Providing Cleanroom Certification, ASHRAE 110 Testing, Calibration, Decontamination, USP 797 Solutions, Compressed Air Line Testing, Environmental Monitoring and Qualification Services

Facility Systems Qualification

Alarms

Building Automation Systems (BAS)

Boilers

Chillers

Clean Steam

Cleanrooms

Compressed Air/Gas

Dust Collectors

Generators

HVAC

Water (PW, RODI, USP, WFI)

QUALIFICATION SERVICE

Validation Service to Qualify Facilities, Systems and Equipment

Qualification is essential to successful process validation, product quality and time-to-market. Micro-Clean has an experienced team of validation professionals who provide qualification of direct impact systems and critical components in GMP environments. In addition to partnering on validation strategy, we offer a full portfolio of services including Protocol Development, Execution and cGMP-compliant Documentation for:

• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)

  Qualification Services span critical environment facilities and equipment systems from cleanrooms, environmental chambers and autoclaves to process equipment, water systems, utilities and HVAC systems, including computer-automated equipment and building automation systems for monitoring and control. We qualify a wide variety of Facilities and Equipment.

Qualification Projects – A small sample of our commissioning and qualification projects include:

Large Pharmaceutical – New Jersey: Cleanroom Qualification of suite of renovated Class 100,000 clean rooms with custom laminar flow hoods, controls and associated equipments

Large Pharmaceutical – Pennsylvania: Cleanroom Qualification of suite of renovated Class 100,000 clean rooms, HVAC, conditioners, exhaust systems and building automation systems

Small Biotech - Maryland: Qualification of new Production Facility in Shady Grove, MD. Designed and executed IQ, OQ, PQ for direct impact systems including HVAC, compressed air, de-ionized water, BAS, laser etching machines, clean steam, boilers, coaters, fluid bed dryers, roller compactors and blenders.

Small Biotech – New Jersey: Qualification for new Purified Water, Purified Steam and WFI Water Systems

Large Pharmaceutical – New Jersey: Developed qualification acceptance criteria and certification plans for over 1000 assets.

Large Pharmaceutical – Nevada: Qualified large distribution center.

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