As part of good manufacturing practice (GMP) compliance, medical and pharmaceutical manufacturing operations must qualify and routinely monitor microbial contamination levels in cleanrooms and clean spaces such as isolators and restricted access barrier systems (RABS). The use of active air samplers (AASs) is an essential part of this process.
Even though impaction-based microbial samplers have been in use since the middle of the 20th century, currently there is no standard defining minimum performance requirements. As a result, there are significant differences in performance for AASs in use today, which can lead to improper evaluation of cleanroom microbial contamination levels. Therefore, proper characterization of microbial air sampler performance is a critical aspect of a contamination control program.
TSI recently introduced a new AAS—the TSI AeroTrak®+ Remote Active Air Sampler (AAS) Model 7010. It uses external vacuum to draw air through the AAS. With an impaction velocity of 43 m/s, the AAS is designed to provide high physical and biological efficiency over a broad range of particle sizes. This document describes testing that was done to determine the performance of AeroTrak+ Remote AAS, and includes complete test results.