In regulated environments such as pharmaceutical, biotech, or medical device manufacturing, precision is critical. Master Compliance is our quality promise: every MAS-100 instrument is designed, manufactured, and documented to be fully compliant with all relevant regulatory requirements.

From precise airflow mechanics and pressure compensation to traceable calibration—every detail supports data integrity and ensures reliable, traceable measurement results.

• ISO 14698-compliant microbiological testing of cleanrooms
• EU GMP Annex 1–ready
• FDA 21 CFR Part 11-compliant data management with audit trail
• Fully documented IQ/OQ 
• Traceable calibration according to international standards

MBV is actively engaged in the standardization committees ISO TC 209 and CEN TC 243, which define standards for cleanrooms and controlled environments. We also actively participated in the development of the first version of EN 17141.

The qualification of active MAS‑100 microbial air samplers in accordance with ISO 14698 and EN 17141 ensures precise and reproducible measurement results. It also fulfills the EU GMP Annex 1, paragraph 9.29 requirement to provide supporting data: "Supporting data for the recovery efficiency of the sampling methods chosen should be available."

Our sales and service team supports you with GMP-compliant qualification, maintenance, and re-qualification, ensuring that regulatory requirements are consistently met.

Our Swiss representative in ISO TC 209 and CEN TC 243 is Dr. Miriam Schönenberger, Head of Product Management.

ISO TC 209 develops standards for cleanrooms and controlled environments, ensuring cleanliness and other key attributes regarding facilities, sustainability, equipment, and processes.

CEN TC 243 is responsible for the EN 17141 standard, which defines requirements for the classification and design of controlled environments to minimize contamination risks.

Through our engagement in these committees, we ensure MBV instruments meet the latest regulatory requirements while providing the highest precision.