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Serialization Lessons from a CMO

PACK EXPO East: Patheon, which has invested a lot of time and energy designing and building out serialization on pharmaceutical packaging lines, has learned a lot from the experience. Here’s what you need to know.

Christopher Howell, Patheon’s senior director of global engineering and technology.
Christopher Howell, Patheon’s senior director of global engineering and technology.

As a contract development and manufacturing organization, Patheon provides services to big and small pharmaceutical companies—and packaging is a key part of what it does. Therefore, the company must be able to accommodate the global supply chain and serialization efforts of its clients, regardless of size.

In order to deliver such services, the company has been tackling these issues for some time, and, will have about 25 lines designed and assembled for serialization before the end of this year—with a keen focus on the U.S. and European requirements, said Christopher Howell, Patheon’s Senior Director of Global Engineering and Technology. Howell was presenting at the Healthcare Packaging & Processing Conference this week, co-located with PACK EXPOEast in Philadelphia, where serialization was a major theme.

To ensure its partners are ready for the regulations, Patheon has a core global team, which Howell is responsible for, that provides business management, IT, quality computer system validation (CSV), purchasing, project management, engineering and legal and regulatory services. In addition, a local site team, which supports the clients’ specific requirements, extends to production, engineering and packaging.

The technology underneath the serialization efforts vary from North American and European regions. In North America, TraceLink is used as Patheon’s provider of GS1 Electronic Product Code Information Service (EPCIS), ROC IT Solutions is used for warehouse management and Optel Vision for line level serialization. In the EU, OCS is used for line level equipment and Advanco for warehouse management. And, SAP ERP is used globally for managing the master data.

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