Microbial identification to the genus level provides valuable insight into the origin of the recovered microorganism. However, the June 2019 revision to Chapter <797> made genus-level ID required for sterile compounding only when the count exceeds the action level. This change makes sense for microorganisms recovered from a less controlled area, such as an anteroom. However, the chapter does not distinguish between those areas and spaces like an ISO Class 5 cleanroom, which has raised some questions about when and when not to perform genus-level ID.
Join us as we address those concerns and discuss other topics about how changes to Chapter <797> affect microbial ID including:
- What genus-level identification entails, and why Gram stains are insufficient to accomplish this
- Current and future requirements for microbial identification
- Importance of microbial identifications and remediation of exceeded action levels
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