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CoreRx Installs Optel Serialization and Aggregation System


To support commercial liquid dosage form manufacturing

CoreRx, Inc. has expanded its cGMP manufacturing capabilities to support niche commercial products, with the installation of the Optel Line Master Serialization and Aggregation System to support commercial liquid dosage form manufacturing. In addition to handling serialization, the system also supports aggregation of commercial products. 
Serialization provides unique identification of individual packs (cartons or bottles) of medications and as each batch of finished product is packaged, a globally unique code is assigned and physically marked on the packaging in the form of a two-dimensional datamatrix code. The serial numbers are then electronically linked to the product's batch number.

Aggregation is then taking that individual unit and tracing it to the larger bundle, case, and/or pallet it came from. By having aggregation in place now, CoreRx will be ahead of the aggregation deadline the FDA has set for November 2023. 
"With this new system in place, CoreRx has successfully produced launch supplies for one of our client's commercial products, the first commercial product to be manufactured at CoreRx," said Todd R. Daviau, president, and chief executive officer. "As a CDMO, our customers' requirements are ever-changing and cover a wide range of product types and packaging configurations. As such, we made sure to implement an accurate and versatile system to fit our client's varying production needs."