Cleanroom Installation Qualification
Phase Two: Installation Qualification
The purpose of this Installation Qualification (IQ) phase is to confirm through verification that equipment — as installed — confirms to user requirements and design requirements. Verification is focused on the following items that should be called for in your IQ protocol:
• HVAC calibration
• P&ID loop verification
• HEPA filter integrity test data review
• Critical equipment calibration status
• Site Acceptance Tests(SATs)
• Installation Qualification tests
• Piping and welding documentation
• Utility verification
• System standard operating procedures and work instructions
The output of this phase should be an IQ report addressing all the above elements, and an SDL file that documents the following elements:
• Project changes
• IQ tests performed
• Calibration
• Supplier supplied documents
• Equipment certificate
• Installation deviations
• Site Acceptance Tests (SAT)
• Consumable list
• Spare part list
• Environmental review report
• List of Operational and Instructional documents
IQ approval is a pre-requisite for the start of the Operational Qualification (OQ) phase.
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