The proposed revisions to the EU GMP Annex 1 states in Section 9.27 that continuous microbial monitoring in Grade A and B areas should be undertaken for the full duration of critical processing, including aseptic equipment assembly and filling operations. Furthermore, isolates should be able to be identified down to species level (Section 9.33).
To meet these extended microbial monitoring requirements, PMT (GB) has brought to the market the ImpactAir ISO-90, an Annex 1-ready range of active air samplers.
John Cobb, a microbiologist at PMT (GB), explained: "ISO-90 employs slit-to-agar technology to impact particles onto a 9cm TSA plate, widely accepted as the method of choice for Grade A and B critical areas.
Due to the controlled rotation of the plate under a fixed slit, this permits continuous sampling onto fresh agar for up to a Performance Qualified (PQ) time of four hours, before the need for a plate change. This period complies with the industry’s best practice towards minimising human operator intervention within Grade A areas during aseptic manufacturing."
Sampler efficiency
When selecting an active air sampler for a Grade A area, factors that must be considered include the biological and physical efficiency of the sampler, along with the d50 cut off value. To meet the requirements of ISO 14698-1 an air sampler must be able to capture particles down to 1µm.
"The ISO-90 range of air samplers comfortably meet these ISO 14698 Part 1 guidelines and maintain them throughout the entire sampling regime<' Cobb said. This method also allows for a time of contamination to be approximated and a colony-forming unit (CFU) can be identified down to species level, as per 9.33 in Annex 1 proposed revision.
Featuring a host of customisable options, the ISO-90 comes with filtered or trunked away exhaust; independent operation via an Iso-Con controller, or by power over Ethernet (POE) as part of a client’s operating system, if a bespoke option is required.