Enhancing Confidence in Cleanroom Air Sampling Validation by Bridging ISO Standards with the ARMM Framework: Poster...

Reliable monitoring of airborne microbial contamination is critical for maintaining GMP-compliant cleanroom environments in pharmaceutical manufacturing. While EN ISO 14698 and EN 17141 provide the regulatory framework for validating the physical and biological performance of portable air samplers, they may not fully reflect real-world production conditions or ensure methodological robustness.To strengthen validation confidence, we incorporated criteria from Alternative or Rapid Microbiological Methods (ARMM)-including ruggedness, robustness, equivalence, and specificity as outlined in Ph. Eur. 5.1.6, USP < 1223>, and PDA Technical Report 33-into the conventional ISO-based validation of a portable air sampler. This integrative approach enables a more practical assessment of sampler performance under actual cleanroom conditions.In collaboration with Hoffmann-La Roche AG, we applied this methodology to a portable air sampler in a real-world cleanroom setting.The study demonstrates how ARMM criteria can enhance the reliability of microbial monitoring and support robust cleanroom validation strategies.