PTBA 211E
PTBA 211E ampoule breakpoint tester to control the quality during production of empty ampoules
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
