Sale - 20% off!
Original Price US$800 PDA Member, US$1,000 Nonmember, US$700 Government
Sale prices are already displayed and will be reflected during checkout
The past decade has seen a global emphasis on environmental monitoring. Regulatory bodies worldwide have all established standards and guidelines for environmental control. Unfortunately, the requirements are not equivalent among documents or nations. The Environmental Monitoring series edited by Jeanne Moldenhauer provides guidance through the ins and outs of the multitudinous aspects of compliance. They are a must have for anyone involved in any way with environmental monitoring concerns.
These three volumes, with 73 chapters written by subject matter experts worldwide, describe methods for developing and operating an appropriate, sustainable microbiological program for production and the laboratory. Each volume is different insofar as each speaks about different environmental monitoring issues.
Volume 1 & Volume 2: July, 2005
Volume 3: August, 2009
Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file 8.30 MB)
Key topics include: Practical Issues in Designing and Implementing an
Environmental Control ProgramCompliance Issues for Environmental MonitoringEnvironmental Control Systems used in Parenteral
FacilitiesCleanroom MicrobiologyEstablishing a Disinfection ProgramPractical Aspects of Cleaning, Sanitizing and
Disinfecting Rooms and SurfacesMasterplan for Microbiological MonitoringCleaning/Sanitization QualificationMicrobiological Risk AnalysisMethod ValidationValidation of Water Systems
Click here to download >>> Detailed Table
Click here to download >>> Detailed Table
Establishing Ongoing Monitoring, Surveillance and
Evaluation ProgramsEstablishing Alert and Action Levels: The Analysis of
Environmental Monitoring DataTrending Data/Reporting DataEnvironmental Monitoring InvestigationsChange Control and Preventative MaintenanceTypical Procedures Required for an Environmental Control
ProgramWhat is Required Following RemodelingEnvironmental Monitoring in Non-Sterile Product
ManufacturingIntroduction to Rapid Microbial Methods for
Environmental MonitoringRapid Methods for Water Monitoring
VOLUME 3 Environmental Monitoring, byJeanne Moldenhauer Asepsis and the Foundations of Infection Control by James Akers Avoiding Viable Microbial Contamination Events Ã¢â‚¬â€ Illustrative Case Studies by Kenneth Muhvich Global Approach to Environmental Monitoring by Joseph J. Lasich Trending in the EM Program by Scott Sutton Technology/Application: Qualification of New High Recovery Flocked Swabs as compared to
Traditional Rayon Ã¢â€žÂ¢ Swabs for Microbiological Environmental Monitoring of Surfaces by Gilberto Dalmaso, Manuela Bini, Roberto Paroni, and Michela Ferrari Real-Time and Sensitive Surface Monitoring with ChemSWAB and ScanRDI by Philippe Gadal Microbial Recovery from Surfaces using Contact Plates and Swabs by Dawn McIver Microbial Detection, Identification and Enumeration based on Raman
Spectroscopy by T. J. Ronningen and A. P. Bartko A Rapid Non-Destructive Automated Compendial Method for Environmental
Monitoring by Andrew Sage and Don Straus Active Microbial Air Sampling with CoriolisÃ‚Â®Ã‹Å“Ã‚Âµ Air Sampler and ScanRDIÃ‚Â®by Philippe Gadal and Quitterie Desjonqueres 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 Pharmaceutical Microbiology Laboratories Proficiency and Competency by Jerry Tjernagel Best Practices in Environmental Monitoring Automation by Robert Toal, Michael Goetter, Susan Harrison, Jeremy Tanner, Timothy A. Coleman and Robert Lutskus Evaluation of the BiovigilantÃ‚Â® IMD-AÃ¢â€žÂ¢, A Novel Optical Spectroscopy Technology for the Continuous and Real-Time Environmental Monitoring of Viable and Nonviable Particles by Michael J. Miller
Click here to download>>>Detailed Table of Contents
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.