Thermal Validation in Moist Heat Sterilization (single user digital version)

Feb 2015
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Since the advent of the Parenteral Drug Association's technical report on the validation of moist heat sterilization processes (PDA, 2007), it has been recognized that both the physical and the biological characteristics of a cycle should be included in the validation.

While some concepts of microbial lethality and microbial validation are presented in this book, the focus of the book is the physical validation. Since the main physical parameter being evaluated is temperature, this is also known as thermal validation.

The various authors cited in this book have a wealth of practical experience in thermal validation of moist heat sterilization processes that has been incorporated into their writing.

This book is an essential guide and reference for managers, supervisors and all others concerned with preparing validation plans acceptable to regulators worldwide.

Literature Cited
Parenteral Drug Association (2007) PDA Technical Report 1, Revised 2007, (TR 1) Validation of Moist Heat Sterilization Processes Cycle Design, Development, Qualification and Ongoing Control. PDA: Bethesda.

Book written in July, 2011.

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Format: PDF (1 file 8.59 MB)

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Table of Contents

Table of Contents:

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  1. Thermal Validation and Why it is Important by Jeanne Moldenhauer
  2. Steam Sterilization Process Validation by James Agalloco
  3. Regulatory Expectations for Thermal Validation — USA by Jeanne Moldenhauer
  4. European Expectations for Thermal Validation by Roland Marie Frederic Guinet
  5. The EMEA`s Decision Tree for Selection of Sterilisation Methods by Jeanne Moldenhauer
  6. Importance of Accurate Measurements in Thermal Validation Studies by Goran Bringert
  7. Performance of Thermal Validation Studies by Kevin Trupp
  8. Practical Aspects of Thermal Validation for Moist Heat Sterilization by Angela S. Coon and Michael J. Sadowski
  9. Analysis of Heating and Cooling Data by Dr. Irving Pflug


About the Authors

About the Editor

Jeanne Moldenhauer, Excellent Pharma Consulting, has nearly 30 years of experience in the pharmaceutical industry. She chairs the PDA Environmental Monitoring/Microbiology Interest Group, serves on the PDA Scientific Advisory Board, founded the Rapid Microbiology User`s Group™, and is a member of ASQ and RAPS. She is the author of Recent Warning Letters Review for Preparation of a Non-Sterile Processing Inspection, Volume 2; Recent Warning Letters Review for Preparation of an Aseptic Processing Inspection and the Editor of Environmental Monitoring Volumes I, II, III, IV, V, VI, VII; Steam Sterilization: A Practitioner`s Guide; Laboratory Validation: A Practitioner`s Guide; and Systems Based Inspections for Pharmaceutical Manufacturers among numerous other recent publications.