Healthcare Packaging July/August 2020

RACING TO FASTER CASE PACKING WITH ROBOTICS

JULY/AUGUST 2020

+ Flexible Production for Roche’s HIV Test Innovation + 3 EPCIS Data Exchange Issues in Pharma Traceability + MIT Researcher Talks COVID-19 Vaccination Hurdles + Sustainable Package Reformatting on the Rise PMMI Media Group | www.HealthcarePackaging.com

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Joining the Fight Against COVID-19 WLS VR-72 The labeler of choice for North American COVID vaccine labeling applications Label and code your vaccine vials at speeds in excess of 700 vpm with quick changeover and improved OEE. WLS is delivering multiple 600 vpm vial labelers for COVID applications in as little as 24 weeks.

NJM COURSERÂŽ Vial/Syringe Labeler This vial/syringe labeler supports the packaging needs for COVID vaccines. This operates with quick changeover from vials-tosyringes and runs up to 200 cpm.

It also meets the growing demand for small batch manufacturing of personalized medicines (503B pharmacy).

PHARMAWORKS The TF2 blister machine is generally used for pharmaceutical and medical device blister production. Pharmaworks converted and re-tooled the TF2 to produce plastic face shields helping to fill the PPE gap created

by COVID-19. This re-tooling shows the machine’s great versatility.

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CONTENTS

↑ pp.13 Robotics Speed Wet Wipe Case Packing 16 Diagnostics

Flexible Production Makes Roche’s HIV Test Innovation a Success

Roche designed a plasma separation card that greatly simplifies blood sampling and transport. Beckhoff Automation made production of the card cost-effective with its flexible, compact eXtended Transport System.

19 Supply Chain

Q&A: MIT Operations Researcher Talks COVID-19 Vaccination Hurdles

An expert discusses some of the environmental, research, and packaging concerns in supplying populations with a COVID-19 vaccine.

22 E-Commerce

Smart Supplement Shipper is LetterboxFriendly, Sustainable Brain health company Heights launches its D2C supplement product in a unique bottle and shipper made from bio-based materials that together measure less than one inch deep.

24 Factory Acceptance Tests

Virtual FATs: New Guidance Addresses Critical Need During COVID-19 Pandemic Brand-new guidance from PMMI’s OpX Leadership Network addresses the critical need for virtual factory acceptance testing during the COVID-19 pandemic.

25 Sustainability

30 Reusable Packaging

Loop Launches E-Comm Platform Nationwide

Loop products in returnable packaging are scheduled for launch nationwide this month, while retail partners in the U.S., France, and Japan plan to offer Loop in their stores later this year.

32 Cannabis Packaging

Embossed Wallet for Sublingual Strip

A recurring theme when it comes to packaging of cannabis is the transition from having an army of people in manual mode to an operation where automated or semi-automated systems reduce the amount of packaging that’s done by hand.

33 Virtual Reality

Part 1: Sterile Manufacturing Training Gets Immersive with VR

You’ve heard of OEMs offering augmented reality tools, but virtual reality has come to pharmaceutical processing training. This technology is transcending boundaries to enable hands-on skill building focused on the “why.”

COLUMNS 05 KEREN SOOKNE’S PERSPECTIVE 11 COLD CHAIN CORNER DEPARTMENTS 06 QUICK HITS 07 NEWS

Sustainable Package Reformatting on the Rise

10 QUOTABLES/BY THE NUMBERS

According to a new report by PMMI Business Intelligence, over half of CPGs are changing product packaging to meet sustainability goals by moving from one format to another. Recycling takes another hit during the pandemic.

13 OEM APPLICATION NOTE

12 MATERIAL DEVELOPMENTS 36 NEW PRODUCTS

27 Traceability

3 EPCIS Data Exchange Issues in Pharma Traceability Conformance testing services have emerged to cut down on wasted back-and-forth between manufacturers and trading partners to get efficient data exchange up and running.

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www.healthcarepackaging.com

Editorial DIRECTOR OF EDITORIAL CONTENT Keren Sookne

ksookne@pmmimediagroup.com EDITOR AT LARGE Aaron Hand

Art UX/UI DESIGNER Maggie Wilson ASSOCIATE ART DIRECTOR Jonathan Fleming CREATIVE DIRECTOR Dave Bacho

Publishing PUBLISHER Elizabeth Tierney, 815.861.2992 VICE PRESIDENT, CONTENT AND BRAND STRATEGY Jim Chrzan MANAGER, STRATEGY & COMMUNICATIONS Courtney Nichols AD SERVICES/PRODUCTION MANAGER George Shurtleff DIRECTOR OF MARKETING Sue DaMario FINANCIAL SERVICES MANAGER Janet Fabiano

Digital & Custom Media SENIOR VICE PRESIDENT, DIGITAL & DATA David Newcorn SENIOR DIRECTOR, DATA & INFRASTRUCTURE Elizabeth Kachoris SENIOR WEB DEVELOPERS Yevgeny Ananin, Andrew Tate DIRECTOR, WEBSITES + DIGITAL DESIGN STRATEGY Jen Krepelka

PMMI Media Group 401 N. Michigan Ave., Suite 300 Chicago, IL 60611 p: 312.222.1010 | f: 312.222.1310 www.pmmimediagroup.com PMMI The Association for Packaging and Processing Technologies 12930 Worldgate Dr., Suite 200, Herndon VA, 20170 p: 571.612.3200 | f: 703.243.8556 | www.pmmi.com

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Healthcare Packaging® (ISSN # 21543666) is a registered trademark of PMMI, The Association for Packaging and Processing Technologies. Healthcare Packaging® is published bi-monthly by PMMI with its publishing office, PMMI Media Group, located at 401 N. Michigan Ave, Suite 300, Chicago, IL 60611; 312.222.1010; Fax: 312.222.1310. Periodicals postage paid at Chicago, IL, and additional mailing offices. Copyright 2020 by PMMI. All rights reserved. Materials in this publication must not be reproduced in any form without written permission of the publisher. Applications for a free subscription may be made online at www.healthcarepackaging.com/ subscribe. Paid subscription rates per year are $55 in the U.S., $80 Canada and Mexico by surface mail; $130 Europe, $200 in all other areas. Single copy price in U.S. is $20. Free digital edition available to qualified individuals outside the United States. POSTMASTER; Send address changes to Healthcare Packaging®, 401 N. Michigan Avenue, Suite 300, Chicago, IL 60611-3789. PRINTED IN USA by Quad. Volume 14, Number 4 The opinions expressed in articles are those of the authors and not necessarily those of PMMI. Comments, questions and letters to the editor are welcome and can be sent to: editors@healthcarepackaging.com. Mailing List: We make a portion of our mailing list available to reputable firms. If you would prefer that we don’t include your name, please write us at the Chicago, IL address.

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PERSPECTIVE

Production Lines: Fast and Flexible Being nimble isn’t reserved solely for COVID-19 efforts.

While COVID-19 dominates the news, the healthcare packaging community continues to press on with sustainability initiatives, automation, and more.

You may notice themes of speed and flexibility in this issue, particularly in our cover story, where Medline Industries replaced an aging case-packing system for its wet wipe line with a system that accommodates large- and small-scale operations at 160 products/ min (pp.13). One clutch feature: it allows for small batches of test product to be packed in semi-automated operations, too.

Flexibility was also key in the production line for Roche’s plasma separation card for HIV testing (pp. 16), where a unique transport system made for efficient and cost-effective manufacturing.

On the COVID-19 front, an MIT professor discussed some of the hurdles the healthcare industry will face in distributing a vaccine (pp.19). One thing that really struck me as we talked was just how critical traceability will be in ensuring the vaccine is getting to populations in the order that experts deem the most helpful (be it children, vulnerable citizens, healthcare workers, etc.) without leaving people behind.

Meanwhile, one supply chain victory is the U.S. launch of the Loop shopping platform, which allows consumers to opt for durable, reusable packaging in a convenient e-commerce model. Packaging is returned and professionally cleaned before re-filling, and so far, the company is reporting positive reception and even a 97% packaging return rate within 90 days. Check out pp. 30 for more.

KEREN SOOKNE is the Director of Editorial Content of Healthcare Packaging. She may be reached at ksookne@pmmimediagroup or at linkedin.com/in/kerensookne

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QUICK HITS

1

Amazon Targets Counterfeit Crimes

A recent article posted on Amazon’s blog, dayone, discussed the company’s effort to crack down on counterfeits. The company is launching a new Counterfeit Crimes Unit consisting of former federal prosecutors, investigators, and data analysts whose job it is to prevent counterfeit products from being listed on its website. The initiative aims to help effectively pursue civil litigation against suspected criminals, support brands, and aid law enforcement officials across the world in action against counterfeiters. Amazon’s primary focus continues to be in preventing counterfeits from ever being listed in its stores. In 2019, Amazon invested over $500 million and had more than 8,000 employees fighting fraud and abuse, including counterfeits.

2 3 4

Novartis to Forgo COVID-19 Profits in Developing Countries

When a global pandemic strikes, it’s important to use the resources at your disposal to help others. According to a recent FiercePharma article, Swiss-based pharma giant Novartis is doing its part by promising zero profit from sales of 15 generic and over-the-counter drugs that manage COVID-19 symptoms in developing countries. The medicines, all from Novartis’ Sandoz unit, include widely used antibiotics, anti-inflammatory therapies, and medications for cardiovascular and gastrointestinal diseases. On top of that, Novartis has pledged to donate $40 million to support communities affected by the pandemic.

New Breathalyzer Detects COVID

Current COVID-19 tests consist of a deep nasal swab that collects a fluid sample and is sent to a lab. Results typically come days later, which can be problematic. Producing results in seconds would dramatically reduce the global pandemic’s impact. A recent Medgadget article discussed a new way to detect the virus: a breathalyzer. A team of researchers at Ohio State University has developed and is now testing a device that detects metabolites related to the COVID-19 infection within 15 seconds. The breathalyzer is inexpensive to manufacture, and easy to use. Early results are promising, but continued testing is necessary before the device can be used for mass screenings.

New Four-Wheel Wheelchair Lets Disabled People Go Off-Roading

Traditional wheelchairs certainly increase accessibility for people with physical disabilities, but they can still be limiting. A recent Medgadget article discussed a new product that aims to change that. The Rig, aka “Not a Wheelchair,” is a four-wheeled wheelchair that employs electric bike components to help people with lower limb paralysis enjoy long treks (up to 100 miles!) on rugged terrain. The device costs around $5k and was originally designed/developed by a Utah couple as something they could use themselves.

5

TIM HAYES, CONTRIBUTING EDITOR, HCP

Scientists Grow Operational Livers from Skin Cells

A recent Good News Network article discussed a new development in organ generation. A team of scientists at the University of Pittsburgh used skin cells to create small human livers, and then successfully transplanted them into rats. The team took adult skin cells and genetically altered specific genes and transcription factors to make “pluripotent stem cells,” which can develop into liver cells. The method could also be used to create “part-time liver grafts,” which could prolong the lives of people on the transplant waiting list.

6

Wildlife Activists Target Use of Crab Blood

Each year, hundreds of thousands of horseshoe crabs are netted and drained of their milky-blue blood for medical safety tests that detect bacterial contamination in drugs and implants. According to a recent Reuters article, activists from The National Audubon Society, Defenders of Wildlife, and other groups are pressuring the pharma industry to switch to a synthetic version of the blood, known as recombinant Factor C (rFC). The Horseshoe Crab Recovery Coalition says the shift to rFC could save 100,000 horseshoe crabs each year, and help threatened migratory birds that feed on crab eggs. However, there are regulatory hurdles for rFC preventing it from being on-par with industry-standard crab blood trials. Only two drugs, both from Eli Lilly, have been approved after rFC endotoxin testing.

To keep up with the latest news bits from around the world visit healthcarepackaging.com to subscribe and get Quick Hits sent right to your inbox.

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NEWS

New FDA Insight Podcast on Emerging Topics Dr. Anand Shah, FDA’s deputy commissioner for medical and scientific affairs, hosts a new podcast with other FDA leader guests as they provide their insight into issues facing the agency—including the COVID-19 pandemic and other emerging topics. As Dr. Shah explains, “The goal of our podcast is to educate our many stakeholders about the products that we regulate, the issues we face, and the processes that we follow in everyday plain language. We’ll be discussing COVID-19 and non-COVID-19 related topics.” New podcasts appear on Tuesdays and most are under 15 minutes in length.

— Keren Sookne

TEVA’s Abrasion-Resistant Adrenaline Injector Label TEVA offers adrenaline in a single-dose, prefilled disposable autoinjector for life-threatening allergies. The company selected an autoinjector label with special protection against abrasion and scratch-resistant reverse printing developed by Schreiner MediPharm. Allowing vital user and product information to remain legible over an extended period of time, the TLMI award-winning label is particularly resistant against chemical/mechanical impacts it may encounter while being carried (e.g. in a purse or backpack). An additional cover for protection is not necessary, which reduces waste and environmental footprint.

—Keren Sookne

Healthcare Market Equipment Investments Poised for Growth in 2021

Proposed Med Device Standard Will Help Validate Cleaning Methods

According to the May 2020 U.S. Packaging Machinery Purchasing Index report by PMMI Business Intelligence, end users in personal care and pharmaceuticals/medical devices are optimistic about current business conditions driving expansion in 2021, despite COVID-19 shutdowns and oil market surpluses creating a drop in other industries. Respondents in life sciences are reporting some expansion in planned projects, and increased usage of remote access. End users in the personal care industry are outperforming the total market in all metrics, likely due to demand for items such as hand soaps, sanitizers, and other assorted toiletries.

Download your FREE copy of the report at hcpgo.to/380.

A proposed ASTM International standard presents methods for detecting and quantifying cleaning markers (analytes) on reusable medical devices.

The goal of the proposed standard is to help medical device manufacturers, testing laboratories, and regulatory bodies identify the appropriate method(s) for evaluating whether a medical device can be adequately cleaned.

ASTM’s committee on medical and surgical materials and devices (F04) is developing the proposed standard. ASTM welcomes participation in the development of its standards. Become a member at www.astm.org/JOIN.

— Kim Overstreet

— Keren Sookne

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NEWS

Viral Hashtag Highlights Disparities in Academia, Healthcare It's critical to hear the experiences of Black scientists and academics as one facet of workplace and societal equality efforts (to be clear, there are many facets). To view tweets with personal stories, check out Twitter for #BlackInTheIvory, which refers to the “ivory tower” of academia.

In a recent Nature article, Nidhi Subbaraman spoke to the viral hashtag’s founders, Dr. Shardé Davis and Joy Melody Woods—assistant professor at UCONN and PhD student at the University of Texas at Austin, respectively—about how the hashtag began, the fear of repercussions, and more. Note that the stories shared are not an exhaustive list.

— Keren Sookne

Companies Collaborate to Bring Circular Materials to the Biomedical Industry Westfall Technik is announcing a new partnership with Polycarbin—a software enabled biomedical plastic recycling company that has developed a method for diverting single-use scientific plastics from landfills and incinerators, and recycling it back into the hands of scientists and clinicians as circular economy products. Using a system that leverages low-cost, frontend segregation and a waste analytics platform, Polycarbin is positioned to capture and repurpose valuable scientific plastics.

Polycarbin’s services aim to provide more cost-effective and environmentally responsible waste management solutions to research labs, biopharma, and clinical labs while closing the loop on the biomedical plastic life cycle.

— Keren Sookne

Med Devices and the FDA: Extended Deadline, Worker Safety Study Evaluates Benefits of Atmosphere Control in Blisters FreeThink Technologies, Inc., Aptar CSP Technologies, and PCI Pharma Services collaborated on a research study comparing the efficacy of Activ-Blister packaging configurations with cold-form foil in maintaining the stability of a model tableted drug product. Activ-Blister technology with molecular sieve (as well as Activ-Blister technology with silica gel) was found to be more protective than cold-form foil or thermoform blister alone.

The advantage over cold-form foil was particularly pronounced when the drug product had a high initial water content. The ASAPprime program was found to be effective at modeling packaging configurations incorporating molecular sieve and silica gel versions of Activ-Blister. For more: hcpgo.to/379.

— Keren Sookne

The FDA issued an immediately-in-effect guidance on Jul. 1, 2020 on its policy regarding compliance dates for class I and unclassified devices that are not implantable, life-supporting, or life-sustaining.

The guidance cited coronavirus as one reason for the extension, noting that “for those labelers that have not already implemented UDI requirements for class I and unclassified devices, preparing to implement UDI requirements while addressing the challenges related to Coronavirus Disease 2019 (COVID-19) could be very difficult and could divert resources from COVID-19 response efforts.” Additionally, CDRH recognized the need for reducing the risk of COVID-19 exposure among medical device manufacturing personnel, issuing 10 recommendations for worker safety in device production environments.

— Keren Sookne

8 | Healthcare Packaging • July/August 2020

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BY THE NUMBERS

QUOTABLES

The big picture? Packaging isn't seperate from “society, it's a reflection of it. As such, the industry is constantly struggling to reinvent itself to match the society it serves. And that's not going to stop anytime soon.

”

-MATT REYNOLDS, EDITOR AT PACKAGING WORLD

Another key [UDI] benefit, because “we're calling that product by the same name across the healthcare supply chain… rich and robust data that we can access around supply consumption and utilization rates. One of the buzz terms we've heard during the COVID-19 crisis was, 'What's my burn rate? How fast am I going through gowns, masks, gloves?'

”

– MIKE SCHILLER, SENIOR DIRECTOR AT AHRMM

Jun. 25, 2020

THE DATE that the WHO marked as the end of the 2018 Ebola outbreak in the Democratic Republic of the Congo (DRC), noting that vigilance against flare-ups must continue.

52%

THE PERCENTAGE of CPGs that agree that consumers need to be better educated to understand sustainability and what it really means for packaging design and costs.

Source: PMMI’s “Packaging Sustainability: A Changing Landscape”

$301 MILLION

THE PROJECTED GROWTH of the medical device security solutions market between 2020 and 2024.

“

As reported in the peer-reviewed article, The Importance of Climate Risks for Institutional Investors, researchers found in a survey of 439 investment professionals that only 7% of institutional investors said they had done nothing to manage climate risks in the last five years.

”

-REUSABLE PACKAGING ASSN.’S INNER LOOP BLOG (JUN. 8)

Source: Technavio

23%

THE REDUCTION in emergency department (ED) visits for heart attack in the 10 weeks following declaration of the COVID-19 national emergency.

Per the CDC, stroke and hyperglycemic crisis visits declined as well.

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COLD CHAIN CORNER

Transport Bag Offers Pre-Hospital Blood Protection on Air Ambulances KEREN SOOKNE, DIRECTOR OF EDITORIAL CONTENT

Pre-hospital care given by first responders can be critical to a patient’s survival: the ability for responders to give a transfusion at the scene of an incident could be lifesaving for a patient suffering significant bleeding and blood loss.

Many Helicopter Emergency Medical Service (HEMS) first responders including some in Europe are using Pelican BioThermal’s Crēdo ProMed transport bag, including Great North Air Ambulance Service, London’s Air Ambulance Charity and Yorkshire Air Ambulance. The medical transport bag is designed to protect health products, ensuring lifesaving blood products can be used at the scene of emergencies before the hospital.

One of the latest air ambulance charities to implement Crēdo ProMed is Essex & Herts Air Ambulance (EHAAT) in the UK, which now carries blood supplies on board its helicopters and Rapid Response Vehicles (RRVs).

Since introducing blood on board they have carried out 48 transfusions. Scott McIlwaine, operations manager at EHAAT, said, “The decision to start carrying blood products on board our helicopters and RRVs was a major one for the charity, one which has significantly improved the care that can be delivered to patients.”

“It was important for us to make sure that our critical care teams had the right equipment. That includes containers to ensure the blood is stored, transported and the correct temperature is maintained in the field for periods of up to 24 hours. After comprehensive research we selected Pelican BioThermal Crēdo ProMed transport bags, and they have never let us down,” added McIllwaine.

EHAAT’s helicopters and RRVs carry packed red blood cells of type O Negative, which can be used on any patient. When required, these are given with plasma, the other major component of human blood. Together these form a vital replacement for patients who have lost blood.

Other air ambulance deployments Dr. Anne Weaver, consultant in emergency medicine & pre-hospital care with London’s Air Ambulance said, “When we arrive at the scene of a serious incident, we often find a patient losing a signif-

icant amount of blood. In these cases every second counts and, as the first UK Air Ambulance to carry blood on board, we see the vital importance of being able to deliver transfusions on scene, pre-hospital, any time of the day or night.”

“After extensive validation carried out with the Transfusion team at Barts NHS Health Trust, we found the Crēdo ProMed transport bag to be the most suitable and have used them ever since,” noted Weaver. “Carrying blood on board our aircraft and in our rapid response cars has undoubtedly been a big change and we continue to innovate to create the next generation of survivors in the capital.”

At Great North Air Ambulance Service (GNAAS), introducing blood on board has resulted in the administeration of more than 300 transfusions. Andy Mawson, Great North Air Ambulance Service (GNAAS) director of operations, said, “To those patients who need them, transfusions are a vital lifeline which only a few years ago would not have been available outside of hospital. Without the right kit in place to protect those precious blood and plasma products, the procedure would be futile.”

↑ Essex & Herts Air Ambulance (EHAAT) in the UK now carries blood supplies on board its helicopters and Rapid Response Vehicles (RRVs).

Credit: ehaat.org

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MATERIAL DEVELOPMENTS

Combining the Benefits of Glass and Plastic for the COVID-19 Effort SiO2 Materials Science receives a $143 million contract from the U.S. government.

KEREN SOOKNE, DIRECTOR OF EDITORIAL CONTENT Operation Warp Speed (OWS) is a partnership among components of the Department of Health and Human Services (HHS), including the CDC, FDA, NIH, the DoD, and the Biomedical Advanced Research and Development Authority (BARDA).

As of press time, the OWS effort aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021—part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (collectively known as countermeasures) which will require a significant number of vials and other packaging components.

SiO2 Materials Science, a U.S. materials science corporation with novel technology for packaging biological pharmaceuticals and vaccines, recently announced a $143 million agreement with BARDA to accelerate the scale-up of the company’s vial technology.

The primary packaging system combines a plastic container with a microscopic pure silica (glass) coating, undetectable to the naked eye. The patented multi-layer system measures under 0.5 micron thick and includes: • Primary container • Adhesion layer to adhere the coating to the plastic • Silica coating • pH protective layer of silica mixed with carbon “The nation can produce all the vaccines we want, but we must have appropriate containers to store them and deliver them to patients safely,” explained Dr. Robert S. Langer, institute professor at MIT and advisor to SiO2.

The company reports that its coated materials feature a thermal stability range of -196˚C to 121˚C, with a seal integrity down to -80˚C to accommodate a number of storage conditions. Chemical stability makes the system suitable for a wide range of drug characterizations, including pH ranges from 3-14.

The system is resistant to breakage, withstanding 1,500 pounds of direct force, with the potential to save time, money, and resources in eliminating breakage on the line and post-fill. With a gas barrier, the vials have gas permeation properties like glass to provide the shelf life and stability required by many therapies.

SiO2 currently employs more than 200 engineers, scientists, and technicians, most of whom live in Lee County, AL. The company expects to hire 200 more.

↑ Automated transfer station of SiO2 product into the coating machine.

Additional Vaccine Vial News + BARDA is partnering with and providing $204 million to Corning to expand domestic manufacturing capacity to produce an additional 164 million Valor Glass vials each year if needed.

Corning will accelerate the scale up of Valor Glass tubing and vial manufacturing at the company’s facilities in NC, NY, and NJ. + The CEOs of Gerresheimer, Stevanato Group, and SCHOTT recently made a statement that they are committed to ensuring ample supply of pharmaceutical containers for any COVID-19 vaccine and treatment that is developed, and that no patient shall be left behind, no matter what region of the world they live in. + The DoD and HHS announced a $138 million contract with ApiJect for more than 100 million prefilled syringes for distribution across the U.S. by year-end 2020, as well as the development of manufacturing capacity for the ultimate production goal of over 500 million prefilled syringes in 2021.

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OEM APPLICATION NOTE

↖ With new equipment for secondary packaging that includes three Fanuc six-axis robots, Pearson was able to exceed Medline’s rate expectations, delivering 160 products/min.

Wet Wipes Case Packed via Robots at 160/min ANNE MARIE MOHAN, SENIOR EDITOR, PACKAGING WORLD Medline Industries of Northfield, IL, is the largest privately held manufacturer and distributor of medical supplies, including medical-grade wet wipes. Not long ago, the medical resource provider realized that its existing system for case packing wet wipe products comprised outdated equipment that no longer fulfilled its needs.

To find new equipment to replace its aging machinery, including a 2004 Goodman gantry packer, Medline turned to Pearson Packaging Systems, which had acquired Goodman in 2008.

Medline was looking for a solution that could accommodate largeand small-scale operations at 150 products/min. They also wanted the ability to quickly scale production, anticipating rapid market acceptance of a test product.

Pearson’s solution also needed to address the old machine’s limited two-axis, gantry-style movements, which caused the product’s corners to catch on the corrugated during packing. Additionally, product shingling during transfer at higher rates restricted the speeds at which the previous solution could pack product.

↘ The new Medline case-packing line uses a U-shaped floorplan, allowing a single operator efficient visual and physical access to the entire line.

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OEM APPLICATION NOTE

Through simplified and accelerated changeovers, decreased downtime and maintenance, and reduced dependence on low-skilled labor, Medline was hoping to achieve a significantly reduced Total Cost of Ownership (TCO).

With new equipment for secondary packaging that includes a Pearson CE15-T case erector, three Fanuc six-axis robots with continuous-motion conveying—all model M-10iD/12 robots—and a Pearson CS2542T case sealer, Pearson was able to exceed Medline’s rate expectations, delivering 160 products/min. The system also includes an ergonomic hand-pack and hand-seal station with case start-and-stop foot pedals that allow for small batches of test product without needing to program new recipes into the HMI. The flexibility innate to robotic solutions supports easy accommodation of different product types, rates, and pack patterns.

The corner snagging issues were resolved through corner guards on the end-of-arm tools (EOAT) to protect product during packing and articulated motion to nimbly move the product into tight spaces. Product shingling was overcome using vision and line tracking to ensure proper spacing between products for a reliable pick.

Three EOATs per robot supported by

↑ Robotic Top Loaders use custom end-of-arm vacuum tooling to pick packs of wipes in groups of two, three, or four, according to the recipe.

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OEM APPLICATION NOTE

automatic changeover enable quick and easy accommodation of new product runs, while continuous-motion conveying minimizes product damage, leading to increased uptime and reduced maintenance.

Additionally, the solution uses a U-shaped floorplan, allowing a single operator efficient visual and physical access to the entire line.

Sequence of operation Knockdown RSCs are stacked into the extendable, horizontal case magazine of the CE15-T. Blank suction cups advance to select the case, which is then indexed into the case-feed roller and transferred into the case-flight system. Opposed vacuum cups engage the case, and a pneumatic-operated set-up arm erects the case. The minor flaps are then closed and sealed with pressure-sensitive tape.

For smaller-scale productions, an operator station set up immediately downstream from the case erector includes a case escapement and a foot pedal to release cases. Empty erected cases exit the machine upright to be conveyed downstream to three Fanuc six-axis M10 Robotic Top Loaders (RTLs).

While cases are being erected, a pre-feed conveyor transports product—seam up and short dimension leading—through the product conveyor. A regenerative vacuum blower jump transfers product onto the vacuum infeed conveyor. As the product passes over the backlit conveyor, a vision system determines the position and orientation of the product as it moves upstream toward the top loaders. Rejected product runs off the end of the product conveyor and collects in a discharge bin.

The RTLs use custom end-of-arm vacuum tooling to pick in groups of two, three, or four, according to the recipe. After picking the product, the robots rotate 90 degrees and place it in the case in a single-layer pattern to maximize space and eliminate the chance of product corners snagging on case flaps during packing. Three

EOATs included with each robot allow operators to modify pack sizes and patterns, reducing changeover time.

Full cases are discharged from the cell via the full case conveyor and are conveyed to the CS25-42T case sealer. The minor and major flaps are folded, and the case is sealed with the pressure-sensitive tape. For smaller-scale productions, an operator station set up immediately upstream from the case sealer includes a case escapement and a foot pedal to release cases. Finally, the cases are conveyed to an upward gravity conveyor where they are transported to the palletizing area for shipping preparation.

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DIAGNOSTICS

↖ The PSC layers are placed in the workpiece carrier of the XTS mover using vacuum grippers and dynamically transported to the production and testing stations.

Credit: Beckhoff Automation.

Flexible Production Makes Roche’s HIV Test Innovation a Success AARON HAND, EDITOR AT LARGE TOP THREE TAKEAWAYS 1. Roche designed a plasma separation card that greatly simplifies blood sampling and transport.

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2. Production was cost-effective due to Beckhoff Automation’s flexible, compact eXtended Transport System.

lose to 38 million people in the world were living with HIV— the virus that causes AIDS—by the end of 2018, and some 8 million of those people did not know they were living with the virus, according to UNAIDS. Roche, a leader in personalized medicine, aims to help curb the public health threat through improved examination and monitoring of HIV patients. The company has developed a novel test device to make this possible.

In turn, that breakthrough was made possible through advances in production technologies from Beckhoff Automation.

At its site in Mannheim, Germany, Roche developed a new plasma separation card (PSC) that not only requires just a small amount of blood from a patient’s fingertip, but it also greatly simplifies sample transport. For the first time, blood plasma samples no longer need to be cooled during transport to the laboratory. This is particularly important given that more than two-thirds of the people infected with HIV live in sub-Saharan Africa.

The cobas PSC significantly changes the way plasma samples are taken and prepared and facilitates reliable quantitative testing even

3. The card features a carrier layer with a bonded nonwoven fabric and an upper layer for protection and labeling.

in environments with extreme heat and humidity. Roughly a credit card in size, the stable and easy-to-use blood plasma sampling card was achievable through Beckhoff ’s eXtended Transport System (XTS), a flexible, compact and dynamic production technology that allows it to be made cost-effectively.

The Beckhoff XTS is central to the compact (3.5 x 3 m) machine that makes the cobas PSC. The mechanical engineering specialists in Roche’s Manufacturing Service & Technology department had just two years to get the project ready for production. As a highly flexible transport system, the XTS helped the production unit adapt to changing requirements during the development process.

Its software-based functionality, which is easy to modify, means that process optimizations can be implemented quickly.

The complex structure of the PSC makes this particularly important. “A carrier layer is used for mechanical fixation,” describes Lukas Nagel, specialist engineer at Roche’s Mannheim site. “Next, a thin adhesive layer attaches to the plasma-separating membrane. Underneath is a non-woven material separated with a chemical stabilizer

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DIAGNOSTICS

to preserve the human plasma for up to six weeks during transport.

A label is provided on which the patient information can be recorded by hand. Finally, there is a protective layer.”

A key aspect that sets the PSC apart from other testing solutions is that the human plasma only needs to dry a little for safe transport, and then can be liquefied again in the laboratory to be analyzed in the same way as blood plasma is normally analyzed, Nagel notes.

The carrier layer—used mainly for sample transport—is just one part of the complex structure of the card, however. Two adhesive strips are applied to the carrier layer, followed by the nonwoven fabric for plasma absorption. The desired geometry is punched into a carrier tape and small adhesive dots are then applied to seal the plasma in. Finally, each card is laminated with an adhesive tape to form the underside and then it is bonded to the carrier layer. Those two layers form the first intermediate product.

The second intermediate product—the top side of the PSC—is formed in a similar way. The desired geometries are also punched and the card corners are rounded off for easier removal in a subsequent step. After several optical test steps, both intermediate products are bonded. The assembly and label placement then undergo a final check.

Exacting demands The special fabric for the plasma-separating membrane is very sensitive and expensive, resulting in stringent demands in order to minimize waste, Nagel says. Forces must not exceed 7 N to avoid altering the structure of the nonwoven fabric—to guarantee this, a laser cuts out the membrane very gently. “When the unit starts up, the processing table from which the membrane is collected is

measured. The system then checks the workpiece carriers on all 10 XTS movers,” Nagel explains. “In this way, all component tolerances are compensated. In order to exert as little process force as possible, the membrane is applied to the adhesive layer with vacuum grippers.”

One advantage of the XTS, Nagel notes, is that the component tolerances can be stored in software and then assigned to each mover individually for the entire production process. “In a conventional transport system, this would have to be implemented mechanically at each workstation and would therefore be much more complex,” he says. “In addition, XTS automatically provides traceability, which would otherwise have to be implemented using QR codes, for example.”

The XTS also provides high precision and software functionality in the motion axes of the workstations—such as cutting units, rotary tables, and transfer arms—implemented using EL7211 servo motor terminals and AX5000 servo drives. One example is the measuring probe function of the AX5000 servo drive, which can be used to store the actual position of the controller without time offset, depending on an event.

“This function comes into play when punching the geometry into the carrier tape and has been a great advantage during the development process,” Nagel says. “Initially, neither the exact card size nor the number of openings to be punched for subsequent application of the plasma were known. The lifting and punching sequences could be quite easily determined by software and adapted as required.

For example, the card size could be optimized very efficiently, the number of application fields defined, and the card corners rounded off.”

Flexibility in a compact design

↑ The complex structure of Roche’s cobas plasma separation card consists of a carrier layer with a bonded nonwoven fabric and an upper layer for protection and labeling. Credit: Beckhoff Automation.

With limited space available in its production environment, Roche also relied on the XTS to provide high flexibility within a compact system. Roche is using an XTS with 10 movers and a 3 m track length, with individual workstations set up around it. “This results in a symmetrical machine layout in which the first preliminary product—the carrier layer—is processed on one side and the second preliminary layer—the upper layer—is processed and optically inspected on the other side,” Nagel explains. “The membrane is cut out in the center of the unit so that the complete card can be produced in a single XTS cycle. A system based on a rotary indexing table, which had been considered initially, would have been much larger.”

A key benefit of the XTS is its asynchronous motion between stations—providing the ability to synchronize fast workstations with slow process sequences. Rather than the speed of the line being dictated by the slowest process, the system flexibility lets workstations be better utilized by duplicating time-consuming work July/August 2020 • Healthcare Packaging | 17

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The carri gripp the p Beck To pr XTS Cred

DIAGNOSTICS

processes. Beckhoff ’s conveyor automatically adjusts itself to the slowest process step and remembers the current processing status and missing input materials for each mover, Nagel adds.

In the case of the cobas PSC, the slowest processes are laser cutting of the nonwoven fabric and the associated pick-and-place,

↑ To produce the cobas PSC, Roche uses an XTS with 10 movers and a 3 m track length. Credit: Beckhoff Automation

Nagel says. “With XTS, it is now very easy to prepare six cards at a time, transfer them to the laser cutting unit, and then glue them individually to the corresponding card tops,” he says. “Without this high flexibility offered by XTS, we would have had to process much larger membrane pieces or make provisions for multiple transfer stations.”

This capability also simplifies early ejection of defective subcomponents. If a part is recognized as a reject, its mover disregards all other workstations, simply pushing the part through each step until it can be ejected from the process. Unlike a rotary indexing table, the XTS avoids further processing of reject parts.

Beckhoff ’s TwinCAT 3 XTS Extension software provides collision avoidance and synchronization functions to achieve this flexibility.

But the XTS also has the ability to limit the current or force available for each mover, increasing or decreasing the current as needed for each individual mover even if both movers are on the same motor. This gives Roche the ability to better control the interaction between tooling. “We use this function when the workpiece carriers for opening the holding clamps are mechanically fixed,” Nagel explains. “Limiting the controller current simplifies this mechanical referencing without losing the position control via the XTS encoder system that is advantageous elsewhere in the system.”

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SUPPLY CHAIN

Q&A: MIT Operations Researcher Talks COVID-19 Vaccination Hurdles KEREN SOOKNE, DIRECTOR OF EDITORIAL CONTENT

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round the world, scientists and citizens alike are hoping for a COVID-19 vaccine. Dr. Anthony Fauci is “cautiously optimistic that we will have a vaccine within a reasonable period of time, not only from Moderna, but from other companies too.”

Healthcare Packaging spoke with MIT’s Dr. David Simchi-Levi, an operations research scientist who has thought through some of the challenges of preparing for the vaccine rollout. His research currently focuses on developing and implementing efficient techniques for logistics and manufacturing systems.

HCP: What do you feel is that first hurdle that people are overlooking in distributing an effective vaccine?

Dr. David Simchi-Levi: The vaccine rollout has many different challenges. I’ll start with some of the observations about the vaccine development. Part of the challenge is making sure that we focus on the safety of the vaccine itself in providing long-term protection for all the people. There are several technologies considered for the vaccine.

When we talk about product, we don’t know which one will be July/August 2020 • Healthcare Packaging | 19

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SUPPLY CHAIN

successful just yet and we don’t have many examples where the scientific community has been successful in developing vaccines for infectious diseases in the last 100 years.

So which one will be successful? And once you develop one, it’s typically a sequential process. You start in the lab, you test on animals, then you test on people in several trials, then you create specialized manufacturing processes. It’s a very linear process that can take several years. The problem is that we don’t have time now, and we need to do many of these steps in parallel. And challenge number one is that we don’t know which technology will be successful so we don’t know which manufacturing process to invest in.

are at high risk? Should it go to medical staff first because they are exposed? Should it go to young people because they interact a lot with others?

All of these questions are on the table, but for now the main question is, for all the steps that normally follow a sequential process, how do we do many of them in parallel?

HCP: What are your thoughts on effective and ethical allocation?

DSL: It’s a critical question: What is that allocation mechanism? How can the federal government, health insurance companies, etc. make reasonable allocation decisions that benefit the population as a whole?

This is exactly what my team at MIT is working on now: a model that tries to identify HCP: And with different manufacturan effective allocation strategy that will ing processes, there could be different allow us to improve the effectiveness of the supply chains? vaccination, when not being able to give it ↑ MIT’s Dr. David Simchi-Levi.

DSL: Exactly. The Gates Foundation is now to everyone. We need to vaccinate as many building or investing in the seven most as 70% of the population, while making sure promising technologies, because they don’t know which one it will there’s no spread of the epidemic because we couldn’t get to everybe. You may not use all of them because maybe only one of the techone.

My team studies what we need to decide, what is the best way from nologies will be effective. a community point of view to allocate the available inventory. Our government here in the U.S. is looking into this, the EU, the Chinese HCP: How does packaging come into play?

DSL: The second challenge is that in order to use the vaccine effec- government—everybody’s looking at the same issue. tively, you need to provide storage to make sure that the vaccine itself does not degrade. The entire process has to be controlled, just HCP: We hear a lot about “a vaccine” or “a treatment,” but as with any drug. Vaccines are extremely sensitive. They lose effec- what are some of the supply chain considerations if there’s a tiveness if stored at the wrong temperature. So packaging, distribution, and the temperature-controlled supply chain are a critical Workforce Issues part of the challenge.

In addition, each dose, each unique vaccine requires all sorts of HCP: With the sheer size of the target market (essentially, components that are low-cost, but we don’t have the supply. We everyone) do you foresee workforce shortages either in drug don’t have the ability to produce a package for the product right manufacturing or with healthcare workers? now: vials, stoppers, needles, caps and so forth. Making sure that DSL: This is another important issue. It’s both in healthcare we have the inventory of specialized glass for vials domestically is and in manufacturing because in the manufacturing process, a challenge. These components are produced mostly in China and you need to maintain social distancing because of the virus in India. For example, there is only one company in North America which reduces productivity. You also need to make sure that able to produce needles in large scale. people have core skills training to be able to move from one You can expect that—and this is not politics—we’ll see some countechnology to another. Remember that we don’t know which tries blocking, say, a shipment of this type of supply because they technology will dominate, and there are seven different factowant to keep it for their own citizens. So logistics is going to be a ries in the Gates example. You need a workforce that is capable challenge. of switching from one to another, depending on which one And finally, no matter what we do, there will not be enough supply is successful. I think this becomes really a critical part of the to cover the demand, so there will be a need for a decision: who supply chain solution. gets it and who doesn’t? Should it go to elderly people because they 20 | Healthcare Packaging • July/August 2020

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combination of drugs that works versus one silver bullet?

DSL: If there is one silver bullet that is successful, one advantage is that we can scale very well, but the disadvantage is not having enough capacity. If only one is successful, six of the manufacturing facilities that, say, the Gates Foundation is focusing on will not be able to produce this one silver bullet, unless they build flexibility into these manufacturing facilities to change from one technology to another.

That will allow us to scale very quickly once we know which technology is effective, but flexibility does not come free… there is a cost associated with that. I’m not sure what exactly the plan is, but flexibility is one important element that can help us scale very quickly if we are willing to invest in it.

HCP: Any comments on vaccine traceability?

DSL: One thing I’ll note is that people talk about the use of blockchain as a way to allow you to trace the product and origin and make sure that it is not counterfeit. I’m sure traceability technology will be one part of the solution.

HCP: How might climate change and the carbon footprint of manufacturing and logistics tie into the effort to reshore operations?

DSL: This is a very interesting topic. We know that for a lot of these manufacturing processes, you need certain chemicals and a lot of these chemicals are now produced, not here, but in India and in China.

People often say the reason they’re produced oversees is to reduce cost. This is only part of the reason. The second driver of the move of these chemical manufacturing activities to India and China is because chemical manufacturing processes are highly polluting.

And so the move to Asia in part is driven by environmental concerns.

Now, if companies say they’re moving API manufacturing to North America or Europe, this will increase cost, but the issue is that nobody’s going to agree to build these chemical manufacturing facilities that will be highly polluting.

So you need clean chemical manufacturing processes, and that requires time and significant investment. Who will make this investment? Is this going to be the federal government, or private investors? The European Union may have one opinion and the U.S. federal government here may have a different opinion.

These manufacturing challenges are not only about the cost. It’s a lot about environmental issues. China is not relaxing their effort either. They’re looking for clean manufacturing processes. So if China figures this out and has a low cost, it will be very difficult to motivate the move to North America. That’s why I’m saying it’s time and investment.

People will be looking for reusable packaging materials. But to me,

even before that, there are issues with pollution and the fact that the U.S. is already coping with a shortage in the specialized glass needed for the vials. Even before packaging exists, these are important challenges that you need to address today, in order for packaging to be there five months from now.

Supplier Side: Using Automation to Fast Track COVID-19 Vaccine Production On the heels of the FDA creating the Coronavirus Treatment Acceleration Program (CTAP)—an emergency initiative aimed to support clinical trials that are testing new treatments for COVID19—Honeywell has introduced Fast Track Automation, a technology package that can help accelerate the production of vaccines.

Using a combination of its proprietary automation and process technologies for the life sciences industry, Fast Track Automation enables vital vaccines, treatments, and therapies to move from regulatory approval to full production in as little as two months, depending on process requirements, the company said.

The offering brings together the cloud, virtualization, batch software, remote asset management from a data center, and the flexible assignment of computing power. The technology combination prepares manufacturing automation designs in parallel with clinical trials, designed to ensure production is ready to go once a medical therapy is approved.

Specifically, the set up incorporates process automation elements that can be configured in a virtual environment, then implemented rapidly once a therapy is approved and ready to be produced for public distribution. Manufacturers can even use the system to digitize manual steps during clinical trials to better consolidate and analyze data and more seamlessly prepare electronic submissions for regulatory body review and approval, using this data to prepare final production automation design.

Fast Track Automation is a direct response to the global COVID19 outbreak. According to the company, at the point in time when clinical trials are nearing completion, the ability to rapidly pivot and scale up to meet production demand will severely test existing technology infrastructures. “Our solution allows for end-to-end manufacturing process and data visualization, providing realtime visibility and predictive insights while offering benefits like enhanced audit-readiness and data integrity, minimized regulatory risk, increased operational efficiencies and reduced rejects and waste,” said Cynthia Pussinen, vice president and general manager, Life Sciences, Honeywell Process Solutions. Fast Track Automation, available now, can be quickly scaled up or down depending on needed changes and demand.

—Stephanie Neil

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E-COMMERCE

Smart Supplement Shipper is LetterboxFriendly, Sustainable

↘ Foregoing the usual cold, sciencelike design language used by supplement brands, the clear 60-ct bottle for Heights’ supplements has a soft, asymmetric ‘thought bubble’ shape and is flat on the front and back to reveal distinctive capsules inside.

ANNE MARIE MOHAN, SENIOR EDITOR, PACKAGING WORLD TOP THREE TAKEAWAYS 1. Brain health company launches its D2C supplement product in a slim bottle and shipper.

2. The bottle and shipper are made from bio-based materials that together measure less than one inch deep.

3. The clear 60-ct bottle has a soft, asymmetric ‘thought bubble’ shape.

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rain health and mental wellness supplements company Heights has pioneered a new dimension in e-commerce packaging—and it’s only 25 mm, or 0.9 in., deep. The impossibly thin shipper, with an even slimmer, 23-mm bottle inside, was designed by the London-based company to easily fit through a UK letterbox-style mailbox.

Being unique is not new for this startup company; its distinctive supplement uses “capsule in a capsule” technology whereby the dry ingredients are in one capsule that is suspended in an outer capsule of Omega 3 oil. Says the company, “Most vitamins need to be taken with food or a fat-soluble substance. Because ours comes ready-made inside an Omega 3 oil and dissolves slowly in your lower intestine, you get more of the nutrients reaching your bloodstream than in traditional pills, which break down too early to be effective.

An added benefit to this—no nausea.”

Specifically designed to give the brain the fuel it needs to improve its health and performance, the easy-to-swallow “smart capsules” are made from natural ingredients—among them, B12, blueberry

extract, and 16 other essential vitamins—in the most biologically active form and are augmented with educational content for consumers on how to optimize brainpower.

Says Heights co-founder Daniel Murray-Serter, “We use all natural nutrients and no synthetic fillers or caking ingredients and track your journey with us from day one, sharing insightful content from the world’s leading experts to help coach you on your journey to mental wellness.”

Heights began working on the package design in early January 2019 with design firm Pentagram. The project was led by Pentagram partner and industrial designer Jon Marshall. Explains the firm, because Heights is a D2C brand, the design of the bottle was

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E-COMMERCE

↖ The slim, e-com shipper comprises a hinged tray fitted with movable inner trays that securely hold the bottle and product literature.

driven by two factors: It needed to be highly distinctive in order to launch the brand, and it also needed to be less than 25-mm thick to fit through the letterbox for efficient delivery and a great customer experience.

Adds Murray-Serter, “We were 100% committed to fitting through the letterbox for environmental reasons, accessibility, and the ability to send internationally as a large letter. That was the starting challenge for the design project in general.”

Foregoing the usual cold, science-like design language used by supplement brands, the clear 60-ct bottle for Heights’ supplements has a soft, asymmetric “thought bubble” shape and is flat on the front and back to reveal the distinctive capsules inside. A narrow neck tapers into the main body of the bottle, making it easy for consumers to remove the daily dosage of two pills at a time, while ensuring the bottle can be easily filled during the packaging process.

According to Pentagram, the design team used a combination of software simulation and extensive development and prototyping with the (proprietary) blow-molding manufacturer and with the bottle filling line to achieve the distinct bottle shape.

In order to minimize the shipper’s carbon footprint and stay within the 25-mm overall package thickness for economic delivery, Pentagram engineered the special shipping box so that it adds

just 2 mm to the thickness of the product. The package comprises a hinged tray fitted with movable inner trays that securely hold the bottle and product literature and can be swapped out for future Heights’ products.

Besides being letterbox-friendly, the entire package is also very eco-friendly—a must for Heights. “The packaging had to be bestin-class for sustainability because we have always planned from day one to qualify as a B Corp,” explains Murray-Serter.

While the initial bottle design was tested and pre-launched using PET plastic, the final, commercial-scale version uses bio-based polylactic acid (PLA). The shipper is constructed of sugarcane-based pulp, and the information inside the package is printed on recycled paper.

Heights launched the e-commerce product in the mail slot-compatible shipper in Nov. 2019. Says Murray-Serter, “The response has been phenomenal. We’ve had customers tagging themselves in places like the Alps, on beaches, and as far as Easter Island, just to show off the amazing bottle design.”

For the latest in packaging design and materials, make plans to visit PACK EXPO International/Healthcare Packaging EXPO 2020. For more information visit packexpointernational.com.

July/August 2020 • Healthcare Packaging | 23

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FACTORY ACCEPTANCE TESTS

Virtual FATs: New Guidance Addresses Critical Need During COVID-19 Pandemic JIM CHRZAN, VP OF CONTENT AND BRAND DEVELOPMENT

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he OpX Leadership Network released best practices and leadership guidelines for executing virtual factory acceptance tests (vFATs) to address the changing operational landscape brought on by COVID-19.

This addendum to the existing Factory Acceptance Test (FAT) work product tackles how to most effectively use communication and connection technologies to allow consumer packaged goods (CPG) companies to interact remotely with original equipment manufacturers (OEMs).

“The pandemic has required new methods be established for executing FATs, which are likely to become standard procedures in the post-pandemic ways of working. This document provides the guidance both CPGs and OEMs need to successfully implement these new processes,” says Bryan Griffen, director of industry services, PMMI. “The OpX Leadership Network’s unique perspective blending CPG and OEM input makes these best practices critical learning for anyone interested in virtual FAT options.”

The OpX Leadership Network was founded in 2011 by PMMI, The Association for Packaging and Processing Technologies, to ensure CPG companies and OEMs are well-connected and well-prepared to solve common operational challenges, make smarter decisions, and achieve operational excellence.

There are two parts to both the FAT work product and vFAT addendum–the playbook and an editable checklist. Both the FAT and vFAT work products, as well as other operational solutions, are available for free download at OpXLeadershipNetwork. org/projects (FAT downloads are listed under Capital Projects).

Virtual FAT for a Blister Machine Romaco is one supplier taking a new approach with FATs due to customers’ travel restrictions. Their first live remote FAT for a Noack 623 blister machine was recently completed at the Romaco manufacturing facility in Karlsruhe, Germany. The machine—purchased by a pharmaceutical producer in southern China to seal ultra-lightweight gelatin capsules in aluminum-aluminum blisters—can now be shipped and placed into operation as planned.

The vFAT took a half a day. Personnel at the customer site in China monitored the functional tests closely during the live broadcast. The project manager in charge at Romaco China was at their side to translate questions and provide answers.

“The only things we have to do without when carrying out digital acceptance tests are the meals we normally eat together and of course the group photo standing next to the machine after it’s passed the FAT,” says Markus Frey, area sales manager at Romaco Pharmatechnik GmbH in Karlsruhe. “We intend to catch up on all of that later on after the pandemic is over.”

Romaco has other vFATs planned, including a blister line with cartoner and case packer for a French contract packager and packaging lines destined for a pharmaceutical group in the U.S. —Keren Sookne

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SUSTAINABILITY

Sustainable Package Reformatting on the Rise KIM OVERSTREET, CONTENT STRATEGIST

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rand owners and retailers are “hungry” for new sustainable format packaging solutions, and 56% of CPGs are switching or considering new packaging formats to improve recycling.

In 2019, the Flexible Packaging Association reported that 67% of brand owners were putting more effort into sustainability efforts, and statistics show consumers are buying these sustainable products. In the U.S., products marketed as sustainable made up $113.9 billion in sales in 2018, an increase of 29% from 2013. Sustainable products grew, on average, 5.6 times faster than products not marketed as sustainable, and accounted for 50% of CPG market growth from 2013 to 2018.

But while reducing packaging’s impact on the environment can build brand loyalty and connect with customers, changing a product’s packaging format—particularly novel and/or highly functional changes—can add challenges when testing and formatting new materials, according to PMMI’s report, Packaging Sustainability: A Changing Landscape. Also, CPGs are looking for even greater machine flexibility to handle variances in recycled materials.

“One of our main challenges is communicating the up and down sides of implementing sustainable packaging with CPGs to help make them aware of the impact at all levels of their organization,” said a packaging services director at a material supplier.

Some of the format changes that CPGs are implementing include using more standup pouches than bags; moving from PVC to PET, or from PET to aluminum; changing from rigid to flexible or returning to paper from plastic; eliminating bags and filling directly into paperboard cartons; migrating from 100% virgin plastic to 100% PCR plastic, or using more sustainable labels.

An operations director at a personal care company said, “Our goal is 100% recycled materials in the future; looking for biodegradable closures now but we have not yet found a solution.”

Materials innovations such as recyclable barrier layers, renewable plant-based materials, or 100% recyclable mono-material with barrier properties are all being explored, and while biodegradable and compostable materials are becoming more popular, other excit-

ing innovations like edible membranes are emerging.

These changes create challenges. The pharmaceutical industry requires thorough equipment validation with each packaging change. Conveying lighter gauge materials can cause jams, and sealing and closing during filling can be a problem with thinner film.

Also, machinery requires highly reliable data collection from sensor feedback to measure sustainability goals accurately.

Download the FREE executive summary of the report (PMMI Members can download the entire report) at hcpgo.to/376.

For the latest in sustainable packaging design and materials, make plans to visit PACK EXPO International/Healthcare Packaging EXPO 2020. For more information visit packexpointernational.com.

Recycling Takes Another Hit During Pandemic The coronavirus pandemic is creating a growing waste crisis even as we see images of the earth’s environment clearing from less pollution. A few months into the crisis, the numbers are staggering.

According to a Jun. 22 article by The Economist, the U.S. consumption of single-use plastic may have grown by 250-300% since the beginning of the pandemic. Consider these numbers: Grand View Research projects the global disposable-mask market will spike from an estimated $800M in 2019 to $166B in 2020; Amazon had approximately 2.5 billion customers visit in March alone, an increase of 65% from 2019; Uber Eats first-quarter sales were up 54% from 2019; and, more than 25% of China’s physical goods were bought online during Q1 2020, according to the Peterson Institute for International Economics.

All of these figures add up to an increase in plastic and packaging. And to add fuel to the proverbial fire, the oil market crash early in the year made plastic cheaper to produce, which in turn is a (temporary) disincentive to use recycled materials.

July/August 2020 • Healthcare Packaging | 25

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TRACEABILITY

3 EPCIS Data Exchange Issues in Pharma Traceability KEREN SOOKNE, DIRECTOR OF EDITORIAL CONTENT TOP THREE TAKEAWAYS 1. The global GS1 standard, EPCIS, offers a common information exchange language.

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2. In AmerisourceBergen’s initial testing, nearly every EPCIS file had data issues.

harma companies continue to make inroads to meet the DSCSA 2023 requirement for unit-level traceability at each change of ownership between trading partners. “Capturing and exchanging information at this level of specificity requires a common information framework,” explained Gary Lerner, president at Gateway Checker Corporation, at the GS1 Connect: Digital Edition virtual conference in June.

“This information framework captures what happens in the physical world with an electronic twin, essentially an information encoded representation of packing and shipping events that can be exchanged with trading partners. What’s needed to accomplish that is a common vocabulary and structure that enables trading partners

3. Conformance testing services have emerged to cut down on wasted back-and-forth.

to then share and exchange essential trading information in a consistent, accurate, and interoperable manner,” said Lerner. Without a common standardized approach, there will be considerable waste in time and effort with trading partners negotiating the structure and content in each point of connection.

EPCIS Lerner pointed to the value of the global GS1 standard, EPCIS (Electronic Product Code Information Services), which enables the common information exchange language that can be shared.

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suit a specific industry and application. In 2015, the GS1 US Healthcare working group recruited more than 50 companies representing a cross section of the pharmaceutical industry to adapt EPCIS to address DSCSA specific requirements. And in 2016, the application standards governing DSCSA traceability were published. Adopting these standards therefore helps different businesses within the drug supply chain to more efficiently and effectively connect and share information,” he said.

Challenges of data exchange

going through downstream distribution at a case level. That would be understandable. This is something that is shipped typically at the unit level.

“At ABC, we shipped 3 million units outbound every day, and we must make sure that all the data is available to us on the inbound shipment. So when we send out nearly 4,000 purchase orders to manufacturers a day, we’re getting back nearly 4,000 shipments every day. Some of them are one case and some of them are multiple tractor trailer loads for a single purchase order. So it’s very important that that data for the inbound shipment to us is accurate because if it isn’t, it will impact our ability to receive the product,” said Denton.

As testing is underway, AmerisourceBergen Corporation (ABC) is already seeing issues with EPCIS files coming in from drug manufacturers. Jeff Denton, vice president, global secure supply chain at ABC, said at this point, they’ve received about 30 to 40 Testing delays files and “nearly every single one of them Hidden issues in bills impede a distributor’s ability to pick and ship the product to had issues upfront with their initial testing.

I don’t think I had a single file come in for customers downstream. All the issues listed ↑ Jeff Denton, vice president, global the first time that was accurate.” above lead to delays in testing. “Once an secure supply chain at AmerisourceBergen He shared three of the issues observed: issue is identified by a system when we’re Corporation (ABC).

Event time is missing: Denton explained going through the test phase with a trading that event time describes when something partner, all the processing of that file stops. occurs such as commissioning a bottle on So we go back and forth with manufacturers the packaging line, packing it into a case, and in some cases, we’ve had to do that for three months,” Denton said. or shipping it. Those events need to be in a sequence. When the data arrives at your This may mean emails, phone calls, and downstream trading partner, he said, “The possibly even conference calls. It’s a considvery first thing their system is looking for erable amount of activity to remedy and is making sure it’s all in sequence, and they ensure the sender understands why the file use that event time as a process to do that.” is incorrect or incomplete. Denton noted, In one case, the majority of the file was “We have made zero changes in our system. fine, but some events had dates missing. For It is completely designed around GS1 standards for EPCIS messaging. So what we’re some reason, there isn’t consistency in the ↑ Gary Lerner, president at Gateway event time being represented accurately or doing is we’re identifying the problems, Checker Corporation. being present. communicating back to the manufacturer Duplicate SGTINs (serialized GTINs): One example he referred and then multiple retests.”

Once the initial problem is resolved, that’s it, right? Not so fast. to is a case of 12 identical bottles. “They all have the same GTIN, but the serial numbers on each bottle are unique. We’re getting data Once the problem is fixed and the processing passes, the system that now is showing the exact same serial number on more than one may find yet another issue, stopping the process once again. “You bottle, which shouldn’t happen, whether it was in one case or differ- have to fix it and then start over. So delayed testing is a significant issue for us when we’re talking 450 trading partners and only 30 or ent cases, but we are finding that,” Denton said.

40 currently onboarded,” said Denton.

No children: Another major error they’ve observed is a file lacking There isn’t enough time between now and 2023 to devote these child records. “We get the serial number for the case, but we don’t get the serial number for the contents of that case,” he explained. labor-intensive remediation efforts to every trading partner. He He recalled an example for a large file, where they had the chil- added, “Of course, there’s a lot of resource time on both sides with the sender and the receiver repeated retesting. And then all of this dren and the case for the majority of the shipment, but only had the case for some products. “This is not [a product] that would be relates to increased cost.”

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Help is available

sign up and ensure files are accurate before they come to ABC. “Hopefully we can get to a point where you process one test file and you’re accepted for being put into production. Data sharing is not easy… moving from an ASN to an EPCIS file is quite a transition.

And the resources and resource skillsets are not always the same.

Be proactive in the steps that are necessary for success,” he said, keeping in mind the overall goal. “The key takeaway is we must all remain responsible in our ability to deliver for healthier futures.”

The good news is that GS1 has put together a conformance testing process, hiring service providers to perform testing of EPCIS data.

As Lerner explained, “To accomplish conformance and to take the guesswork out, GS1 US Healthcare established a GS1 Trustmark.

The Trustmark signifies that an EPCIS event file follows the format and structure of the DSCSA application standard, and that this file fully conforms to a pharmaceutical traceability scenario.” Lerner’s company, Gateway Checker, established a conformance testing application which GS1 validated and certified as a GS1 conformance Action item testing service in 2019, after a rigorous assessment against GS1 and Denton said it’s important to be sure you’re comfortable that the DSCSA standards. quality of your file is extremely high before testing with a trading “This system assures that the file contains all of the appropriate partner. If you’re generating an EPCIS file, “I strongly recommend you go through conformance testing first.” information such as trading partner and drug product information, and other elements required for conforming DSCSA transactions,” said Lerner. The submitted file is then assessed against a specific drug traceability scenario. If each of the conditions are met, GateFor the latest in traceability, make plans to way certifies the submission and informs GS1 that a GS1 Trustmark visit PACK EXPO International/Healthcare can be issued.

Packaging EXPO 2020. For more information Denton added, “So you’re able to prepare your files, send it to one visit packexpointernational.com. of these services, run it through their system very, very quickly and come back to identify” if there are issues. Manufacturers are able to resolve and retest with the service providers in a faster manner. Then when they engage with trading partners such as ABC, they know the file meets all of GS1’s standards.

“It’s a proactive measure to ensure quality in your data sharing that is extremely important, more so now than ever,” said Denton, adding that multiple service providers are available for this performance testing via GS1.

Two key points to highlight: the service providers use portals and they do not store any of the manufacturer’s data. “When you sign up with one of them, you’re able to use their portal to run your process of testing with a file From remote support and implementation services, cloud that you’ve created. Test results are hosting options and more, DELMIAworks provides the almost immediate, so you’re able to react,” Denton noted. agile tools you need to adapt to COVID-19 challenges.

This means manufacturers eliminate troubleshooting emails, phone calls, and conference calls with trading partners, and they’re able to address issues and retest on their timeline.

Denton hopes that manufacturers

Manufacturing Software to Help with the New Normal

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www.iqms.com • DELMIAworks.Sales@3ds.com • 866.367.3772

8/4/20 9:02 AM

REUSABLE PACKAGING

Loop Launches E-Comm Platform Nationwide ANNE MARIE MOHAN, SENIOR EDITOR, PACKAGING WORLD TOP THREE TAKEAWAYS 1. The Loop circular shopping platform offers consumers convenient, reusable packaging.

2. Loop will be launching in retail stores—including Kroger in the U.S.—in 2020.

3. Deposit costs for packaging have not been a deterrent to consumers thus far.

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onsumers across the U.S. who are interested in shopping online for a range of grocery, household, and personal care products in gorgeously designed, durable, and resusable packaging will now have the chance with the nationwide launch of Loop.

Since May 2019, the ground-breaking Loop circular shopping platform has been available in 10 states in the Northeast and in Paris. According to Tom Szaky, founder of recycling company TerraCycle and of Loop, the 10-month pilot allowed participating Consumer Packaged Goods (CPG) companies, retailers, and Loop itself to gain insights and tweak the program for wider availability.

Just as exciting, if not more so, accord- ↑ For those consumers going the e-commerce route, there is a $20 shipping fee for orders ing to Szaky, is the news that Loop will be under $150. In addition, the tote used to deliver and return product comes with a $15 deposit fee. launching in retail stores, including Kroger in the U.S., Carrefour in France, and AEON in Japan, later this year. a platform and not a producer or retailer.” He continues, “By being Currently 400 brands have joined Loop, 20% of which are now a platform, it is really our fantastic brand partners that are doing all available for purchase on Loopstore.com and 80% of which are still the production and ramping up, and the retailers that are doing the in development. Says Szaky, it can take a CPG anywhere from six scale up and later the in-store deployments. What we really have to to 18 months from the time they join Loop until they have prod- ramp up is the ability to accept that used packaging, sort it out, and uct ready to ship. Among some of the more well-known CPGs that clean it. And that’s an area that TerraCycle has almost two decades have signed on are Seventh Generation, Clorox, Procter & Gamble, of experience doing in disposables. Now we just have to bring the same experience to reusables.”

Nestlé, Unilever, and Mars Petcare. Loop also sells a “private-label” brand, Puretto, which Szaky says is being used by name-brand With the e-commerce model, all packaging—both filled and companies to test products on the platform while they develop their empty—is handled through Loop’s Northeast location, from which own, unique version. “As soon as that version is live, we disable the it sends orders to consumers and where it cleans the empty packPuretto version,” he explains. aging. Loop will also soon be adding another location on the West Szaky notes that the rapid speed of the nationwide launch—Loop Coast. “As the stores move into bigger and bigger volumes, we will was only just unveiled in February 2019—is due to the fact that “it’s deploy in total seven major facilities in the U.S.,” Szaky says. “I 30 | Healthcare Packaging • July/August 2020

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expect that to take about two to three years.” Outside the U.S., Loop has one facility in each country in which it operates and is planning to add more.

When the in-store platform becomes available, CPGs will supply the stores with product directly. Then, when consumers are through with the product, they will drop off the empty packaging at the store,

↑ When the in-store platform launches, CPGs will supply product to the store. Consumers will drop used, empty packaging at the store, where Loop will pick it up for cleaning.

and Loop will pick it up for cleaning.

For those consumers going the e-commerce route, there is a $20 shipping fee for orders under $150. In addition, the tote used to deliver and return product comes with a $15 deposit fee. Deposits are also required for every package and range anywhere from $1.25 for a glass liquid soap dispenser bottle from Soapply, for example, up to $10 for a rust-resistant metal container with one-touch dispensing lid for Clorox disinfecting wipes.

One of the biggest learnings from the Loop pilot says Szaky is that the deposit costs have not deterred consumers from using Loop. “I thought they would be, but they haven’t in any capacity,” he says.

“Even deposits as high as $10 have not been a deterrent. So we’re very, very happy about that.”

Not only that, Szaky says, but they also found that within 90 days of purchase, there was a 97% return rate for the packaging by consumers. “I was surprised, but I think it has to do with the fact that people want the product inside, and they’re happy to have us professionally clean it and have it professionally refilled so they can access it again.”

For the in-store business, the only deposits are for the containers, which consumers are refunded when they return the empty packaging to the store.

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CANNABIS PACKAGING

Embossed Wallet for Sublingual Strip PAT REYNOLDS, VP EDITOR EMERITUS, PACKAGING WORLD TOP THREE TAKEAWAYS 1. Cannabis firm Kin Slips added a semi-automated pouch packaging system for its sublingual strip.

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2. The system only requires one or two operators to interact with the line, placing and advancing pouches.

recurring theme when it comes to packaging of cannabis is the transition from having an army of people in manual mode to an operation where automated or semi-automated systems reduce the amount of packaging that’s done by hand.

That transition took place recently at San Francisco-based Kin Slips. Now operating at the firm is a semi-automated pouch packaging system that lets one or two operators perform the tasks for which several were required in the recent past. Says CEO Josh Kirby, “We’re very glad that’s over with.”

The rotary system for filling and sealing premade pouches that Kin Slips fills was installed in the summer of 2019. Before exploring how it works, it’s important to point out that the product being packaged is a sublingual strip. As for the premade pouch that serves as the primary package, it comes from Fortis Solutions Group. The pouch is a three-side-sealed pouch made from a three-layer lamination consisting of reverse-printed matte polypropylene/metallized polyester/polyethylene. These pouches arrive in 2,500-count corrugated cases. An operator puts the pouches into four magazines in a Pouchmaster ABS system supplied

by About Packaging Robotics Inc.. A vacuum cup picker picks up four pouches at a time from the four magazines and rotates to the station at which two operators sit.

The operators put a slip into each pouch and then one of them hits a foot pedal to advance the four pouches to a station where the ambient air is pressed out and a heatseal bar seals the pouches closed. Then the pouches drop into a bin. All that’s left is for

3. The paperboard wallet features a unique embossed effect produced by refurbished letter press machines.

the operator to place the pouches into the secondary packaging, which Kirby refers to as a “wallet.” The wallet is closed and then a pressure-sensitive paper label is applied. Applied to the bottom is a second pressure-sensitive label that has all of the specific batch information that is required.

The paperboard secondary packaging, or wallet, comes from Studio on Fire. “They have this amazing letterpress studio where they’ve been able to refurbish these old letter press machines that lets them make a beautiful package for us,” says Kirby. “By its very nature, it’s a relatively slow process, which is why you don’t see it used for packages that are produced in huge volumes. But for us it produces a beautiful and precise embossing effect. And when you’re in a business like ours where you can’t sell outside your own state lines, large volumes are never an issue.”

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VIRTUAL REALITY

Part 1

Sterile Manufacturing Training Gets Immersive with VR KEREN SOOKNE, DIRECTOR OF EDITORIAL CONTENT TOP THREE TAKEAWAYS 1. One company sought to change pharmaceutical technician training, including concepts of aseptic technique, with virtual reality.

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2. Virtual reality is transcending boundaries to enable remote expert instruction and hands-on skill building focused on the “why.”

f we know that teaching operators to a test or a specific machine doesn’t work that well, why hasn’t training changed in decades?

One company set out to change things with on-demand virtual reality (VR) training, which offers promise in teaching concepts resulting in more well-rounded staff that can move to other machines and facilities. In Part 1 of this two-part series, we’ll delve into how VR can help some of the issues seen in common training scenarios.

Virtuosi is a training platform developed by Quality Executive Partners, Inc. (QxP), a management consulting firm specializing in compliance consulting for the life sciences industry. The company’s leadership has extensive backgrounds as former executives at global pharmaceutical firms.

“In the pharmaceutical industry, the way we educate people has regressed a bit since many of us started our careers, myself in the ’90s,” says Brian Duncan, chief operations officer at QxP. “We

3. A setup of a computer, hand devices, a headset, and a couple of sensors can immerse trainees in an environment to practice.

saw that foundational education just wasn’t being done anymore.

Predominantly it’s not really education as much as it is teaching people to follow a procedure, a step-by-step process.”

Train the trainer challenges One issue is that subject matter experts (SMEs) are highly leveraged within most organizations, spending much of their time troubleshooting issues and establishing or updating standards and procedures. This leaves little time or opportunity for company experts to engage in a meaningful way with educating staff at the shop floor or benchtop level. Second, some technically skilled operators aren’t natural teachers, at times lacking the understanding of what a student needs to know or what they may find challenging.

These were both common themes the consulting company encountered among small and large organizations. Often, training means sitting in a new employee orientation session with days of July/August 2020 • Healthcare Packaging | 33

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mind-numbing slideshows, where somebody points out what might be on a quiz.

On-the-job (OJT) training typically follows more of a see, do, teach approach. A trainer points out some critical concepts, watches the new employee try the technique, and then signs them off. “That has a lot of limitations,” Duncan says. “Looking at high-risk operations such as aseptic manufacturing, the employee may learn, ‘I don’t put my hand there,’ but they should really know the principle of why you don’t put your hand there. Why do you need to sanitize surfaces and equipment? We realized that there was a need, and we wanted to find a way that we could help these companies in finding a way to scale quality, technical education.”

Why VR? “We had tried to develop educational materials, training courses, and certification programs for individuals to leverage these SMEs from within pharma organizations, train them on the right content so that they could go out and teach others… a train the trainer concept,” explains Duncan. “We found out very quickly that has a lot of limitations. On one such project, for example, we prepared a comprehensive program of microbiological content only to eventually certify six of the initial 65 candidates resulting from limitations in SME availability, breadth of technical knowledge, or teaching capability.”

The company looked at a number of digital video platforms alone, but VR piqued the company’s interest because it seemed to be the only medium that could transcend boundaries in a remote way to enable both expert instruction and hands-on skill building focused on the “why.”

“NO ONE WAS USING VR IN PHARMACEUTICAL EDUCATION TO FULLY LEVERAGE THESE CAPABILITIES… THAT LED US TO THE MEDICAL SURGICAL COMMUNITY… SOME OF THE DATA WE SEE IS THAT FOLKS WHO ARE TRAINED IN VRASSISTED CURRICULA ARE 29% FASTER AND SIX TIMES LESS LIKELY TO MAKE A MISTAKE WHEN THEY TRY IT FOR THE FIRST TIME ON THEIR OWN.” -QxP’s Brian Duncan When QxP decided to go down this road, they studied the landscape. “No one was using VR in pharmaceutical education to fully leverage these capabilities,” Duncan explains. So they asked themselves, who uses VR for education and has learned to do it successfully? “That led us to the medical surgical community,” he says. They focused on lessons learned and publicly available scientific studies with control groups and real data. “Some of the data we see is that folks who are trained in VR-assisted curricula are 29% faster and six times less likely to make a mistake when they try it for the first time on their own.”

A setup of a computer, hand devices, a headset, and a couple of sensors can immerse trainees in an environment to practice.

“We wanted to bring that same impact to the pharmaceutical industry and to scale learning,” Duncan explains. “The great thing about practicing is you can make mistakes, and when you make mistakes, depending on how you program your VR, it can coach you in real-time. And unlike an OJT trainer, it knows exactly where the trainee put their hands. It’s never distracted, and it’s always watching exactly what you do.”

Nuts and bolts ↑ A setup of a computer, hand devices, a headset, and a couple of sensors can immerse trainees in an environment to practice.

The Virtuosi product itself is set up with episodes—technical modules—that build upon one another with the focus on educating staff in the foundational principles explaining the “why” behind the

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tasks performed every day. Such contextual understanding enables critical thinking and directly influences the skills and behaviors needed to perform sterile manufacturing and microbiology testing.

Technical experts worked to lay out a comprehensive series of topics with defined learning objectives, then leveraged VR to take the trainees’ understanding and lessons learned into the actual environment in which they would be operating. For example: • People can enter a sterile filling line to learn about aseptic connections, seeing an exercise and then trying it on their own.

• Trainees can learn critical aspects of environmental monitoring (EM) programs. “Students can figure out what goes into designing an EM sampling plan within a manufacturing filling suite. What are my hot points and why? What kind of samples do I pull from there and why? What factors do I need to consider in developing that sampling scheme?” says Duncan.

“Our technical experts have spent entire careers building sterile facilities, building course materials, and teaching these topics. We paired deep subject matter expertise with a thoughtfully selected VR partner,” Duncan notes. “We selected a VR partner that used predominantly classically trained engineers, who knew and appreciated the science behind what we were trying to achieve, in addition to computer programming. So when we look at things like airflow, they know the principles of fluid dynamics behind what we are creating.”

The company saw a need to move from a check-the-box, qualification-based training paradigm back toward educating on principles and providing on-demand, experiential educational opportunities.

• In total, there are 31 episodes in the first series of Virtuosi, each about 60 to 90 minutes long.

• Complimenting the technical lectures—delivered via a cloudbased multimodal platform—are 18 VR interactive experiences (approximately 30 minutes each). Depending on the number of iterations one goes through in the VR sessions, it’s approximately 80 hours of content.

• Within each episode are coached process checks to ensure engagement and understanding, and there is a knowledge assessment at the conclusion of each episode that must be passed in order to receive credit.

The company received support from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), which reviewed the program as a primary beta partner in the pilot program in advance of its commercial launch in Q1 of 2020. “MHRA promotes innovation across all stages of the pharmaceutical lifecycle and provides regulatory advice to stakeholders through initiatives such as its Innovation Office. The MHRA’s inspectorate welcomes the opportunity to support and adopt new technology such as innovative approaches to delivering education,” an MHRA spokesperson told Pharmacy Business.

Stay tuned for the second installment of this two-part series in the next issue, covering the hidden costs of limited training and nonconformances.

A New View The concept of a smoke study is fairly understandable, but VR allows the student to see things and interact with the environment in a novel way, opening myriad opportunities to engage learners through experiential learning models. VR not only lets one see the movement of airflow; but it can also place the person inside the filling line to interact with the airflow in the form of visible smoke.

Duncan says, “In the past, demonstrating the same principle in a video format would literally require putting a person in a room to watch 12 hours’ worth of smokes studies,” looking for events such as the background interfering with the flow, or a door where there is turbid airflow. “To show interrupted unidirectional airflow through classical methods, a company would need video that was very clear, had good contrast and backgrounds to see the smoke— and a bad study because we had to see disrupted air that you’re not supposed to see. VR not only allows you to see it, but you can also interact with it and create those conditions in real time to understand the principles and the interaction between differently shaped objects and their positions and movements on a filling line.”

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NEW PRODUCTS

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NEW PRODUCTS

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7/31/20 2:34 PM

MULTIVAC manual, semi-automatic, and fully-automatic medical and pharmaceutical packaging solutions are available with robotic product loading and label vision systems that enable your company to keep up with growing demand.

With more than 4,000 US-based machines installed, 24/7 support, and 75+ US-based service technicians, you can be assured your packaging operations will perform with maximum output and quality.

Increase output. Reduce cost.

MULTIVAC Syringe Packaging Line Available with Allen Bradley controls by Rockwell Automation

us.multivac.com 800-800-8552

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7/31/20 2:28 PM