Pharmaceutical Commerce - November/December 2017 - 23
Information Technology Blockchain coming on Seemingly from left field, a relatively n e w t e c h n o l o g y - t h e "d i s t r i b u t e d ledger" technology commonly known as blockchain-is generating more interest among traceability experts (Pharmaceutical Commerce, July/Aug, p. 22). The inherent nature of blockchain is a network of linked databases, with cryptographic methods to store time-stamped data, such that altering the data undetected is virtually impossible. As a p p l i e d to p h a r m a t r a ce a b i l i t y, blockchain could enable trading partners to exchange transaction data of serialized pharma shipments with each other, with an "immutable" record of the transaction, and w ith the record being "hashed" (cryptographically encoded) so that the trading partner originating the message can protect all or part of it from others' view. It is also possible for a blockchain network to run without any central authority, although most conversations about the application involve some method to validate who can participate in the network. One indicator of interest in blockchain is its growing interest at HDA. From a one-hour session at the 2016 Traceability Seminar, this year's meeting will feature a five-hour workshop on the technology. Also, the Institute of Electrical and Electronic Engineers (IEEE) held a meeting in mid2017, with more in the works. Bob Celeste, a former GS1 US Healthcare manager and now principal of a consulting firm called the Center for Supply Chain Studies (www.c4scs.org) has run a series of study projects on the topic, with a proof of concept study scheduled for 2018. Work to date has determined the six challenges the topic currently faces in pharma traceability: * To establish an electronic connection between non-adjacent trading partners * To establish trust between these trading partners * To sha re required data w ithout exposing proprietary data * To support traceability activity at trading partners * To design for expansion beyond DSCSA compliance * To fund the architecture. A feature of C4SCS' approach is to use simulation modeling tools for network activity: "Study participants suggest use cases or modifications to traceability activity, and the model can determine what is feasible," he says. Another effort has been announced by a partnership of two San Francisco startups: The LinkLab LLC and Chronicled, who have developed a prototype blockchain called MediLedger. Genentech, Pfizer, AbbVie, AmerisourceBergen and McKesson have participated in the endeavor to date. Susanne Somerville, co-founder of The LinkLab, says that the prototype is "blockchain agnostic" (i.e., of the variety of blockchain frameworks in existence, there is no preferred version as yet), but the prototype work has been performed with Quorum, an offshoot of the Ethereum protocol, which is supported by J. P. Morgan and Microsoft, among others. Interestingly, both the C4SCS and MediLedger projects, as well as a blockchain effort by Unisys, are looking at pharma cold-chain logistics as a test case for applying the technology to life sciences. A progress report is promised from LinkLab before the end of the year. Optel extends serialization technology into the pharmacy Optel Certa scanner confirms inbound serial data on packages; HD PrintSafe upgrades barcoding quality While a lot of the attention on pharma traceability today is getting readable barcodes onto packages, eventually there will be an equally important task to confirm receipt of those barcoded packages at pharmacies and other destinations. This is especially true of Europe's Falsified Me d i c i n e s D i re c t ive ( F M D ) , w h i ch is a "bookend" approach to product authentication: barcodes are verified at the beginning and end of a supply chain, but not intermediate points. (The US' Drug Supply Chain and Security Act mandates step-by-step confirmation of product transfers.) To this end, Optel Vision has introduced Optel Certa, a scanning station (including a handheld device) that enables users to scan a barcode (at rates up to 2,000 per hour), designed specifically for the pharmacy environment. Certa connects to an Optelmanaged data network, which in turn provides automatic linkage to the National Medicines Verification System (NMVS) that has been set up in Europe. The immediate result is to confirm the authenticity of the code against the national database; subsequently, decommissioned, recalled or outdated products can be verified. Optel also offers to link the barcode reading system with in-house inventory control solutions. Meanwhile, the company has also announced an upgraded set of barcoding and vision-inspection resources for the initial coding of life sciences products (either the serial numbers of pharma packages, or the Unique Device Identifications [UDIs] of medical devices). HD PrintSafe combines a high-speed digital inkjet system (OEM: Bell-Mark) with a web inspection system to verify artwork and variable data. The technology is said to be especially suited for thermoforming packaging operations. Supply Chain/Logistics Big Pharma requires big help in protecting CRT products continued from page 20 Know your shipping environment To understand passive temperature protection, you first must understand the effects weather has on the shipping environment. Know what temperatures your products are exposed to and for what length of time. For example, if the temperature outside is 85°F, how hot is it in a trailer that has been sitting in the sun for six hours in a parking lot? Does the temperature change if the truck is moving? Is there a difference between trailers and containers? Containers are shipped over land and sea, and for longer periods of time. How does this impact the internal shipping environment? Airfreight that sits outside waiting to be put on a plane is another set of environmental conditions to consider. Make sure you work with a company that has years of experience in this area, are experts in passive thermal protection and have the answers to these questions, as well as the many others related to the mode and lane your shipment travels. "The idea is to avoid using a cover designed to protect for three hours in the sun on a shipment that requires three days of protection in a trailer. On the flip side, you don't want to spend the money on a thermal cover designed to protect for days when your window for temperature excursion is only three hours on the tarmac," says O'Donnell. QPS has added to its consultative services by partnering with Riskpulse, a meteorological firm to analyze weather conditions regionally and nationally in predicting temperature conditions in trade lanes. Know your technology Behold the price-performance continuum (fig. 2) portraying the cost and effectiveness of passive thermal protection products. With many shapes, sizes, benefits and features, it all comes down to what level of performance you need in order to validate and approve the protection you can count on. With a simple cover for starts and finishing with a hard-shelled, fully insulated shipping box, the cost variance is extreme. Passive thermal technology relies on some basic principles of thermal dynamics: radiant, convective and conductive heat, and inversely the loss thereof. A proven solution for both convective and radiant heat can be found on the lower end of the continuum and include the popular reflective bubble covers. As the shipping environment becomes more demanding, moving up the continuum to a quilted solution provides more robust protection. The conclusion: know your product, know the risks throughout your transportation network and thus make an informed decision. Choose wisely! As the US steadily moves towards stricter GDPs, and Europe and Canada lead the hunt for a tightly knit, overall turnkey solution to cold chain transportation, more than just one solution comes into play. Looking forward, the future of shipping protected product encompasses not only the physical tools we use every day, such as refrigerated equipment and passive thermal protection, but also a mix of less tangible services, such as historical/predictive weather data and lane analysis on the planning side, or the re-use and reclamation of thermal blankets continued on page 26 ABOUT THE AUTHOR Tony Dellumo is sales and marketing coordinator, QProducts & Services, where he manages marketing efforts and inside sales support. He has a BA in marketing and media management from Columbia College Chicago. November | December 2017 Visit our website at www.PharmaceuticalCommerce.com 23
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