GMP Spezial

This book addresses current scientific, regulatory and technology environmental monitoring concerns for both aseptic processing and isolation technology. The environment in which aseptically filled products are manufactured plays a key role in final product quality. The manufacturing environment must be tightly controlled to ensure it does not adversely affect the microbial quality of the product.

1. Environmental Monitoring, by Jeanne Moldenhauer

2. Asepsis and the Foundations of Infection Control by James Akers

3. Avoiding Viable Microbial Contamination Events — Illustrative Case Studies by Kenneth Muhvich

4. Global Approach to Environmental Monitoring by Joseph J. Lasich

5. Trending in the EM Program by Scott Sutton

6. Technology/Application: Qualification of New High Recovery Flocked Swabs as compared to Traditional Rayon ™ Swabs for Microbiological Environmental Monitoring of Surfaces by Gilberto Dalmaso, Manuela Bini, Roberto Paroni, and Michela Ferrari

7. Real-Time and Sensitive Surface Monitoring with ChemSWAB and ScanRDI by Philippe Gadal

8. Microbial Recovery from Surfaces using Contact Plates and Swabs by Dawn McIver

9. Microbial Detection, Identification and Enumeration based on Raman Spectroscopy by T. J. Ronningen and A. P. Bartko

10. A Rapid Non-Destructive Automated Compendial Method for Environmental Monitoring by Andrew Sage and Don Straus

11. Active Microbial Air Sampling with Coriolis®˜µ Air Sampler and ScanRDI®by Philippe Gadal and Quitterie Desjonqueres

12. Hygiene Screening System, a Real-Time PCR Method for the Rapid Identification of Major Microorganisms in Environmental Monitoring by Anna Soderholm-Labre and Kornelia Berghof-Jager

13. Pharmaceutical Microbiology Laboratories Proficiency and Competency by Jerry Tjernagel

14. Best Practices in Environmental Monitoring Automation by Robert Toal, Michael Goetter, Susan Harrison, Jeremy Tanner, Timothy A. Coleman and Robert Lutskus

15. Evaluation of the Biovigilant® IMD-A™, A Novel Optical Spectroscopy Technology for the Continuous and Real-Time Environmental Monitoring of Viable and Nonviable Particles by Michael J. Miller

Jeanne Moldenhauer has over 25 years of experience in sterile process validation, regulatory affairs and microbiology. She is now the Vice President of Excellent Pharma Consulting, Inc. Moldenhauer is an Interest Group Leader for Microbiology and Environmental Monitoring at PDA, Chair of the Rapid Microbiology User`s Group and a member of the Scientific Advisory Board of PDA. Moldenhauer is a published author and editor of four previous PDA-DHI books: Environmental Monitoring: A Comprehensive Handbook, Steam Sterilization: A Practitioner’s Guide, Laboratory Validation: A Practitioner’s Guide, and Systems Based Inspection for Pharmaceutical Manufacturers. She is the winner of the 2005 PDA/DHI Distinguished Editor/Author Award.

PDA/DHI Publication