Environmental Monitoring: A Comprehensive Handbook, Volume 1 (single user digital version)
- Published
- Dec 2014
- ISBN
- 19330114540
- Pages
- 458
- PDA Item Number
- 17977
- Format
- PDF Single user
- Member Price
- $268.00
- Nonmember Price
- $335.00
- Government Price
- $232.00
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
Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file 2.42 MB)
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 in PDF
format |
Table of Contents
Table of Contents:
Click here to download >>> Detailed Table of Contents
VOLUME 1
PART 1 - GENERAL
INFORMATION
Practical Issues in Designing and Implementing an
Environmental Control Program by Jeanne Moldenhauer
(Click here to
download >>>Chapter 2)
Compliance Issues for Environmental
Monitoring by Jeanne Moldenhauer
Environmental Control Systems used in
Parenteral Facilities by Franco De Vecchi
Unidirectional Airflow
Devices by Allan Pfitzenmaier
Isolators and Barriers by Jeanne
Moldenhauer
Cleanroom Microbiology by Scott Sutton
Particle
Counting Applications in the Pharmaceutical Environment by Mark
Hallworth
Establishing a Disinfection Program by Vivian F.
Denny
Disinfectants by Vivian F. Denny
Cleanroom Supplies by
Jeanne Moldenhauer
Practical Aspects of Cleaning, Sanitizing and
Disinfecting Rooms and Surfaces by Jeanne Moldenhauer
PART 2 -
VALIDATION AND QUALIFICATION
Masterplan for Microbiological
Monitoring by Jeanne Moldenhauer
Validation of HVAC Systems by
Jeanne Moldenhauer
Monitoring of Utilities: Compressed Gases by
Jeanne Moldenhauer
Validation of Water Systems by Jeanne
Moldenhauer
Cleaning/Sanitization Qualification by Jeanne
Moldenhauer
Sampling Equipment by Arthur L Vellutato,
Jr.
Sample Site Selection by Jeanne Moldenhauer
Selection of
Sample Sites using Grid Profiling by Tom O'Connor
Microbiological Risk
Analysis by Dilip Ashtekar
Personnel Gowning by Jeanne
Moldenhauer
Personnel Monitoring and Certification by Jeanne
Moldenhauer
Training Personnel to Collect Environmental Samples by
Michele M Conway
Surface Monitoring by Jeanne
Moldenhauer
Method Validation by Dawn McIver
Performance
Qualification of an Environmental Monitoring Program by Jeanne
Moldenhauer
Media Fills/Process Simulations by Jeanne
Moldenhauer
Airflow Visualization and Design of Aseptic Procedures by
Charles S Levine
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.