PDA TR 61

This technical report complements PDA Technical Report No. 1 (Revised 2007): Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control with a focus on steam-in-place (SIP) processes. The primary objective of the task force responsible for this technical report was to develop a scientific technical report on SIP processes that provides recommendations for use by industry and regulators. References to appropriate and up-to-date scientific publications, international regulatory documents, journal articles, technical papers, and books are used to provide more detail and supportive data can be found. 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. This technical report was disseminated for public review and comment prior to publication, to provide the widest possible review and ensure its suitability as a guide to industry.