ABSTRACT
Aseptic processing gains an increasing importance within the biotech industry due to the fact that cold sterilization by membrane filtration is the only option to sterilize biological solutions. The lack of appropriate aseptic connectivity has been recognized and addressed with newer more effective designs. Disposable aseptic processing bag assemblies need to be installed in stainless steel or plastic totes to support the functional filling, draining, storage, transportation, and transfer operations. The final aseptic transfer of liquids and solid goods such as vial stoppers, syringe stoppers and plungers, monitors, and other items necessary for the aseptic process is certainly one of the most critical operations. The installation qualification and operational qualification steps are generally supported by the supplier of the aseptic transfer door in collaboration with the supplier of the isolator, restricted access barrier system, or clean room and the end user.
