Aseptic processing

Carrying out manufacturing steps with sterile materials in a controlled environment so that no microorganisms are introduced, used when a product cannot be terminally sterilized. Most biologics and all cell therapy products depend on it; in cell therapy the whole process, from receipt of the starting cells to filling and freezing, is done aseptically. Japan's Guidance on the Manufacture of Sterile Pharmaceutical Products by Aseptic Processing sets expectations for drugs, and EU GMP Annex 1 and PIC/S apply the same principles. Japanese documents also use a related term for the aseptic manufacturing method as a whole (無菌操作法).