Microbiological workplace tests are an important part of cleanroom qualification, as they help to monitor and ensure the quality and cleanliness of a cleanroom.
Microbiological workplace tests
Sensitive products, such as pharmaceutical products and medical devices, are manufactured in cleanrooms. Contamination of these products with microorganisms can lead to serious health risks or quality problems. It is therefore crucial to continuously monitor the microbiological quality of a cleanroom.
The microbiological workplace examination focuses on various factors and hygienically relevant areas. By carrying out microbiological workplace tests, potential sources of contamination can be identified and appropriate measures taken.
To carry out the surface inspection at the workplace, our field service takes swab samples from people, their work clothing and the working environment in the cleanroom. Sedimentation and impaction methods are used for microbiological air testing in the workplace.
The samples taken in the clean room are then incubated in the laboratory and examined for colony growth. The colony-forming units (CFU) are determined on the culture media plates for this purpose.
Any microbial contamination detected should be removed by appropriate cleaning and disinfection measures in order to restore the cleanroom quality.
We document the results of the microbiological workplace tests in the form of reports and these can be used to document the cleanroom status as well as for statistical checks (e.g. trends, outliers) and to derive measures.
Guidelines:
- DIN EN 17141
- GMP Annex 1
We will be happy to assist you with your questions at
aussendienst@gfps.de