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A Guide to Control Microbial Risks in Sterile and Aseptic Drug Manufacturing
1st edition 2014
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Excerpt from the GMP Compliance Adviser
When manufacturing and filling sterile drug products, all possible sources of microbial contamination must be controlled. This primarily concerns air, surfaces and personnel. Microbiological monitoring is therefore indispensable. The aim of the monitoring is to detect deviations from the validated state. Monitoring is designed to demonstrate that the process is under control.
A monitoring program must be established which defines levels, sampling points, frequencies, methods/equipment and measures in the event of deviations.
In this e-book you will find answers to the following questions:
1 Introduction2 Sources of contamination3 Room classification4 Monitoring program5 Level5.1 Air5.2 Surfaces (rooms/technical equipment)5.3 Personnel6 Methods and equipment6.1 Microbiological testing of air6.2 Microbiological testing of surfaces and personnel6.3 Culture media6.4 Incubation6.5 Method validation7 Sampling7.1 Sampling Frequencies7.2 Sampling points8 Measures if levels are exceeded8.1 Investigation plan8.2 Investigation report9 Organism identification10 Author
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This e-book leads you step by step through the 4 key processes in microbiological...
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