The concepts and ideas presented in this book were developed jointly by the members of the PDA Biotechnology Cleaning Validation Subcommittee.

This book is intended to serve as a source of practical technical information for those persons in the biotechnology industry. Case studies and/or actual industry examples are used to support the text wherever possible. While much of the material contained within this text is equally applicable to non-biopharmaceutical processes, the emphasis has been focused directly upon biopharmaceutical manufacturing.

• Section I provides an in-depth analysis of the design concepts that lead to cleanable equipment. Also covered are cleaning mechanisms and cleaning systems. The first section is particularly useful to those persons faced with the task of designing systems that will be cleaned and also provides the biochemical background of the mechanisms associated with the removal of common biotechnology soils.
• Section II focuses on cleaning validation concepts. While the material is equally useful for single product cleaning, emphasis is placed upon multi-product cleaning validation. Included are general validation principles as they apply to cleaning validation, detailed analysis of cleaning process validation, sampling techniques, analytical methods and acceptance criteria. The material in Section II will be useful to anyone responsible for the development of a cleaning validation program.
• Section III provides an overview of multi-product biotechnology manufacturing procedures. Included an analysis of the risk to benefit scenarios associated with the various forms of product manufacturing, analysis of changeover programs, equipment considerations and material transport as they are affected by multi-product manufacturing strategies.

Table of Contents:

Preface
About the Authors
Introduction
Section I - Design Concepts
1. Process Equipment Design Considerations
2. Cleaning Mechanisms and Strategies
3. Automatic Cleaning Equipment
Section II - Validation Concepts
4. Validation Study Design
5. Sampling Methods
6. Analytical Methods That Support Cleaning Validation Studies
7. Approaches to Establishing Cleaning Validation Acceptance Criteria
Section III – Multiproduct Concepts
8. Special Issues for Multiproduct Facilities
Glossary
Appendix
Index