Designing, Developing SOP's and Validating Filter Steam Sterilization Cycles

A one-day training program

The conception and validation of modern aseptic processing systems has become more and more complex with the introduction of automated procedures and the emergence of new regulatory requirements. Aseptic filling processes are under regulatory scrutiny, and require thorough validation programs to ensure reliable, safe and reproducible performance. The control of the aseptic process starts with the validation of the appropriate filter, continues with good process engineering and validation practices, and concludes with the establishment of adequate standard operating procedures (SOPs). Critical process steps such as filter steam sterilisation must be considered at the early stage of the process development to guarantee proper design of the filtration system and ensure straight-forward validation.