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Welcome To Quality Solution (India)

Validation

TEMPERATURE MAPPING

QSI also performs Autoclave validations and Temperature Uniformity surveys as per AMS-2750D, AMS-2750E, API-6A Appendix-H, API-6A Annex – M & CQI-9.

We can perform temperature mapping of equipment such as fridges, freezers & ULT freezers, environmental test chambers and stability chambers, incubators, ovens, furnaces & cold stores, autoclaves etc.

With years of experience in multi point temperature we produce fast and accurate temperature mapping results.

HVAC VALIDATION

QSI HVAC division carries out validations as per ISO 14644, EU cGMP, US Federal Standard 209E, US (FDA) Schedule M (National Regulatory Body), WHO Geneva, USFDA, TGA (Australia), European Standards (EMEA), MHRA (European countries) guidelines.

We carry out following tests to validate clean rooms : –

  • Air Velocity Measurement
  • Particle Count Test
  • PAO HEPA Filter Integrity Test
  • Air Exchange Ratio
  • Airflow Visualisation Test
  • Room Pressurisation Test
  • Recovery Test
  • Temperature and Humidity Test
  • Light Intensity Test
  • Noise Level Test
  • Containment Test