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:
Glossary of terms
Sterilization Process Development