Terminal sterilization

Sterilizing a product in its final sealed container, usually by moist heat, so that sterility is assured with a quantified sterility assurance level. It is the preferred route whenever the product can withstand it. Proteins, viral vectors and living cells cannot, so biologics are almost always made by sterile filtration and aseptic processing instead. In Japanese documents, whether a product is terminally sterilized or aseptically processed decides which guidance, validation approach and cleanroom grades apply.