Anaerobes and the cleanroom operator association: Is there a case for anaerobic environmental monitoring?

Abstract

Is anaerobic environmental monitoring necessary? For obligate anaerobes the case for doing so is low. For facultative anaerobes, where aseptically filled parenteral products are involved, the case is far higher. Any such consideration should be based on a quality risk assessment taking into account the interactions between people and exposed product or product components and the opportunity for particle deposition. In many cases, the risk will not be known unless selective environmental monitoring has been performed given the slow growth rate of organisms like Cutibacterium acnes and the preferential growth obtained using an anaerobic atmosphere and a blood-based culture medium. The argument of this paper is not so much with whether anaerobic monitoring is necessary for aseptically filled products, but with how often should this be performed?