Tris Pharma chooses software from Adents to meet serialization compliance regulations.
Tris Pharma, a specialty pharmaceutical company engaged in research, development, and manufacturing of both OTC and Rx branded and generic products, has chosen software from Adents, a provider of serialization and track-and-trace software solutions, to assure compliance with upcoming U.S. serialization deadlines.
For the new venture, Tris Pharma has designated a centralized serialization room servicing packaging lines as well as rework stations. The dedicated serialization suite will provide track and trace solutions for such high-profile customers as Pfizer, Vernalis, and Breckenridge.
The Adents serialization and aggregation suite of software enables companies to achieve traceability and documentation compliance, addressing both current and emerging regulations while also minimizing impact on production processes and productivity. The software configuration takes place completely at the site level, making per-line configuration unnecessary. It also helps with marketing and eliminating counterfeiting.
Adents serialization software is hardware agnostic, meaning it is compatible with a wide range of equipment. At Tris Pharma, the dedicated serialization suite contains a Pineberry Flat Carton Mark & Verify unit for cartons, and a mark & verify labeler from Weiler Labeling Systems. Both machines will employ laser marking, DataLase coatings, and Cognex smart cameras for inspection.
Although full implementation of 2013’s Drug Supply Chain Security Act will be phased in over the next decade, the next milestone for manufacturers is November 27, 2017, by which date pharmaceutical manufacturers are required to print a unique product identification code on all Rx units of sale and homogenous cases distributed domestically.
Due to Tris Pharma’s GMP procedures, the centralized serialization room will be limited to production of either labels or cartons at any given time. As Tris expands, however, it likely will house the Weiler and Pineberry units in separate rooms, enabling them to run simultaneously.
“One of the reasons we chose Adents is that its solution is both versatile and scalable,” said Brian Weiss, Associate Director of Engineering for Tris Pharma. “The flexibility offered through Adents allows us to comply with the short-term serialization mandate while remaining adaptable for both future regulations and evolving business needs.”
Currently, each of the four Rx packaging lines serviced by the serialization suite has two aggregation stations, for manual unit-to-case aggregation and manual case-to-pallet aggregation, respectively. Products from Tris Pharma are typically shipped as whole batches to customers and third-party logistics providers.
Moving forward, Tris Pharma also has plans to automate work order entry. At present, the company handles work order entry manually, but is looking to migrate to JD Edwards-generated work orders upon the ERP system’s completion. An enhanced setup will ease the exchange of serialization data.
“We are so pleased Tris Pharma will be using Adents serialization software to help it comply with serialization deadlines,” said Christophe Devins, CEO of Adents, “and are confident the company will quickly see evidence of the effectiveness, flexibility and ease-of-use of our modular software solution.”