Japanese–English glossary
Aseptic filling
無菌充填mukin jūten
Filling sterile-filtered drug solution into sterilized containers and closing them under aseptic conditions in a Grade A zone, typically inside an isolator or a restricted access barrier system. It is used for products that cannot be terminally sterilized, which includes most biologics. Quality built up through upstream and downstream processing can be lost at this last step, so aseptic filling is validated by media fills and monitored continuously. Filter integrity, container closure integrity and environmental monitoring results all feed the release of an aseptically filled batch.