White paper: BSL3 ASD validation

White paper: ASD Validation in a BSL3 laboratory:

In every biodecontamination project, the Airborne Surface Disinfection (ASD) expertise of our teams makes all the difference: protocol implementation, specific environmental conditions, experience with multiple viruses or micro-organisms, etc.

Today, we are proud to present the project we carried out with Naobios, a CDMO located in Nantes, France, within their BSL-3 cleanroom. The aim was to develop a strategy for validating the ASD within their facilities. As a CDMO, Naobios works with various viruses and organisms; perfect disinfection is key to avoid contamination, as well as cross-contamination.

This complex project enabled us to support Naobios at every stage, guiding them to meet their specific requirements.

Indeed, as it is GMP-certified, Naobios must comply with strict constraints to ensure the safety of its personnel, its facilities and the products handled. This therefore involves achieving bioburden reduction targets. The project covered a total cleanroom volume of 270 m³, with several types of rooms to be treated. This area includes: personnel airlocks, equipment airlocks, corridors, production areas and extraction areas.

The specifications were clear:

• A 6 log 10 reduction in bioburden (in Geobacillus stearothermophilus spores),
• A reduction of 4 log 10 in the bioburden (in viruses),
• Staff safety,
• The safety of the equipment on the structure of the controlled zone,
• Simple implementation, rigorous traceability and data compliance (Annex 11 and 21 CFR Part 11).

How did we successfully complete this project with the teams from Devea Biodecontamination Services? Why validate against viruses? How was the Naobios site able to validate the DSVA in just a few months? Did we validate other cleanrooms within Naobios premises?

Download our white paper from our website, and let’s make an appointment to discuss your project!