The proposed changes to Annex 1 of the GMP Guide to the Manufacture of Sterile Medicinal Products will change the way environmental monitoring of microorganisms will be performed from routine, interval sampling to continuous monitoring.
ImpactAir is a microbiological active air sampler designed for use in pharmaceutical cleanrooms or other highly controlled environments.
ImpactAir active air sampler is a “Slit to Agar” design using 140mm agar plates located on a rotating turntable to prevent twin impingement of impacted organisms, to minimise drying of the agar medium and to provide a time correlated deposition of captured microbes.
ImpactAir has been designed to optimise the impaction and growth of airborne microbial contamination down to 1 micron (d50 value of 0.45). This has been achieved by a combination of the design of the area of the slit, coupled with sufficient air flow (calibrated for accuracy at 28.3 LPM, equivalent to 1 cfm), giving an air velocity of 70 metres per second. The Physical and Biological Efficiencies of ImpactAir have been independently validated by Public Health England (with and without remote probe attached), to meet the requirements of ISO 14698, Part 1, Annexe B, for use of an appropriate active air sampler in an EU Grade-A clean room.
ImpactAir can be used as a stand-alone active air sampler; or as a remote sampler, allowing the instrument to be located away from the critical sampling point. To perform remote sampling, a maximum length of 8 feet (2.2 metres) of half inch (12.6 mm) bore stainless steel tubing, with up to 3 x 90 degree elbows (this set-up validated by P.H.E.), is attached over the slit assembly of the air sampler by a stainless steel bayonet cap and the other end of the tubing is terminated with an isokinetic probe adjacent to the critical sampling location.
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