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

Aug 2007
PDA Item Number
Softcover: 01001 | Digital: 43381

Premium Members: to claim your annual free technical document download, email [email protected] and indicate the document you wish to claim.

Member Price
Nonmember Price

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.

Available to download immediate

Format: PDF (1 file - 5.04 MB)

Click here for the digital downloading instruction and Terms of Usage.

Click here to order Spanish version (Item no. 43550).

Volume 61 No. S-1.

*To purchase licensing, please contact PDA at [email protected].

Table of Contents

Table of Contents:

Glossary of terms
Sterilization Science and Technology
Sterilization Process Development
Process Performance Qualification
Ongoing Process Control