Section I

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 nonbiopharmaceutical 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 in the first section 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

Section II focuses on cleaning validation concepts. While the material is equally useful for single product cleaning, emphasis is placed upon multiproduct cleaning validation. Included in Section II 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 this section will be useful to anyone responsible for the development of a cleaning validation program.

Section III

The final section, Section III, provides an overview of multiproduct biotechnology manufacturing procedures. Included in this section is an analysis of the risk-to-benefit scenarios associated with the various forms of product manufacturing, analysis of changeover programs, equipment considerations, and material transfer systems as they are affected by multiproduct manufacturing strategies.