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Afton Scientific Uses Customized Serialization for Vial Cartons

Cartons and cases of aseptically filled glass vials are serialized and aggregated in advance of DSCSA deadlines.

With an international client base that ranges from emerging biotechs to established pharmaceutical giants, it’s no wonder that Afton Scientific®’s Contract Manufacturing Organization (CMO) AnovaFill® is fully compliant with U.S. FDA and European Medicines Agency regulations.

AnovaFill provides cGMP contract sterile filling services of investigative new drugs, biologics, and commercial injectable pharmaceuticals. The facility produces small batch and clinical trial liquid fills of 1 to 100 mL/vial, with production sizes from 100 to 15,000 units and soon to be 50,000 units.

Afton Scientific, AnovaFill’s parent, provides pre-sterilized and custom packaged Ready-to-Fill® components such as sterile vials, stoppers and seals for immediate use in cGMP filling of sterile human drugs. These components are shipped to firms in North America, Europe, Asia, Australia and Africa.

Considered a small contract pharmaceutical facility, AnovaFill works to stay ahead of the competitive curve, particularly when it comes to satisfying 2017 DSCSA serialization deadlines. Much of this “edge” is attributable to its work with partner Videojet. The two companies began working together in late 2015.

According to Ashley Umberger, Afton Scientific’s Manager, Engineering, “FDA guidelines state that the smallest unit placed into interstate commerce by the manufacturer or the repackager that is intended for individual sale should be the item that is serialized. In our instance, we package vials into cartons (in different quantities depending on drug product package), therefore we label cartons as the smallest unit. We implemented both the serialization and aggregation portions now, although aggregation is not required by the November 2017 deadline.”

She states, “When we started our serialization initiative we researched different vendor combinations to get the best in both equipment and flexibility. Videojet designed a system specifically for Afton, giving us an all-in-one-type system.

“We needed a flexible system to accommodate different products in smaller quantities; therefore a rigid, high-volume and elaborate system was not suitable for our needs. Videojet created a system that was flexible, while also catering to other requirements, such as equipment footprint and cost.”

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