Healthcare Packaging November/December 2020

ROUND TRIP Fragile 3D microtissues must remain upright in transit. A floating sphere delivers them safely around the world.

+ COVID-19 Test Medium Production Ramped Up By 20,000% + Seven Recent Statistics in Pharma Cargo Theft + Cartoner Customized for Visually Impaired Operators + FDA Considers Incentivizing Quality Management Maturity

NOVEMBER/DECEMBER 2020

PMMI Media Group | www.HealthcarePackaging.com

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CONTENTS

↑ pp.29 Supply Chain Expert Talks Cargo Security 18 COVID-19 DIAGNOSTICS

COVID-19 Test Medium Production Ramped Up By 20,000% in Six Months

Viral transport media tubes filled with liquid media are used to store and transport nasal swabs for viruses including COVID-19. Sixteen integrated lines were designed, built, and installed in 20 weeks to meet demand.

22 LOGISTICS

Cells Remain Upright in Floating Spherical Shipper Fragile 3D microtissues for drug development and testing must remain upright in transit. This sphere-on-water system takes cues from boats while keeping products in temperature range.

26 REGULATORY

FDA Considers Incentivizing Quality Management Maturity (QMM)

From PDA/FDA: The Agency solicited feedback from manufacturers on assessing and rewarding QMM. Reduced audit frequency may one day be an incentive for high performers.

29 LOGISTICS/SUPPLY CHAIN

32 CAPSULE FILLING

Pharma Contract Manufacturer Expands Large Batch Production to 110,000 Capsules Per Hour

Wiewelhove expands its capsule filling line, enabling the company to fill pellets into capsules. Collaboration with the machine builder on special requests led to a smooth implementation.

34 CARTONING

Custom Cartoner Helps Employ Workers with Blindness

As a non-profit with a mission to create jobs, automation can be a tricky proposition. But with a custom machine optimized to be easily used by legally blind operators, Horizon Industries struck a positive balance between labor and automation.

COLUMNS 05 KEREN SOOKNE’S PERSPECTIVE 12 COLD CHAIN CORNER DEPARTMENTS 06 QUICK HITS

Seven Recent Statistics in Pharma Cargo Theft

07 BUSINESS INTELLIGENCE

A supply chain security and resilience director takes a look at recent trends from 2019 and 2020, and talks COVID-19 product security.

10 NEWS

08 QUOTABLES/BY THE NUMBERS 14 MATERIAL DEVELOPMENTS 16 OEM APPLICATION NOTE 36 NEW PRODUCTS

November/December 2020 • Healthcare Packaging | 3

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www.healthcarepackaging.com

Editorial

DIRECTOR OF EDITORIAL CONTENT Keren Sookne

ksookne@pmmimediagroup.com MANAGING EDITOR Natalie Craig CONTRIBUTING EDITOR Melissa Griffen

Art

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

Publishing

PUBLISHER Elizabeth Tierney, 815.861.2992 VICE PRESIDENT, CONTENT & BRAND STRATEGY Jim Chrzan MANAGER, STRATEGY & COMMUNICATIONS Courtney Nichols AD SERVICES/PRODUCTION MANAGER George Shurtleff

Audience & Digital

SENIOR VICE PRESIDENT, DIGITAL & DATA David Newcorn SENIOR DIRECTOR, DIGITAL & DATA Elizabeth Kachoris DIRECTOR, WEBSITES + DIGITAL DESIGN STRATEGY Jen Krepelka

Advertising

VICE PRESIDENT, SALES Wendy Sawtell

wsawtell@pmmimediagroup.com PRODUCTION MANAGER Lara Krieger

lkrieger@pmmimediagroup.com SENIOR DIRECTOR, CLIENT SUCCESS & MEDIA OPERATIONS Kelly Greeby SENIOR MANAGER, PRODUCT & REVENUE STRATEGY Alicia Pettigrew

Advertising

PRESIDENT Joseph Angel DIRECTOR MARKETING Susan DaMario SENIOR MARKETING MANAGER Amber Miller BRAND OPERATIONS MANAGER Bea Greany DIRECTOR, MEDIA INNOVATION Sarah Loeffler FINANCIAL SERVICES MANAGER Janet Fabiano FOUNDING PARTNER Lloyd Ferguson

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 11911 Freedom Drive, Suite 600, Reston, VA 20190 p: 703.243.8555 | 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 2019 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 13, 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

Custom Packaging Projects Abound in Logistics and More From microtissues to diagnostics, brand owners are taking an active approach in developing unique, right-sized packaging and automation.

While vials are in the spotlight these days, drug development efforts require specialized packaging, too.

Our cover story profiles the development of a unique new packaging system for shipping 3D microtissues to companies investigating and testing new drugs (pp. 22). To keep these fragile tissues upright during transit, the shipper takes inspiration from boats, creating a floating sphere-on-water within an outer package.

In automation news, one company ramped up production of viral transport media tubes from 50,000/week to 10 million/week in six months (pp. 18). The collaboration effort between the brand owner, OEMs, and partners was remarkable—remote installation

also played a role, which we’re seeing more of due in part to limited travel. Recently, PMMI released two related resources to help companies navigate this “new to some” arena: the Virtual Factory Acceptance Test (vFAT) guide from the OpX Leadership Network and the Trends in Adoption of Remote Access report.

On pp. 34, read about a cartoner that was customized to help employ visually impaired operators, balancing automation with job creation.

If you didn’t make it to PACK EXPO Connects—or didn’t get to see everything you wanted—be sure to check out the on-demand content at packexpoconnects.com!

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

Ingestible Capsule Treats GI Disorders

A recent Physics World article discussed a new device intended to treat gastrointestinal disorders. Previous ingestible robotic systems had no way of controlling electrical microstimulation. To address this, a team at MIT collaborated with Novo Nordisk and KTH Royal Institute of Technology to develop an orally administered electrical stimulation device. The ingestible pill mimics a parasitic worm that attaches to the GI tract of its host. It anchors to the stomach wall via needles that act as probes to create timed electrical pulses, thereby improving the device’s controllability. The device remains attached for up to two hours after being swallowed.

2 3

New Microneedle Patch Detects Malaria

Medgadget reported that a team of researchers at Rice University created a microneedle patch that users can apply to their skin to determine if they have malaria. The low-cost technology can be widely used and produces results in about 20 minutes. The patch contains a 4 x 4 matrix of hollow microneedles that collects interstitial fluid and tests it for protein biomarkers of malaria. Like a pregnancy test, the device provides a visual result with colored strips. The patch costs around $1 when produced in bulk and can be used to detect a range of other diseases, including COVID-19.

Dr. Reddy’s Shuts Down Plants Amid Potential Cyberattack

As Big Pharma races to create a vaccine for COVID-19, they’re susceptible to data breaches that could compromise intellectual property. A recent FiercePharma article discussed a recent event that led to the shutting down of multiple plants to contain the issue. As a preventative measure, Indian generics manufacturer Dr. Reddy’s Laboratories isolated all data center services after they detected a breach. The company has shut down “key” plants in the U.S., U.K., Brazil, India, and Russia. Dr. Reddy’s noted that they do not anticipate any major disruptions to operations due to the incident.

4

CA Will Review FDA-Approved COVID-19 Vaccines Independently

The state of California definitely seems to do things their own way, and administering coronavirus vaccines is no exception. A recent AXIOS article discussed Governor Newsom’s announcement that the state will “independently review” all coronavirus vaccines approved by the FDA before distribution is allowed. The decision is likely due to concerns that the federal government could potentially release a vaccine with political motives in mind, beyond solely safety and efficacy.

5

TIM HAYES, CONTRIBUTING EDITOR, HCP

MIT Grads Make Skin Repair Mist

An innovative new device has been invented by MIT alums that could change delivery methods in the skincare industry, according to a recent Forbes article.

The device delivers over-the-counter products such as vitamin C, retinol, collagen, and peptides with a quick mist that penetrates the skin. The painless mist replaces needles that can cause pain, bleeding, scarring, or infection.

The company, Droplette, intends their “contactless droplets” for at-home use. They’re currently in testing with Harvard and MIT dermatologists and plastic surgeons. The product costs $299, and includes three capsule types: retinol, collagen and peptides, and glycolic acid and salicylic acid.

6

Should the FDA Have Approved Remdesivir?

In October, the FDA gave full approval to the first drug intended to treat COVID-19, but a recent Vox article suggests they may have acted prematurely. Remdesivir is an antiviral drug developed by Gilead Sciences and received emergency use authorization back in May for severe COVID cases. Full FDA approval means Remdesivir is now the standard of care for hospitalized patients. Prior to approval, the World Health Organization (WHO) announced preliminary results that Remdesivir had no effect on mortality. Some researchers now claim there wasn’t enough data for full approval and want the FDA to pump the breaks in the absence of a vaccine.

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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BUSINESS INTELLIGENCE

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QUOTABLES

BY THE NUMBERS

are a heavily regulated industry. It’s “notAirlines easy to mothball an airline and then just restart them again because crews lose their certifications. It would be devastating for transporting the COVID-19 vaccine to lose more airlines.

”

—BARRY CONLON, CEO & FOUNDER, OVERHAUL GROUP, INC.

In the USA, research earlier this year “revealed that almost 70% of consumers have expressed worries about the health crisis driving online sales in counterfeit or sub-standard quality products.

”

—INTERNATIONAL HOLOGRAM MANUFACTURERS ASSOCIATION (IHMA)

reusable packaging, what we're looking to “doWith is to divide any primary manufacturing eco impacts such as CO₂, by the number of reuses, so that we deliver a low overall environmental impact. But it's important to be realistic about the number of reuses that will actually be seen from a container and to make sure that it's used more times than the break-even point.

2,700

THE APPROXIMATE NUMBER of product demos offered through PACK EXPO Connects from more than 700 solution providers.

$57 BILLION

THE VALUE of the precision medicine market (also known as “personalized medicine”) in 2019, estimated to grow at a CAGR of over 11% between 2020 and 2026.

Source: Global Market Insights

November 27, 2023

THE FDA’S new enforcement date for wholesale distributors to verify the product identifier prior to further distributing returned product as required under the DSCSA.

$35 BILLION

ADROIT MARKET RESEARCH predicts that the global blister packaging market size will surpass $35 billion by 2025, due in part to rising demand for tamper-evidence.

”

—MARTIN BLACHER, DIRECTOR OF SUSTAINABILITY, BOCKATECH

8 | Healthcare Packaging • November/December 2020

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NEWS

Blister Package Wins IoPP Ameristar Award The Arthrex Custom Medical Package by Placon won the IoPP Ameristar Award in the medical device category. The release notes, “It creates a different way of aseptic presentation within a small-footprint, double-sterile barrier blister, and it allows the implant or instrument to be used surgically without having been touched prior to use. The overall 50% smaller package from a previous design combines easy opening of a PETG blister and Tyvek sterile barrier with the benefits of aseptic presentation from a polyurethane tube. The modular design allows users to keep the same end-panel size and have a variety of product lengths included and allow future products to be easily added to the sterile barrier system.” —Institute of Packaging Professionals (IoPP)

Miss PACK EXPO Connects? No Problem Did you miss it? Or maybe you were able to attend some of it but didn’t get to everything you wanted to. Fortunately, one of the many benefits of virtual events (besides being able to attend from your couch wearing jogging pants) is that all of the content can be recorded and saved for future consumption. That’s just what PMMI Media Group has done with PACK EXPO Connects, so it’s all still available at your fingertips until March 31, 2021. Here’s some of what you can still find, at your leisure, at packexpoconnects.com: product demos, Trend Chats, Jumpstart sessions, Innovation Stages, and more. —Matt Reynolds

Trends and Growing Pains in the Cannabis Market Green Thumb Industries (GTI) is a rapidly scaling cannabis company, which has begun implementing automation into its lines. A difficulty in deploying automation is what Greg Flickinger, senior VP of operations and supply chain at GTI, called the “white space” between semi-manual and automation. In other words, finding OEMs who have the flexibility to run multiple SKUs and then grow with the company as its volume grows has been quite the challenge.

At PACK EXPO Connects’ Cannabis Trend Chat, Flickinger said, “When looking at time scales with CPGs, you’re looking at maybe a year by the time you’re pulling in automation, upscaling, and transforming your workforce. We’re operating in one, two, and three-month segments because we’re going from manual and semi-manual to automation.”

Madinah Allen, GTI’s vice president of engineering, explained their cross-functional marketing-engineering operation strategy: “We are looking by brand and saying, ‘Ok, these are the products we have. Which ones are the highest volumes that we have to go after from an automation perspective?’ And then we’re asking the questions ‘Does that automation already exist?’ and ‘Who’s willing to partner with us?’”

A further challenge is the large issue on consumers’ minds of sustainable packaging. GTI reports that some items can be recycled, however child-resistant (CR) mechanisms and tamper strips make the process more difficult. (Pictured here, a CR paperboard carton from GTI.) “The CR mechanism at times can be in conflict as you sometimes need plastic elements,” said vice president of consumer products, Cristin Rudolph. “It continues to be a point of interest with us that we are executing on the CR mechanism but also starting to think through suppliers–different sources of materials that can help us reduce the overall footprint of the packaging while still enabling that CR function.” —Melissa Griffen

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NEWS

Saleable Returns Verification Delayed to 2023 for Wholesalers FDA guidance says distributors will not be required to verify the product identifier of returned drugs before resale until Nov. 27, 2023.

The Agency noted some stakeholder issues that factored into the decision, including that there are continuing challenges posed by the large volume of saleable returned product. More time is needed for distributors to test verification systems with real-time volumes vs. small-scale pilot volumes of returned product. Additionally, there were significant delays in testing verification systems due to the priority of responding to the COVID-19 pandemic, “namely the reassignment of logistics and supply chain experts from DSCSA matters to COVID-19 pandemic response.”

—Keren Sookne

Survey: Sustainability Momentum in Temperature Control Packaging Softbox Systems, provider of temperature control packaging, released recent worldwide survey results from senior managers and directors in the life sciences sector. Almost 90% of those polled stressed sustainability’s importance, while 72% stated that the development of sustainable temperature control packaging systems is significant to their operations and their organizations’ sustainability ambitions. Nearly one-third claim they are prepared to put at least an additional 10% on top of their current budgets to reach those ambitions. The survey notes that most companies struggle to even recover 10% of their systems for reuse, pointing to the need for affordable, curbside-recyclable systems.

—Melissa Griffen

COVID-19 Vaccine: HHS Partnering with Major Pharmacy Chains Reuters reports that the “U.S. government is partnering with regional pharmacy chains and independent community pharmacies to increase access to COVID-19 vaccines whenever they are made available,” according to the U.S. Department of Health and Human Services. Participating partners include Walgreens Boots Alliance Inc, CVS Health Corp, Walmart Inc, Kroger Co, and Costco Wholesale Corp. These vaccines supported by Operation Warp Speed will be administered at no cost to patients, and this will cover approximately 60% of pharmacies throughout the U.S., D.C, Puerto Rico, and the U.S. Virgin Islands. —Keren Sookne November/December 2020 • Healthcare Packaging | 11

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COLD CHAIN CORNER

Four Tips for Collaborating with Contract Organizations for Increased Efficiency How Bayer manages CMOs and gets the best of their relationships.

KEREN SOOKNE, DIRECTOR OF EDITORIAL CONTENT It’s clear that COVID-19 response will affect capacity of all healthcare supply chains. At a recent Cold Chain Council webinar, Jeff Tucker of Tucker Company Worldwide noted that there’s never been a logistics effort in the world close to what we as an industry have to take on, “and incidentally, we’ve got to do it extremely cold.”

With limited temperature-controlled capacity, life science manufacturers have to start planning for a capacity squeeze with their contract service providers now.

One key to overcoming these challenges according the Cold Chain Council is building strong relationships with business partners and maintaining them. “And if there was ever a year where that message was important, it’s certainly 2020 where seemingly everybody’s supply chains were turned upside down,” said Kevin Lynch, director of sales at Q Products and Services.

With over 30 years in the life sciences at Bayer, Luiz Barberini, operations manager, LATAM, has extensive experience in areas such as cold change distribution, logistics, manufacturing, planning, procurement, and more in locations like Brazil, which can be very challenging places for logistics.

Barberini highlighted that many people are feeling a range of emotions—afraid, depressed, and more—while most are working from home offices. He said, “It’s a huge time to change the way that we do our business, the way that we relate to our CMOs, the way that we keep our relationships moving. In such a challenging scenario, it’s important to have the right partnerships and look for innovation.”

He offered the following tips on getting the most out of contract service relationships, in cold chain and beyond: 1. Find those who share the customer’s focus The first commandment is that a supply chain partner must share the customer’s focus. Barberini pointed to the classic optical illusion where the person on the left sees four bars on the ground and the person opposite sees three, since they have different perspectives.

“It’s a matter of how you see problems. Make sure that you’re all speaking the same language,” he said. A “focus on the customer”

is about to fulfilling the customers’ needs for products or services, while “sharing the customer’s focus” is more holistic and driven by the customer’s mission. He said the former is much like a fast food chain delivering goods to a customer, while the latter is akin to a chef at a fine restaurant catering to the patron’s experience and anticipating their needs.

2. Think digital but have the best sailors on board Digitalizing operations and optimizing your network are essential. Simulation, augmented reality, and other tools offer great promise—with cyber security in place—because resilient supply chains of the future will need smart, connected, self-learning processes.

“Industry 4.0 is both process and information, but it must rely on people to define processes, establish connections, and properly

G

↑ From top: Jeff Tucker, Tucker Company Worldwide; Kevin Lynch, Q Products and Services; Luiz Barberini, Bayer

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pharmaHC

COLD CHAIN CORNER

manage all the systems. So keep one eye on Industry 4.0 to navigate on the sea. But when you talk about navigation, please consider the sailors that you you’re going to use. It’s very important to pay attention to the people,� he said.

Many companies may claim something is not their problem, it’s their supplier’s problem. “No. It’s on the hands of your supplier, but it’s your problem. If you don’t do things correctly, they can’t do their best,� he said.

3. Be transparent with your contact organizations “At Bayer, we try to be very honest and transparent with our suppliers and be very collaborative with them,� he said. This includes clear discussions with your suppliers about capacity (both current and in the future), technology, on-time delivery, and whether competitors will be sharing production lines.

The second key relationship factor is one that Barberini likens to a paddleball game. “I live in Brazil, we have nice beaches and we love to play paddleball at the beach. Playing paddleball is about keeping the ball in air.� If you hit the ball well to your partner, odds are they will send a good hit back to you. He explained, “Do you play paddleball with your CMOs, partners, 3PLs, temp control device suppliers?

Do you give them enough information about your process—good balls—so they can do their best and send you good balls back? It’s important to have this kind of approach. You have to do your best so they can do their best.�

4. Don’t forget the human connection In Barberini’s last tip, he cited a quote from Simon Sinek: “100% of customers are people, 100% of employees are people. If you don’t understand people, you don’t understand business.� There may be stress or long hours, but your CMOs, 3PLs, 4PLs, and suppliers are people. “Give them all the respect that they deserve. It’s very, very important. We are all individuals, but we are all the same,� he said.

Cold Chain Council Webinar Series Due to ongoing safety and health initiatives, many live events have moved online. The Cold Chain Council’s Webinar Series brings industry experts and participants together to discuss current challenges, shifting landscapes, and innovations in the world of global cold chain logistics. Visit: coldchaincouncil.com

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MATERIAL DEVELOPMENTS

↙ The company uses a two-part labeling system, with the main label displaying the brand name and the product type. The supplementary label contains the lot number, the specific testing results, and any state-specific content.

Packaging Technology Keeps Vireo Health’s Cannabis Flower Flavorful and Potent Longer The packaging system preserves naturally occurring compounds within the flower, creating a robust, consistent product for consumers.

MELISSA GRIFFEN, CONTRIBUTING EDITOR A group of compounds collectively referred to as terpenes are what provide the characteristic smell and flavor of cannabis. There is evidence that terpenes are also responsible for some of the pharmacological benefits of medical cannabis. These compounds are very volatile, however, so as soon as the plants are harvested, these molecules begin evaporating into the air–especially during drying and storage.

Vireo Health International Inc., a physician-founded, science-focused multi-state cannabis company, signed an exclusive licensing agreement with eBottles420–a supplier of high-quality packaging for the cannabis market–to manufacture and distribute Vireo’s patent-pending, terpene-preserving packaging system to keep the product consistent.

How the system works This system is designed to preserve cannabis flower by inhibiting the gradual loss of terpenes within jars–made from any standard material, such as glass or plastics–by including a source of volatile terpene compounds within the package itself. These will resupply the headspace equilibrium, meaning the terpenes in the flower won’t have an equilibrium drive to fill the air space.

Using a 12-cavity injection mold, eBottles420 created a basket– made from a proprietary blend of recyclable plastics to ensure material compatibility with terpenes (as those compounds can have some incompatibilities with some plastics)–that fits into the underside of the jar’s cap, which hangs down slightly into the jar’s headspace.

Inside the basket is the matrix that cannabis producers impregnate

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MATERIAL DEVELOPMENTS

with the terpene compound.

The process method is dependent on the producer. It can be done with a robotic filling system or by hand with a dropper.

These efforts are meant to ensure the terpene levels in cannabis products are preserved throughout the distribution chain–from greenhouse to the customer’s home–so that consumers can have a robust and consistent flavor profile.

“From a medical point of view, we are focused on consistency,” says Eric Greenbaum, chief science officer at Vireo Health.

“We want to make sure that when customers buy the strain that they prefer, a month or two months from now it’s the same.”

While the system is designed to work with most materials, Vireo does encourage the use of recyclable materials and is working with eBottles420 to ensure that materials used in the company’s initial offerings are recyclable.

↑ eBottles420 created a basket that fits into the underside of the jar’s cap, which hangs down slightly into the jar’s headspace.

The labeling Vireo says there are no special labeling requirements with their packaging. As the company is multi-state, the label content changes based on the state program overseeing production. The company uses a two-part labeling system, with the main label displaying the brand name and the product type. The supplementary label contains the lot number, the specific testing results, and any kind of state-specific content.

Future plans for cannabis packaging The current packaging system is only for cannabis flower in jars, so Vireo is working toward making it available in bags as well. The company is also experimenting to test whether or not the system works with concentrates. Another future endeavor is to add a temperature and humidity controlling system in the packaging.

Vireo recently established a subsidiary called Resurgent Biosciences to house Vireo’s portfolio of intellectual property and related initiatives in a non-plant-touching entity meant to broaden potential partnership opportunities or other strategic outcomes. Technologies like the terpene-preserving packaging system have a variety of potential applications in many industries beyond cannabis, says the company, including food & beverage and health & beauty products.

Voice of the Packaging Industry: Sustainable Packaging Packaging professionals from engineering, packaging, operations, and sustainability in a range of industries were interviewed for PMMI’s Packaging Sustainability: A Changing Landscape.

Here’s a look at just a few of the comments from life science respondents: +“We’ve created healthcare product recycling for hospitals and a returnable program for vision care products.” - Sr. director of Packaging, Global Leader in Healthcare Products +“We converted our medical products packaging from a rigid tray to prefilled pouch requiring a new FFS machine.” - Sr. director of packaging, Global Leader in Healthcare Products +“Our labeling has been improved by using rotary type labeling which is faster and more precise.” - Packaging engineer, Vitamins/Supplements +“We don’t have any sustainability goals for packaging right now, we are focusing on monitoring and reducing our utility usage.” - Packaging manager, Contract Manufacturer, Pharma +“We are trying to eliminate the need to cellophane wrap our cosmetic products but still looking for a tamper evident solution.” - Project engineer, Personal Care Download the FREE Executive Summary, or PMMI Members can download the entire report at hcpgo.to/376.

November/December 2020 • Healthcare Packaging | 15

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OEM APPLICATION NOTE

Robotic Precision in Small Batch Aseptic Processing KEREN SOOKNE, DIRECTOR OF EDITORIAL CONTENT

Growing demand for small batch processing poses new challenges for the life sciences sector, as the healthcare industry trends toward drugs more tailored to certain patient populations. Adapting to variances while maintaining quality, efficiency, and adherence to aseptic processing requirements is more complex than ever.

Automated Systems of Tacoma (AST) is a U.S.-based pharmaceutical machine manufacturer specializing in advanced aseptic filling equipment and packaging machines. With a relationship spanning more than two decades, AST chose Stäubli robotics in 2010 to develop a multi-format robotic filling machine–reportedly the first ever capable of processing different types of container formats on a single machine.

AST launched its GENiSYS R in 2018; this flexible modular system automates aseptic filling and closing of ready-to-use vials, syringes, and cartridges in strict accordance with cGMP requirements. It can be integrated with isolator-barrier or RABS technologies to maintain required aseptic conditions in tightly controlled ISO 7 and ISO 5 environments.

The GENiSYS R is optimized for small batch filling, with a focus on dosing precision and high yield, and uses robotics to achieve 100% in-process control (IPC). This makes it suited for clinical and commercial applications in drug manufacturing, compounding, cell and gene therapy development, personalized medicine, cytotoxic drug processing, and other areas.

The IPC provides real-time fill weight feedback and control, which can be used to identify issues early on, ensuring quality, minimizing waste, and maximizing product yield. Electronic batch record (EBR) software records key production data that can be used to create 21 CFR Part 11-compliant batch reports.

Product flexibility The combination of modular design and advanced robotics allow the GENiSYS R to be configured to meet different process requirements and containers without the cost or extra time associated with customization. Operators can program recipes specific to container

formats and drug products, as well as precise robot movements and pump settings, using the intuitive human-machine interface (HMI), ASTView. This can include fine-tuning needle fill depth and speed to prevent bubbling, or exact positioning in a given space to mitigate air disturbance, for example, with minimal downtime during changes.

The system’s modular design also provides flexibility with regard to the degree of automation desired: bag and tub opening can be manual, semi-automated, or fully automated, while filling and vial sealing are always fully automated.

Robotics for sterility, quality, and safety For pharmaceutical and biotech labs tasked with processing complex small batches, precision, flexibility, reliability, IPC, and protection from contamination are all critical elements. The GENiSYS R meets these requirements thanks to Stäubli’s six-axis TX2-40 and TX2-60 Stericlean robots. The robots are entrusted with a variety of delicate and repetitive yet critical tasks that could otherwise put product quality, the operator, or the end user at risk.

In addition to its past experience with Stäubli, AST had a variety of reasons for choosing Stericlean robots for the GENiSYS R. As CEO Joe Hoff explained, “We needed robots that are reliable over a long period of time, extremely precise, and completely sterile, and the Stericlean line is designed for exactly that.”

Stäubli’s Stericlean range is suitable for GMP grade A and grade B tasks, and known for high performance in aseptic and sterile conditions. Extremely low particulate generation and VHP-resistant design enable the robots to reach cleanliness level ISO 2. They feature a fully enclosed IP65 arm with IP67 wrist, as well as a smooth surface free of retention areas and coated with a high-resistance surface treatment. The arm is also equipped with specialized lip seals, and cables run through the arm and out vertically through the base. Critical parts are made of stainless steel.

A spherical work envelope and compact size make TX2 robots easier to integrate within machines like the GENiSYS R. They can work nimbly in tight workspaces, and their small footprint allows

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optimization of the surrounding workspace.

Speed and repeatability are also important considerations. With Stäubli robots, the GENiSYS R can process up to 20 units/min, depending on container, product, and IPC rate. Several unique attributes make this possible, even when using NSF H1 foodgrade oil. Chief among them is Stäubli’s own patented gearbox, which the company manufactures in-house. This ensures minimum backlash and unmatched arm rigidity, allowing for extreme repeatability–translating to higher speed, shorter cycle time, and greater productivity.

Flexibility from opening to closing Depending on the level of automation desired within the GENiSYS R system, the TX2-40 and TX2-60 Stericlean robots can handle or assist with critical steps in each stage of the aseptic process: bag and tub opening, filling, stoppering, sealing/closing, and reject handling. If some tasks along the production line need to be manual, the GENiSYS R can easily accommodate that need while ensuring operator safety and product sterility.

The robots offer reliable repeatability in their motions as they carefully manipulate the vials, which is essential to reducing particle generation, air disturbance, unexpected vial shaking, and other potentially damaging variables. This helps prevent spills and other incidents that would otherwise result in unplanned manual interventions, which risk compromising the aseptic environment.

The use of the Stäubli robots engineered for dexterity and use in aseptic environments play a significant role in the GENiSYS R’s high flexibility, enabling the precise filling and closing of ready-to-use nested, pre-sterilized vials, syringes, and cartridges.

Without these advanced robotic capabilities, the changes between recipes and formats demanded in small batch processing would be considered prohibitively complex to producers.

↙ A Stäubli TX2 series Stericlean robot presents vials for secure stoppering with reliable repeatability and no risk to the aseptic environment.

↙ The GENiSYS R fill/ close module during vial processing.

↙ An operator manually transfers containers into a tub opening module—a task which can be semi- or fully- automated.

↙ Stäubli robots filling and stoppering a nest of ready-to-use vials.

↙ A robotic arm prepares to place a finished vial back into the nest.

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COVID-19 DIAGNOSTICS

Deemed Project Patriot, the new $40 million facility is strictly dedicated to VTM production and quality control, and it will serve a role going forward for flu and other viral products.

COVID-19 Test Medium Production Ramped Up By 20,000% in Six Months KEREN SOOKNE, DIRECTOR OF EDITORIAL CONTENT TOP THREE TAKEAWAYS 1. Viral transport media tubes filled with liquid media are used to store and transport nasal swabs.

2. Indexing vials through filling can be a challenge due to the conical shape of tubes, which makes them unstable.

“

Nimble” is an understatement for most life science manufacturers producing COVID-19 test materials, PPE, or treatment this year.

Thermo Fisher Scientific snapped into action and began ramping up production of its viral transport media (VTM) tubes at the outset of the pandemic. Later they received orders from the U.S. government to scale production from 50,000/week to 10 million/ week.

VTM tubes filled with liquid medium are used to store and transport nasal swabs for viruses including SARS-CoV-2. In March, the Thermo Fisher facility in Lenexa, KS, was already filling 10 and 15 mL conical tube configurations. The company ramped to 24/7 operation and retrofitted their lines to run faster at the outset of the pandemic, but it was clear that they needed new machines to meet demand.

Considerations beyond speed included:

3. Sixteen integrated lines were designed, built and installed in 20 weeks to meet demand, along with a facility buildout.

• Some of the conical tubes are skirted, but the tubes without skirting do not stand up on their own.

• The medium has similar viscosity to water, but Jason Gourley, strategic projects, sr. project engineer at Thermo Fisher Scientific, says, “From a filling perspective it’s very similar to water, but if it lands on a surface, drips, or spills and begins to dry, it becomes sticky. If it’s not immediately wiped or cleaned, it turns into a goo, similar to spilled soda left to dry.”

This didn’t cause issues with capping, but if a tube happened to spill and medium got on other components—such as the feed screws or labeler—equipment could bind up and require downtime in cleaning.

VTM lines also needed to be ramped up at Thermo Fisher’s sites in Perth, Scotland, and Wesel, Germany. In both Perth and Wesel, the operation switches between filling VTM and saline, depending

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on current demand. Gourley explains, “It’s the same tube and cap, same fill size. The difference is the liquid itself, the labeling requirements, and different pump settings.”

Speedy timeline When Gourley arrived in Lenexa from his usual Rockford, IL, facility in March, the immediate need was to understand the process and determine where automation could increase throughput dramatically.

Speed was key. The Thermo Fisher project team had vendors offering to drive components to the facility—instead of overnight or two-day shipping—because they knew every hour counted.

Gourley suggested working with Morrison Container Handling Solutions for high speed integrated lines. “I’ve worked with Morrison for about three or four years. They’ve done some screw feeds and integration with a line in Rockford,” he notes.

The initial request to Morrison was whether they could create a smaller system within approximately a week. “They immediately hopped on it and followed through. They had a quote ready the next day, working through the night and everything,” he says. Some projects take a step-wise approach to implementation. But Gourley says time didn’t allow for that in this case, noting, “This was all at once. We drew it out on a napkin one morning. The next morning, we were putting it together.”

It was difficult to nail down project specifics with a constantly moving target. “Every day something changed. One million per week was the initial goal and it was only going to be for about three or four months,” Gourley says. “Everything started out with, ‘Maybe. But could you do it?’ We had four on order and then the question came down from the government on how we can get 10 million a week and what it would take.”

The original order for machine #1 was placed in early April and it shipped in approximately five weeks. That included design from scratch to manufacturing, build/assembly, and testing. A total of 14 systems shipped to Lenexa and two systems shipped overseas in the next 20 weeks. To put things in perspective, the normal quoted lead time for one system/line can be 20 weeks or more.

Fill and torque checks are performed by production every 15 minutes. There is also a no-cap sensor and crooked cap sensor at the discharge of the machine. If a cap issue is detected, the machine will stop, alert the operator to remove that tube, and then the operator is able to reset and start the machine. Every second counts when running at a rate between 120-132 ppm.

Tubes exit the machine in different orientations based on the machine and location.

• Machines #1 and #2 run pointed tubes which don’t stand on their own.

• Machines #3 through #16 run skirted tubes that technically have the ability to stand on their own, but Gourley notes that even the skirted tubes—moving at rate, with liquid—do not stand securely on their own.

• Dorner Conveyors move tubes directly from the machine, out of the cleanroom to the labeling machine, autofeeding onto the labeler. There is still an operator to perform quality checks or interventions at the labeler. (Label applicators are supplied by Pack Leader USA.)

↑ From a filling perspective the medium is very similar to water, but if it lands on a surface, drips, or spills and begins to dry, it becomes sticky.

System details The Morrison systems allow Thermo Fisher to orient, contain, move, and support the pointed conical tubes. They are handled from a dual feeder bowl solution to drop into the screws. (R-Tech Feeders Inc. supplied the tube elevators, feeder bowls, and shuttle dropping mechanism for the tubes into the Morrison screws.)

The system then indexes six tubes at a time underneath the filling head, indexes along underneath the cap applicator, and then into a spindle capper. (APEX Filling Systems supplied the cap sorters and cappers.)

↑ The Morrison systems allow Thermo Fisher to orient, contain, move, and support the pointed conical tubes.

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Remote installation

Regulatory considerations

As many business travelers have found, travel restrictions have held up some trips. Gourley says, “Between Chicago and Lenexa, there were still restrictions, but we had higher level approvals due to the critical needs of the project.”

For the sites in Europe, it was a different story. “For Scotland, we tried to go through the embassy and the government to get those supporting individuals on-site in Chicago around the 4th of July weekend, to review their machine at Morrison and to be a part of an installation in Lenexa. But we weren’t able to get approval prior to their machine arriving at their site,” he explains.

Gourley and his colleagues performed all 16 factory acceptance tests (FAT) on-site at Morrison. The company performed/recorded virtual FATs for the European sites. He says, “For the first two, we developed/worked through a protocol and had it circulated for approval, so we knew what we were looking for. But we also had timeline restrictions—we already had the plane booked. There’s only so many tubes we could run and only so much time we had with the new system.”

Both Perth and Wesel received their machines with only instructions, videos, and the ability to call for support. Yet each site respectively had their first machine received, installed, and running at rate in five to six days.

By then, Lenexa staff had installed about seven machines in the U.S., so they had plenty of lessons learned, videos, PowerPoints, instructions on the sequence, and items to pay attention to. “We were a part of the complete build, the complete runoff, and the complete disassembly in creating these specific systems. We went through rolls and rolls of blue tape, putting on notes, alignment features, noting all the dimensions, anything we learned from the first several machines. It is wild to think that we shipped machines around the world to sites that had never physically seen or ran the equipment. A lot of thanks go to those receiving individuals for their patience and perseverance,” Gourley says.

The company made use of Microsoft’s HoloLens program for live video feeds from the augmented reality headsets. “We were able to see their troubleshooting issues live, and they were able to liveview their machine during validation and ask as many questions as possible. We built up the files and everything to have immediately available, so if they had a question and they were viewing it right in their headset, I had the pictures, dimensions, and videos available to pull right onto their screen and into their viewpoint to do a direct comparison,” Gourley explains.

One of the toughest parts of the remote work was not the machine integration itself, but the time differences between sites—six hours to Perth and seven hours to Wesel. Which site worked during business hours and which worked off-shifts? “Everybody did everything.

It was 24-hour support,” he says.

The largest regulatory hurdle that they had to overcome was making sure they met all the CE mark requirements—mandatory for equipment in Europe to demonstrate safety conformance—for the Perth and Wesel units. Gourley says, “As soon as possible, we brought in a third party to fully understand the CE standards and additional safety requirements. We immediately started talking with both sites’ environmental health and safety teams to ensure that we were going to comply not only with CE, but also be aligned with their site safety expectations.”

20,000% increase After ramping up 20,000%, you might think it would be time to relax. The facility in Lenexa now has 14 lines installed (as of Aug. 25), with the capacity to produce 10 million VTM tubes per week.

But the work continues. Thermo Fisher has ordered 14 more systems —four for Lenexa and 10 for Scotland. “A lot of credit goes to the teams at Morrison and supporting vendors to start from scratch and build 30 systems between March and the end of the year. It was really a team effort with a lot of credit to Thermo Fisher personnel—including the engineering and procurement groups— between R-Tech, Apex, and many sub-contractors. There was definitely a lot of collaboration,” he says.

It’s too soon to really talk efficiency, particularly with the rapid increase in staffing and training (see sidebar), but they are averaging

Staff and Facility Expansions Understandably, Thermo Fisher ran into space issues, especially with the supply chain to get tubes, caps, and media to the machine. Machine #1 has a much smaller footprint than the others to fit in the room. It is still a screw feeder, but the cap delivery and exit are different.

When they ran out of space in the existing facility, they needed to build out an entire second facility in Lenexa for filling lines, packaging, and more. Over 300 new employees were hired and the site is looking to hire over 100 additional employees. The new $40 million facility is strictly dedicated to VTM production and quality control, and it will serve a role going forward for flu and other viral products. Deemed Project Patriot, the 120,000 sq ft build-out and tube production can be viewed in action at hcpgo.to/patriot.

“When we signed the lease on May 18th, this was an empty shell, and by July 4th, our country’s Independence Day—our milestone for Project Patriot—the first production units coming off the line were achieved,” said Bret Johnson, VP of global operations for Thermo Fisher’s specialty diagnostics business.

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over 100 tubes/min per machine. Gourley explains, “The machines run very well and they’re well over the OEE that we were anticipating. Now we’ve gotten the initial kinks out of the way and the operators are a lot more familiar with the operation.”

thanks to the new machines.

Gourley comments, “The Morrison machines, along with the efforts of all of the other vendors, and all of the dedication of the Thermo Fisher individuals were

key in enabling us to deliver on the federal government contract. Overall, we’ve met our commitment with a lot hard work and with everybody invested 110% in making these test kits available for society.”

Key takeaways The Lenexa team learned a lot along the way, especially with Machine #1 since it was a completely new system in some ways for Thermo Fisher, Morrison, and everyone involved. “For Machine #2 through #16, we took a ton of lessons learned and worked to implement on the fly. We’ve gone back and implemented some on #1 also,” says Gourley.

The collaboration between Morrison, Thermo Fisher, and other vendors was key. He adds, “We were getting the Morrison machine ready on Monday, receiving vendor components on Tuesday, running the full system on Wednesday, and FAT-ing and shipping on Thursday and Friday. At one point we shipped three systems in one week and one of them was international.”

Next steps The team continues to investigate more streamlined processes and automation to help aid in inspection and packaging. Currently operators perform a visual inspection for media content and cap, and check for wrinkles, damage, and legibility of the label.

Then tubes are passed to an operator who populates 72-count boxes in Lenexa.

Each machine produces one lot of approximately 24,000 tubes every three and a half to four hours—about a pallet and a half worth of material. At peak, with 12 machines running, it’s a pallet approximately every four minutes, so there’s considerable volume to handle Nov/Dec 2020 • Healthcare Packaging | 21

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Servo Filling Systems

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LOGISTICS

Cells Remain Upright in Floating Spherical Shipper KEREN SOOKNE, DIRECTOR OF EDITORIAL CONTENT TOP THREE TAKEAWAYS 1.Fragile 3D microtissues for drug development and testing must remain upright in transit.

2.This EPP sphere-on-water system takes cues from boats while keeping products in temperature range.

L

ogistics for fragile products can be hard enough to control, but add in the words “living” and “microtissue” and the shipment is even more challenging. Taking inspiration from boats that remain upright in harrowing conditions, one 3D cell technology company developed a spherical shipper that floats on water to keep cells upright.

Switzerland-based InSphero AG specializes in delivering assay-ready and custom 3D tissue models to pharmaceutical and biotech companies worldwide for investigating, developing, or testing new drugs.

They produce a variety of models derived from human liver, pancreatic islet, and tumor cells, to provide insights into liver toxicology, metabolic diseases (e.g., diabetes and liver diseases), and oncology.

The shipping process was already tightly controlled so that these delicate cells arrive safely and on time. “Sterility and temperature must be maintained throughout shipment,” explains Olivier Frey, Ph.D., InSphero head of technology & platforms, and a former Olympic-bound pole vaulter and award-winner for contributions to the advancement of organ-on-a-chip technology. “They are living tissues and need to be maintained at 37°C. They can go a bit lower, but shouldn’t go over 40°C as too much heat will kill the cells and denature proteins.”

The lifetime of the microtissues is

3.Finding the right dimensions took some time—the system balances ease of assembly with being leakproof.

limited, though putting them into a three-dimensional structure extends that lifetime. Any wasted time in shipment would cut into the customer’s experimental window.

Additionally, there are specific consumables—culture media— to consider. “The microtissues are around 200 or 300 microns in diameter (three or four times the thickness of a hair). They’re not anchored in a well, but free-floating in a suspension in a specially designed well,” Frey explains. “If the plate shakes, flips, or sits sideways for too much time, the microtissues can get attached to the plate wall or ceiling. Then if you turn it right-side up again, you have the microtissues outside of the medium and they will die.”

Eureka! moment The company has been designing their own packaging from the outset due to the specialized nature of the products.

InSphero CEO Dr. Jan Lichtenberg was working with his son on a new shipper that would keep the plates oriented properly. He had what the company calls a “eureka!” moment for a spherical shipper, initially performing trials using a sphere inside of another sphere with ball bearings and some lubrication. At a ↖ The shipper was developed to balance watertight design with ease of packout.

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LOGISTICS

certain point, they thought of how boats are constructed, with a heavy keel at the bottom to keep the boat upright, even in heavy winds.

“They thought, ‘Why can’t we put this on water?’ And that’s when we started discussing at the office with materials from the hobby store. We did some early prototyping with styrofoam spheres floating and saw that it worked,” says Frey. “Then we further developed the system with a lot of design iterations in a step-by-step team effort.”

InSphero selected Taracell AG from a short-list of companies they looked at, due in part to their specialty in pharmaceutical packaging. Frey notes, “The reason we chose them ultimately was that they were quickly fascinated and showed enthusiasm.

We knew from the beginning it was going to be a challenge, but we had the impression that they also wanted to tackle this and put in extra effort. It was a great collaboration.”

They were also close geographically, only 15 or 20 minutes away. “For such a new shipper, we knew it would require iterations, and that it would be good to quickly meet and discuss next steps,” he adds.

Sphere on water

↗ The microtissues are not anchored down, but free-floating in a suspension in a specially designed well.

↗ The four-part shipper keeps fragile microtissues in plates upright.

The final product, the InFloat Shipping System, is a spherical shipper floating on water inside of a rectangular outer container (not quite a cube as it’s taller in height than width—a rectangular cuboid for geometry fans). Both of the aforementioned parts are composed of expanded polypropylene (EPP).

Extruded polystyrene (XPS) was considered but lacked flexibility.

“We needed to ensure that the packaging was watertight and the closure required some elasticity of the material. And that’s why we chose EPP,” Frey explains.

In total, the system is composed of four main parts.

• The 3D microtissues sit in the company’s Akura assay plate technology, sealed with a film in sterile conditions. These plates are wrapped in a small plastic bag to maintain sterility. Depending on the customer’s order, a few plates are then placed in a small paperboard box.

• The box sits inside of the sphere, which opens in half. Within the sphere are heating elements added for temperature control.

The sphere is secured closed by a single plastic strap.

• The sphere sits inside the larger rectangular EPP box, floating on 0.5 liters of water. The EPP box has handles for easy carrying and opening. The box features plastic straps to secure closure.

• The EPP box is then housed in a large corrugated shipper.

“The function of the inner box is branding for the product and keeping everything packaged in a proper, easy-to-handle box. The two black EPP containers keep the microtissues upright and maintain temperature” says Frey. View a video of the InFloat packout and unboxing at hcpgo.to/385.

Taracell manufacturers the shippers at their facility, and assembly steps are performed during packout at InSphero. During packout, InSphero adds ELPRO temperature data loggers.

Key learnings There were a couple of challenges Frey points to as learning opportunities. “It seems simple, but it’s complex in that from the beginning we wanted to have a solution that functions so that the November/December 2020 • Healthcare Packaging | 23

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sphere is floating and stays upright all the time, while keeping the temperature in range. But at the same time we wanted to design something which is also easy for our team to pack. We wanted it to be intuitive so you show them once how the whole thing is packed and then they always do it properly.”

And on the end user side, they wanted the customer to open it with just a couple of steps so that they can quickly get access to the plates. This meant a lot of discussion and a lot of testing.

The most challenging part was that the water inside has a crucial function. “We had to put quite some effort to really match the correct dimensions so that it was both easy to assemble and leakproof with just a few steps of closure,” says Frey.

During the manufacturing process, there were a few optimization steps regarding the choice of the material and the density of the injection molding process. “We have a lot of thermal elements on the inside that need to be correctly assembled, everything has to match. So from the geometry viewpoint, we had to think about a lot of different things,” he says.

Unique shipping temperature The product itself is rather unusual in shipping around 37°C. Many similar products in the industry are shipped frozen and need to be placed in the refrigerator upon arrival. InSphero ships live cultures across continents in ready-to-use condition for laboratory experiments.

The shipper is qualified for three days, and the company aims to have microtissues at the company in two days for U.S. shipments.

(Shipping is three days for Japan.) This is heavily dependent on the lifetime of the microtissue because they are not oxygenated during shipment. Frey notes that one shipper was held up at a logistics center for one week due to a Boston snowstorm. When it arrived at its destination in Brunswick, ME, the shipment of plates was still intact. These were a different product (not microtissues) but the shipper remained functional.

Commercialization The systems were launched in Q2 2020, and are already shipping to pharmaceutical sites on a daily basis. The unique structure of the shipper garners attention. “Everyone that sees it is seeing this type of package for the first time, and there tends to be this wow effect that’s transmitted back to our sales representatives,” Frey says. The system recently won the Red Dot Best of the Best award for product design in the category of industrial equipment and automation.

The shipper is disposed of in the regular waste stream. Frey explains, “This is something we’re looking into at the moment.

What we observed is that more and more customers write asking how they can ship the system back to us.”

Initially, the team considered reuse and systems that need to

AN ANECDOTE: WHEN THEY WERE TESTING THE PROTOTYPE SHIPPING SYSTEM, DR. FREY AND DAVID FLURI PUT TWO UNCOVERED GLASSES FILLED WITH WINE IN THE INNER BOX COMPARTMENT AND SECURED THE STEMS IN PLACE. THEY CLOSED THE SPHERE AND THE OUTER BOX, FLIPPING IT OVER FOR ONE FULL ROTATION. WHEN THEY OPENED THE SHIPPING SYSTEM, THE GLASSES WERE STILL FULL OF WINE, WITH NO EVIDENCE OF SPILLS. THE TEAM THEN TOASTED TO THEIR SUCCESSFUL TRIAL RUN.

be shipped back. “We looked at the whole picture, including the CO₂ footprint because shipping a packaging twice over the Atlantic would not be carbon neutral. So we went in the direction of singleuse. The size of the new package is not larger than the size we had before, but I think due to the visual it has, people don’t want to throw it away. We also want to take care of this and we are currently thinking about how these shippers can be reused without losing function,” he says.

They are also looking at how these shippers can be recycled. Frey notes, “Sustainability is important to us and to our customers. There are specific recycling stations for EPP, so we are thinking about the logistics in order to simplify that.”

Shipping, Regs, and Customs + InSphero’s shipping experts handle customs and paperwork requirements, which can be quite intricate depending on the model. They have cells based on animal models; cynomolgus monkey models, for example, need specific regulatory requirements as well as some additives. + Liquid hasn’t been an issue. They tested it, shipping prototypes overseas to understand how it is received. Liquids are shipped regularly and thermal shippers have liquid, ice blocks, cold packs, etc. + There have been occasions where the end user’s lab staff was desperately looking for a box that was stuck in their own mail room. InSphero’s customer service department works closely with the customer to ensure that the urgency is emphasized not only in the lab, but also in the shipping facility.

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REGULATORY

Live from PDA/FDA: FDA Considers Incentivizing Quality Management Maturity (QMM) KEREN SOOKNE, DIRECTOR OF EDITORIAL CONTENT TOP THREE TAKEAWAYS 1. The FDA solicited feedback from manufacturers on assessing and rewarding QMM.

2. Reduced audit frequency may one day be an incentive for high performers.

3. To support industry, health authorities should be sharing information and best practices.

F

mendations into an international standard, in this case, ICH Q10, which lays out a model for an effective quality management system in manufacturing.

The third step is QMM. “It’s a culture first and foremost in a particular manufacturing site devoted to quality. It’s about the people, it’s about anticipating challenges rather than reacting to them when they occur, it’s about putting in place a model that measures quality in a way that allows you to anticipate problems rather than identifying them after the fact and having to respond to them,” said Throckmorton.

Each piece is intended to build on the last, and management must set the tone to be successful. The anticipation of challenges should result in better quality, better equipment availability, reduced manufacturing errors, and greater availability of product for public health. “We believe there’s a case to be made for reduced cost as well. There’s less response that has to be made, fewer recalls that have to occur,” he noted. Hopefully these lead to fewer drug shortages.

“Each of those three pieces together, fundamentally, are important to revising QMM ↑ Dr. Douglas Throckmorton, deputy Throckmorton offered a stair-step graphic and improving the current system. Where director for FDA regulatory programs. that encapsulates the pieces (see next page). we are right now is not low quality—it is a “A critical first step is the cGMPs. Those are very robust manufacturing sector—this is a standards that we’ve all applied for decades. We understand them, way to improve on that robust sector that we think is really importour inspectorate understands them. They’re the bedrock of what ant,” he added.

QMM is important to all stakeholders... we need to build on,” he said.

• For patients: It’s important to have available, reliable, and The next step is cooperation and consolidation of those recomDA continually looks at ways to uphold long-term quality and may one day offer incentives to those who demonstrate Quality Management Maturity (QMM). FDA solicited feedback on this topic through a survey in fall 2020.

As Dr. Douglas Throckmorton, deputy director for FDA regulatory programs, explained at the virtual 2020 PDA/FDA Joint Regulatory Conference, QMM is a collection of business processes needed to consistently implement and maintain quality in the marketplace.

While QMM is built on current Good Manufacturing Practices (cGMP) compliance, it’s more than that.

“You’re building a culture to build in a larger business case for sustained and consistent high quality manufacturing,” said Throckmorton. He added that the focus is on stronger quality management systems that are proactively focused on performance, especially those that reduce adverse events, reduce shortages, and ultimately become more efficient in manufacturing.

(Editor’s note: If you’re already familiar with QMM, jump to Incentives, below).

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REGULATORY

high-quality medicines. Reduced shortages are an essential part of creating the best possible sources for American public health.

• For industry: The key to QMM is informed and intelligent oversight and control over the manufacturing of drugs to assure quality and increased efficiency. Fewer recalls lead to improved corporate reputation. It enables the continued improvement of products through improved understanding.

• For FDA: Throckmorton noted, “It’s important to the FDA because we believe that these objective insights into the state of quality allow us to: do our job better, to better target our allocation of surveillance tools, to work with you better, to be more flexible, to create a way that we can all work together to improve the quality of the manufacturing of medicines.”

It will also help FDA identify potential vulnerabilities so that they can work with manufacturers to prevent shortages from occurring.

Data is key Quality metrics are an important element of understanding QMM and implementing it. These metrics should identify ways to truly assess the quality of a product while it’s being manufactured, and look for potential vulnerabilities to manage them, and ideally, forecast and increase the reliability of supply.

FDA will continue to keep an open dialogue with pharmaceutical manufacturers regarding any metrics rollout.

Incentives Throckmorton said that CDER has a vision for QMM. “We believe it’s important as a system to measure and rate a drug quality manufacturing system. We believe that metrics to identify high-quality systems are an important element to help reward those that deliver high-quality drug products reliably, and without disruption,” he explained.

One goal they have is to provide a way to make high performers known to the marketplace. “We’re in the process of putting in place a stakeholder input program to understand on a voluntary basis how this system might work and what quality metrics you think would

be useful in identifying a high-quality system,” he said of the new benchmarking survey.

An audience question noted that FDA does well at telling industry about sub-standard performance through 483s, warning letters, and so forth, and asked for specifics on how QMM role models might be acknowledged. Other agencies, such as OSHA, recognize high achievers.

Appropriate acknowledgement is still under development for high-quality performers.“We want to find a way to reward them in as public away as possible. Exactly what that looks like I can’t answer.

I hope people participate in that survey,” he said.

Another important premise he noted is that as companies are able to demonstrate understanding and are able to anticipate problems well, the agency may look at changing the way they oversee that facility. “We need to be able to devote resources to the places that need help. We don’t need to be devoting resources to a manufacturing site that’s already at a high state of readiness and already doing a good job of anticipating manufacturing challenges,” he explained.

Changes in inspectional frequency are one of the concepts November/December 2020 • Healthcare Packaging | 27

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REGULATORY

This is the headline This is the deck.

BYLINE, BYLINE’S TITLE TOP THREE TAKEAWAYS Leadin, lorem ipsum dolor sit amet sin qua non Ratio excerferibus seque cusam ut quodit omnim quissim fuga. Apit, torepelest mo molupta

Leadin, lorem ipsum dolor sit amet sin qua non Ratio excerferibus seque cusam ut quodit omnim quissim fuga. Apit, torepelest mo molupta

Throckmorton has heard people ask about. He hoped people were very granular in their suggestions in the survey.

Other areas of FDA interest This effort is part of a broader landscape of efforts that the agency is taking on to support quality manufacturing, including the following initiatives.

• Advanced manufacturing technologies: “I hope many of you have taken us up on our offer to work with you, to help find ways to improve the efficient manufacturing of complex and challenging molecules.”

• Supply chain, redundancy, resiliency, and information sharing: This is a particular interest of Throckmorton’s.

COVID-19 has highlighted the need to improve information sharing to understand the state of quality promptly and efficiently. Under the right circumstances, this will help the industry prevent shortages.

• Global partnerships: COVID-19 has given us an opportunity to build the global partnerships that we have in place and to make greater use of them. He added that we cannot let this effort slip as COVID-19 potentially improves. Health authorities should be talking, sharing information, and sharing best practices to make certain they are doing the best job to support industry.

• QMM: “I do believe it is a cornerstone of the next step in quality manufacturing. Regulatory convergence is something that I know that is very important to [PDA members]. We’ve talked a great deal about the importance of regulators finding a way to ask for common sets of requirements wherever possible to aid the efficiency with regards to regulatory activities,” he said.

Throckmorton ended his talk with a unifying message, saying, “Fundamentally, no one is going to be able to do this alone… The last

Leadin, lorem ipsum dolor sit amet sin qua non Ratio excerferibus seque cusam ut quodit omnim quissim fuga. Apit, torepelest mo molupta

“WE NEED TO BE ABLE TO DEVOTE RESOURCES TO THE PLACES THAT NEED HELP. WE DON’T NEED TO BE DEVOTING RESOURCES TO A MANUFACTURING SITE THAT’S ALREADY AT A HIGH STATE OF READINESS AND ALREADY DOING A GOOD JOB OF ANTICIPATING MANUFACTURING CHALLENGES.” —Dr. Douglas Throckmorton, FDA

decade has seen a blossoming in terms of the quality, the consistency, the trajectory of positive change in the manufacturing of U.S. pharmaceuticals. I believe we need to continue with that work together. We need to work as an agency to be responsive, sciencedriven and as flexible as we possibly can to support that work that you all are doing to improve the maturity of the manufacturing of pharmaceuticals. I believe that we can work together to improve the global pharmaceutical quality resulting in improvements in the life of patients, decreased shortages, and increased consistency and quality of products as they’re manufactured for those patients to use.”

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LOGISTICS/SUPPLY CHAIN

Seven Recent Statistics in Pharma Cargo Theft KEREN SOOKNE, DIRECTOR OF EDITORIAL CONTENT TOP THREE TAKEAWAYS 1. A supply chain security and resilience director takes a look at recent trends from 2019 and 2020.

A

2. Pharmaceuticals account for a relatively low proportion of all cargo theft, but are higher value on average than other thefts.

t HDA’s 2020 Pharmaceutical Cargo Security Coalition (PCSC) Educational Seminar (held virtually Oct. 6 through 8), Tony Pelli, practice director, security and resilience at BSI Supply Chain Services and Solutions, shared recent trends in pharmaceutical cargo theft, highlighting upticks in theft of PPE and medical devices due to COVID-19.

In addition to consulting, auditing, and standards, BSI offers a Supply Chain Risk Exposure Evaluation Network (SCREEN) intelligence tool and its Supplier Compliance Manager (SCM) tool that tracks and mitigates threats to operations, and tracks the progress of supplier risk and compliance audit programs. Pelli offered statistics gleaned from the SCREEN tool, including: 1. Pharmaceutical cargo thefts account for a relatively low proportion of all cargo theft at 2.9%. The top commodities stolen are food & beverage, electronics, and alcohol and tobacco, with pharmaceuticals ranking at the 11th spot for overall theft. Lower value shipments such as food do not have the same security measures and are less complicated to move.

2. In 2019, pharma theft tended to happen most often via hijacking—accounting for over 40% of thefts—and facility break-ins. With such high value cargo, smaller incidents perpetrated by smash and grab, employee theft, and theft of container/trailer are less likely than in consumer goods and automotive industries.

3. The median value of a pharma theft is $100,000. Pelli said, “Even the smaller pharma thefts are larger than the typical thefts in other industries,” including food and apparel. “When pharmaceutical thefts happen, they tend to be big… an entire truck, a facility break-in.” Pelli advised attendees to focus less on the number of incidents but more on the potential impact of those incidents.

4. The top countries where thefts occur varies quite a bit from year to year. Brazil, Mexico, and the U.S. were the top three coun-

3. In 2020, there’s been a dramatic uptick in theft of medical devices and supplies spurred

by COVID-19.

tries for pharma cargo theft in 2019. Recently, Italy has bubbled up as more of a hot spot, as well as India.

5. One of the biggest pharma thefts in 2020 was in Italy, in which $1.2 million in oncology drugs were stolen from a cold storage warehouse. The second largest, also in Italy, involved approximately $600,000 worth of pharmaceuticals stolen from a distributor. In that case, employee involvement was suspected in a long-running scheme. Pelli noted that due to organized crime, Italy has a fairly sophisticated network for stealing and redistributing drugs to other countries. “That’s something that we’ve seen over and over again— drugs are siphoned out of legitimate markets in Italy, and in some cases resold in places like Germany, where you can get much higher prices for them,” he said. Higher prevalence of mafia activity equates to greater numbers of cargo thefts, including in regions such as Naples.

6. The most targeted drugs still depend on the region. In Mexico, the most targeted drugs were (as expected) erectile dysfunction treatments and (unexpectedly) oncologic drugs. Typically more specialized medicines for cancer and arthritis require a more sophisticated resale network. “This is suggestive of the kinds of risk factors in Mexico with its greater organized crime presence than you see in countries like the U.S. or Canada, where thefts are targeting more expected opioids or lifestyle drugs,” noted Pelli.

7. Theft of PPE and medical devices have typically accounted for a very low percentage of overall theft. This was true prior to Q1 and Q2 of 2020, when there was a significant jump in PPE and medical device theft. This includes N95 masks, gloves, and COVID-19 tests being stolen or counterfeited throughout the supply chain. “One thing that we’re seeing is that they’re being diverted from hospitals as well,” said Pelli. “If you look at the types of products that were stolen in Spain in 2019, you’ll see apparel and footwear was at November/December 2020 • Healthcare Packaging | 29

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LOGISTICS/SUPPLY CHAIN

the top in addition to food and beverage.”

There’s been a dramatic shift in 2020, with almost 40% of incidents in Spain involving medical devices and supplies, where the rest remains as expected.

Pelli said he encourages attendees to look at reported incidents, but also look at risk factors such as organized crime groups that would be able to siphon drugs from legitimate supply chains into illegitimate supply chains. He asked, “Are there major price differences that make it attractive to do so? Is there a scarcity of the drug that creates that kind of black market? Is there corruption that facilitates all of that or government policies that have unintended consequences resulting in those types of issues?”

↑ 2020 saw a marked jump in theft of PPE and medical devices. Typically these products account for a very low percentage of overall theft. Image credit: BSI

COVID-19 concerns In terms of COVID-19 vaccines, there is certainly much to figure out in securing supply chains. Chuck Forsaith, vice president at HDA’s PCSC, noted that the federal government has visited manufacturers and distributors for security assessments because they know the visibility of this particular type of product.

“We’re not going to know this until distribution starts, but at this point in time, I’m not as concerned about inside thefts ↑ In 2019, pharma theft tended to happen most often via hijacking and facility break-ins. Image relative to the people that are producing credit: BSI the vaccine. I still have concerns about outside thefts and the like. That’s going to be something that BSI PPE supply and PCSC will be watching closely,” said Forsaith. “I think if there’s PPE requires the same due diligence as any material sourcing. any supply chain that will get plenty of attention, it will be that “Start checking the business history of that company—if there vaccine supply chain,” added Pelli. “So you may have better vetting have been frequent business transformations, if they’re a company of carriers than you typically would, but I think the concern would that never made PPE, but all of a sudden is making a whole lot of be where capacity is really stretched.”

PPE,” said Pelli. “Be wary of people saying, ‘Hey, we can get you For vaccines in development that require subzero temperature five million of these tomorrow,’ but they’ve never had that kind of distribution, there isn’t a high volume of capacity. “I think there volume before. Ask them for references from other customers that may be cases where you’ll see some fly by night carriers or logistics you can actually follow up on and chat with. Also be wary if they companies that are potentially able to be included in some of those want to change their payment terms or price at the last minute.” supply chains, just because of the urgency and the lack of capacity,” BSI has put together a short primer on factors to look out for when said Pelli. “And that would be where you need to look out for insider sourcing PPE. The company is following stories in their SCREEN theft. But that’s true generally anyways—it’s those less-known carriintelligence tool. Clients typically have access to that information, ers where you’re going to have issues. For the major parts of the but they are also making the COVID-19 related information available supply chains, it should be pretty well in hand.” for free without a subscription.

30 | Healthcare Packaging • November/December 2020

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CAPSULE FILLING

Pharma Contract Manufacturer Expands Large Batch Production to 110,000 Capsules Per Hour KIM OVERSTREET, CONTENT STRATEGIST, PMMI MEDIA GROUP TOP THREE TAKEAWAYS 1. Wiewelhove expands its capsule filling line with the GKF 2600 from Syntegon Technology.

2. Training sessions took place two weeks before the Factory Acceptance Test (FAT).

W

iewelhove GmbH has been a contract manufacturer of solid oral dosage forms for more than 15 years, processing plant-based and synthetic active ingredients. Established in 1976, the family business has developed into an international contract manufacturer of pharmaceuticals, homeopathic products, and dietary and vitamin supplements. With two production sites and a laboratory in Ibbenbüren, Germany, the company has a range of machines suited for all common manufacturing processes for solids and uses the Syntegon Technology GKF series including the GKF 400, GKF 700, and GKF 2000 capsule filling machines.

When Wiewelhove decided to expand its production capacity to accommodate large batches with a high unit count, it decided to add another GKF machine. Rainer Wibbelmann, technical director at Wiewelhove, said, “We can look back on good experience with the company and their machines, which have been running reliably for many years at our sites. After some market research, we quickly realized that we again wanted a GFK.”

3. High filling flexibility of the machine makes it possible to fill different capsule sizes.

must be trained before operating the machines—making training and education a top priority. “When we order new machines, training sessions held by our supplier are part of our requirements specification,” Wibbelmann said. “Our operators need to become experts so that they can use all the machines’ advantages for our production—and ultimately for our customers. In turn, we must give them the opportunity to ask questions before new machines

Training, a successful strategy Both the number of machines and employees is increasing at Wiewelhove.

In addition to its long-standing workforce, Wiewelhove relies on young talent who

↑ The GKF 2600, which was developed for the high-performance range, achieves an output of more than 110,000 capsules/hour with capsule size 00.

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CAPSULE FILLING

are put into operation. Only then will they feel comfortable with the technology and look forward to using it.”

Employees were trained in two three-day training sessions on the new GKF 2600 capsule filling machine at the equipment provider’s site in Waiblingen. Production staff learned how to start-up and prepare the machine for production runs and how to perform format changeovers. Calibration, troubleshooting, and maintenance were also part of the in-depth training, and, since the training sessions took place two weeks before the Factory Acceptance Test (FAT), there was time to submit requests for changes. “During the FAT, we took over a machine that met our requirements down to the smallest detail,” Wibbelmann said.

Details that count The most important change affected the scanning station of the GKF 2600. With the machine knowledge already acquired before the FAT, Wiewelhove opted for a single-capsule scanning system.

In combination with the “no cap, no fill” feature and an automatic error clearance, Wiewelhove now has increased operational reliability that saves both product and empty capsules. Wiewelhove also suggested replacing the metal slide used to adjust the suction with a plastic one, which is easier to clean and makes for gentler handling.

“Any potential for optimization that we address at the supplier’s site is much easier to implement,” Wibbelmann said. The training sessions and the discussions also provided interesting insights for Syntegon Technology. For example, some of the suggestions from Wiewelhove could be incorporated into the standard version of the GKF 2600. “In the end, it’s the small things that make the difference between good and great,” Wibbelmann said. “We really enjoyed and benefitted from working on constructive solutions together.”

ent products in a short time with its accessibility and the extended machine platform. Rapid format changes and easy changeovers with a plug-in system minimize standby times and machine downtime.

Well-positioned for the future Technological highlights and cooperation during the project were both key for Wiewelhove. “The entire process, from initial discussions and on-site appointments to training and adjustments, through to installation and implementation was very target-oriented and well structured,” said Lars Peters, head of the capsule filling department at Wiewelhove. For the contract manufacturer, the new machine is “the logical extension of the GKF 2000 range.”

It facilitates product transfer and can also be used as a back-up for the slightly older GKF 2000.

The most important innovation of the new capsule filling machine is that powders and pellets can be filled on a single dosing station.

“We observe a trend in pellet filling that we couldn’t have responded to so far,” said Peters. With the new machine, we are well prepared for future requirements…We want to expand our capacities and ability to fill pellets into capsules to compensate for bottlenecks and quickly respond to new customer inquiries.”

Flexible and reliable Since production started in August 2018, the company has been able to take full advantage of the new capsule filling machine. Its high filling flexibility makes it possible to fill different capsule sizes from 1 to 00 elongated, such as longer capsules of the same diameter, which can be processed on the GKF 2600 without separate format parts. The patented slidegate technology reduces scatter loss, which is important for critical products that should not get into the machine interior. In addition to the standard features, Wiewelhove has the option of adding a KKE capsule checkweigher for 100% in-process control. The GKF 2600 can also be upgraded for micro-tablets.

The compact capsule filling platform GKF 2600 was developed for the high-performance range. It is cGMP-compliant and fulfills the various requirements of the pharmaceutical industry. Wiewelhove achieves an output of more than 110,000 capsules/ hour with capsule size 00. The flexible capsule filling machine can be adapted to differ-

↗ With an extended machine platform and good accessibility, the capsule filling machine can be adapted to different products in a short time.

November/December 2020 • Healthcare Packaging | 33

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CARTONING

Custom Cartoner Helps Employ Workers with Blindness MATT REYNOLDS, EDITOR, PACKAGING WORLD TOP THREE TAKEAWAYS 1. A Criterion CLT-240 was customized to meet workforce needs.

2. Standard grey infeed buckets were modified in favor of bright orange bucket walls.

3. The new system has drastically cut down on changeover time.

N

on-profit Horizon Industries, a division of East Texas Lighthouse, is one of the largest converters of industrial cleaning towels for the U.S. government, and uniquely is based on initiatives meant to rehabilitate and support the blind community. Industrial towels converted and packaged at Horizon are sold through distribution to government institutions like the military, schools, and federal and state agencies, among other accounts. The mission underpinning Horizon’s core paper converting competency is to empower the visually impaired population to succeed through rehabilitation, education, training, and, most prominently, employment.

Horizon currently has about 40 legally blind employees working at its facility, accounting for more than 75% of direct labor and more than half of all the personnel in the company.

The 2020 pandemic precipitated a big bump—newfound consumer adherence to sanitation, and a whole lot more surface cleaning and hand-washing. “That’s a slight understatement to call it a bump. It’s been more like a mountain,” says Lee Tillson, vice president sales/business development at Horizon. “Essentially, we almost doubled our business overnight. I think the pandemic started making waves for us around March 13, and we started seeing a huge increase the very next week.”

“Overkill” automation ended up just right: In July 2019, Horizon had upgraded its primary packaging machinery from older, slower legacy equipment to a new Criterion CLT-240 cartoner from R.A Jones primary and secondary packaging equipment, capable of cartoning towels at speeds of 240/min.

Since the company was—and still is—hand-loading the infeed, the blazing 240 carton/min speeds wouldn’t seem necessary.

Currently, the speedy machine is running at a leisurely pace of around 40 cartons/min.

So why automate to that degree of speed and sophistication?

What at first blush seems to be overkill was in fact a well-laid plan rooted in the local workforce dynamics, a previously unmet need for parts and service, and a blend of safety and flexibility considerations that are truly unique to Horizon.

First, with a mission to employ those who are blind, Horizon’s recruiting focus must be very specific to continue to find people who are qualified to work, ready to work, and also happen to be blind or visually impaired. And Packaging World readers know that there’s already a nearly pan-industrial labor shortage. And there are only so many people who are blind or visually impaired in any given

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CARTONING

population—and Tyler, Texas isn’t a major metro area with a lot of candidates from which to choose.

“From that standpoint, we needed automation that could stand in for any potential lack of employees in the future,” Tillson says. “But on the other hand, we’re in the business of employing people, not eliminating jobs through speed and automation. We’re not looking to reduce jobs, that’s not what we’re about.”

Flexibility and safety are 1A and 1B For Horizon, visual acuity considerations not present in most production facilities required further machine customization on the line. Some custom features of this Criterion CLT-240 system included modifications to the standard infeed buckets, which were monotone gray metallic steel in appearance, in favor of bright orange bucket walls. The infeed is manual, but it’s a continuous operation with one to two operators having to keep pace with loading. Colors that readily reflect light are easiest for legally blind personnel to see, so bright orange sheet metal plates were added between the article bucket openings as a color contrast to aid the operators in loading the article bucket pocket and preventing access to the bucket conveyor chains.

The infeed itself was also lengthened by about 10 feet to allow more operators or allow the standard operator configuration more room to load buckets. Another feature is the ergonomic, low-level magazine. Operators find it easier to load at waist height, around 36 to 40 in with more of a bird’s-eye view of their task, instead of loading at shoulder or eye height. Once loaded, magazines incline to be fed into the cartoner. Machine design alterations also included a safety lift gate and a lifeline emergency stop for added protection and assurance.

Beyond the structural considerations, a custom fault-zone system, developed with the help of Banner Engineering sensors, vision, lights, and optical controls, uses Banners’ WLS28-2 two-color red/white lights, with the XS26-2 safety controller, to direct operator’s attention directly to the precise location of any problems.

This bypasses the need for an operator trip to the HMI to determine where a detected fault resides.

The CL-240 was already equipped with a number of other carton configurations that are ideal for these particular working conditions, including Acc-U-Change and Fault Zone Indication. Acc-UChange provides validated changeover, which ensures setpoints are placed for vertical start-up, while Fault Zone Indication illuminates the work area and highlights the area of the machine where a fault may occur. The carton depth maximum was extended from 14 to 16 inches. “And those two inches might as well be a mile,” says Tillson.

“Changeovers used to mean involving our maintenance department, and if we wanted to make a major change, it would take two to three hours,” he says. “I don’t even think the maintenance depart-

ment is involved anymore, now it’s our operators that do it. Most changeovers are down to eight or nine minutes.”

Taken together, the triad of (1) greatly shortening changeover time, (2) drastically limiting the labor involved, and (3) eliminating dial-in time and waste via the vertical startup account for perhaps the most significant practical performance improvements on the line. Future packaging requirements for the company were also considered in the design, providing the ability to easily modify or enhance as their needs may grow.

[This was adapted from a Packaging World story. Read the longer version at hcpgo.to/386. ]

↑ The machine’s Acc-U-Change feature provides validated changeover, which ensures set-points are placed for vertical start-up, while Fault Zone Indication illuminates the work area and highlights the area of the machine where a fault may occur.

↑ Colors that readily reflect light are easiest for legally blind staff to see, so bright orange sheet metal plates were added between the article bucket openings as a color contrast to aid the operators in loading the article bucket pocket and preventing access to the bucket conveyor chains.

November/December 2020 • Healthcare Packaging | 35

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36 | Healthcare Packaging • November/December 2020

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NEW PRODUCTS

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Editor (Name and complete mailing address)

Keren Sookne, PMMI Media Group, 401 North Michigan Ave., Suite 300, Chicago, IL 60601 Managing Editor (Name and complete mailing address)

10. Owner (D o not leave blank. If the publication is owned by a corporation, give the name and address of the corporation immediately followed by the names and addresses of all stockholders owning or holding 1 percent or more of the total amount of stock. If not owned by a corporation, give the names and addresses of the individual owners. If owned by a partnership or other unincorporated firm, give its name and address as well as those of each individual owner. If the publication is published by a nonprofit organiz ation, give its name and address.)

Complete Mailing Address Full Name

PMMI

2

12930 Worldgate Drive, #200, Herndon, VA 20170

www.bioffex.com Morrison Container

5

11. K nown Bondholders, Mortgagees, and Other Security H olders Owning or H olding 1 Percent or More of Total A mount of Bonds, Mortgages, or Other Securities. If none, check box .

N one Full Name

Complete Mailing Address

www.morrison-chs.com Multivac Inc

31

13 . Publication Title

PRIVACY NOTICE: See our privacy policy on www.usps.com.

14. Issue Date for Circulation Data Below

Healthcare Packaging

July/Aug 2020

15. Ex tent and Nature of Circulation

39

www.packexpoconnects.com ProSys Innovative Packaging

H as N ot Changed During Preceding 12 Months H as Changed During Preceding 12 Months (Publisher must submit explanation of change with this statement.)

PS Form 3526-R, July 2014 [Page 1 of 4 (See instructions page 4)] PSN : 753 0- 09 - 000- 8855

us.multivac.com PACK EXPO Connects

12. Tax Status (For completion by nonprofit organiz ations authoriz ed to mail at nonprofit rates) (Check one) The purpose, function, and nonprofit status of this organiz ation and the ex empt status for federal income tax purposes:

21

Average No. Copies No. Copies of Single Issue Published Each Issue During Preceding 12 Months Nearest to Filing Date

18,587

a. Total N umber of Copies (Net press run)

b. Legitimate Paid and/or In- County Paid/Requested Mail Subscriptions stated on PS Form 3 541.

Requested (Include direct written request from recipient, telemarketing, and Internet Distribution (2) requests from recipient, paid subscriptions including nominal rate subscriptions, (By mail employer requests, advertiser’s proof copies, and exchange copies.) and outside Sales Through Dealers and Carriers, Street V endors, Counter the mail) (3 ) Sales, and Other Paid or Requested Distribution Outside U SPS® (4)

Sonoco TEQ

(1)

9

d. N onrequested (2) Distribution (By mail and outside the mail) (3 )

www.teqnow.com Stevanato Group www.stevanatogroup.com

(4)

40

16,696

0

0

180

185

16,791

16,881

0

Requested Copies Distributed by Other Mail Classes Through the U SPS (e.g., First- Class Mail®)

c. Total Paid and/or Requested Circulation (Sum of 15b (1), (2), (3), and (4))

www.prosysfill.com

17,606

16,611

Outside County Paid/Requested Mail Subscriptions stated on PS Form 3 541.

(Include direct written request from recipient, telemarketing, and Internet (1) requests from recipient, paid subscriptions including nominal rate subscriptions, employer requests, advertiser’s proof copies, and exchange copies.)

0

Outside County N onrequested Copies Stated on PS Form 3 541 (include sample copies, requests over 3 years old, requests induced by a premium, bulk sales and requests including association requests, names obtained from business directories, lists, and other sources)

0

0

In- County N onrequested Copies Stated on PS Form 3 541 (include sample copies, requests over 3 years old, requests induced by a premium, bulk sales and requests including association requests, names obtained from business directories, lists, and other sources)

0

0

N onrequested Copies Distributed Through the U SPS by Other Classes of Mail (e.g., First-Class Mail, nonrequestor copies mailed in excess of 10% limit mailed at Standard Mail ® or Package Services rates)

0

0

N onrequested Copies Distributed Outside the Mail (Include pickup stands, trade shows, showrooms, and other sources)

300

225

e.

Total N onrequested Distribution [Sum of 15d (1), (2), (3) and (4)]

f.

Total Distribution (Sum of 15c and e)

g.

Copies not Distributed (See Instructions to Publishers #4, (page #3))

h.

Total (Sum of 15f and g)

i.

Percent Paid and/or Requested Circulation (15c divided by 15f times 100)

300 17,091 1,496 18,587 98%

* If you are claiming electronic copies, go to line 16 on page 3 . If you are not claiming electronic copies, sk ip to line 17 on page 3 .

225 17,106 500 17,606 99%

Statement of Ownership, Management, and Circulation (Requester Publications Only) 16. Electronic Copy Circulation

Healthcare Packaging Magazine a. Requested and Paid Electronic Copies b. Total Requested and Paid Print Copies (Line 15c) + Requested/Paid Electronic Copies (Line 16a)

Total Requested Copy Distribution PS c.

Form 3526-R, July 2014 (Page 2 of(Line 4) 15f) + Requested/Paid Electronic Copies (Line 16a) d. Percent Paid and/or Requested Circulation (Both Print & Electronic Copies) (16b divided by 16c Í 100)

Average No. Copies Each Issue During Previous 12 Months

No. Copies of Single Issue Published Nearest to Filing Date

3,487 20,278 20,578 99%

3,851 20,732 20,957 99%

I certify that 50% of all my distributed copies (electronic and print) are legitimate requests or paid copies.

17. Publication of Statement of Ownership for a Requester Publication is required and will be printed in the issue of this publication.

18. Signature and Title of Editor, Publisher, Business Manager, or Owner

Nov/Dec 2020 Date

38 | Healthcare Packaging • Nov/Dec 2020 I certify that all information furnished on this form is true and complete. I understand that anyone who furnishes false or misleading information on this form or who omits material or information requested on the form may be subject to criminal sanctions (including fines and imprisonment) and/or civil sanctions (including civil penalties).

NovDec_2020.indd 2

11/20/20 9:05 AM

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