Environmental Monitoring Volume 9
- Published
- Jun 2025
- ISBN
- 978-1-917195-18-6
- Pages
- 395
- PDA Item Number
- 43578
- Format
- PDF Single User
- Member Price
- $269.00
- Nonmember Price
- $299.00
- Government Price
- $299.00
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Hardcopies are available for purchase on the Euromed Communications website.
Volume 9 of the Environmental Monitoring series provides insight on methodologies for establishing an environmental monitoring program. There are a total of 18 chapters authored by leading experts in this area. This latest volume in this series includes useful and important topics such as requirements for incubation conditions, material transfer risks, airflow visualization studies, new insights on contamination control, and information on the various requirements for compounding pharmacies. There is guidance on how to conduct a risk assessment. There are several chapters on aerobiology, use of new technologies for air monitoring, case studies, a mold investigation plan, and concerns for dust, humidity and cleanrooms. You will find comprehensive information on molds, including a glossary of mold, prevention methods, and medical concerns with molds. A new environmental monitoring system is also introduced.
Table of Contents
1. Introduction
by Jeanne Moldenhauer
2. Design of an Environmental Monitoring Program
by Marsha
Steed
3. Environmental Monitoring in Compounding
Pharmacies
by
Susannah Davis
4. Incubation conditions and the Need for Validation of
Methods
by Jeanne Moldenhauer
5. Material Transfer into Controlled Environments: A
Hierarchy of Contamination Control
by Tim Sandle
6. Airflow Visualization Studies: Looking at Contamination
Control
by Tim Sandle
7. Best Practices in Maintaining Contamination
Control
by David
Shields, Matt Hofacre, Aaron Mertens, Bruno Aze
8. Investigating Microbial Contamination: A Lifestyle
Approach
by Victoria Galliani
9. Conducting an Environmental Monitoring Risk
Assessment
by Vanessa Vasadi Figueroa
10. Aerobiology - How this Field May Influence
Environmental Monitoring and Control in Aseptic Processing Areas
by Tony Cundell
11. Real-time Viable Particle Monitoring with
Biofluorescent Particle Counters: Enhancing Contamination Control
by
Christine Troutman
12. A Case Study using the BAMS Bioaerosol Counter
by Chun Yin Or
13. Mold Remediation: An Eight-Step Practical Approach for
Pharmaceutical Manufacturing Environments
by Crystal Booth
14. Dust, Humidity and Fungal Growth: Designing Cleanrooms
for the Better
by Tim Sandle
15. Environmental Molds: Clinical Implications
by Michael
Mansour and Maria Lampou
16. Prevention of Contamination
by Brian G.
Hubka
17. Environmental Monitoring in FDA Regulated Production
Facility: Requirements and Benefits of Automated Systems
by Jim Radigan
18. Fungal Glossary
by Jeanne
Moldenhauer
About the Authors
Jeanne Moldenhauer is Vice-President of Excellent Pharma Consulting and has more than 30 years’ experience in the pharmaceutical industry. She is a senior quality and regulatory consultant. Jeanne chaired the Environmental Monitoring/Microbiology Interest Group of PDA for many years, served on the Scientific Advisory Board of PDA for many years, founded the Rapid Microbiology User’s Group™, currently serves on the Regulatory and Quality Board of PDA, and is a member of ASQ and RAPS. Jeanne is the author of many books and numerous publications (Book Chapters, Journal and Magazine Articles).