Volume 4 complements Destin LeBlanc's earlier three books on the same subject. This book modifies and updates LeBlanc's monthly Cleaning Memos originally published from January 2013 through December 2016. More than half of the chapters in the book are on setting limits in one way or another, so the use of health-based limits will require balanced reading (and thinking) for an overall understanding.
Each Cleaning Memo is presented as a chapter, with the chapters also organized by common topics. For example, topics related to setting limits are in one section, those related to sampling in another section and so forth. In all cases, the content focuses on changes for improving clarity and applicability as well as to modify the text with new information. There is one appendix with a list of acronyms used in this volume as well as a second appendix dealing with the author's shorthand method of expressing limits.
The author would also like to encourage pharmaceutical manufacturers, and particularly upper management, to meet the challenges of the science-based and risk-based approaches to cleaning validation. Using some of the principles and practices in this Volume may help in designing a more effective and efficient cleaning validation program.
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Table of Contents:
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- Health-Based Limits
- Limits for API Manufacture
- Limits — General
- Visually Clean
- Sampling and Sampling Recovery
- Analytical Methods
- Limits for Lyophilizers
- Protocols and Procedures
- Miscellaneous Topics
About the Author
Destin LeBlanc is a consultant at Cleaning Validation Technologies. He has extensive experience in product development and technical services for cleaning and antimicrobial applications. He is an international lecturer on contamination control and has written widely on cleaning validation topics including four volumes in the Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing series published by PDA and DHI. He is a member of PDA and ISPE and trains FDA personnel on cleaning validation. He is a graduate of the University of Michigan and the University of Iowa.