CLEANROOM

CLEANROOM

Cleanroom

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, study their classifications, and develop comprehensive environmental monitoring protocols. Upon request, we will train your employees in any new SOPs.

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

Cleanroom 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 Compedia Requirements (Water Vapor, Air Viable, Air Non-viable, and Hydrocarbon)
  • On-site Water Quality Sample Collection
  • Viable Surface Monitoring (including RODAC Plates, and Swabs)
  • Cleanroom Commissioning and Qualification
  • Water Purification System Validation and Routine Testing
Cleanroom commissioning and qualification