Reliable monitoring of airborne microbial contamination is fundamental for maintaining GMP-compliant cleanroom environments in pharmaceutical manufacturing. While EN ISO 14698 and EN 17141 provide the regulatory basis for validating the physical and biological collection efficiency of portable air samplers, these standards alone may not fully address performance under real-world conditions and ensure robustness of the method.

To address this gap, an extended validation framework that incorporates the additional parameters ruggedness, robustness, equivalence, and specificity drawn from Ph. Eur. 5.1.6, USP , and PDA Technical Report No. 33 is suggested. Although originally developed for alternative or rapid microbiological methods (ARMM), they offer valuable insights for enhancing the validation of conventional portable air sampling systems.

In collaboration with the pharmaceutical manufacturer Hoffmann La-Roche AG, this framework was tested in practice. This presentation outlines the integrative framework, describes the experimental design, and presents key results.