The proposed Annex 1 Revision has outlined 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 are delighted to introduce the ImpactAir ISO-90 “Annex 1 ready” range of active air samplers.
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 4 hours, before the need for a plate change. This complies with the industry’s best practice towards minimising human operator intervention within Grade A areas during aseptic manufacturing.