Vetter’s first U.S. development facility is now fully operational. The 24,000-sq-ft. site in Skokie, IL includes microbiology and chemical analysis labs, material preparation and compounding functions, three cleanrooms for aseptic filling, and visual inspection. The facility is the first to use Bosch’s new MHI 2020 B fully automated vial filler, offering technology and processes to support preclinical through Phase II compounds.
The new automated vial filler can run as many as 10,000 liquid or 6,000 lyophilized vials per batch. The unit is capable of running a range of fill volumes, from 0.1 to 23 ml. A second cleanroom houses a flexible semi-automated filler for liquid fills. The system can fill a variety of packaging materials — syringes, cartridges and vials — with a capacity of up to 500 units per batch.
According to the company, both automated and semi-automated units provide a 100% in-line check-weigh system, which helps ensure accurate fill volume — critical in small, early-stage fills. Because no sampling is required to verify fill volume, the system increases API yield. The facility uses disposable components in material preparation, compounding and filtration areas, which eliminates the need for cleaning validation. A third clean room will expand current operations and provide filling of pre-sterilized syringes.
Vetter managing director Peter Soelkner commented, “Our Chicago facility provides customers with a top-of-the-line clinical manufacturing site located in the heart of the U.S. Because Vetter consistently strives to stay at the forefront of innovation, securing Bosch’s new fully automated vial filler was a natural for us. Here in Chicago, our state-of-the-art systems and infrastructure, coupled with our professional expertise, offer customers the quality they expect from Vetter.”