Environmental Monitoring

Microbial assessments and environmental monitoring are carried out to ensure that medicines and biologics are manufactured safely and comply with relevant regulatory guidelines. Protheragen Lab is committed to offering high-quality, affordable analytical testing services to pharmaceutical and life science companies around the world. Protheragen Lab provides microbial air and surface environmental monitoring services for cleanrooms, USP <797> compliance laboratories, ISO cleanrooms, and other controlled environments. Our environmental monitoring services focus on the control of viable (living microorganisms) and non-viable particles in critical areas and compressed gas sources.

Each environmental monitoring project in our company is based on the specific needs of the customer to create a unique and customized project designed to ensure that all quality standards are met. Our company provides all the necessary personnel and materials for a complete environmental monitoring project.

Our Services

Protheragen Lab's environmental monitoring services are a professional, comprehensive solution designed to ensure environments comply with stringent international standards and regulatory requirements. Our service is especially suitable for environments where high pollution control is required, such as pharmaceuticals, biotechnology and other industries.

We use the latest technology, equipment and software to provide our clients with fast and accurate results. Our environmental monitoring services include:

• Controlled environments layout inspection.
• Develop an environmental monitoring protocol.
• Classification testing and assessment of environmental parameters.
• SOP training and technical support to help customers understand and apply monitoring results.
• Collect environmental monitoring data to identify any factors that may affect cleanroom performance.
• Based on the collected data, risk assessments are conducted to identify potential contamination sources, and corresponding management is developed.
• Regular environmental monitoring reports, including trend analysis, abnormal event recording and improvement recommendations, help customers continuously improve environmental control.

Our Environmental Monitoring Service Project

Cleanroom Testing Services

• Environmental monitoring in compliance with USP <1116> & PDA Tech Report 13
• On-Site sampling capabilities are available at select locations
• Disinfectant efficacy studies - custom designed based on USP <1072> & AOAC Guidance
• Non-Viable particulate air monitoring
• Viable surface monitoring (including contact plates and swabs)

Compressed Gas Monitoring

Protheragen Lab's gas monitoring services utilize equipment for both high and low flow systems. Sample types analyzed include: viable, non-viable, hydrocarbon, water vapor and dew point.

Support for In-House Environmental Monitoring

If clients perform in-house Environmental Monitoring, Protheragen Lab can provide all of the growth-promoting media needed for testing. We can also incubate the resulting plates and enumerate and/or identify the resulting microorganisms.

EM and Utilities Program Design

Protheragen Lab has the experience necessary to implement EM program design. Our experts help our clients complete the process of determining sample locations and frequencies. Protheragen Lab can handle the program from start to finish, including routine sampling activities to maintain compliance.

Environmental monitoring and prevention of microbial contamination are essential to ensuring the efficacy and quality of drugs or biological products. Contact us today to learn more about our environmental monitoring services, or to consult about customized testing protocols. Our accurate, reliable results and personalized customer service make Protheragen Lab the perfect choice for your environmental monitoring needs.