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Jennifer Markarian is manufacturing editor of Pharmaceutical Technology.
Sharp Packaging Services adds Biotechnology Center of Excellence to its to its Allentown, PA campus.
Sharp Packaging Services, a contract packaging organization that is a division of UDG Healthcare, recently expanded its Allentown, PA campus, adding a 112,000-ft2 center of excellence for specialty, biologic, and cold-chain packaging as well as four new bottling lines within an adjacent building. Commercial packaging activities began at the new center in June 2016. Growth of specialty and biologic products, along with increasing industry demand for contract packaging of bottled and blister-packed pharmaceuticals, led Sharp to make the investments, the company noted in a June 27, 2016 press release. “We have customers with vials that need labeling and serialization, syringes with a label pack-out, oral thin film strips and then those with automatic, self-injected devices requiring special assembly. With our new facility, we have the dedicated space to meet the most demanding requirements,” said Doug Hill, senior vice-president and general manager of Sharp Packaging Solutions in the press release. Many biologic drugs require cold storage, and the center has cold-storage housing at 2-8 °C for 500 pallets.
In addition, Sharp is adding serialization capability to its packaging lines in preparation for the November, 2017 Drug Supply Chain Security Act (DSCSA) deadline for unit-of-sale level serialization. The company now has 26 lines capable of serializing six different packaging formats and plans to add four or five more lines per quarter through 2017. The lines can serialize down to the individual blister cavity, with up to five levels of aggregation. “Besides the regulatory requirements, serialization is a value proposition that can improve operations such as logistics,” Hill said at a September 13, 2016 open house event at the Allentown site. With the pending DSCSA deadline, the company expects the number of clients serializing their packages to continue to grow. “We are encouraging people to start serializing as soon as possible,” said Hill.
Sharp has been serializing products since 2008 and formed a Technical Services group to combine the information technology and engineering skill sets necessary for serialization. “Serialization is complex because it is a convergence of the physical product flow with the electronic data flow,” noted Gaurav Banerjee, director of Technical Services at Sharp in a presentation at the open house. Experience is needed to understand the problems that can arise. “For example, you can’t remove bottles from the line and reintroduce them later, and you can’t just reprint a torn label,” notes Banerjee. Validation includes both packaging validation and computer validation, he adds.
Implementation of product serialization can take four to six months, says Banerjee. It is crucial to clarify the user-requirement details at the outset of any project, and to establish agreements to delineate responsibilities for specific situations (e.g., finding a lost package), he adds. To speed the process, Sharp has introduced a “rapid deployment” program called the Sharp Standard Serialization Solution (S4), which can typically be implemented in 90 days after receipt of order and confirmation of requirements. S4 includes three levels of aggregation (carton or bottle to case to pallet) for specific package types and standard specifications, such as font size and artwork placement. Blisters, vials, and biotech kits can be cartoned, and the carton serialized as the unit of sale. Customers can choose to connect and transfer data through technology vendors Systech, Covectra, or TraceLink. TraceLink can connect to any enterprise resource planning system or Electronic Product Code Information Service (EPCIS).