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HVAC Validation
Following tests are performed:
  • Air Balancing
  • Pressure Balancing
  • Blower Static Pressure Test
  • Vibration Test of Blower
  • Air velocity test (ACPH)
  • HEPA Filter Integrity test (Using PAO)
  • Non Viable Particle count test
  • Viable Particle Count
  • AHU Recovery test / Sweep test.
  • Air flow Pattern test (smoke test)
  • Air flow Pattern test ( with Water Fogger)
  • Room Leakage Test
  • Light intensity testing.
  • Sound Level Test
  • Vibration Test ( For Clean Room Walls and Window)
  • RH and Temperature Mapping
Compressed Air Validation
Following tests are performed:
  • Dew Point
  • Water Vapors
  • Oil and Mist
  • Carbon Dioxide
  • Carbon monoxide
  • NO 2 /NO
  • Oxygen Concentration
  • Hydrocarbon (Lower Class)
  • Hydrocarbon (Higher Class)
  • Viable Particle Count
Nitrogen Gas Validation
Following tests are performed:
  • Description
  • Solubility
  • Identification
  • Assay (Nitrogen Purity Test)
  • Oxygen Contents
  • Water Vapors
  • Dew Point
  • Carbon Dioxide
  • Carbon monoxide
  • NO 2 /NO
  • SO 2
  • Non-Viable Particle Count
  • Viable Particle Count
Pure Steam Validation
The Pure steam generation system and distribution system evaluated for following Tests:
  • Non-Condensable Gases Test
  • Super Heat Test
  • Dryness Value
Thermal Validation
Thermal Validation done as per HTM, PDA, USFDA Guidelines
  • Autoclave Validation
  • Tunnel Validation
  • DHS or Hot Air Oven Validation
Temperature Mapping
Temperature Mapping is done as per WHO guidelines.
  • Deep freezer Mapping
  • Lyophilizer
  • Refrigerator
  • Incubators (BAC/BOD)
  • Quarantine/Process Area
PLC and SCADA /CSV Validation
PLC and SCADA System and Excel sheet Validation done to meet the requirement of 21 CFR Part 210 and 211 and EU-GMP Annexure-11 and GAMP-5 guidelines.
  • Computer system Validation Master Plan
  • System Parameters assessment
  • Risk assessment
  • GxP System Assessment
  • 21 CFR Part 210 and 211 Compliance system assessment
  • Installation Qualification
  • Operational Qualification
  • Performance Qualification