A contract development and the manufacturing organization that specializes in the aseptic filling is the vetter. The first to use Bosch’s a new MHI 2020 B fully automated vial filler Vetter Chicago facility offers state of the art technology and the processes to support the preclinical through the Phase II compounds. The fully automated vial filler at Vetter’s Chicago facility prepared for the capping. The designed specifically for the early clinical stage, high value biopharmacauticals, Vetters new automated vial filler can run up to 10,000 liquid or 6,000 lyophilized vials per batch.
The minimum tubing lengths help reduce API loss and increase product yield, the systems use of the restricted access barrier system and its degree of the automation including the both filing and capping. The unit is capable of the running a range of the fill volumes from the 0.1 to 23 ml providing the ample flexibility. The intend for the liquid fills a second clean room houses a flexible semi-automated filler. The system can fill a variety of packaging materials, syringes, cartridges and vials with a capacity of up to 500 units per batch. Both automated and semi automated units provide a 100 percent in line check weigh system which helps ensure accurate fill volume critical in a small, early stage fills because of the no sampling is required to verify the fill volumes.
The facility uses exclusively disposable components in the material preparations, compounding and filtration areas which eliminates the need for the cleaning validation and saves valuable time and cost. The third cleanroom will expand current operations and provides a filling of the pre sterilized syringes. Their Chicago facility provides a customers with a top of the line clinical manufacturing site located in the heart of the United States this is because Vetter consistently strives to stay the forefront of the innovation. The outsourcing helps to improve the industry. The strategic to vetters plan for the worldwide growth, the launch of the Chicago operations in highlights dedication to serving the North American market where nearly half of Vetters clients base resides.
The Chicago site and its processes meet the stringent FDA and EMA quality requirements. The services include the regulatory counsel and the product lifecycle management. The experienced project managers steer all the product development projects so that it can stay a quality standards that can be maintained and deliverables that can be met on the time and on the budget. The Chicago facility provides seamless product transfers to Vetters ,large scale manufacturing facilities in the Europe for the Phase III and the commercial manufacturing.
REFERENCE:
http://www.pharmpro.com/news/2011/10/outsourcing-news-Vetters-Chicago-Facility-is-Fully-Operational/
