CoreRx has completed installation of the Optel Line Master Serialization and Aggregation System for support of commercial liquid dosage form manufacturing.
In addition to handling serialization, which the FDA has mandated for commercial products by November 2018, the system is also able to support aggregation of commercial products.
Serialization is the unique identification of individual packs (cartons or bottles) of medications. 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 code known as a datamatrix. At the conclusion of the packaging order, the serial numbers are 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.
CoreRx president and CEO Todd Daviau said: “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.
“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.”
Source: Company Press Release.