Pharmacy Courses

URS for Hardness and Thickness Tester


Objective

To procure a hardness and thickness tester which will be used to measure hardness and thickness of different size and shaped tablet.


Functional Requirements

  • In compliance with cGMP, USP <1217> and EP 2.9.8.
  • The instrument should be fully automated.
  • 10 samples should measure in a one test run.
  • Selectable hardness measurement mode (kg, N, kp etc.) is required.
  • Tablet collection container is required.
  • Quick start functionality is required to start testing with minimal preparations.
  • Should have option to enter “product name” and “batch no” up to 12 digit.
  • Digital PLC with keyboard is required.
  • Printing option through PLC is required.
  • Easy to carry and transferable.


Technical Requirements

  • Weight range: 0.02 g – 64 g
  • Hardness range: 2 N – 500 N
  • Diameter: 2 m – 26 m
  • Thickness: 2 m – 15 m
  • Width: 2 m – 26 m


Documents Requirements

  • Operational and maintenance manual
  • IQ & OQ documents


Life Cycle Requirements

  • Commissioning requirement
  • Qualification requirement
  • Maintenance
  • Training


Other Requirements as Appropriate

  • Type of construction
  • Materials to be used
  • Cleaning
  • Delivery
  • Traceability
  • Factory acceptance test (FAT)/Site acceptance test (SAT)


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