New: PDA Technical Report No. 61

This document focuses on the various applications of steam for in situ sterilization for “sterile” applications and for in situ sanitization and other bioburden control applications widely used for systems that do not claim to be “sterilized” via steam. Risk management employed throughout the lifecycle of SIP equipment and processes to efficiently focus and allocate resources commensurate with the probability of impacting final product purity and safety is also covered.

The task force was composed of European, North American, and South American industry professionals to ensure the methods, terminology, and practices of SIP reflect sound science and can be applied globally.