ABSTRACT
Sterilization-in-place (SIP) utilizing saturated steam has become a widely used procedure in the parenteral and biotechnology fields. It offers a method of sterilizing equipment that is either too large or inconvenient to place in an autoclave and can enhance sterility assurance by reducing the amount of aseptic assembly. This chapter provides the necessary information to engineers, microbiologists, and sterilization scientists to design, troubleshoot, and validate steam SIP processes. An overview of steam sterilization principles is included as the basis for the discussion of deadleg sterilization. Steam sterilization is the best understood and most dependable process for the destruction of microbial life. The effect of moisture on heat sterilization is evidenced by the difference in temperature required for dry heat versus saturated steam processes. The factors most often resulting in steam SIP failures are condensate accumulation and air entrapment. Condensate accumulation can result in inadequate temperature, while air entrapment can result in inadequate moisture.
