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Cleanroom Documentation

Design Qualification (DQ)

  • User Requirement Specifications(URS)

  • Vendor documents and specifications

  • Facility layout

  • Purchase orders

  • Design documentation

  • Factory Acceptance Tests (FATs)

  • As build drawings

  • Data sheets

Operational Qualification (OQ)

  • HVAC calibration

  • HEPA filter integrity test data review

  • Critical equipment calibration status

  • Site Acceptance Tests(SATs)

  • Installation Qualification tests

  • Chilled & Hot-water Piping documentation

Installation Qualification (IQ)

  • Testing HVAC system operation against specified functional requirements

  • Critical & Interlock Alarms

  • Critical operating parameters

  • Filter integrity tests

  • Standard operation for the clean room

  • Air speed,  flow & patterns

  • Pressure differential

Performance Qualification (PQ)

  • Airborne particulate levels

  • Surface particulate levels

  • Viable microbial particulates

  • Relative humidity

  • Differential pressure

  • Temperature