JULY/AUGUST 2018PMMI Media Group | www.HealthcarePackaging.com +U.S. Customs on Brand Protection +J&J's Serialization Strategy +Drug Shortage Solutions +Smart Blister Pack for Clinical Trials1804_Cover_nolabel.indd 17/25/18 4:14 PMVRC 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 or RTD’s… seal after seal.Learn more at www.PackworldUSA.com ©2018 PackworldUSA · Nazareth, PA 18064 USA · Telephone: 610-746-2765HEAT SEAL PERFECTIONvalidatable - repeatable - consistentImpulseTemperatureControlsImpulsePowerSupplyHeat SealJaw BarsHeat Seal Bands & Ribbons Variable Resistance ControlavailableworldwideWE ARE MEDICAL HEAT SEALERSBooth N-5213 October 14–17, 2018Chicago, ILFind out more about the precision, validatable medical heat sealers from PackworldUSA - visit us at:HCP PAGE Ad template.indd 337/18/18 1:49 PMJuly/August 2018 • Healthcare Packaging | 320 BIOLOGICSCRISPR Technology Embarks on ‘Fantastic Voyage’CRISPR is gaining recognition as a revolutionary gene-editing tool to treat and possibly cure multiple diseases. But what role will packaging play in this disruptive technology? 26 SERIALIZATIONJohnson & Johnson Employs Global Serialization StrategyWith a heritage of 130+ years of helping people live longer lives, J&J Supply Chain’s serialization/traceability efforts focus on safely delivering medicines to healthcare providers and patients worldwide. 28 ANTI-COUNTERFEITINGThe Best $200 You’re Not Spending on Brand ProtectionRegistering your trademark and copyright with Customs and Border Protection can help expedite the seizure of counterfeit drugs, alerting you to the product in question and where it’s headed.30 OPERATOR SAFETYUsing Machine Learning to Analyze Personnel RiskNIOSH research focuses on hazards and injury prevention efforts. Plus, the dangers of ototoxic chemicals, mergers and acquisitions, and more.32 BRAND AUTHENTICATIONSwisse WellnessMelbourne-based Swisse Wellness employs a desiccant and a scannable label to protect and authenticate its growing portfolio of products worldwide.COLUMNS05 KEREN SOOKNE’S PERSPECTIVE06 ERIC GREENBERG’S LEGAL + REGULATORYDEPARTMENTS08 COLD CHAIN CORNER10 MATERIAL DEVELOPMENTS11 PDA CORNER12 QUICK HITS14 QUOTABLES/BY THE NUMBERS16 TECH OEM APPLICATION NOTE18 NEWS36 NEW PRODUCTSpp. 20 CRISPR Technology Embarks on ‘Fantastic Voyage’1804_Contents.indd 37/19/18 10:44 AMwww.healthcarepackaging.comHealthcare 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 2018 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/sub-scribe. Paid subscription rates per year are $55 in the U.S., $80 Canada and Mexico by surface mail; $130 Eu-rope, $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 Graphics. Volume 12, Number 4The opinions expressed in articles are those of the authors and not necessarily those of PMMI. Comments, ques-tions 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 #25469PLEASE RECYCLE THIS MAGAZINERemove inserts or samples before recycling.PMMI MEDIA GROUP 401 N. Michigan Ave., Suite 300Chicago, IL 60611p: 312.222.1010 | f: 312.222.1310www.pmmimediagroup.comPMMI The Association for Packaging and Processing Technologies11911 Freedom Drive, Suite 600, Reston, VA 20190p: 703.243.8555 | f: 703.243.8556 | www.pmmi.comEDITORIALDIRECTOR OF EDITORIAL CONTENT KEREN SOOKNEEDITOR JIM BUTSCHLICONTRIBUTING EDITOR ERIC F. GREENBERG ARTCREATIVE DIRECTOR DAVID BACHODIGITAL MEDIA ART DIRECTOR MAGGIE WILSONPUBLISHINGPUBLISHER ELIZABETH TIERNEY, 815.861.2992VICE PRESIDENT, CONTENT AND BRAND STRATEGY JIM CHRZANMANAGER, STRATEGY & COMMUNICATIONS COURTNEY NICHOLSAD SERVICES, PRODUCTION MANAGER GEORGE SHURTLEFFDIRECTOR OF MARKETING SUSAN DAMARIO FINANCIAL SERVICES MANAGER JANET FABIANODIGITALSENIOR VICE PRESIDENT, DIGITAL & DATA DAVID NEWCORNSENIOR DIRECTOR, DATA & INFRASTRUCTURE ELIZABETH KACHORISSENIOR WEB DEVELOPERS YEVGENY ANANIN, ANDREW TATEDIRECTOR, WEBSITE PRODUCT MANAGEMENT JEN KREPELKAAUDIENCE DEVELOPMENTDIRECTOR OF AUDIENCE DEVELOPMENT JEN LADALSKIAUDIENCE DEVELOPMENT MANAGER BRUCE SPRAGUE1804_Masthead.indd 47/19/18 10:44 AMPERSPECTIVEWith minimal impact to existing workflows, Bell and Howell’s Pharma Factory uses proven Track & Trace technologies to provide complete identification, tracking, validation, process management and report creation from a single point of control in as little as three months.Learn more at bellhowell.net/Track-Trace-TechnologieseavaEnd-to-End Serialization Solutions:• Unit Serialization• Line Aggregation• Data Management• Application Services• Product Support• Workflow Automation & OptimizationHesitant or Hopeful?We’re into the second half of the year. Time to check in on goals, projects… and serialization.I recently went to a serializa-tion summit and was struck by the polarity of views in the presentations and attend-ee chatter. Some are done implementing serialization systems—perhaps making adjustments—but breathing a sigh of relief on being com-pliant. Others seemed a bit further behind, compliance-wise.With mere months to go to the DSCSA enforcement date and EU Falsified Medicines Directive (February 2019), I’d be lying if I said I wasn’t concerned about drug shortages and companies meeting the requirements in time.But there’s also hope—hope that these regulations will add a much-needed layer of protection to drugs we trust.Another topic filed under “hesitant yet hopeful”: CRISPR. The technology has so much potential for health outcomes (along with the expected crazies, as John Oliver recently showcased). Packaging technologies are here to help, as Jim Butschli reports on pp. 20.We’re into the second half of the year. Many of you have probably already evaluated your goals, both personal and professional. Ready to tackle the rest of 2018? KEREN SOOKNE is the Director of Editorial Content of Healthcare Packaging. She may be reached at ksookne@pmmimediagroup.com or at linkedin.com/in/kerensookne1804_Perpsective.indd 57/20/18 9:46 AMLEGAL + REGULATORY6 | Healthcare Packaging • July/August 2018ERIC 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 312.977.4647Obviously, FDA-approved drugs are es-sential to our healthcare system and the health—and even survival—of many indi-viduals. Just as obviously, much disruption and suffering could result if one day any particular drug becomes unavailable. Un-fortunately, shortages of drugs arise with depressing frequency.Drug shortages are caused by a wide range of factors and therefore require a wide range of responses. FDA says sometimes shortages are caused by delays in produc-tion, or delays in manufacturers receiving raw materials or components from suppliers. And sometimes, a company decides for busi-ness reasons to discontinue a drug.Other times, it’s a company’s failure to meet its regulatory ob-ligations that leads to a shortage. FDA says, “A major reason for…shortages has been quality/manufacturing issues.”In recent years, a number of shortages have been prevented, or their effects lessened, because of more frequent early notifications from drug makers. One big help in this regard has been a 2012 law in which Congress required drug makers to report several types of information to FDA. As a result, the law now requires a broad range of drug makers to notify FDA of potential discontinuances of drugs, whether they are expected to be permanent or merely temporary. It gave FDA the power to extend these requirements to biological products as well.Maybe it’s supremely unfair to FDA to say so, but it’s not uncom-mon to perceive FDA as stiff, slow and bureaucratic. Nevertheless, the agency’s approach to drug shortages makes them appear flex-ible, creative and swift. When it learns about a shortage, FDA addresses the causes if it can. Some of the causes of shortages are beyond the agency’s control. But if the cause is a manufacturing or quality problem, it works with the company and might employ “regulatory discretion,” it says, a deceptively idle-sounding phrase that can refer to a variety of ways in which the agency makes exceptions from its usual requirements for a product. In some situations, the agency will work closely with other makers of the drug that is in short supply, “to help them ramp up production if they are willing to do so,” providing swifter review and approval of new production lines or new raw material suppliers. The agency might also allow a drug maker to extend the product’s expi-ration dating beyond the approved label statement—if the company has data to sup-port it. In that way, more stock of a drug is available for sale. FDA sometimes will take a close look at foreign makers that are “willing and able to redirect product into the U.S. market” if the need is critical and domestic makers aren’t able to solve it quickly. If FDA is satisfied that product safety and effectiveness are assured, it will allow sale here. The agency says it “worked with manufacturers to prevent 145 drug shortages in 2017,” though 39 new shortages arose during 2017. The highest number of new shortages, 251, occurred in 2011, so it’s good to see the numbers decrease. As FDA points out, however, a fuller evaluation of the seriousness of the problem requires looking at the raw numbers as well as the health effects involved with each. FDA says it “continues to see shortages involving older sterile injectable drugs,” including “cancer drugs, anesthetics used for patients under-going surgery,” emergency medicine drugs, and electrolytes needed for intravenous feeding. Though the effects of drug shortages can be severe, the combined creative efforts of FDA, Congress and industry carry the promise of effective shortage prevention and mitigation. No Shortage of Creative SolutionsDrug shortages can have serious health effects, but early notifications from manufacturers and creative and flexible FDA actions are making a dent.1804_Legal+Reg.indd 67/19/18 10:39 AMwho can use cutting-edge technology to detect fraud and protect their brand? you can.working for you.Counterfeiting is a global problem. In your world, that means thieves are trying to steal your most prized possession — your reputation. Fortunately, Sun Chemical has the anti-counterfeiting technology you need to protect your brand and reputation. From infant formula to adult beverages and more, it’s just one more way Sun Chemical helps you go securely from concept to consumer — all from a single, trusted source.Request your copy of our white paper, Anti-counterfeiting Technologies for Packaging, at www.sunchemical.com/anticounterfeiting or call 1-708-236-3798.Visit us atPACK EXPObooth #8856HCP PAGE Ad template.indd 337/18/18 2:08 PMCOLD CHAIN CORNER8|Healthcare Packaging • July/August 2018time for… Transporting temperature-sensitive pharma-ceuticals, biologics and combination prod-uct therapies from the point of manufacture to a medical facility—and ultimately the “last mile” to the patient—requires the pre-vention of temperature excursions through-out the complex supply chain.If you’ve attended “cold chain” confer-ences, you’ve likely heard anecdotes about pallets containing high-value medications sitting for hours on airport tarmacs in exces-sive heat or extreme cold temperatures. But what happens if a delivery vehicle carrying such therapies breaks down on the road? A June 14, 2018 Digital Journal article says, “The adoption of temperature-controlled packaging systems depends largely on the aspect that mechanical issues and external forces do not inhibit packaging ef ciency. This has led to a surging adoption of passive temperature-controlled packaging systems over their active counterparts.”The article points to Future Markets Insights (FMI) research forecasting a 9% Compound Annual Growth Rate (CAGR) between 2017 and 2027 for the global passive temperature-controlled packaging market, predicting it will reach a value over $18 bil-lion by 2027.FMI notes, “Passive temperature-con-trolled packaging consists of specially de-signed packaging shippers and containers that maintain a controlled temperature Transportation Issues Challenge Temperature-Controlled Packaging Summer may be the perfect time for a family vacation, but an excursion is not suitable for temperature-sensitive pharmaceuticals, biologics and combination products.JIM BUTSCHLI, EDITOREXCURSION RESOURCESEven with the availability of monitoring devices, GPS and other technologies, temperature excursions do exist in the real world. Re-sources to help prevent or manage them include the following:+ U.S. Pharmacopeia’s <1079> provides general guidance about the storage, distribution and shipping of Pharmacopeial prepa-rations. http://hcpgo.to/333+ USP’s revised General Chapter <659> Packaging and Storage Requirements provides packaging de nitions and information related to the storage and distribution of active ingredients, excipients, and medical products, such as pharmaceuticals, devices, combination products and dietary supplements. http://hcpgo.to/334+ The Centers for Disease Control and Prevention’s temperature excursion checklist presents an easy-to-follow one-page list of actions to take in the event of an excursion. http://hcpgo.to/335+ A Vaisala cold chain compliance “Application Note” offers regulations and standards for temperature-controlled supply chains citing guidance from the FDA and ICH (Intl. Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use). http://hcpgo.to/3361804_ColdChainCorner.indd 87/19/18 10:38 AMCOLD CHAIN CORNERtime for… COMPLIANCE 715 Church Road, Elmhurst, IL 60126 • 630-530-2203 • www.guk-vijuk.comCall today for more information! Booth 813West BuildingVisit us at … SERIALIZATION... TRACEABILITY ANTI-COUNTERFEITING• Print a unique code on each outsert for traceability• Print and dimensional verification• Log all verification results, good and bad, for an accurate record of existing numbers• In-line or off-lineOctober 14–17, 2018 McCormick Place Chicago, IllinoisINTERNATIONALenvironment to limit exposure of the packed product to high or low temperatures during transit. In recent years, the need for transport-ing specialized pharmaceutical products globally has signi cantly risen, and so the need for its packaging and logistics.”The report also expresses some limiting factors, saying, “However, [the] high cost of advanced Temperature Controlled Packaging (TCP) restrains those to be utilized for cheaper pharmaceutical products, and hence poses a signi cant restraint for the growth of passive temperature-controlled packaging globally. This, coupled with increasing preference towards rental and reusable packaging, is further shifting revenues from the sales of passive temperature-controlled packaging on a down side.”Reusability factors inReusability also factors into global temperature-controlled packag-ing in a report at XploreMR. It notes, “International organizations such as World Health Organization (WHO) are continuously fo-cusing on reducing wastage of vaccines across the globe. As a part of this, various programs are initiated to monitor vac-cine wastage at country levels. These programs also focus on proper handling and transportation of vaccines. This particular factor surges the demand for temperature-controlled packaging in the healthcare sector. Another factor that is creating a positive impact on the market is an unprecedented shift towards structurally complex biotechnol-ogy drugs over chemical-based drugs. Drugs used in the treatment of cancer or cold chain drugs such as insulin require constant temperature control.”Outsourcing on the riseFMI’s report also suggests a trend for both food and pharmaceuti-cal manufacturers to outsource packaging and the transportation of temperature-sensitive products to third-party logistics rms. It notes, “Additionally, growing demand for passive temperature-controlled packaging solutions in developing countries has led many global passive temperature-controlled packaging solutions providers and 3PLs to expand their passive temperature-controlled packaging solutions offerings in countries such as China, India and Indonesia.”A further challenge for temperature-controlled product packaging cited in new research from Absolute Reports points to the high cost of diesel and fuel maintenance. A market trend, says the report, is the integration of GPS tracking and temperature monitoring systems to help ensure successful deliveries. 1804_ColdChainCorner.indd 97/19/18 10:38 AMNext >