This article by John Cobb, a GMP Microbiologist with PMT (GB) Ltd. considers a new design of active air sampler, the ImpactAir ISO-90, that is capable of a very high, industry-leading, Biological Efficiency, which can be used for an interval sample of 1 cubic metre of air. A d50 value in the region of 0.5µm (depending on the slit dimensions selected), enables accurate sampling down to at least 1 µm particle size in an area where zero growth needs to be proven.

The ImpactAir ISO-90 can sample at critical risk assessed locations within an EU Grade A area, whilst exceeding all the Guidelines as outlined in ISO 14698-1, the forthcoming EN 17141 and the latest Revision 12 of the EC GMP Annex 1.

The sampler can run for up to 4 hours on a single 9cm TSA plate reducing human interventions and the potential introduction of microbial contamination into your critical areas. Monitoring microbiologically throughout an entire production run with minimum human intervention for plate changes is now possible and worth considering for the enhancement of product quality and patient safety.

This method of active air sampling can supplement or replace settle plates for more accurate microbiological sampling over an entire production run, providing a greater understanding of the level of microbiological control in the Grade A zone.

Download the full article here: to find out:

• current standards concerning the choice of the most appropriate AAS (Active Air Sampler) as part of an EM programme
• Different AAS designs/methods
• Pros and cons to consider when choosing an AAS for Grade A and the plated media used
• Initial validation results of this new slit-to-agar design