In this App Note, MBV AG showcases the MAS-100 Sirius as the advanced successor to the MAS-100 NT, offering significantly enhanced capabilities for quantitative monitoring of airborne viable particles in cleanrooms.
The MAS-100 Sirius is the successor of the microbial air sampler MAS-100 NT®. It is designed for reliable monitoring of viable airborne particles for GMP-compliant cleanroom environments in pharmaceutical manufacturing.
To go beyond standard requirements of air sampler qualification according to ISO 14698 Annex B and EN 17141 Annex E and to ensure comprehensive validation of the industry’s performance. MBV AG applied an extended validation strategy inspired by guidelines for alternative and rapid microbiological methods (ARMM), including Ph. Eur. 5.1.6, USP <1223> and PDA Technical Report No. 33. It included the validation of the four parameters: equivalence, ruggedness, robustness, and specificity. Although the MAS-100 Sirius is not classified as an ARMM, these guidelines offer a sound scientific basis for performance validation akin to chemical method validation as per ICH Q2(R2).
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