Environmental Monitoring: A Comprehensive Handbook, Volume 2
- Published
- Dec 2014
- ISBN
- 1930114885
- Pages
- 458
- PDA Item Number
- Hardcover: 17237 | Digital: 17978
- Format
- Book
- Member Price
- $268.00
- Nonmember Price
- $335.00
Please sign in or become a member to purchase items from the PDA bookstore.
Sale - 20% off!
Original Price US$335 PDA Member, US$419 Nonmember, US$290 Government
Sale prices are already displayed and will be reflected during checkout
Environmental monitoring programs are appropriate for
manufacturing of sterile products and non-sterile products. The most stringent application of these procedures is for sterile products manufactured by aseptic processing, while less stringent procedures may be appropriately employed for terminally sterilized products, and even less stringent procedures for non-sterile products.
Environmental Monitoring, written by authors with extensive experience in environmental monitoring and should provide practical guidance on how to establish and maintain a system that will be meaningful, manageable and defendable.
Winner, 2010 and 2005 PDA/DHI Technical Book Distinguished
Editor/Author Award
Book written in July 2005
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
VOLUME II
PART 3 - ONGOING
MONITORING, SURVEILLANCE AND EVALUATION
Establishing Ongoing
Monitoring, Surveillance and Evaluation Programs by Jeanne
Moldenhauer
(Click here to download >>>Chapter 1)
Establishing Alert and Action Levels: The
Analysis of Environmental Monitoring Data by Tom Genova
Trending Data
by Jim Radigan
Reporting Data by Jeanne Moldenhauer
Using
Environmental Monitoring Data to Support Steam Sterilization Process Validation
by Jeanne Moldenhauer and Michael S Korczynski
Environmental
Monitoring for Sterilization Process Development by Anne
Booth
Challenges with the Identification of Organisms by Mike
Waddington
Environmental Monitoring Investigations by Karen
Ginsbury
Change Control and Preventative Maintenance by Jeanne
Moldenhauer
Environmental Monitoring and Control System Assessments
Typical Procedures Required for an Environmental Control Program by Jeanne
Moldenhauer
What is Required Following Remodeling by Jeanne
Moldenhauer
Automating an Environmental Control Program by Jeanne
Moldenhauer
Environmental Impact on Media Fills by John
Lindsay
Environmental Monitoring in Non-Sterile Product Manufacturing by
Anthony M Cundell
PART 4 - RAPID METHODS APPLIED TO
ENVIRONMENTAL MONITORING
Introduction to Rapid Microbial Methods for
Environmental Monitoring by Jeanne Moldenhauer
Rapid Methods for Water
Monitoring by Jeanne Moldenhauer
Environmental Monitoring Using the
Scan RDI Polym'Air by Jeanne Moldenhauer and Pascal Yvon
Rapid
Environmental Monitoring Using the Growth Direct Test by Don Strauss et
al
Identification Systems by Jeanne Moldenhauer and Scott
Sutton
Pall System by Lucia Ceresa
PART 5 -
APPENDICES
Glossary by Jeanne Moldenhauer
Start-Up Limits
for Environmental Monitoring by Jeanne Moldenhauer
Implementation and
Automation of the LIMS System by George M Levinson
Acquisition and
Implementation of an Environmental Monitoring Software Program by Susan
Cleary
Automating, Managing and Tracking Investigations by Jeanne
Moldenhauer and James Radigan
Comparative Mold and Yeast Recovery
Analysis by V Marshall, S Poulson-Cook, J Moldenhauer
HEPA Mobile
Storage Carts by Seth Pyers
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.