Cleanroom Documentation
Design Qualification (DQ)
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User Requirement Specifications(URS)
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Vendor documents and specifications
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Facility layout
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Purchase orders
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Design documentation
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Factory Acceptance Tests (FATs)
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As build drawings
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Data sheets
Operational Qualification (OQ)
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HVAC calibration
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HEPA filter integrity test data review
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Critical equipment calibration status
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Site Acceptance Tests(SATs)
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Installation Qualification tests
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Chilled & Hot-water Piping documentation
Installation Qualification (IQ)
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Testing HVAC system operation against specified functional requirements
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Critical & Interlock Alarms
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Critical operating parameters
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Filter integrity tests
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Standard operation for the clean room
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Air speed, flow & patterns
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Pressure differential
Performance Qualification (PQ)
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Airborne particulate levels
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Surface particulate levels
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Viable microbial particulates
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Relative humidity
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Differential pressure
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Temperature
