CE Critical

Services for Specialized Cleanrooms

Sterile, Aseptic Cleanroom Environments

CE has the expertise to handle the intricacies of the specialized cleanrooms used primarily in the pharmaceutical industry. We help prevent the spread of pathogens by creating a sterile environment for:

  • IV compounding facilities
    • USP <797,800,825> Facilities
    • FDA 503A + 503B
  • Oral solid dose (OSD) facilities
  • Blow/fill/seal facilities
  • cGMP facilities
  • FDA Validated Facilities

Cleanrooms in which drugs are produced must meet very stringent standards. CE’s professionals thoroughly understand the regulations for pharmaceutical cleanrooms, and every design/build/install project is undertaken in a way that meets all relevant standards.

Specific design and construction techniques required for high-quality pharmaceutical cleanrooms include compliant air filtration and circulation systems. Clean systems with smooth surfaces, impervious and hydrophobic, that are easy to clean and resistant to scratches which can hide microorganisms and environmental contaminants.

Facilities Designed to Maintain Aseptic Conditions

As a respected cleanroom consulting firm, CE helps you set up a monitoring system to detect changes in environmental conditions.