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CLEANROOM and CRITICAL UTILITIES SERVICES

CLEANROOM

Cleanroom

Onsite environmental testing services with cleanroom commissioning and qualification

Looking for a company that offers cleanroom and critical utilities Services? Boston Analytical provides on-site microbial air and surface environmental monitoring services for cleanrooms, USP <797> compliant laboratories, ISO cleanrooms, and other controlled environments in the northeastern United States. We provide all personnel and supplies necessary to visit the site and to perform a microbiological evaluation of cleanroom suites.

Onsite environmental testing services includes experts examine the layout of your cleanrooms, review their classifications, and develop comprehensive environmental monitoring protocols. Upon request, we will train your employees in any new SOPs.

The importance of these cleanroom monitoring services cannot be understated. Microbiological evaluation and environmental monitoring are performed to ensure that drugs and biologics are produced safely and in compliance with relevant regulatory guidelines. These services help prevent microbial contamination, which can alter the pharmacology of drugs, impacting their effectiveness. Microbial contamination of drugs can also cause both short- and long-term harm to patients’ health and may increase the risk of developing conditions including autoimmune conditions, cancer and other diseases.

If you perform cleanroom environmental monitoring in-house, Boston Analytical can provide you with the qualified supplies you need for your testing regimen.

If you are looking for cleanroom services, contact Boston Analytical. We use the latest technology, equipment and software to give you fast, accurate results. We are also committed to providing the highest quality analytical testing services to life science companies throughout the world. You can rely on us to conduct all necessary testing quickly and expertly while meeting all regulatory/compliance requirements. Contact us today to get started.

Cleanroom Qualification Services

  • On-Site Environmental Monitoring
  • Environmental Monitoring Testing in Our Laboratory
  • USP <1116>, “Microbiological Control and Monitoring of Aseptic Processing Environments”
  • PDA Technical Report “Fundamentals of an Environmental Monitoring Program”
  • Disinfectant Efficacy Study, USP <1072>, “Disinfectants and Antiseptics”
  • Aseptic Environmental Monitoring
  • Non-viable Particulate Analysis Testing
  • Air Monitoring Testing
  • Compressed Gas Monitoring for USP, EP, and JP Compendia Requirements (Water Vapor, Air Viable, Air Non-viable, and Hydrocarbon)
  • On-site Water Quality Sample Collection
  • Viable Surface Monitoring (including RODAC Plates, and Swabs)
  • Water Purification System Validation and Routine Testing

Cleanroom Inquiry Form

If you have a project that requires the expertise and knowledge in Cleanroom that Boston Analytical can provide, please complete the form below:

Cleanroom