Microbiological environmental monitoring

RSSL can provide consultation and analytical services for environmental monitoring to enable manufacturers to accurately determine microbial bioburden.

 

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. 

Our approach

 

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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