Installation Qualification Checklist

Installation Qualification Checklist

Major Component Verification

Confirm that major HVAC and Cleanroom components are installed and correspond with the design specifications.

  • Mechanical Services Specification
  • Area Finishes Schedule
  • Instrument Schedule

Engineering Drawings

Verify that all relevant “as-built” drawings have the correct information and accurately reflect the installation.

  • Mechanical Drawings – Duct & Filter installation, diffusers, & etc.
  • Cleanroom Construction Drawings – details, penetrations, & etc.
  • Layout and arrangement drawings
  • Electrical SLD
  • Control Schematics

Engineering Documentation

Verify that all documents associated with the Cleanrooms are present.  All final documents to be included and reviewed for correctness as per the installed equipment / system configuration.

Where applicable, construction handover and acceptance files provided by vendors shall include detailed equipment, instrumentation, electrical installation and testing documents.

  • Airflow Velocity and Uniformity Test Sheets
  • HEPA Filter Installation Test Sheets
  • Equipment Specification Data Sheets
  • Equipment Installation Test Sheets
  • Instrument Specification Data Sheets
  • Instrument Installation Test Sheets

Calibration Certification

The instruments used on the Cleanrooms are required to be recorded, categorized as critical / non-critical.  Critical instruments are defined as those instruments whose accuracy / precision may have an influence on product quality, equipment operability or safety.

Ensure that all critical instruments have been identified in the “Instrument List” in the protocol.  Verify that all the critical instruments listed in the protocol have:

  • Been tagged
  • Calibrated prior to operation to a NATA traceable standard or appropriate calibration procedure
  • Been labeled with a valid calibration sticker, within expiry period
  • Lie within the calibration lifetime
  • Have the above details logged and filed in the IQ protocol

Verify that the non-critical instruments listed in the protocol have either of the following:

  • A calibration certificate
  • Test report or
  • Set point or normal operating range documented in the Protocol

Design Documents Required For IQ

  • Mechanical Services Specification
  • Area Finishes Schedule
  • Equipment Schedule
  • Instrument Schedule
  • Mechanical Drawings – Duct & Filter installation, diffusers, & etc.
  • Cleanroom Construction Drawings – details, penetrations, & etc.
  • Layout and arrangement drawings
  • Equipment Specification Data Sheets
  • Instrument Specification Data Sheets

Operational Qualification Checklist

  • Air Quality / Particulate Testing
  • Air Velocity / Room Change Rates
  • Room delta P / Pressure Regime Testing
  • Filter delta P Testing
  • Room Temperature, Humidity Control
  • HVAC Controls (start / shutdown / alarms)
  • Noise Level Testing

Design Documents Required for OQ

Verify that all document associated with the Cleanrooms and HVAC systems are present.  All final documents to be included and reviewed for correctness as per the installed equipment and systems.

Where applicable, construction handover and acceptance files provided by vendors shall include detailed equipment, instrumentation, electrical installation and testing documents.

  • Room Test Sheets
  • NEBB Test Sheets
  • HVAC Test Sheets
  • Instrument / Controls Output Traces
  • Noise Level Test Sheets