Contamination Control in Healthcare Product Manufacturing, Volume 4

May 2016
PDA Item Number
Hardcover: 17336 | Digital: 18017
Member Price
Nonmember Price

Edited by experts and written by global subject matter professionals, this vital addition to the Contamination Control series offers new chapters covering current, relevant information including:

  • Regulatory changes relative to ISO 14644, Parts 1 and 2
  • Updates to ISO 11737-1
  • Risks of spores including preventive measures and disinfection
  • Utilities, surfaces and practices that impact cleanrooms
  • Cleanroom gowning and behavior
  • Regulatory guidance and how-to relative to handwashing
  • Contamination in water systems
  • Contamination in gaskets, drains, cooling systems and many other problem areas
  • And more including chapters covering Monitoring relative to USP <1116>, control limits, excursions, risk-based big data in aseptic processing and methods for effective use of Maldi-Tof

    This text is an essential complement to a contamination control library as a guide and reference when combined with the previous three volumes.

  • Table of Contents

    Table of Contents:

    Click here to download >>>Detailed Table of Contents

    Regulatory Changes Relative to Contamination Control

    1. ISO 14644 Parts 1 and 2 — The Revised Cleanroom Standard and Contamination Control by Tim Sandle
    2. Updates to the ISO Bioburden Standard P.S. What Happened to the Micro-biologists? by Martell Winters

      Risk Assessment

    3. Risk of Microbiological Spores, Prevention Measures and Disinfection Strategies by Tim Sandle
    4. How Issues Related to Utilities, Surfaces and Practices Impact Cleanroom Environments by Jim Polarine and Beth Kroeger

      Gowning and Cleanroom Behavior

    5. Cleanroom Gowning by Crystal M. Booth
    6. Handwashing in the Pharmaceutical Industry by Jeanne Moldenhauer


    7. Investigation of Microbiological Contamination in Water Systems: A Case Study by Walid El Azab
    8. The Fight Against Contamination is Difficult but not lost by Olivier Chancel

      Environmental Monitoring

    9. Microbial Monitoring in Cleanrooms: Use of Contamination Recovery Rates (USP<1116>), Real Time Monitoring, and the State of Contamination Control by Claudio Denoya and Gilberto Dalmaso
    10. Approaches to Charting and Setting Control Limits for Environmental Monitoring Microbial Data by Raphael Bar
    11. A Practical Approach to Investigating Environmental Monitoring Excursions by Robert Westney
    12. Risk Based Environmental Monitoring in Aseptic Processing, in the Era of Big Data by Parsa Famili, Susan Cleary and Marsha Hardiman

      Identification Systems

    13. Pros and Cons of Using Maldi-TOF MS For Microbiological Identification by Elvira Engelmann and Frank Kugler

      About the Authors

      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.