Cleaning and Cleaning Validation, Volumes 1 and 2 (single user digital version)

Table of Contents:

Volume 1

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SECTION ONE: Cleaning Validation Basics and Expectations

1. Process Validation Basics by Paul L. Pluta
2. Cleaning Validation Basics by Destin A. LeBlanc
3. Cleaning Validation — Application in the Laboratory byCindy Green
4. The Cleaning Validation Policy and the Cleaning Validation Plan by Miguel Montalvo
5. Global Regulatory Inspection Standards for Cleaning Validation by Clive G. Blatchford
6. Quality by Design for Cleaning Validation by Rizwan Sharnez and Martin Van Trieste

SECTION TWO: General Technical Principles — Cleaning Chemistry and Engineering

7. Cleaning Agents and Cleaning Chemistry by George Verghese and Nancy Kaiser
8. Cleaning Engineering and Equipment Design by George Verghese and Paul Lopolito

SECTION THREE: General Technical Principles — Residues

9. Residues and Cleaning Chemistry by William R. Porter
10. Microbial and Endotoxin Residues — Product Contact Surfaces by Jeanne Moldenhauer
11. Cleaning of Non-Product Contact Surfaces by Anne Marie Dixon
12. Residue Pharmacology and Toxicology Considerations by William H. Houser
13. Residue Grouping Strategies by William E. Hall
14. A Scientific Approach to the Selection of Cleaning Validation Worst-Case Soils for Biopharmaceutical Manufacturing by Rod J. Azadan and Alfredo J. Canhoto
15. Visual Cleanliness by Richard J. Forsyth
16. Personnel Training — Visual Inspection of Cleaned Equipment by Paul L. Pluta

SECTION FOUR: Specific Residues for Cleaning — Part 1

17. Biotech Residues and Cleaning by Jennifer Carlson
18. Case Study — Cleaning Process Optimization for a Manufacturing Process Change by Soren Damkjaer and Pernille L. Johansen
19. Manual Cleaning Processes and Procedures by Valerie Welter

Volume 2

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Section One: Cleaning Validation Basics and Expectations — Continued

1. Lifecycle Approach to Cleaning Validation by Paul L. Pluta

Section Two: General Technical Principles — Cleaning Chemistry and Engineering — Continued

2. Equipment Design Considerations for Cleaning and Cleaning Validation by Gamal Amer
3. Equipment Sampling Locations and Sampling Methods for Cleaning Validation by Paul L. Pluta
4. Procedure for Spray Coverage Testing with Riboflavin by Allan Marinelli and Cor Alleblas
5. Miscellaneous Equipment Cleaning Topics by Destin A. LeBlanc

Section Three: General Technical Principles — Residues

6. Polymer Residue Cleaning Method Development: Case Study by Dijana Hadziselimovic and Paul Lopolito
7. Cleaning and Contamination Control in Medical Devices by Barbara Kanegsberg and Edward Kanegsberg
8. Characterization of Protein Residues After Cleaning by Alfredo J. Canhoto, Kathleen Bellorado and Michael Kreuze
9. Master Soils for Cleaning Cycle Development and Validation: Case Study by Rizwan Sharnez

Section Four: Specific Residues for Cleaning

10. Cleaning Programs for Manufacturers for APIs by William E. Hall
11. Vaccine Residues — Cell Culture Manufacturing and Cleaning by Vivienne Yankah
12. Biotech Manufacturing Cleaning Validation: Case Studies by Michael Parks and Brian J. Lloyd
13. Cleaning of Fermentation Tanks for Manufacture of a Small Molecule API: Case Study by Michael J. Egan and Thomas J. Paulus
14. Aseptic Parenteral Products — Residues and Cleaning by Valerie Welter
15. Cleaning Process and Validation for MDIs by Michael Taylor, Paul Sullivan, Jay Holt and Li Li Bovet
16. Transdermal Patches — Residues and Cleaning by T.J. Woody and Rashmi S. Upasani
17. Medical Device Reagent Product Residues and Cleaning by Robert W. Marshman

Section Five: Analysis of Residues

18. Process Analytical Technology for Cleaning Systems by Keith Bader and Peter Watler
19. Swab Sampling for Cleaning Validation by Sandeep Kalekar and Jay Postlewaite
20. Swab Sampling Training and Sampling Person Qualification by Brian P. Huey

Section Six: Cleaning and Cleaning Validation Quality Systems

21. Quality Systems Approach to Cleaning and Cleaning Validation by Timothy J. Fields
22. Change Management in Cleaning and Cleaning Validation by David E. Jones
23. Control Charting Fundamentals by Bernard M. McGarvey
24. Analytical Cleaning Laboratory Gap Analysis by Brian P. Huey

Epilogue Problems in Cleaning and Cleaning Validation

25. Cleaning and Cleaning Validation General Problems by Paul L. Pluta, Rizwan Sharnez, Cormac Dalton and Kevin O'Donnell

About the Editor

Paul L. Pluta, Ph.D., is a pharmaceutical scientist with extensive industrial development, manufacturing, and management experience. He has been involved in nearly all phases of product development and manufacturing for small molecule dosage forms. His validation experience includes manufacturing process validation, cleaning validation, and qualification of associated support systems. Dr. Pluta is also Associate Professor of Biopharmaceutics at the University of Illinois at Chicago (UIC) College of Pharmacy. Dr. Pluta edited and authored chapters in Cleaning and Cleaning Validation, Volume 1, Basics, Expectations, and Principles, published by PDA and DHI Publishing.