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IQ OQ PQ

IQ, OQ and PQ are performed to provide documented evidence that a critical system is properly installed, operates as intended, and performs adequately throughout the intended range of operation.

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Installation Qualification

  • Inspection and Test Reports
  • Major Components
  • Distribution Pumps
  • Ultraviolet Sanitizers
  • Filters
  • Instrumentation
  • Valves
  • Distribution Loop Piping
  • Controls
  • Utilities
  • Specifications and Purchase Orders
  • Drawings
  • Lubricants
  • Spare Parts List
  • Engineering Documentation

Operational Qualification

  • Airborne particle counts to ISO 14644-1
  • Air and surface microbial monitoring
  • HEPA and ULPA Integrity tests
  • Filter velocity tests
  • Air Changes per Hour
  • Room pressure differential
  • Room recovery from generated challenge
  • Room Finishes
  • Electrical Installation
  • Plumbing Installation
  • Power Failure Shutdown and Startup

Performance Qualification

  • Operational ISO 14644-1 particle counts
  • Maximum and minimum load studies