Catalent Biologics Stays Compliant with a Track & Trace Solution for Vials and Syringes
There is a requirement that individually saleable units are serialized, but Catalent wisely made the decision to include an aggregation step in the process to increase the security and ease of traceability of their products. After discussing their needs, Catalent decided to use a mixture of automatic and manual methods to perform the serialization and aggregation step.
As the cartons produced are meant to be individually saleable, each carton must be serialized, and then – depending on the wishes of the customer – aggregated from bundles to cases to pallets, or the bundling step is skipped, and individual units are aggregated into cases and then pallets.
The serialization of individual cartons is managed automatically, while the aggregation process is conducted by two systems: a manual system for the creation of bundles (when required) and an automatic system for the aggregation of cartons or bundles to cases. When cases are loaded onto a pallet, they are aggregated manually.
For more information on how Catalent implemented their Track & Trace solution – and how it's performed for them so far – you can download the full case study.