LeBlanc D.A. Validated Cleaning Technologies for Pharmaceutical Manufacturing

Boca Raton: CRC Press. – 2000. – 304 p. This text is based on my experience with validated cleaning applications in pharmaceutical process manufacturing for the past 10 years. This book is designed for those who face the difficult task of designing validatable cleaning processes, and then validating those processes, in pharmaceutical process manufacturing settings. It is designed to be used by those people involved in the overall validation program. This book can be read by those entirely new to the field of cleaning validation. However, its best use is as a tool for those who have been (or are) in the trenches, doing the hard work of fitting all the pieces together. It is hoped that insight for designing a better program will be provided. For those who read this book as a frst introduction to cleaning validation, it would be helpful to reread the book (or at least selected chapters) after becoming more involved in the actual work of cleaning validation. Learning can be so much more effective when combined with hands-on experience. This book starts with cleaning objectives in Chapter 1 and moves to the cleaning process in Chapters 2-.
7. Issues related to validation, such as residue limits, sampling, analysis, and change control, are covered in Chapters 8-.
12. Chapter 13 covers special topics and/or issues for dealing with validated cleaning in different areas of the pharmaceutical industry. Finally, this volume is not designed as a how to cookbook for cleaning validation. It does not cover such subjects as how to write a good cleaning SOP or how to write a good cleaning validation protocol. However, applying the principles covered in this book, along with the experience and documentation system in an individual facility, can help unify and simplify the process.Author Biography.
Cleaning Objectives.
Cleaning and Cleaning Agents.
Cleaning Methods.
Process Parameters in Cleaning-Part I.
Process Parameters in Cleaning-Part I1.
Cleaning Cycle Development.
Grouping Strategies.
Setting Acceptance Criteria.
Analytical Methods for Cleaning Validation.
Sampling Methods for Cleaning Validation.
Microbial Issues in Cleaning Validation.
Change Control And Revalidation.
Special Topics in Cleaning Validation.
FDA Expectations.
Guide to Inspections of Validation of Cleaning Processes.
Cleaning Validation Glossary.