3302-A - Pharmacy Cleanroom Environmental Monitoring: The Microbe Matters

Session Description: Maintaining a Pharmacy Environmental Monitoring (EM) program is a requirement of United States Pharmacopeia (USP) Chapter 797. The EM program allows the Pharmacy Sterile Compounding cleanrooms to measure and monitor cleanliness and contamination levels to maintain a state of microbial control. Beginning in December 2019, routine air sampling of an infusion center cleanroom revealed failures. With standard remediation procedures and corrective actions, microbial levels would fluctuate between being in and out of control. In April 2020, our third-party laboratory notified the Compounding Compliance Team (CCT) that sample sets beginning in January 2020 were misidentified as Bacillus species (spp), when they should have been identified as Mycobacterium mucogenicum (M. mucogenicum). M. mucogenicum is a colony-forming unit (CFU) known to be sourced from water, while Bacillus spp. is a CFU that enters cleanrooms through inadequately filtered air, on clothing and shoes of personnel, and on incoming materials. Interventions that were implemented to control Bacillus spp within the clean room were not effective in addressing a water-related organism, which prolonged the issue. This presentation highlights the importance of correctly identifying microorganisms of concern so that appropriate interventions may be implemented. Misidentification of microbial growth can lead to ineffective remedial actions that can cause continued compliance issues. The objective of this presentation is to share the importance of a robust EM program in detecting potential means of contamination and the multi-departmental corrective actions that were taken to remediate this issue, as well as how we successfully repeated the same actions in another cleanroom later, that was also showing Mycobacterium growth.