Pharmacy Courses

User Requirement Specification (URS) for Disintegration Tester

1. Objective and Scope

To procure a disintegration tester for determination of disintegration time of tablets and capsules.

2. Functional Requirement

  • Digital LCD display for time and temperature
  • Programmable timer with alarm and temperature controller
  • Illuminated water bath for better visibility 
  • Both timer mode and registration mode
  • `PAUSE' facility: This facility permits to check disintegration state of the tablets intermittently and continue test without disturbing the test parameters.
  • Print out option for disintegration time with temperature
  • Facility to print company’s name on test report.
  • Regulatory compliant

Technical requirements for a disintegration tester are summarized in below table -

3. Documents Requirement

  • Operational and maintenance manual
  • DQ, IQ & OQ protocol

4. Life Cycle Requirements 

  • Design Review
  • Commissioning Requirements
  • Document Requirements
  • Qualification Requirements
  • Life Cycle Testing
  • Maintenance
  • Training

5. Other Requirements as Appropriate

  • Type of Construction
  • Materials to be Used
  • Cleaning
  • Effectiveness of Seals
  • Heat Insulation
  • Electrical Requirements
  • Noise
  • Delivery
  • Traceability
  • Factory Acceptance Test (FAT) / Site Acceptance Test (SAT)

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