PDA Technical Report No. 1, Revised 2007, (TR 1) Validation of Moist Heat Sterilization Processes Cycle Design, Development, Qualification and Ongoing Control

PDA's original Technical Monograph No. 1, Validation of Steam Sterilization Cycles, published in 1978, introduced the principles of steam sterilization to an entire generation of pharmaceutical scientists and engineers. The revision retains a focus on the microbiology and engineering of moist heat sterilization and the general approach to sterilization science embodied in the original document, and updates it by including contemporary subject matter.

The overarching goal was to provide enough information to convey understanding of the science of moist heat sterilization with sufficient technical detail to assist in developing a sterilization policy.

This technical report was prepared by the task force that composed of 42 European and North American industry and regulatory professionals to ensure the methods, terminology and practices of sterilization science presented reflect sound science that should be able to be used globally. It was disseminated in draft for public review and comment prior to publication providing widest possible review of the document to ensure its suitability as a valuable guide to industry in steam sterilization. It is organized in a logical progression from the essential elements of sterilization science and technology through sterilization cycle development and qualification.

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Volume 61 No. S-1.

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