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New device addresses continuous monitoring as per EU GMP Annex 1 revision

New device addresses continuous monitoring as per EU GMP Annex 1 revision
12/11/2019

Bicester, UK, 29th October 2019: Cherwell Laboratories, specialist suppliers of environmental monitoring and process validation solutions for the pharmaceutical and related industries, will once again be supporting Pharmig’s Annual Conference. The aim of the conference is to keep individuals within the pharmaceutical, healthcare and NHS industries up to date with the latest developments and hot topics in microbiology. So, Cherwell will showcase for the first time, the latest addition to the ImpactAir® microbial air sampler range which aims to support the new EU GMP Annex 1 requirements for continuous environmental monitoring (EM).

Pharmig’s 27th annual event will be held on the 13th and 14th November at the Nottingham Belfry Hotel. Topics covered at the event include: MHRA recent findings and expectations; API filling in isolators; Microbiological considerations for ATMPs; Challenges in viable colony counting by visual inspection of growth media as part of EM programs, as well as the new Annex 1 and its impact on environmental monitoring activities.

Cherwell, distributors of the ImpactAir range of microbial air samplers from Pinpoint Scientific, will be displaying the prototype of the new ImpactAir® ISO-90 Monitoring Platform on their stand. ImpactAir is designed for continuous monitoring in high-grade 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, using an external controller and remotely located air mover.

The new ImpactAir® ISO model can be designed in almost any orientation using standard or custom-made . 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.

Andy Whittard, Managing Director at Cherwell commented, “We are really excited about the latest developments from Pinpoint and feel the ImpactAir ISO-90 will address a key requirement within pharma EM. That is to achieve higher sample volume within grade A environments and minimise risk in these critical zones. Further developments to the ISO-90 range promise to make installation within existing facilities easy.”

Cherwell will also be displaying a selection of other products suitable to meet the environmental monitoring and process validation requirements of the pharmaceutical, healthcare and other related industries. The Cherwell range includes 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.

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