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)
Related:
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