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Facility Qualifications

Facility Qualification is documented verification that a finished facility complies with the engineering design specifications and user requirements. Encompasses typical IQ/OQ components in one plan.

Facility Qualification Key Tests

  • 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
  • Smoke visualization
  • Room recovery from generated challenge
  • Room Finishes
  • Electrical Installation
  • Plumbing Installation
  • Calibration Verification
  • SOP Verification

Experience and Equipment needed to complete the validation project

Gerbig Engineering Validation Services has over 60 specialized test and measurement instruments maintained in calibration to NIST-traceable standards. Extensive experience in cGMP equipment qualification for medical device and pharmaceutical applications