Contamination Control in Healthcare Product Manufacturing, Volume 1 (single user digital version)

May 2013
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PDF Single user
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Contamination Control in Healthcare Product Manufacturing, Volume 1, edited by Russell E. Madsen and Jeanne Moldenhauer, is primarily focused on microbiological contamination and the methods used to monitor and control it, a secondary focus looks at chemical contamination that may result from the use of cleaning and disinfecting agents. There is something for almost everyone who has responsibility for developing or using microbiological contamination control programs and systems.

In this first book of the contamination control series, you will be provided with a wealth of information that can aid you in understanding the sources of contamination, types of control measures that can be used, methods to use when contamination occurs and regulatory expectations for management of these systems.

Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file 4.73 MB)

Bundle Vol. 1, 2 & 3
Volume 1
Volume 2
Volume 3
Volume 4

*To purchase licensing for multi-user intra-company use, please contact PDA at [email protected].

Table of Contents

Table of Contents:

Click here to download >>>Detailed Table of Contents

    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

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.