Pharmaceutical Manufacturing:

Understanding Your Process Series

In the past 15 years, PDA/DHI has published more than 1,000 practical scientific and regulatory chapters, written by
global subject matter experts, which have been designed to help pharmaceutical and biotech manufacturers stay
abreast, streamline processed and comply with regulators.
We have now collected bestsellers in electronic book form covering three vital topics: Cleaning
and Cleanrooms; Sterilization and Environmental Monitoring.

New!
These easily accessible, reasonably priced, informative collections offer background and hands-
on applications that will help with a myriad of activities for manufacturers. These chapters were
taken from books currently available at the PDA Bookstore website.

Cleaning and Cleanrooms Environmental Monitoring, Volume

The Development of Cleanrooms: An Historical Review 1: Establishing the Process
Part 1: From Civil War to Safe Surgical Practice
The Use of Risk Management in Environmental Monitoring
Part 2: The Path Towards International Harmonization
Tim Sandle Karen Ginsbury
Understanding Cleanroom Classifications Environmental Monitoring: A Practical Approach
Cleanroom Supplies Tim Sandle
Practical Aspects of Cleaning, Sanitizing and Disinfecting Rooms Environmental Monitoring of Microbiology Laboratories
and Surfaces Frank Settineri
Jeanne Moldenhauer
Designing and Validating a Contamination Control Program
Cleaning Validation: Process Life Cycle Approach
Paul Lopolito, Elizabeth Rivera Sandra A. Lowery and Maureen Mueller
Item No. 18028 Environmental Monitoring and the Microbial Control Strategy
Karen Ginsbury
Sterilization: Establishing the Process
Developing an Environmental Monitoring Program
Compliance Aspects of Sterility Testing
Barry A. Friedman
Ensuring Sterility: Autoclaves, Wet Loads and Sterility Failures
Item No. 18031
Preparing for Regulatory Inspections of Sterile Facilities: The Focal
Points
Biological Indicators for Steam Sterilization: Failure Investigations
Environmental Monitoring, Volume 2: Practical Approaches
Containment System Sterility Rapid Microbiological Monitoring in Pharmaceutical Environments
Sterility Test Failure Investigations Mark Hallworth
Variations in the Resistance of Biological Indicators used to
Assess Sterilization
Environmental Monitoring for Non-Sterile Operations
Tim Sandle Miriam Rozo
Item No. 18029 Environmental Monitoring for Sterility Test Isolators
Claire Fritz Briglia
Sterilization: Practical Approaches
Presenting Environmental Monitoring Data to Internal and
Practical Approaches to Sterility Testing External Stakeholders
Application of Sterilization by Gamma Radiation for Single-Use
Kim Van Antwerpen Sobien
Disposable Technologies in the Biopharmaceutical Sector
Gaseous Sterilization
Neutralization of Disinfectants by Culture Media used in
Environmental Monitoring
Dry Heat Sterilization
Sterile Ophthalmic Preparations and Contamination Control Reiner Hedderich, Anne-Grit Klees
Tim Sandle Item No. 18032
Item No. 18030

Price for each Series: PDA Member $120 | Non-Member $150

Purchase Your Copies Today at pda.org/bookstore!

www.pda.org/bookstore | Tel: +1 (301) 656-5900 | Fax: +1 (301) 986-1361

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Prices are subject to change at any time. 2017AD

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2. Items Ordered
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18028 Cleaning and Cleanrooms $120/$150
18029 Sterilization: Establishing the Process $120/$150

18030 Sterilization: Practical Approaches $120/$150

18031 Environmental Monitoring: Vol. 1: Establishing Process $120/$150

18032 Environmental Monitoring: Vol. 2: Practical Approaches $120/$150

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