as of 2018 - 12 - 03

10.E Microbiological monitoring

10.E Microbiological monitoring
Here you will find answers to the following questions:

Which microbial contamination risks should be anticipated during the manufacture of sterile and non-sterile preparations?

What levels (limit values) should be defined for the individual cleanroom grades and other manufacturing areas?

What detection methods are used during monitoring?

What must be observed when appropriate testing frequencies and sampling points are determined?

Which testing methods are suitable for monitoring air, surfaces and personnel?

What is the significance of growth tests?

What actions should be taken when levels are exceeded?

How are isolates identified?

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