Environmental Monitoring: A Comprehensive Handbook, Volume 1, 2 and 3 (single user digital version)

Published
May 2015
Pages
1231
PDA Item Number
18007
Format
PDF Single user
Member Price
$640.00
Nonmember Price
$800.00
Government Price
$560.00

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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 or nations. The Environmental Monitoring series edited by Jeanne Moldenhauer provides guidance through the ins and outs of the multitudinous aspects of compliance. They are a must have for anyone involved in any way with environmental monitoring concerns.

These three volumes, with 73 chapters written by subject matter experts worldwide, describe methods for developing and operating an appropriate, sustainable microbiological program for production and the laboratory. Each volume is different insofar as each speaks about different environmental monitoring issues.

Book written:
Volume 1 & Volume 2: July, 2005
Volume 3: August, 2009

Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file 8.30 MB)


 
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 in PDF format
 

Table of Contents

Key topics include:

VOLUME 1
Click here to download >>> Detailed Table of Contents

  • Practical Issues in Designing and Implementing an Environmental Control Program
  • Compliance Issues for Environmental Monitoring
  • Environmental Control Systems used in Parenteral Facilities
  • Cleanroom Microbiology
  • Establishing a Disinfection Program
  • Practical Aspects of Cleaning, Sanitizing and Disinfecting Rooms and Surfaces
  • Masterplan for Microbiological Monitoring
  • Cleaning/Sanitization Qualification
  • Microbiological Risk Analysis
  • Method Validation
  • Validation of Water Systems

    VOLUME 2
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  • Establishing Ongoing Monitoring, Surveillance and Evaluation Programs
  • Establishing Alert and Action Levels: The Analysis of Environmental Monitoring Data
  • Trending Data/Reporting Data
  • Environmental Monitoring Investigations
  • Change Control and Preventative Maintenance
  • Typical Procedures Required for an Environmental Control Program
  • What is Required Following Remodeling
  • Environmental Monitoring in Non-Sterile Product Manufacturing
  • Introduction to Rapid Microbial Methods for Environmental Monitoring
  • Rapid Methods for Water Monitoring

    VOLUME 3
    Click here to download>>>Detailed Table of Contents

  • Environmental Monitoring, byJeanne Moldenhauer
  • Asepsis and the Foundations of Infection Control by James Akers
  • Avoiding Viable Microbial Contamination Events — Illustrative Case Studies by Kenneth Muhvich
  • Global Approach to Environmental Monitoring by Joseph J. Lasich
  • Trending in the EM Program by Scott Sutton
  • Technology/Application: Qualification of New High Recovery Flocked Swabs as compared to Traditional Rayon â„¢ Swabs for Microbiological Environmental Monitoring of Surfaces by Gilberto Dalmaso, Manuela Bini, Roberto Paroni, and Michela Ferrari
  • Real-Time and Sensitive Surface Monitoring with ChemSWAB and ScanRDI by Philippe Gadal
  • Microbial Recovery from Surfaces using Contact Plates and Swabs by Dawn McIver
  • Microbial Detection, Identification and Enumeration based on Raman Spectroscopy by T. J. Ronningen and A. P. Bartko
  • A Rapid Non-Destructive Automated Compendial Method for Environmental Monitoring by Andrew Sage and Don Straus
  • Active Microbial Air Sampling with Coriolis®˜µ Air Sampler and ScanRDI®by Philippe Gadal and Quitterie Desjonqueres
  • Hygiene Screening System, a Real-Time PCR Method for the Rapid Identification of Major Microorganisms in Environmental Monitoring by Anna Soderholm-Labre and Kornelia Berghof-Jager
  • Pharmaceutical Microbiology Laboratories Proficiency and Competency by Jerry Tjernagel
  • Best Practices in Environmental Monitoring Automation by Robert Toal, Michael Goetter, Susan Harrison, Jeremy Tanner, Timothy A. Coleman and Robert Lutskus
  • Evaluation of the Biovigilant® IMD-Aâ„¢, A Novel Optical Spectroscopy Technology for the Continuous and Real-Time Environmental Monitoring of Viable and Nonviable Particles by Michael J. Miller

    • 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.

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