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 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.