Contamination Control in Healthcare Product Manufacturing, Volumes 1, 2 & 3 (single user digital version)

Table of Contents:

Volume 1

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1. Introduction by Russell E. Madsen and Jeanne Moldenhauer
2. The Contamination Control Plan in Facility Validation by Scott Sutton
3. Facility Design and Control: Materials and Design by Gary Devloo
4. Facility Design and Control: HVAC by John Pinto
5. Facility Design and Control: Personnel by Anne Marie Dixon
6. Facility Design and Control: Cleaning and Sanitization by Anne Marie Dixon
7. Single-Use Systems for Contamination Control by Maik W. Jornitz
8. Selecting an Appropriate Process Cleaning Detergent by Mark Compo
9. Disinfectant Qualification by Ziva Abraham
10. Environmental Monitoring for Non-Sterile Operations by Miriam Rozo
11. Fungal and Bacterial Spores: Contamination and Disinfection by Jim Polarine, Carol Bartnett and Dan Klein
12. Microbial Control: Mold by Brian G. Hubka
13. Sterility Test Failure Investigations by Jeanne Moldenhauer
14. Endotoxins by Karen Zink McCullough
15. An Audit Approach to Address Microbial Contamination in Process Equipment by Paul Lopolito and Elizabeth Rivera
16. Impact of Biofilms in Contamination Control by Lucia Clontz
17. Deviations and Investigations by Frank Settineri
18. Contamination Control Risk Assessment by Tim Sandle
19. The Role of In-House Microbial Isolates in Contamination Cotrol by Robert Westney

Volume 2

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1. Introduction by Russell E. Madsen and Jeanne Moldenhauer
2. Microbiological Product Safety and Contamination Control in a Changing Technological Environment by Jim Akers
3. Application of Human Factors in Aseptic Processing by Miguel A. Nogueras
4. Contamination Risks and the Patient by Mark Hunter, Michelle Luebke, and Mark Pasmore
5. Particulate Matter in Injectable Drug Products by Stephen E. Langille
6. The Microbiologist's Contamination Control Kit by Hilary Chan, Lynn Johnson and Jill Larivee
7. Implementing a Contamination Control Strategy in the Biotech Industry to Effectively Maintain Microbial Contamination Control by Jane Wyatt
8. New Risk Assessment Tools for Sterile Products by Gunther Gapp
9. Assessing Resistance and Appropriate Acceptance Criteria of Biocidal Agents by Art Vellutato
10. Sterilization Processes by Jeanne Moldenhauer
11. Microbial Decontamination Using Chlorine Dioxide Gas by Kevin Lorcheim
12. Contamination Control in Drug Substance Manufacture by David Fletcher

Volume 3

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1. Introduction by Russell E. Madsen and Jeanne Moldenhauer
2. Design and Sanitization of Water Systems to Prevent Contamination by Teri C. Soli
3. Real Time Microbial Analyzer for Water by J. P. Jiang
4. Use of Ozonated Water as an Aid to Contamination and Biofilm Control by Bruce Hinkle and Brian G. Hubka
5. Testing and Verification of Ventilation Systems for Biosafety Level 3 (BSL-3) and Animal Biosafety Level 3 (ABSL-3) Facilities by Farhad Memarzadeh and Louis DiBerardinis
6. Microbiology Laboratory Spearheading Microbial Contamination Control by Mary J. Griffin
7. Understanding, Preventing and, and Remediating Mold in Cleanrooms by Ziva Abraham
8. Contamination Control Considerations for Microaerophillics in Controlled Aseptic Manufacturing Areas by Veronica Marshall and Daniel Eshete
9. The Problem of Burkholderia Cepacia by Jeanne Moldenhauer
10. Cleaning Validation: Process Life Cycle Approach by Paul Lopolito and Elizabeth Rivera
11. Risk Management of Microbial Contamination Control in Aseptic Processing and Interventions Risk Assessment Model (IREM): The Use of Critical Thinking to Make Informed Decisions by Hal Baseman and Mike Long
12. Understanding Cleanroom Classifications by Jeanne Moldenhauer
13. Disinfection Qualification Testing Considerations for Aseptic and Cleanroom Manufacturing Environments by Dave Rottjakob and Scott Steinagel

About the Editors

Jeanne Moldenhauer, Excellent Pharma Consulting, has nearly 30 years of experience in the pharmaceutical industry. She chairs the PDA Environmental Monitoring/Microbiology Interest Group, serves on the PDA Scientific Advisory Board, founded the Rapid Microbiology User`s Group TM, and is a member of ASQ and RAPS. She is the author of Recent Warning Letters Review for Preparation of a Non-Sterile Processing Inspection, Volume 2; Recent Warning Letters Review for Preparation of an Aseptic Processing Inspection and the Editor of Steam Sterilization: A Practitioner`s Guide; Laboratory Validation: A Practitioner`s Guide; Systems Based Inspections for Pharmaceutical Manufacturers and Thermal Validation in Moist Heat Sterilization among numerous other recent publications. She is the winner of the 2010 and 2005 PDA/DHI Distinguished Editor/Author Award.

Russell Madsen, President, The Williamsburg Group, LLC, has led the organization since its founding in 2003 and has over forty-five years of experience in the pharmaceutical industry. The Williamsburg Group provides expert pharmaceutical consulting services including CGMP compliance, quality systems, aseptic processing and sterilization, sterilizing filtration, design review, due diligence and regulatory liaison.