Environmental Monitoring

Environmental Monitoring Program Design

Your EM program must demonstrate control over viable and non-viable particles found in critical areas of your operation. However, standards and guidances are not prescriptive and do not instruct a pharmaceutical or medical device manufacturer on how to achieve this control.

With two decades of testing experience, Infinity can help guide your EM program with a risk-based approach that demonstrates understanding of and control over the operation. A robust EM program will include monitoring the air, personnel, and surface areas within the cleanroom environment to understand the presence and levels of viable and non-viable particles.

Scientist injecting fluid into medical pouch for testing.

Environmental Monitoring Testing Services

Air Monitoring

Environmental Monitoring Testing

Utilizing active and passive air sampling techniques and counting nonviable particles provides critical insights into the cleanliness and control of the environment.

Surface Monitoring

Environmental Monitoring Testing

Surface environmental monitoring using swab sampling techniques, contact plates, surface contamination evaluation, and trend analysis to determine potential surface contamination sources within key production areas. Over time, surface monitoring data provides supporting evidence for the effectiveness of cleaning and disinfecting protocols.

Personnel Monitoring

Environmental Monitoring Testing

Particularly within aseptic environments, facility workers are one of the most significant sources of contamination risk. Personnel monitoring is critical during the donning and doffing qualification process. Additionally, contact plate sampling of personnel is typically conducted after suspected contamination events.  

Water Monitoring

Environmental Monitoring Testing

Water system validation and thorough water environmental monitoring strategies are necessary to maintain water compliant with all regulations and standards. Given its role as a critical raw material and cleaning and process utility, understanding water quality, specifically its microbial bioburden and endotoxin levels is essential. 

Utility Monitoring

Environmental Monitoring Testing

Microbial monitoring of utilities such as compressed air and steam for sterilization systems must be included within a pharmaceutical or medical device facility’s EM program.

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