Validated Cleaning Technologies for Pharmaceutical Manufacturing

Validated Cleaning Technologies for Pharmaceutical Manufacturing

This text is based on my experience with validated cleaning applications in pharmaceutical process manufacturing for the past 10 years. It is partly based on seminars on cleaning validation I have pre­sented over the past 5 years to industry and regulatory groups. It is also partly based on articles and papers I have written, both journal articles and Technical Tips generated by Calgon Vestal/STERIS on various topics related to cleaning validation. Finally, it is based on the experience of the technical support group at STERIS Corporation (and Calgon Vestal) in working with pharmaceutical customers in validated process cleaning applications.

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. The attempt is to brinmany topics together so that the interdependence of different technical areas and disciplines is evident. Seeing how each piece fits into the overall program can be valuable for streamlining the overall validation program, as well as for making each part stronger and more defendable in both internal quality audits and external regulatory audits.

It is designed to be comprehensive, covering aspects from designing the cleaning process, establishing residue limits, and selecting appropriate sam­pling and analytical procedures to revalidation issues. Most of the examples given in this book in­volve simple cleaning systems, such as the cleaning of a process vessel. The cleaning of more complex systems, such as ultrafiltration membranes or chro­matographic columns, will generally require more consideration of the details, limitations, and interactions of various issues involved. Although no volume can cover all of the questions validating cleaning processes, it is hoped that this book will provide a framework for how questions can be addressed in more complex systems and for developing scientifi­cally justified answers.

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 first 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. The last chapter covers U.S. Food and Drug Administration (FDA) expectations for cleaning validation. Each chapter has its own references for additional reading. Two appendices, one the FDA's guidance document on cleaning validation and the other a cleaning validation glossary, close out this book.

Because  of  the interdependence of subjects, there is some overlap and repetition between different chapters. Despite modern teaching techniques, I be­lieve repetition is good for learning, so I make no apologies for the repetition. In addition, the repetition allows each chapter to more or less stand on its own as a valuable future reference, so that a specific topic can be researched  without  rereading the entire book. In discussing regulatory requirements, I  make reference mainly to the U.S. Food and Drug Administration (FDA). The FDA is not any smarter or wiser

than other regulatory agencies in other countries, but they have taken the lead in establishing what is acceptable for cleaning validation. At the present time, because of the FDA's leadership, it is believed that meeting FDA expectations for cleaning validation would be acceptable in most countries.

Finally, this volume is not designed as a "-how to" cookbook for cleaning validation. It does not cover such subjects as howto 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.


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