Understanding the new EU GMP Annex 1 environmental monitoring. And how the BioTrak® could be the ARMM you need.
The long-awaited update to EU GMP Annex 1 published in August 2022 moves the regulatory goalposts for aseptic pharmaceutical manufacturing. Among the requirements introduced are mandates for continuous viable air monitoring in Grade A environments, stringent guidelines on contamination control, and strong recommendations to adopt alternative monitoring methods.
Fortunately, we can help. Thanks to our extensive particle monitoring expertise, nationwide support infrastructure and one unique game-changing Airborne Particle Counter (APC) in particular, we can assist by helping pharma manufacturers to comply with key elements of Annex 1 that specify microbial monitoring strategies and solutions. That game-changing APC is the BioTrak® Real-Time Viable Particle Counter – a proven rapid method for air monitoring that’s already approved by the US Food & Drug Administration.
There are many ways in which we at FMS can help with Annex 1 compliance, including with the application of the BioTrak instrument. Download our roadmap to see how the BioTrak meets the requirements of the key aspects of Annex 1.