Objective
To procure a compression machine suitable for smooth manufacturing of tablets.
Functional Requirements
- Machine design in such that it can produce single layer/bi-layer tablets.
- Required maximum output of the machine is to be 1000 to 500,000 tablets per hour.
- No. of stations to be 10 to 30.
- Capable to compress minimum 500 g powder/granules.
- Block dies are to be provided as per number of stations.
- Tablet diameter is to be maximum 16 mm for round tablet and 21 mm for shaped tablet.
- Tablet tooling type to be B & D type.
- Maximum pre-compression force to be 100 kN.
- Maximum main compression force to be 100 kN.
- Automatic lubrication system where required.
- Anti-vibration mounting to reduce noise and vibration.
- Additional lower cam to adjust depth of die fills.
- Additional depth of fill cam size (8 mm, 10 mm, 14 mm, 18 mm).
- Upper and lower punch tightness detector.
- Compaction force monitoring and control system.
- Adjustable upper punch penetration.
- Manual control butterfly valve at the end of powder hopper.
- MOC for product non-contact parts: SS 304
- MOC for product contact parts: SS 316L.
- TSE/BSE certification for all product contact parts (if required).
- Spare parts are to be prepared when required.
- Digital PLC for monitoring and controlling with password protection.
- Recipe creation and administration facility for at least 200 products.
- Batch data report printout facility.
Interface
- Control system with industrial touch screen to ensure safe and efficient operation unit.
- The system is controlled trough comfort panel as HMI with all function deriving from PLC controller.
Documents Requirements
- Operational and maintenance manual
- DQ, IQ & OQ documents
Life Cycle Requirements
- Design review
- 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)
