“The French norm NFT 72-281, the last version of which dated from 2014, is now outdated. It largely inspired the European standard EN 17-272 which is currently in force for any request for authorization which would be submitted since its date of publication (April 2020).
Two points in particular have been developed in EN 17-272 compared to NFT 72-281:
a) A distribution test to validate the homogeneity of the diffusion of biocide fog, with 8 biological indicators distributed in the corners.
b) Populations of microorganisms and a log reduction in these populations variable according to the target industries.
Specifically for the pharmaceutical industry, the production of sterile drugs, ruled by appendix I of ‘Good Manufacturing Practices’, is evolving towards the promotion of barrier technologies, and a limitation of human interventions in grade A areas. Bioburden control, minimization of aseptic risks and a more structured contamination control strategy are the pillars of this new version 12. This appendix I describes the need to biodecontaminate the most critical areas in sterile production, and to validate the effectiveness of cleaning and disinfection. The ASD is therefore a key step to qualify these areas, and choosing the right ASD partner can make all the difference! High-performing equipment, expert support and time saving in establishing effective protocols, simple yet complete traceability, service provision, maintenance and adapted services, etc.”