Microbiological Validation Services

Environmental Monitoring

Environmental monitoring of cleanrooms and controlled environments is used to demonstrate that the area is sufficiently controlled. There are a number of ways to carry out this monitoring:

Non-viable particles: A cleanroom is classified by measuring the number of non-viable particles present in the air, according to ISO 14644-1. Monitoring is carried out on site by one of our trained Environmental Technicians using a calibrated particle counter. Results are available immediately after testing is complete, and give an indication of both air quality and filter integrity, allowing any required corrective action to be carried out quickly.

Viable particles – microorganisms present in the air and on surfaces can adversely affect the bioburden of finished product. Active air samples, settle plates and contact plates (or swabs) demonstrate the level of microbial cleanliness of cleanrooms. Warning and Action limits generated by the data collected from each room help operatives maintain cleanliness and alert customers when limits are exceeded. Water and detergent samples, where available, can be tested for microbial contamination to help prevent the spread of microorganisms in controlled areas.

Environmental monitoring can be carried out on site by one of our Environmental Technicians, or alternatively contact and settle plates can be provided for the remote monitoring of your cleanroom

 

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