Environmental Monitoring: A Comprehensive Handbook, Volume 4

Published
May 2015
ISBN
1933722452
Pages
238
PDA Item Number
Hardcover: 17291 | Digital: 18008
Format
Book
Member Price
$268.00
Nonmember Price
$335.00

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The past decade has seen a global emphasis on environmental monitoring. Regulatory bodies worldwide have all established standards and guidelines for environmental control. Unfortunately, the requirements are not equivalent among documents and nations. The Environmental Monitoring series edited by Jeanne Moldenhauer provides guidance through the ins and outs of the multitudinous aspects of compliance.

This book, Volume 4 in the series, contains perspectives from global subject matter experts and includes:

  • Designing and Validating a Contamination Control Program
  • Real-Time Trending of Environmental Monitoring Data
  • The Use of Risk Management in Environmental Monitoring
  • Lean Microbiology Laboratories
  • Observations in Support of Lean Microbial Identification
  • Dealing with Contamination: What is the Risk to the Product?
  • Collection Efficiency of Microbiological Impaction Air Samplers
  • Microbiological Excursions in Environmental Monitoring: A Risk Based Approach in Sterile Production
  • Overview of Recent Warning Letters for Environmental Monitoring
  • Long-Term Microbiological Air Monitoring
  • Rapid, Simple and Cost-Efficient Environmental Monitoring of Microorganisms by Fourier-Transform Infrared Spectroscopy

    This book is a must have for anyone involved in any way with environmental monitoring concerns.

    Book written in May, 2010


     
    Hardcover
    Digital
    Bundle Vol. 4, 5, 6, & 7
    Bundle Vol. 1, 2 & 3
    Volume 1
    Volume 2
    Volume 3
    Volume 4
    Volume 5
    Volume 6
     
    Volume 7
    Volume 8
    Protocol CD
  • Table of Contents

    Table of Contents:
    Click here to download>>>Detailed Table of Contents

    1. Designing and Validating a Contamination Control Program, by Sandra A. Lowery and Maureen Mueller
    2. Real-Time Trending of Environmental Monitoring Data by Austin Kuo, Terrence Shelley and Thomas Burns
    3. The Use of Risk Management in Environmental Monitoring by Karen Ginsbury
    4. Lean Microbiology Laboratories by Jeanne Moldenhauer
    5. Observations in Support of Lean Microbial Identification by David Shelep
    6. Dealing with Contamination: What is the Risk to the Product? by Jeanne Moldenhauer
    7. Collection Efficiency of Microbiological Impaction Air Samplers by Bengt Ljungqvist and Berit Reinmuller
    8. Microbiological Excursions in Environmental Monitoring: A Risk-Based Approach in Sterile Production by Hanna Filipek
    9. Overiew of Recent Warning Letters for Environmental Monitoring by Jeanne Moldenhauer
    10. Long-Term Microbiological Air Monitoring by Claudia Scherwing, Jasmin Grigat and Karl Pflanz 11. Rapid, Simple and Cost-Efficient Environmental Monitoring of Microorganisms by Fourier-Transform Infrared Spectroscopy by Mareike Wenning, Gernot Rieser and Siegfried Scherer

    About the Authors

    About the Editor

    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.