Environmental Monitoring Services

Protect your products and patients with comprehensive cleanroom monitoring that identifies and addresses contamination risks before they impact quality. Our experienced team delivers data-driven programs that ensure regulatory compliance while reducing operational costs and implementation time. We provide specialized expertise and end-to-end support, letting you focus on delivering safe, high-quality pharmaceuticals to market.

Pharmaceutical Environmental Monitoring Cleanroom

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What are Environmental Monitoring Services at Element?

Environmental monitoring captures and analyzes microbial contaminants and non-viable particles in critical manufacturing environments. At Element, we deliver comprehensive cleanroom testing services for pharmaceutical and manufacturing facilities, evaluating equipment cleanliness, sanitization effectiveness, and maintaining contamination control in environments from ISO 5 to Grade A. Our quality-centric approach ensures reliable results that help establish control of your aseptic environment no matter what product or process may be involved.

Element life sciences testing expert in lab

What Can Element Offer You For Environmental Monitoring Services?

Key tests offered

We provide a complete range of environmental monitoring services tailored to your facility's needs:

Environmental Monitoring:

Personnel (gloves and gowning)
Air (viable and non-viable particle testing)
Surfaces (walls, floors, equipment [swabs and plates], isolators, BSCs)
Gases (compressed gases: viable and non-viable)

Environmental Monitoring Program Validation:

Environmental Monitoring Performance Qualification (EMPQ) and Environmental Monitoring Operational Qualification (EMOQ)
Water Testing (microbial and chemical, including analytical)
Utilities Qualifications (water and gas systems)
Routine Monitoring
Investigation Monitoring
Summary Reports
Engineering Run Environmental Monitoring

Cleanroom and Facility Testing:

On-site gown training and qualification
Cleanroom behavior training
Aseptic technique qualification

Materials we test

We analyze your complete cleanroom environment through comprehensive testing of air, surfaces, personnel, and utility systems. Our testing programs evaluate viable and non-viable particles in air samples, assess surface contamination levels, monitor personnel protective equipment, and verify the integrity of water and gas systems to maintain your controlled environment's safety and compliance.

Methods and solutions offered

Our comprehensive approach combines routine testing, performance qualification, and expert analysis to protect your products and patients. We deliver:

Customized monitoring programs based on your specific requirements
Gown training and qualification services
Aseptic technique qualification
Cleanroom behavior training
Environmental monitoring mapping
Filter integrity testing
Investigation monitoring support
Detailed summary reporting and trend analysis
Program validation and optimization

Which labs offer this service

Our team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find out where your nearest Life Sciences hub is on our Locations Page.

Expert consultation and support

Our experienced team provides comprehensive wrap-around services including:

Environmental monitoring program design
Cleanroom consulting and optimization
Staff training and development
Contamination control strategy development
Regulatory compliance guidance
Individualized workflow development
“First time right” approach that saves time, money, and resources

Standards we test to and materials we test

These are our most prevalent requests. Don't see what you're looking for? Contact us!

ISO 14644-1
EU GMP Annex 1
USP <797>
USP <800>
cGMP FDA compliance

Your Challenges, Our Solutions

Maintaining product safety and quality

Our comprehensive monitoring programs combine expert analysis with proactive contamination control, helping you identify and address risks before they impact product quality or patient safety. We deliver data-driven insights that protect your operations.

Regulatory compliance simplified

Our experienced team understands both state and federal regulatory expectations and implements monitoring programs that meet all requirements while optimizing your processes and controlling costs. We help you navigate complex regulations with our depth of knowledge in ISO 14644-1 and other critical standards.

Resource optimization achieved

Save significant time and money with our efficient monitoring programs that streamline testing while maintaining the highest quality standards. Our quality-centric approach ensures our experienced team handles program design, implementation, and analysis, freeing your resources for core operations.

Expertise gap bridged

Access our thoroughly trained EM technicians who specialize in aseptic technique, gowning, sampling, and cleanroom microbiology. Our team provides comprehensive training and support to enhance your internal capabilities and maintain consistent quality through unparalleled levels of experience and development of individualized workflows.

Why Choose Element

Element scientist in white lab coat working in life sciences testing laboratory

Quality-focused approach

A quality-centric approach that saves you time, money and resources through our depth of experience implementing effective environmental monitoring programs.

Comprehensive Cleanroom Expertise

Decades of experience in understanding regulatory requirements help us develop and implement tailored programs that ensure product and patient safety.

Data-Driven Decision Making

By providing accurate and reliable environmental monitoring data, Element empowers you to make informed decisions and proactively address contamination risks.

Regulatory Compliance and Risk Mitigation

The development and execution of robust EM programs helps you achieve and maintain regulatory compliance, minimizing product recalls and reputational damage.

Explore our global network of labs and find your nearest location

VIEW ALL LOCATIONS

Related services

Disinfection Efficacy Testing (DET)

Element's Disinfectant Efficacy Testing provides in-depth microbial elimination analysis in aseptic and controlled environments. Custom protocols and comprehensive testing address facility-specific surfaces and contamination risks with data-driven results.

Compounding Pharmacies

Element provides expert testing and environmental monitoring services for sterile compounding facilities, addressing contamination risks and regulatory compliance while enabling you to focus on patient care.

Speak to our team of experts

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