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Equipment/Instrument , Building Qualification Study

Equipment Validation - Travel-Paulius-Skema

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 and using a certified and traceable instruments, we performed qualification for the following:

 

    • Water treatment System.
    • HVAC System (Heat Ventilation Air Condition)
    • Compress Air System.
    • Lab Instrument’s
      1. Steam Sterilizer (Autoclave)
      2. Oven’s
      3. Incubator’s
      4. Refrigerator’s
      5. Freezer’s
      6. Balance’s
      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.
    • Production Machine.
      1. Tablet Line
      2. Powder Line
      3. Syrup Line
      4. Suppositories Line
      5. Capsule Line
      6. Cream and Ointment Line.
      7. Powder Line.
      8. Weighing Booth
      9. Packaging line.
      10. Cold Room

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

    • IQ/ Installation Qualification.
    • OQ/ Operation Qualification.
    • PQ/ Performance Qualification.

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