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Pharmaceutical & Medical Packaging News, November/December 2015

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pmpnews.com • Pharmaceutical & Medical Packaging News November/December 2015 22 Contract & Clinical Trial Packaging This team interacts well with the client team to support packaging its projects. To meet the growing IT component of our business, our project management has evolved into two groups: the standard group for onboarding, determining what lines are to be used, what materials, and what type of validation requirements; and then the IT development team where we work with the customer's inter- nal IT team or any of their consultants to support data integrity and transfer. Because we have been at this since 2007, we have been able to standard- ize an approach to serialization, which is very well received by all customers of all sizes. We have worked with SAP, Oracle, and other customer-specific-requirement systems. We are linked with the key ven- dors serving this area and accepted by the industry: Systech, Covectra, TraceLink, QAD, and Domino Printing and Vision Systems. This provides an immediate lev- el of comfort. In addition, we have chosen to build all of the internal Sharp serializa- tion equipment in one location and ship to our European site, so that the same technology is being utilized throughout Sharp. This capability to integrate data and equipment, as well as our techni- cal support team between our U.S. and European sites, ofers a seamless experi- ence to our customers struggling to meet the demands of a global marketplace. Currently we are supporting U.S., European, and Asian customers with serialization on 18+ active lines running 50+ active projects ranging from large pharma and bio-science companies to virtual companies. We can provide up to five levels of aggregation, from printing on the individual blister cavity through the final shipping pallet. Over the last 8 years we have serialized 2 to 3 billion dos- es. Sharp has chosen to make the invest- ment in the infrastructure for printers, cameras, and lines to support serializa- tion. We have control over the technology within Sharp, which is a huge benefit for our customers. We can confidently tell our customers that they will not be the first mover or guinea pig. We can go out and say, "Here's what we are doing." It's validated. Our parent company, UDG Healthcare, has also been very positive in supporting our business case of adding multiple serialization lines a quarter. We are looking to have 80 lines fully serialized within the next 24 months. PMP: What are future industry chal- lenges, and how is Sharp poised to help? Benedict: The rapid increase in spe- cialty medications and biologics requiring cold-chain distribution has escalated the need for refrigeration within packaging facilities, trucks, and packages. To meet this growing demand, Sharp has invested in another 120,000 square feet of produc- tion space for personalized medicines. The facility will open and be validated for 13 rooms and will grow over the next year to 20+, bringing its capability for cold-chain storage to 1000 pallets. All lines in this plant will be serialization ready and focused on specialty pharma and biotech products: vial-labeling lines, pen-assembly lines, oral thin-film packag- ing, and some customer-specific equip- ment. In addition, we are transitioning our cold-chain package to the Credo Cube multi-use packaging system. It is smaller and lighter than traditional poly- styrene and gel pack systems as well as being 100% recyclable. As such, it cuts down on transport emissions, reduces global warming potential by 75%, and reduces post-consumer waste by 95%. It also reduces product destruction costs for the customer through its ability to main- tain the desired temperature. Sharp also recognizes the diminish- ment of pharma's big count bottles of 500 and 1000 tablets or capsules and antici- pates more 30-, 60-, and 90-count bottles coming in the future. As a result, Sharp is investing in count equipment for fillers of scheduled drugs to be ready to convert lines to meet customer requirements. Meeting the needs of evolving mar- kets is also on the horizon. Each coun- try comes with its own set of complex regulations and therefore challenges to be met. Already well versed in meeting U.S., European, and Asian requirements, Sharp has begun testing of packaging and IT serialization and distribution sup- port for companies in South America. As an established commercial and clin- ical contract packager, we believe that Sharp is uniquely positioned to help the industry address these challenges. We offer beginning-to-end packaging solu- tions through robust commercial packag- ing capabilities in both the United States and Europe, as well as clinical packag- ing operations in the United States and the United Kingdom, supporting Phase I through Phase III clinical trials. This validated presence on two continents is a tremendous asset to our global clients in terms of having the authentication and expertise necessary to meet each market's regulatory requirements. In addition, our experience in serving the needs of a broad range of clientele, from large phar- maceutical and bio-science companies; Tier I, II, and III companies and generic manufacturers to virtual companies, gives us a broad base of knowledge to leverage against each new client requirement. For instance, a company can tap our package design lab to develop packag- ing for a new medication or biologic, drawing upon our expertise with other medications or delivery mechanisms in the drug's class. We can also advise a cli- ent on packaging material specifications to meet unique drug requirements such as refrigeration or exposure to humidity or light. This capability help's the clients marketing and brand teams tremen- dously, because they can confidently out- source these functions, preserving their internal resources for other deliverables, and obtain a package that works for the product and patient while performing efectively in the packaging operation. 0 Carding operations. Image courtesy Sharp Packaging Solutions

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