ABSTRACT

DISPOSABLE UNIT OPERATIONS Aseptic processing gains an increasing importance within the biotech industry due to the fact that sterilization by membrane filtration is the generally the only option to sterilize biological solutions. Any heat treatment would destructively affect the drug product and target protein. To more confidently assure that the sterile filtered product maintains its sterile state, sterile closed disposable process solutions are increasingly used to process or store the resulting filtrate.