Microbial Risk Assessment in Pharmaceutical Clean Rooms (single user digital version)

Dec 2001
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This monograph clearly explains the Limitation of Risk Method (LR-Method). When a systematic risk analysis is performed and sampling locations are selected and evaluated in a rational manner using this method, comprehensive monitoring will reduce the number of microbiological samples necessary and provide quality improvement. Tables and charts help complete this text.

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Format: PDF (1 file - 2.04 MB)

Paper version is not available.

Table of Contents

Table of Contents:

Airborne Contaminants, Guidelines for Pharmaceutical Production
Dispersion of Airborne Contaminants
Microbiological Monitoring in the Clean Room
Risk Assessment
Limitation of Risks (LR-Method)

About the Authors

About the Authors

Professor Bengt Ljungqvist, Ph.D., and Berit Reinmuller, Techn.lic., Senior Researcher, are both from the KTH (Royal Institute of Technology), Stockholm, Sweden.

Dr. Bengt Ljungqvist received his Ph.D. in 1978, and was appointed professor of Safety Ventilation in 1986 at Kungl. Tekniska Hogskolan, Stockholm. Since 1978, he has worked in the field of safety ventilation, both as a scientist and as a consultant. In 1993, he was appointed Visiting Professor in the Department of Environmental Sciences and Engineering at the University of North Carolina at Chapel Hill, USA. He is a past chairman of the Nordic Association of Contamination Control (R3-Nordic). As a consultant, he is contracted by Pharmaceutical companies, hospitals, laboratories, etc., to solve problems within this field.

Ms. Berit Reinmuller has spent 30 years in the pharmaceutical manufacturing field specializing in the areas of Contamination Control, Environmental Monitoring, Validation, and Microbiological Risk Assessment. She is also representing Sweden in the ISO 209 work on "Clean Room and Associated Controlled Environments." Ms. Reinmuller is employed as Senior Researcher in Building Services Engineering at Kungl. Tekniska Hogskolan in Stockholm, and is also contracted as a consultant for the clean room industry.

Other titles written by these two authors are Cleaning Clothing Systems: People as a Contamination Source and Practical Safety Ventilation in Pharmaceutical and Biotech Cleanrooms