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Environmental Monitoring (EM) is crucial for drug manufacturers to determine the microbial bioburden within their facility. By taking a proactive approach to monitoring the viable counts in the area and developing a strategy for tackling any contamination, manufacturers can reduce the risk of product contamination and protect patient safety. Moreover, depending on the facility design and specific manufacturing area (e.g. a classified cleanroom), this analysis may be a regulatory requirement.
RSSL are able to consult and assist in recommending an appropriate EM programme schedule, including preparation of Environmental Monitoring Performance Qualification (EMPQ) documentation.
We can also offer a sample processing service to incubate, enumerate and interpret any viable counts observed. Additionally, we provide a microbial identification service, which may assist in root cause analysis and corrective and/or preventive action implementation.
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