SEPTEMBER/OCTOBER 2019PMMI Media Group | www.HealthcarePackaging.com+News on Best Practices for ReusableThermal Packaging+4 Supply Chain Trends from AHRMM+Healthcare Packaging’s UDIResource Guide+New Recyclable Packaging forReef-Safe SunscreenDipping Your Toes intoAugmented andVirtual Reality?nolabel_1905_Cover.indd 110/8/19 10:19 AMVRC heat sealing technology monitors the resistance of the heatseal band and responds in milliseconds to assure precision temperature control over the entire heatseal band without thermocouples… seal after seal.Learn more at www.PackworldUSA.com ©2019 PackworldUSA · Nazareth, PA 18064 USA · Telephone: 610-746-2765HEAT SEAL PERFECTIONvalidatable - repeatable - consistentImpulseTemperatureControlsImpulsePowerSupplyHeat SealJaw BarsHeat Seal Bands & Ribbons Variable Resistance ControlavailableworldwideWE ARE MEDICAL HEAT SEALERSFind out more about the precision, validatable medical heat sealers from PackworldUSA - visit us at:Booth# 1605Mar 3-5, 2020Philadelphia PABooth# 2042Feb 11-13, 2020Anaheim CAHCP PAGE Ad template.indd 3310/2/19 3:50 PMCONTENTS September/October 2019 • Healthcare Packaging | 314 OEM APPLICATION NOTEAugmented, Virtual Reality Are OEM-ReadyOEMs explore practical ways to design, commission, operate and maintain their equipment using altered reality. What does this mean for life science manufacturers? 20 ADHERENCE PACKAGINGCanadian Online Pharmacy Boosts Patient Adherence, Reduces Packaging WasteThe company uses a simple packaging system—able to deliver most drugs—and provides free shipping of packs with easy, detailed instructions, as well as regular consultations to improve patient experience.23 AUTOMATIONIndustry 4.0 with a Pharma FocusKnowing that IoT software and services in pharma are expected to reach $2.5 billion by 2020, this builder of pharmaceutical packaging machinery is rolling out a robust Industry 4.0 program.29 NUTRACEUTICALSE-Commerce and Personalization Drive Packaging Changes in NutraceuticalsPart 2 of a special report: E-Commerce is necessitating a movement away from rigid plastic and glass containers, while personalized supplement packs gain steam.31 MEDICAL DEVICESHealthcare Packaging’s UDI Resource GuideWhere can device packaging professionals get the information they need to meet the UDI regulations? Use Healthcare Packaging’s UDI Resource Guide as a launch pad.34 TRACEABILITY 4 Healthcare Supply Chain Trends from AHRMM86% say a UDI icon or “UDI” near the barcode would help at the point of care. Experts talk RFID tags and product storage space.COLUMNS05 KEREN SOOKNE’S PERSPECTIVE06 ERIC GREENBERG’S LEGAL + REGULATORY08 COLD CHAIN CORNERDEPARTMENTS10 MATERIAL DEVELOPMENTS11 QUICK HITS12 QUOTABLES/BY THE NUMBERS17 NEWS36 NEW PRODUCTS↑ pp.18Saleable Returns: Barcode Issues, Enforcement Delay1905_Contents.indd 310/4/19 2:28 PMwww.healthcarepackaging.comEditorialDIRECTOR OF EDITORIAL CONTENT Keren Sookne ksookne@pmmimediagroup.comCONTRIBUTING EDITOR Eric GreenbergArtUX/UI DESIGNER Maggie WilsonASSOCIATE ART DIRECTOR Jonathan FlemingCREATIVE DIRECTOR Dave BachoPublishingPUBLISHER Elizabeth Tierney, 815.861.2992VICE PRESIDENT, CONTENT AND BRAND STRATEGY Jim ChrzanMANAGER, STRATEGY & COMMUNICATIONS Courtney NicholsAD SERVICES/PRODUCTION MANAGER George ShurtleffDIRECTOR OF MARKETING Sue DaMarioFINANCIAL SERVICES MANAGER Janet FabianoDigital & Custom MediaSENIOR VICE PRESIDENT, DIGITAL & DATA David NewcornSENIOR DIRECTOR, DATA & INFRASTRUCTURE Elizabeth KachorisSENIOR WEB DEVELOPERS Yevgeny Ananin, Andrew TateDIRECTOR, WEBSITES + DIGITAL DESIGN STRATEGY Jen KrepelkaPMMI 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.comPMMI Media Group 401 N. Michigan Ave., Suite 300 Chicago, IL 60611 p: 312.222.1010 | f: 312.222.1310 www.pmmimediagroup.comPLEASE RECYCLE THIS MAGAZINERemove inserts or samples before recycling.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 4The 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.PUBLICATIONS MAIL AGREEMENT NO. 40064408 • USPS #254691905_Masthead.indd 410/4/19 2:28 PMPERSPECTIVE PERFORMANCE, PACKAGED391 Greendale RdYork, PA 17403717-848-3875717-843-6435Greydon.comGreydon@ProMachBuilt.comTop Features•Variable Printing for UDI Compliance•Prints 1-Color, 2-Color or Full CMYK+W•21 CFR Part 11 Compliant•UV Curable Inks with XactCure™TechnologyGenesisDigital Color PrintingGenesisEliminate Preprinted Material forMedical and PharmaceuticalPackaging Machines.The Genesis provides excellent print quality on a range of packaging substrates. Designed to print the complete package, manufacturers can eliminate or dramatically reduce the need to manage pre-printed materials for every item (SKU). This reduces cost, complexity and lead times, as well as reducing changeover time and increasing OEE.‘Reality Check’ for Life Science ManufacturingConnected factories and altered reality inch further into pharmaceutical and medical device spaces.For many life science manufactur-ers, augmented and virtual reality may still seem like buzzwords or pipe dreams—the technologies are technically “there,” but a solid use case hasn’t been presented to compel companies to change their operations.Even when pharmaceutical and medical device producers want to adopt advanced tools, making changes can be, for lack of a better term, scary.To help demystify things a bit, our cover story explores how augmented and virtual reality impact machine builders, and by extension, manufacturers, delving into a couple of use cases (pp. 14). In my personal experience, manufacturers aren’t exactly jumping at the chance to allow supplier cameras in the plant or access to WiFi networks—the story discusses some ways you can address security concerns. For those looking for more incremental change, there’s even power in existing devices like smartphones and tablets.Adding to the connectivity picture is our coverage of how one machine builder is rolling out an Industry 4.0 program and what potential benefits digitization is bringing to pharmaceutical manu-facturing, including remote assistance via augmented reality (pp. 23). Whether you’re diving into the altered reality concept or just getting your feet wet, it’s a great time to consider if these new tech-nologies are right for your operations. KEREN SOOKNE is the Director of Editorial Content of Healthcare Packaging. She may be reached at ksookne@pmmimediagroup.com or at linkedin.com/in/kerensookne1905-Perspective.indd 510/4/19 2:28 PM LEGAL + REGULATORYERIC GREENBERG is Principal Attorney at Eric F. Greenberg P.C., a law firm that concentrates its practice in food and drug law, packaging law, and commercial litigation. He can be reached at greenberg@efg-law.com or at 312.977.46476 | Healthcare Packaging • September/October 2019What is the correct reaction when govern-ments finally do what they should have done years ago? I am trying to decide whether to holler “Hooray” or “What took you so long?” In this situation, the best reaction of all might be, “It’s good that you’re doing that, but now hurry up and finish.”Now, finally, after being pushed by Congress and even by a lawsuit, the Drug Enforcement Agency (DEA) announced in late August that, to facilitate scientific and medical research into marijuana, it would actively begin processing pending applications from applicants who want to be registered as growers of the material that can be used for medical research. Special procedures are needed because marijuana is still a controlled substance under federal law.That’s progress, but DEA’s actions will still take months or years to complete, as DEA expects to make regulations covering new applications and standards for new growers.Sandford Wolgel, PhD, former Chief Science Officer for Canna-bistry Labs, commented, “Along with many others in the field, I am pleased that the DEA is finally moving forward.”This action is only one recent chapter in a long and complex saga in which marijuana and hemp are becoming so widely and quickly popular and in demand by consumers, that state and federal govern-ments have had to scramble to keep up, and usually end up changing the law long after significant portions of the public have indicated their desire for these products regardless of their legality.And the states especially have been giving in to the public’s demands. You have to be old like me to fully appreciate how these actions create significant disorientation of your perceptions of society and law. Even though state after state has been changing its laws to allow medical canna-bis, or legalizing its recreational use, most of these products are still unlawful under federal law, with the exception of hemp plants with less than 0.3% of THC in them, which a recent change in the law exempted from being controlled substances. For years it’s been the case that when asked about cannabis and related products contain-ing it, FDA, wise enough to read the law it operates under, said the same kinds of things it always says about products people want to put on the market: If you’re going to claim it has any health benefits that would make the product a “drug” under the law, it’ll be up to you to prove it’s safe and effective before we allow it to be marketed. And, because this particular substance, cannabis, was listed as a controlled substance by the DEA, one could not willy-nilly grab some cannabis and test it as you might with any other substance under investigation as a drug. In fact, you couldn’t do that with any other substance either, as FDA keeps tight controls on investiga-tional drugs, but with cannabis, it was unusually restrictive because of its status as a controlled substance.Specifically, the only marijuana that a researcher was legally allowed to use to investigate the stuff for medical uses was provided by the University of Mississippi. This very limited—and report-edly low-quality—source was simply not sufficient to support the demand for research into marijuana. The hope is that DEA’s new steps will improve the ability to conduct scientific research into the substance’s effects, which in turn could lead to FDA-approved drug products or acceptance of the safety of the substance in foods. Cannabis Research Lights Finally Turn GreenDEA makes a move to help increase the availability of cannabis for medical research.ERIC GREENBERG1905-LegalReg.indd 210/4/19 2:28 PMNJMPackaging.com / 800-811-6990COURSER™Vial/Syringe Labeler• Flexible production (compatibility of vial and syringe on the same machine)• Compact footprint for space saving• Reduce downtime between batches• Designed to meet the growing demand for small batch manufacturing of personalized medicines (503B pharmacy)• Continuous motion up to 250 / min• Speed for vial: 250 ppm• Speed for syringe: 200 ppmAs seen at the Pharma ExpoALL NEWHCP PAGE Ad template.indd 3310/2/19 3:51 PM COLD CHAIN CORNER8 | Healthcare Packaging • September/October 2019nnTOP THREE TAKEAWAYS1. ’Reusable Passive Thermal Packaging System: Best Practice Guideline,’ provides guidance on the types of materials used and qualification of a reusable system.2. It also describes the return logistics, refurbishment service manage-ment, and inspection details for such systems.3. The ISTA Pharma Committee is currently drafting a “Passive Thermal Packaging System Operational Qualification Best Practice Guideline.”The new International Safe Transit Association (ISTA) Pharma Committee established in 2019, formerly known as the Industry Guidance Task Force (established in 2017), is currently comprised of representatives from the pharmaceutical/biotech industry and suppliers of passive thermal packaging solutions.The purpose of the team and the establishment of the best prac-tice (BP) is to synchronize the industry together as a whole on a standardized OQ approach for the distribution of temperature-con-trolled pharmaceutical/biotech products. The goal is to have the principles described in this guidance be adopted by the entire phar-maceutical supply chain, including manufacturers, suppliers of passive thermal packaging, logistics service providers, carriers, wholesalers, distributors, specialty pharmacies, and any other inter-ested party.These subject matter experts (SMEs) released a USP Stimuli Article in March of 2019 entitled “Reusable Passive Thermal Pack-aging System: Best Practice Guideline.” The best practice provides specific guidance on the types of materials used in passive thermal packaging systems, the qualification of a reusable system, the return logistics and refurbishment service management, and refurbishment and inspection details. The demand for reusable packaging through-out the supply chain continues to grow for the following reasons:• Opportunities for cost savings;• Improved customer experience;• Company sustainability goals;• Receiving site’s in-country regulations;• Cost-eff ective access to higher technology/performing systems;• Receiving site’s intent to reuse the packaging system.The increased demand for reusable passive thermal packaging systems has led to a wide variety of ways to qualify, return, refurbish, and manage these types of shipping solutions. Setting an indus-try best practice, as well as expectations for these aspects, will increase the quality of the systems and services and ultimately lead to increased product quality and solution innovation.The group is currently drafting a “Passive Thermal Packaging System Operational Qualification Best Practice Guideline.” This best practice recognizes various Operational Qualification (OQ) ISTA Pharma Committee Releases USP Stimuli Article on Passive Thermal Packaging SystemsISTA PHARMA COMMITTEE↑ The goal is to have the principles described in this guidance be ad-opted by the entire pharmaceutical supply chain, from manufacturers, suppliers and carriers to wholesalers and more.1905-ColdChainCorner.indd 810/4/19 2:27 PMCOLD CHAIN CORNER Install715 Church Road, Elmhurst, IL 60126 • 630-530-2203 • www.guk-vijuk.comINTEGRATEleaflet folding and immediate insertion along with the product into cartons on your packaging line—at the packaging line's speed, up to 400 per minute! SIMPLE UPGRADEfrom Cartonac 91 or Cartonac 2000 nnnn Innovative Cartonac 2005has a hinged feeding table to allow easy access to the fold plates, rollers and code reader, if one is installed. Improved efficiency of the feed-table air blasts and suction rollers allows you to fold sheets with up to 3 panels—for larger leaflets.approaches as well as already established industry-recognized guid-ance for the OQ process for passive thermal packaging solutions. This document will attempt to blend all of the diff erent approaches into a single best practice guidance document and align the industry on a common approach. This will aid in developing a streamlined OQ approach for the qualification of passive thermal packaging solutions, support an industry alignment for vendor pre-qualified solutions and will improve the speed to market for these solutions.The best practice guideline will cover the following critical subjects along with providing an in-depth discussion supported with specific details and examples to further aid the reader:• Equipment• Test Plan/Methodology• Documentation• Implementation ConsiderationsUpon completion of the best practice, the ISTA Pharma Commit-tee will have provided to the reader an industry-aligned OQ approach that will aid in the development of or use of a qualified passive thermal packaging solution.The ISTA Pharma Committee includes suppliers and end users work-ing together to set guidelines on maximizing efficiencies throughout the supply chain. They presented the paper at the ISTA Forum in Denver and are now expanding and focusing on the OQ approach. Visit their website for information about next year’s ISTA Forum, featuring TransPack and TempPack at https://ista.org/ista_forum.php. Reusable System Guideline AuthorsAlan Forthman, GSKAndrew Heholt, va-Q-tec USAArminda Montero, AbbVieBill Mayer, Pelican BioThermalBryan Cardis, Eli LillyCarolyn Williamson, Bristol-Myers SquibbFrank Butch, Sonoco ThermosafeJason Siwicki, GenentechJeff Sullivan, AeroSafe GlobalRey Chern, AmgenRichard Harrop, Topa ThermalAnthony Rizzo, Cold Chain Technologies1905-ColdChainCorner.indd 910/4/19 2:27 PMNext >