Microbiological surface examination

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.

Microbiological surface tests are used to detect microorganisms on the surfaces in the cleanroom.
Our field service carries out the tests at regular intervals on request and on commission in order to detect contamination at an early stage and take appropriate countermeasures.

During the microbiological surface inspection, critical points such as table tops, handles, keyboards, etc. are examined, depending on the proximity to the product and the use made of them by employees in the cleanroom. Samples are taken using swab plates or swabs.

These samples taken in the clean room are then processed in the laboratory (swab smears), incubated 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.

The results of the microbiological surface tests are documented 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:

• 14698
• GMP Annex 1

We will be happy to assist you with your questions at
aussendienst@gfps.de