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

Dec 2014
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PDF Single user
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This book addresses current scientific, regulatory and technology environmental monitoring concerns for both aseptic processing and isolation technology. The environment in which aseptically filled products are manufactured plays a key role in final product quality. The manufacturing environment must be tightly controlled to ensure it does not adversely affect the microbial quality of the product.

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Format: PDF (1 file 6.06 MB)

Book written in August 2009.

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

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

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