MME builds the tooling and molds the parts for assembly. The assembly involves several steps, including cutting a “port” hole in the side of the bag, impulse welding and heat sealing. The bags are then sent out for bioburden and particle testing.
The Single-Use Beta Bag system consists of Tyvek® and high-density polyethylene (HDPE) bag layers connected to a Beta flange which mates the entire assembly to the Alpha port on an isolator. Once filled with components, these bags can be autoclaved and connected for filling line production. Bag customization is also available to meet specific application needs based on component, processing, and production parameters.
The CRL Single-Use Beta Bag is a safe, efficient, and cost-effective solution for aseptic production processes. This single-use system provides contamination-free transfer of sterile components into isolation or removal of toxic components out of isolation. Used in conjunction with Alpha port systems, sealed containment and sterility of the environment are maintained.