Spectrophotometric particle counters measure the number and size of inert and biologic particles from a volume of air (and thus enable ‘real-time’ microbiological assessment.) Such systems operate in a similar way to conventional particle counters, which measure inert particles as part of the GMP assessment of cleanrooms (and comply with such cleanroom standards as ISO 14644). Here the instruments count airborne particles by measuring light scattering. The difference with the spectrophotometric counters over traditional counters is that the instruments are capable of determining if the detected particles are biological or inert. Thus the key innovation is that such devices can differentiate between non-viable particles and biological material, which may indicate if microorganisms are present in the sample of air.
The
implementation of such technologies is in keeping with the industry and
regulatory drive, particularly from the US Food and Drug Administration, for
rapid methods and for pharmaceutical manufacturers to utilise the concept of
process analytical technology (PAT).
In
relation to this cutting edge rapid microbiological method technology, Tim
Sandle has written an article for European
Pharmaceutical Review.
The
reference is:
Sandle,
T. (2015) Real-time biological particle counting in environmental monitoring, European Pharmaceutical Review, Vol. 20,
Issue 2, pp39-42
Posted by Tim Sandle
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