath-room where there is possibility of highhumidity and in winter temperature conditions. Do all analytics including, assay, dissolution and impurity to find if the last dosage has maintained these quality integrity. I just wanted to share my own experience and related concern, of going through the pharmaceutical packaging and dispensing evolution which I have come across in my life and over these 50 years being in the US and the ABOUT THE AUTHOR

product stability condition provided by the drug product manufacturer.

Packaging

Masih Jaigirdar

Masih Jaigirdar is a Pharmaceutical Scientist. He was a senior Quality Reviewer with FDA/OPQ/OPMA Division III. Besides his quality reviews of many applications including INDs, NDAs and over 500 ANDAs/Amendments before his retirement in October 2020, he has also contributed / participated in FDA OGD/OPF various scientic working groups as a team member. He is M. Pharm and Post Graduate Education in Pharmaceutical Science/Technology and over 35+ years of diverse experience in pharma industry in the eld of Product Development, Process Technology Transfer, Process Optimization, and Scale-up of Products and Manufacturing for Brand and Generic Pharmaceuticals in the US and Overseas (Europe & Middle East).


In Focus Exclusive

KOCH Webcasts

SUSTAINABLE PACKAGING: A hot topic in ASIA The WEBCAST series from KOCH Pac-Systeme GmbH, kicked off on 5th May 2021, focuses on the issues of sustainability, line competence, innovative processes, support and services, automation, technology and digitalization. The innovative, practical solutions that give you real added value in the packaging process and beyond. The webcast on June 01, 2021 at 7:00 am - 7:45 am, titled “Sustainable packaging: a hot topic in Asia”, talks on taking responsibility for the environment, serving consumer interests, and strengthening your brand for the future, and the global challenges that demand differentiated, market-specific answers. In the webcast, the specialists on site share their expertise on packaging solutions designed to employ the principle of “Reduce – Reuse – Replace” immediately – or step by step – in local everyday packaging routines. They present cyclePac® and other monomaterial packaging, and provide information on the numerous options available for driving sustainable packaging forward with KOCH. The 10 webcasts series was kicked off on May 5, 2021. May 05 – Your specifications, our expertise – for the perfect packaging line: The packaging line that perfectly matches specifications, where all the steps are highly automated and run with maximum productivity. May 06 – Packaging medical technology products: special requirements, special solutions: Machine solutions that offer more safety, more technology, more equipment features, and more support.

May 11 – Everything is possible and feasible – with sustainable packaging: Protecting the product and the environment, making your brand stand out, achieving full recyclability: with sustainable packaging solutions for a wide range of requirements. May 12 – Traditional or digital: The best service worldwide: How can service experts provide support during ongoing production? How can machine acceptance tests still be successfully carried out virtually? May 19 – Digital Know-how for a faster start and sustainable, improved packaging: What if we take care of the qualification process for you, giving you a genuine time advantage? High-level automation directly and permanently boosts the productivity of your line. Marking and inspection are carried out in-line at full machine speed. June 08 – Protection against brand piracy and a very special kind of "manager": Markus Eferdinger and Alexander Weiss explain how KOCH enables secure protection against pirate products in the supply chain. June 09 – Productive, integrated, sustainable: triad for tomorrow's packaging technology:


In Focus Exclusive June 09 – Not just OR but AND: conventional and sustainable: The speakers will explain how KOCH intelligently combines all aspects of sustainable packaging and gears them toward meeting future US regulations. June 09, 2021 at 4:00 pm - 4:45 pm. June 15 – Unlocking potential for value added: our K 4.0 smartpacks: Set up machines faster, install preventive maintenance, plan and control production centrally, monitor your equipment according to GMP and 21 CFR Part 11, train staff in short, memorable units.

KOCH Webcasts

The participants can register directly for the respective webcast, and choose the language that suits them. You can decide on the English webcast at 8 am or at 2 pm or the German webcast at 11 am. KOCHlive 2021 Following up with the highly successful premiere of KOCHlive 2021, KOCH Pac-Systeme is offering you an even better and more immersive experience: "The next dimension in packaging". KOCH has transformed the virtual trade fair into a platform offering more intensive live experiences and more content. A real highlight are the webcasts, where KOCH specialists share their expertise on trending topics in packaging, provide information about KOCH's special competencies, and respond to open questions. More information at www.koch-pacsysteme.com/kochlive.

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Lean, Agile & Smart

Courtesy by: www.pcne.eu

In today's time, to meet customer demand and keep the cost of goods at lowest, there is an ever-increasing need for Biopharmaceutical organizations and professionals to adopt lean six sigma methodology, showcase agile mindsets, and move towards digitalization.

Need of Lean, Agile & Smart Pharmaceutical Manufacturing By Bhavesh V Agarwal

The Covid-19 pandemic has disrupted the manufacturing of biopharmaceutical products due to uncertainty in the supply of raw materials, excipients, chemicals and consumables. Even in such situation the biopharmaceutical industry has continued the manufacturing with timely support of essential supplies. However, the cost of procurement has increased substantially and at the same time the availabilityof manpower for ancillary production areas has fallen. All these factors have drastically enhanced the cost of manufacturing the goods. Merits of Lean Six Sigma, Agile Mindsets and Digitalization Lean Six Sigma is a methodology that reduces waste and improves consistency in performance through continuous reduction of variability in critical business processes and ultimately minimizes operating costs, optimizes productivity, and maximizes customer satisfaction. Lean Six Sigma methodology is well-structured data-driven approach that enables organizations achieve effective and accurate outcomes repeatedly over a time. Potential

benefits of lean Six Sigma are: • Financial – decreased operating costs, potential capital reduction. • Quality – more robust processes leading to less errors. • Customer – better understanding of their needs • People – empowered multi skilled teams and efficiency enhancement • Knowledge – increased understanding of the entire supply chain including manufacturing processes and all other processes within the value stream. Lean Six Sigma has the potential to address, mitigate and manage some aspects of business risk in pharmaceutical and biotech Industry caused Agile is a mindset, a set of beliefs/attitudes, and way of thinking. Agile describes the agility of an organization and its process to adapt to changes. It includes qualities such as the ability to adapt to change, take pride in ownership, respect all team


Exclusive members, initiate collaboration, keen for improvement and focus on delivering value. The aim is to encounter the defects at early stages and to concentrate on possible areas of improvement during the development which accelerates the product development by eliminating defects and enhances the product delivery time and quality to the market. In a fixed mindset, people believe their qualities are fixed traits that cannot change. In agile mindset, people create and respond to changes in uncertain and turbulent environment. It is crucial for biopharmaceutical companies to adopt the Agile practices leading to accelerate innovation, shorten time-to-market, and increase operational efficiency. At present, best examples of Agile are companies who have developed the Covid-19 vaccines in such a tough, volatile, and unprecedented situation within a very limited time frame. It brings revolutionary changes in the entire product development cycle. Digitalization is the digital transformation of traditional process to digital processes, with

Lean, Agile & Smart

sophisticated IT infrastructure and networked data. The digital transformation of industrial processes is presently driving the next generation of futuristic solutions that are destined to be much smarter, further automated, and intelligent and cost efficient. Digitalization is drastically changing the face of manufacturing industry. Smart factories are transforming manufacturing process from conventional system to digitalized system by implementing innovative technologies. Digitalized, smart, connected factories generate immense data. These data are converted to information by various advanced automation solutions, helping factories to optimize operations, reduce wastages and losses and improve productivity, efficiency, and overall equipment effectiveness (OEE). It helps greenfield as well as brownfield factories to benefit from higher production uptime, improved efficiency, profitability, and a seamless horizontal and vertical connectivity.


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Lean, Agile & Smart

With digitalization, management can seamlessly connect to their shop floors from anywhere across the globe availing extensive trends and reports in real time. This will enable easier for them to take corrective actions, timely decisions and provide inline control over operations, thus, avoid wastages and losses.

few companies have just initiated and still working on it. Now, there is the need to adopt these initiatives holistically at all stages of product lifecycle and implement the changes to support efficiency improvement, cost reduction and product innovation in pharmaceutical and biotech organizations.

Current Status in Pharmaceutical & Biotech Organizations

Currently, companies are running hard to keep pace with changes brought by digital technology. Many phases, including the lifecycle of the product, manufacturing/maintenance and supply chain phases are on standalone mode with less predictive/low analytical approach. In fact, most of the assets have never been digitally planned and/or designed. Transformation of legacy systems and brownfield plants into digital platform are quite challenging and hence need to be addressed.

Despite the focus of Lean Six Sigma and Agile on quality, efficiency and productivity, pharmaceutical companies have not adopted it completely. The main reason for this being high cost and burden involved in re-validating any process change, even though changes were made in the spirit of improvement. Some companies are reluctant to any process change which are confirmed and validated in cGMP environment. Now, the time is to view biopharma companies for Lean Six Sigma model through cGMP perspective for improvement and changes in existing procedures/ workflow.

Way forward for Pharma/Biotech Companies

Moreover, in the present scenario the Agile approach is needed for improving team efficiency and shortening the decision-making process. Agile transformation is not one-time efforts. It is transformational journey that requires building the right team with the right frame of mind to break dependencies and foster cooperation on all levels.

Today, pharmaceutical/biotech companies are facing unprecedented demands/challenges due to volatile market as well as aiming to meet the needs of their customers with the utmost quality and safety at affordable cost. In order to meet all requirements and respond to such challenges, companies have to find ways to reduce internal costs and cycle times as well as provide high quality services to users, through innovative design and efficient response to the unexpected increase in demand for certain products.

Some companies have adopted these practices across the entire supply chain and are operated through the independent department of Operation Excellence or Continuous Improvement, whereas a

Although there is still no right solution to these economic problems, the methods of Lean Six Sigma and Agile practices can significantly improve the efficiency, optimize the costs, and reduces the


Exclusive defects, while facilitating compliances. First step is to understand and accept the need for change in the organizations to embrace Lean Six Sigma and Agile practices. Lean Six Sigma emphasizes process standardization and control of a process to minimize process variation, whereas Agile emphasizes on creativity and innovation as well as flexibility and adaptivity to maximize the business value of the solution. When we adopt both Lean Six Sigma and Agile methodology in synergy, then we can get results faster with increased value to the customers. Digitalization can fundamentally change the pharmaceutical and biotech industry. Earlier, digitalization was considered as nice to have in pharmaceutical industry, but now it is an essential part of the system to sustain the business after pandemic hit. Biopharmaceutical companies need to embrace the digitalization in all their functions and upgrade their operations in order to improve efficiencies, optimize operations and reduce costs. The most important task is to understand and thereby put across the right digital strategy at each stage of

Lean, Agile & Smart

product cycle. This comes from a deep knowledge and understanding of the entire infrastructure, including each of the assets and its functions, various processes and workflow, health, safety, and environmental aspects and thereby the value chain in entirety. The pairing might seem odd but embracing Lean Six Sigma and Agile together in the digital world can strengthen a company's digital transformation. Lean Six Sigma, Agile and digitalization are three pillars for transforming the conventional model of manufacturing to smart manufacturing. (Figure 1 depicts the integration of three pillars for business transformation)

Pharmaceutical businesses are undergoing a dynamic change and concurrent transformation on multiple areas, changing the whole product lifecycle from early drug development to manufacturing and patient care. It is hard to reflect on what level of economic impact world will experience post-pandemic. However, it's imperative for the manufacturer of life saving drugs to focus on minimizing operating costs, optimizing productivity, enhancing efficiency and maximizing customer satisfaction by supplying cost effective drugs with utmost quality and safety to the patient. With the emergence of novel technologies, innovation and digitalization, changes are inevitable. It is crucial for companies to remain vigilant to the coming futuristic changes and equip themselves to meet the challenges and opportunities that arise from time to time.

ABOUT THE AUTHOR

Conclusion

Bhavesh V Agarwal

Bhavesh V Agarwal is certied Six Sigma Black Belt and Lean manufacturing professional. He has 15 years of experience in manufacturing operations, process development and quality compliance of biotech and pharmaceutical industry. He has executed various continuous improvement and lean projects in earlier assignments. He has a work experience with reputed companies like Plasmagen Biosciences, ZydusCadila, Intas Pharmaceuticals, Pzer and Reliance Life Sciences.


Tech News

Technology Update

iF design award for high speed cartoner system ACG, is one of the world's leading providers of integrated solutions for the pharmaceutical and nutraceutical industries, has received the iF design award for high speed cartoner system. Judged out of Hamburg in Germany, iF awards recognise products from around the world that exhibit superior innovation and exemplary design. After months of research and customer consultations with pharma partners around the world, ACG's global design team, in collaboration with Design Ship in Germany, developed various design concepts for the new equipment, 'Karton X'. The winning idea, modelled on Stealth technology, provides unparalleled UX, intuitive HMI, smooth accessibility, and smart connectivity. ACG is currently celebrating its 60th anniversary, and now provides all requirements of oral solid dosage manufacturing to pharma and nutra companies in 138 countries.

Special recognition for operational agility: Covid-19 Grand River Aseptic Manufacturing, Inc. (GRAM), a leading injectable contract development and manufacturing organization (CDMO), was awarded the 2021 Facility of the Year Award for Special Recognition of Operational Agility: Covid19, by ISPE. GRAM received the distinction for the design and efficacy of its 60,000 sq. ft., world-class, large-scale fill/finish facility in downtown Grand Rapids, Michigan. GRAM designed the fill/finish facility from

53 PHARMA machines & technology

April - May 2021

the ground up with a focus on safety, capacity, and flexibility. Employee safety, exceeding regulatory requirements, and client needs stayed at the forefront by choosing best-in-class technology and facility design solutions first, then building the facility around to support. One-way material and people flows were incorporated to ensure product integrity, client viewing rooms with windows directly into formulation and fill suites were included for transparency, top of the line equipment was installed to provide flexibility, and Current Good Manufacturing Practices to serve a variety of client needs. The CDMO overcame geographical challenges and fasttracked the project to complete construction months ahead of schedule. This accelerated timeline enabled GRAM to open the pharmaceutical manufacturing facility in June 2020 at the height of the Covid-19 pandemic, leading to a contract with Operation Warp Speed and Johnson & Johnson. To further increase capacity, GRAM has invested in adding 18,000 sq. ft. to the facility, a duplicate Bausch+Ströbel vial filler with SKAN Isolator technology, and a VarioSys® syringe and vial filler which are set to arrive in early 2022 to further increase capacity and serve clients with advanced technology.

OBITUARY express our condolence to all the families who have lost the beloved ones in this challenging time, a larger than our client would be an understatement.

He will always be remembered in our organization.

MILAN MISTRY EXPIRED on 24th April, 2021

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