Microbial air samplers are used to collect a predetermined volume of air and operate in a way to remove any microorganisms and to capture the microorganisms onto an agar-based growth medium. Once the sample has been collected and the medium incubated, the results are typically expressed in colony forming units per cubic metre (cfu/m3).
Active air sampling remains a core part of the 2022 revision to EU GMP Annex 1 (see section 9.22 for example). The type of air sampler used has an important bearing on the data.
There are limitations with accuracy and recovery when selecting between air samplers and there is no one model on the market that overcomes all of the difficulties. In examining different models, the first problem is that the results from different types of models (especially those using different sampling techniques) are not comparable. There are also competing ways to validate the samplers.
Effective air samplers must be able to precipitate particle sizes of at least 2µm. There are also differences in the sampling volumes of different model samplers, with most models capable of sampling at least 1,000 litres.
Key criteria for selecting air samplers include:
The most common types of air sampler and the methods of operation are:
In addition to the wide choice of various sampler types of different models of air sampler vary in their efficiency. Some devices themselves can generate non-viable particle counts, and this should be considered in the design qualification of such devices. Other design considerations include the suitability of the sampler to any disinfection procedure for equipment to enter the cleanroom and, for Grade A environments, the sampler’s operation as an isokinetic sampler (that is to match the airflow speed within the UDAF).
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