CLEANROOMS & CONTAMINATION CONTROL: AIR SAMPLING The measure of microbes
Microbial air sampler helps keep clean air microbe free for healthcare and pharmaceutical applications
P ‘
rocess validation and environmental monitoring specialist Cherwell Laboratories has introduced the ImpactAir microbial air sampler range which
aims to support the new EU GMP Annex 1 requirements for continuous environmental monitoring (EM). Pinpoint Scientific, the manufacturers of
the ImpactAir range, have designed it for continuous monitoring in high-grade clean areas, where in-process sampling of viable particles is often critical. The ImpactAir ISO is a modular system designed to integrate into isolators or RABS (restricted access barrier systems), using an external controller and remotely-located air mover. The ImpactAir ISO model can be
integrated in almost any orientation using standard or custom-made connections. The ISO-90-Monitoring Head features a chamber for 90mm agar plates and a highly efficient slit to agar sampling method to give highly reliable and consistent results. The low D50 value and ability to sample for long periods makes the ISO-90 ideal for continuous monitoring as demanded by the Annex 1 revision of the EU standard. According to Andy Whittard, managing director at Cherwell Laboratories, the
We are really
excited about the latest developments from Pinpoint
’
ImpactAir ISO-90 will address a key requirement within pharmaceutical Environmental Monitoring by achieving a higher sample volume within grade A environments and minimise risk in these critical zones. “We are really excited about the latest
developments from Pinpoint as well as future developments to the ISO-90 range, which promise to make installation within existing facilities easier,” says Whittard.
EXTENDED RANGE The ImpactAir ISO model from PinPoint Scientific is part of a much wider range of environmental and process validation products available from Cherwell Laboratories for the healthcare, pharmaceutical and related industries. These products include the Redipor
range of prepared media – such as petri dishes, settle plates, bottled media, vials, broth bags and ampoules; SAS microbial air samplers and environmental monitoring accessories.
THE IMPACTAIR RANGE With three models of the ImpactAir microbial air samplers available, the range is adaptable for use in different highly regulated industries, such as pharmaceutical, healthcare and specialist food production.
❱❱ The ImpactAir ISO microbial air filter
addresses continuous monitoring as per EU GMP Annex 1 revision
Thanks to its innovative modular design,
the instrument can be adapted into a range of formats to suit specific deployment needs, and is controlled via touch screen LCD. With 28.3 litres of air flow a minute, the
instrument can be set to sample air at any time interval from 1 minute to 9 hours. Plate height adjustment is fully
automatic and there are a number of accessories available including trolleys, inlets, isokinetic probes, exhaust ducts, aseptic dish handling tools and an agar plate lid holder. Due to its design, the instrument doesn’t
shed particles so is able to operate in environments alongside particle counting devices without influencing readings. The three available models include the
standard ImpactAir, the ImpactAir RABS with its dual interface for use inside and outside RABs and the ImpactAir ISO, which integrates with isolators, external controllers and remote air movers. In all cases, the instrument operates by
drawing air at high speed through a narrow inlet. Particles and microbes are collected on an agar microbial cultivation mixture in a rotating Petri dish. Fresh agar is presented constantly, significantly reducing the chance of multiple microbes appearing as a single colony after incubation. T&TH
December 2019 /// Testing & Test Houses /// 33
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