Environmental Monitoring Services

Establishing control of your cleanroom environment is critical to product and patient safety. With decades of experience developing and executing Environmental Monitoring (EM) programs in the pharmaceutical and manufacturing industry, Element's comprehensive cleanroom testing services help establish control of your aseptic space. EM methods and equipment are designed to capture microbial contaminants and non-viable particles in your critical environment - we can help perform testing no matter what your product or process may be. 

Environmental Monitoring is a critical component of any contamination control strategy, and we are here to help you succeed. Routine EM testing helps ensure the safety of patients and end-users in part by evaluating cleanliness of manufacturing and packaging equipment and testing the robustness of a sanitization program. A robust EM program ensures that non-viable and viable contamination is unlikely to occur. Pharmaceuticals and manufacturers must complete EM performance qualifications of their facility and demonstrate routine facility cleaning procedures. Whether you have an ISO 14644-1 or Annex 1 space, we can execute your Environmental Monitoring. Our EM analysts have extensive cleanroom experience, including testing in ISO 5 and Grade A environments.

Comprehensive EM programs are composed of testing using aseptic techniques; sampling personnel and gowning, surfaces, air, equipment and utilities. EM also helps provide evidence towards the efficacy of cleaning and disinfection programs, verifying validated cleaning procedures have been implemented effectively. Element offers comprehensive testing, while remaining flexible in our services offered. Element’s consultative experts also offer wrap-around services, including environmental monitoring mapping, filter integrity testing, cleanroom training, training of staff in proper aseptic practices, and a broad range of cleanroom consulting services.  

Key benefits of partnering with Element for Environmental Monitoring Services

• Comprehensive Cleanroom Expertise - Our decades of experience and deep understanding of regulatory requirements enable us to develop and implement tailored environmental monitoring 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 - Our expertise in developing and executing robust EM programs helps you achieve and maintain regulatory compliance, minimizing the risk of product recalls and reputational damage.

Leverage data-driven insights

By analyzing trends and identifying potential contamination risks, Element helps you make informed decisions to protect product quality and patient safety. Our expert team of scientists translates complex data into actionable recommendations for your facility. 

Expertise saves you time and money

By partnering with Element, you can significantly reduce the time and resources spent on environmental monitoring. Our deep industry knowledge and proven methodologies allow us to develop efficient and cost-effective EM programs tailored to your specific needs. Our experts streamline the process, from initial program design to data analysis and reporting, enabling you to focus on core business activities.

Our range of services:

Cleanroom and Facility Testing

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 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

Ensure compliance to microbiological environmental monitoring guidelines

Element’s extensive experience meeting both state and federal regulatory expectations, along with a quality-centric, “first time right” mentality, ensures environmental monitoring programs are designed to yield both cost savings and high-quality results. Our EM technicians are thoroughly trained on aseptic technique, gowning, sampling, and the science of microbiology within the cleanroom environment. This unparalleled blend of experience, staff development and training, and extensive regulatory, industry, and scientific knowledge allow Element to offer industry-leading cleanroom validation solutions, including controlled environment monitoring, cleanroom testing services, and environmental monitoring of sterile compounding areas.

Why choose Element

Comply with regulatory requirements while simultaneously refining manufacturing processes and keeping costs low with Element’s comprehensive environmental monitoring and cleanroom certification and testing services, customized to meet the specific needs of your facility, manufacturing processes, and finished product.

To learn about our customized approach to controlling microbial contaminants in biopharmaceutical manufacturing facilities and more, or to speak with one of our experts, contact us today.