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)
