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.
Section I - Design Concepts
Equipment Design Considerations
2. Cleaning Mechanisms and Strategies
Automatic Cleaning Equipment
Section II - Validation Concepts
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
Special Issues for Multiproduct