It’s BioTrak time! The Annex 1 Update is published, and it puts the BioTrak centre stage.
It’s been a hot topic for months and talked about for years. Last revised in 2008, the much-anticipated update to Annex 1 has arrived. It was published by the European Commission on 22nd August, dictating industry-wide implementation by August 2023.
The recommendations and mandates contained within the update change the game for pharma manufacturers in sterile and aseptic environments. Luckily, the BioTrak Real-Time Viable Particle Counter is a game changer that fits many of the key directives.
Among those, the new Annex 1 actively encourages the deployment of appropriate technologies for sterile manufacturing and the adoption of Alternative Rapid Microbial Methods (ARMM). That’s a great fit for the BioTrak.
It mandates the development of a Contamination Control Strategy (CCS) based on detailed technical and process knowledge along with Continuous Environmental Monitoring for the full duration of critical processing (including equipment set-up). That’s another ideal fit for the BioTrak.
It recommends the application of monitoring systems as a method of demonstrating the correct implementation of design and procedures, and the need for comprehensive investigational tools for cases of environmental contamination. The BioTrak offers the perfect solution to both.
Get in touch to talk about how the BioTrak changes the game in your favour. And please ask for a BioTrak demonstration.
You can download the revised EU GMP Annex 1 document here.
