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Qualification and Validation

We provide industrial field with the services of Buildings, equipment’s, instruments, and utilities qualification studies to ensure its compliance to company specifications, manufacturer specifications, and international standards in a defined plan according to study priority, customer requirements, and study period of time using certified and traceable instruments, we performed qualification for the following:

Utilities

  1. Water treatment System.
  2. HVAC System (Heat Ventilation Air Condition)
  3. Compressed Air System.
  4. Chillers

Production Area and its Machines

  1. Clean room qualification
  2. Filling Machines (Tablet, Capsules, liquid and Semisolids etc)
  3. Tunnels
  4. Autoclaves
  5. Fluid Bed Dryer
  6. Weighing and Sampling Booths

Lab Instrument’s

  1. Steam Sterilizer (Autoclave)
  2. Ovens
  3. Incubators
  4. Refrigerators
  5. Freezers
  6. Balances
  7. Water Bath
  8. Dissolution tester
  9. Hardness Tester
  10. Disintegration tester.
  11. Friability Tester.
  12. Stability Chamber.
  13. HPLC, GC, GC/MS, UV Spectrophotometer.
  14. LAF Safety cabinet
  15. And Others

Qualification studies Include the build Protocol, to each (Machine, Instruments, etc….. ) and the protocol will contains of the followings:

 

  • – DQ/ Design Qualification
  • – IQ/ Installation Qualification.
  • – OQ/ Operation Qualification.
  • – PQ/ Performance Qualification

The qualification protocol may include, but not limit to, the following tests:

  1. Room Differential Pressure.
  2. Temperature and Relative Humidity
  3. Air Volume, and Air Velocity
  4. HEPA Filter Integrity Test (PAO/DOP)
  5. Particle Counter.
  6. Light Intensity.
  7. Sound
  8. Air Change /ACH
  9. Air Balancing for Clean Room
  10. Duct Leak.
  11. Vibration

Done by well trained and expert personnel and calibrated instrument following approved procedures and protocols

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