Environmental Monitoring (EM) is the process of monitoring and measuring the microbial bioburden in the manufacturing environment such as air, surfaces, equipment and personnel.
Environmental Monitoring is crucial for drug manufacturers quality control 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.
