Understanding Your Process Series
Cleaning and Cleanrooms
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 processes and comply with regulators.
We have now collected bestsellers and added materials that have not published before in electronic book form covering three vital topics:
Cleaning and Cleanrooms
These easily accessible, reasonably priced, informative collections offer background and hands-on applications that will help with a myriad of activities for manufacturers.
The Cleaning and Cleanrooms collection features a two-part history of cleaning and cleanrooms, classifications, supplies, sanitization and several other important topics
Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file 1.72 MB)
Table of Contents:
Click here to download >>>Table of Contents
- The Development of Cleanrooms: An Historical Review Part 1: From Civil War to Safe Surgical Practice by Tim Sandle (New)
- The Development of Cleanrooms: An Historical Review Part 2: The Path Towards International Harmonization by Tim Sandle (New)
- Understanding Cleanroom Classifications by Jeanne Moldenhauer. (Chapter excerpted from Contamination Control in Healthcare Product Manufacturing, Volume 3, Chapter 12 published 2014.)
- Cleanroom Supplies by Jeanne Moldenhauer. (Chapter excerpted from Environmental Monitoring: A Comprehensive Handbook, Volume 1, Chapter 11 published 2005.)
- Practical Aspects of Cleaning, Sanitizing and Disinfecting Rooms and Surfaces by Jeanne Moldenhauer. (Chapter excerpted from Environmental Monitoring: A Comprehensive Handbook, Volume 1, Chapter 12 published 2005.)
- Cleaning Validation: Process Life Cycle Approach by Paul Lopolito and Elizabeth Rivera. (Chapter excerpted from Contamination Control in Healthcare Product Manufacturing, Volume 3, Chapter 10 published 2014.)
About the Authors
Dr. Tim Sandle is the Head of Microbiology at the UK Bio Products Laboratory. His role involves overseeing a range of microbiological tests, batch review, microbiological investigation and policy development. Tim has over 20 years experience of work in the scientific and pharmaceutical fields. He serves on several national and international
committees relating to pharmaceutical microbiology and cleanroom contamination control
(including the ISO cleanroom standards), and has acted as a spokesperson for several
microbiological societies. He is a committee member of the UK and Irish Microbiology Society
Pharmig and editor of the organization's newsletter. Tim has written over 200 book chapters,
peer reviewed papers and technical articles relating to microbiology. In addition, Tim runs an
online microbiology website (www.pharmamicro.com) as well as two LinkedIn groups relating
to microbiology and sterility assurance.
Jeanne Moldenhauer, Excellent Pharma Consulting, Inc., 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™, and is a member of ASQ and RAPS. She is a certified quality engineer and a certified quality manager. She is the author of many publications and books.
Paul Lopolito is a technical services manager for the Life Sciences Division of STERIS Corporation (Mentor, Ohio). He currently provides global technical support related to process cleaning and contamination control, which includes field support, site audits, training presentations and educational seminars. Paul has more than 15 years of industry experience and has held positions as a technical services manager, manufacturing manager and laboratory manager. He has authored and published numerous articles on cleaning and contamination control. He earned a B.A. in Biological Sciences from Goucher College in Towson, MD.
Elizabeth Rivera is a technical services specialist for the Life Sciences Division of STERIS Corporation (Mentor, Ohio). Currently, she provides technical support in the areas of formulated detergents, disinfectants for critical environments, and sterility assurance products. In addition, she specializes in cleaning validation processes and lectures at technical educational forums, such as IPA, Interphex, ExpoFYBI, Expofarma, and Executive Conferences. Elizabeth has 10 years of industry experience and she has held positions in pharmaceutical manufacturing companies. She has published articles related to cleaning and cleaning validation. She earned a Bachelor and Graduate degree in Chemical Engineering from the University of Puerto Rico.