Being Compliant Using More Efficient Testing Methods for Viable Air Testing in Aseptic Cleanroom Environments

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). Today, the use of active air samplers (AASs) is an essential part of this process, and knowing how to evaluate them for confidence in test methodology is a critical aspect of a contamination control program. 

Evaluating Air Samplers

Most pharmaceutical manufacturers use microbial air samplers to evaluate cleanroom microbial contamination levels. The d50 value, or the particle size at which 50% of the particles are collected, is used to quantify physical collection efficiency. A high d50 value risks failing regulatory inspection because microbe-carrying particles may not be collected.

Evaluating TSI Active Air Sampler

The TSI AeroTrak®+ Remote Active Air Sampler has a low d50 value of 0.8 µm that you will want to see—with proof in its testing results. You can use this information as part of your validation activities.