Controlled duty
Define heating, displacement, condensate removal, minimum temperature, exposure, coldest locations, pressure, sterile cooling, hold and release for the complete post-process aseptic boundary. The review must also reconcile aseptic boundary and cold-location assessment with qualified sterilisation temperature-time requirement across normal, transition and fault conditions.
- Aseptic boundary and cold-location assessment
- Qualified sterilisation temperature-time requirement
- Required result and acceptable operating range