PTBA 211E Ampoule Breakpoint Tester
PTBA 211E is a specialized instrument designed for testing the breakpoint of ampoules, adhering to the DIN EN ISO <9187-1/2:2010> standard. This ensures quality control during the production of empty ampoules and before the filling process.
Key Features:
- Dual Force Modes: Offers linear speed increase and linear force increase modes for flexibility in testing.
- Automatic Re-Start: Enables immediate testing of subsequent samples with programmable re-start time.
- Data Documentation: Results are displayed and printed with details including date, time, serial number, batch number, mean value, and deviations. Printouts can be done using a PCL5 or dot-matrix printer.
- Safety and Convenience: A Plexiglas (Perspex) screen for operator protection and a built-in lamp for proper ampoule positioning. Exchangeable supports accommodate ampoules from 1-30 ml.
Operating Principle:
- The testing jaw, moved by a stepper motor, applies force in a linear speed mode (standard rate: 10 mm/min) until the ampoule breaks.
- The maximum force at breakage is recorded and printed.
- The jaw then returns to the home position for the next test.
Advantages:
- Compliance with DIN EN ISO <9187-1/2:2010>.
- Automatic re-start and programmable force rate enhance efficiency.
- Detailed documentation with programmable print-out of the force increase curve.
- Data transfer and multiple point calibration ensure precise measurements.
Technical Specifications:
- Display: LED display for test results and breakpoint data.
- Force Range: 5.0 to approximately 300N (optional 500N).
- Accuracy: <1N, resolution 0.074N (300N model) to 0.1482N (500N model).
- Force Settings: Linear speed or linear force increase (standard setting: 10 mm/min).
- Selectable Range: 4.0 – 200 mm/min or 5.0 – 200 N/second.
- Printer Interface: Parallel for dot-matrix or PCL5 printer.
- Data Interface: RS-232 COM port for data transfer.
- Calibration: Multiple point calibration for load cell precision with built-in procedures.
- Adjustments: Two-point adjustment for zero and 10kg.
Instrument Housing:
- Made of stainless steel (312) to meet GLP requirements.
Bench Space Requirement:
- Dimensions: L 30 cm x W 30 cm x H 48 cm (without external printer).
Certification:
- All components certified to DIN EN ISO requirements.
- CE / EMC Certification provided.
- Validation includes IQ & OQ documents.
Included in the Standard Scope of Supply:
- Standard jaw set for testing ampoules up to 30 ml.
- Broken sample collector and protection shield.
- Comprehensive documentation folder:
- User manual
- QC/DQ testing certificate
- IQ documentation
- OQ documentation
- Conformity Declaration
- CE/EMC Declaration
- Instrument logbook