Discussion on environmental monitoring and Annex 1

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Cherwell Laboratories, specialists in cleanroom microbiology solutions, will be leading an open discussion on environmental monitoring (EM) in line with EU GMP Annex 1 at the forthcoming Pharmig 30th Annual Conference. The annual event, to be held at the Nottingham Belfry, 30 November – 1 December, will focus on the ongoing challenges of microbiological contamination control compliance.

In the open discussion session focusing on ‘Environmental Monitoring – let’s settle the debate’, delegates at Pharmig 2022 can join Cherwell for an informative interactive debate considering if settle plates are the right solution for continuous monitoring. Attendees will have the opportunity to challenge industry experts about their theory and hear first-hand about the solutions to reduce risk and monitor environments appropriately in line with Annex 1. This and other open sessions aim to encourage discussion, share issues, solutions and experiences in a smaller, more informal environment to help delegates/companies to benchmark themselves against others.

In addition to offering expert input on contamination risk reduction and EM in line with Annex 1 at Pharmig, Cherwell will be available for discussion on this subject at a forthcoming Society for Contamination Control (S2C2) event, where they will also be exhibiting. At the society’s Learning & Networking Day, 16-17 November, at Camfil Ltd, Haslingden, delegates will be able to learn more about ‘The implications of the new Annex 1 GMP Guide’. At both events Cherwell will demonstrate its comprehensive range of specialist environmental monitoring and process validation products specifically developed for the management of controlled environments and processes.

The new Annex 1 is a key topic of discussion at both events, but for those unable to attend, Cherwell is also providing via its website further background and insight on this latest regulatory update governing the manufacture of sterile medicinal products. Its new online EU GMP and Annex 1 resources pages aim to support preparation for the transition to the new Annex 1 version by bringing together all Cherwell’s latest relevant information into one easy to find place. This includes comparison of differences between the two versions, as well as an infographic highlighting the changes and some key areas of focus around environmental monitoring.

“EM in pharmaceutical manufacturing already plays a vital role in ensuring the safety of patients and the efficacy of drugs. The much-heralded publication of the new version of EU GMP Annex 1 will now further shape EM programs to mitigate risk of contamination during the manufacture of sterile products moving forward,” said Cherwell Laboratories’ Microbiology Product Specialist, Hamish Hogg, who will be attending both events.

He added, “All manufacturing facilities are different, so every facility must review, develop and adopt a holistic EM program that is specific to their individual risks in line with the revised regulations. We hold a lot of in-house expertise in this area and we look forward to supporting our customers in ensuring they can fully establish and demonstrate the contamination control necessary to ensure the microbiological safety of their final product.”

Cherwell experts will be on hand at both Pharmig and S2C2 events to offer practical advice and demonstrate solutions that can be tailored to meet individual customers’ specific microbiological monitoring and validation requirements. These include the Redipor® prepared media range, incorporating agar plates, bottled media, vials, broth bags and ampoules; plus ImpactAir continuous viable air monitoring solutions and SAS microbial air samplers for active environmental monitoring.

For more information about Cherwell Laboratories, please visit our website, follow CherwellLabs on Twitter or follow us on LinkedIn.

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Cherwell Laboratories

Specialists in cleanroom microbiology solutions for the pharmaceutical, healthcare and related industries Read more