PTBA 211E
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Manual Ampoule Breakpoint Test Instrument - Type PTBA 211E The PTBA 211E Ampoule Breakpoint tester is design and manufactured in compliance to the DIN/ISO 9187 standard. According to the DIN/ISO standards Ampoule Breakpoint has to be tested in order to control the quality during production. Principle of Operation… The testing jaw is moved by means of a stepper motor into the neck of the ampoule to be tested. The ampoule is placed onto a DIN/ISO compliant support. As soon as the jaw meets the ampoule the instrument increases the force in a linear speed mode until the sample breaks, the usual force rate is 10 mm/min. As soon as the ampoule is broken, the maximum force will be displayed and printed. The test jaw moves back to the home position ready for the next test. As the operator can enter an automatic re-start time, the next test will be performed immediately after a new sample has been placed onto the ampoule support. A movable tray holds the ampoule support, a Plexiglas (Perspex) screen protects the operator. A built-in lamp illuminates the handling area to ease the correct positioning of the ampoule at the support. Exchangeable ampoule supports allow the test of all kinds of ampoules from 1-30 ml. PHARMA TEST AG Siemensstrasse 5 D-63512 Hainburg (GER)

Manual Ampoule Breakpoint Test Instrument - Type PTBA 211E Calibration and Validation To validate the hardness test station the PT-MT magnetic tablet is used. Select a force, for example 50, 85 or 130 N, and run a test series, the resolution of the results should be within 1.0N. The PT-MT instrument works like an ampoule, it withstands force and than “breaks”. For the 2 point calibration (adjustment) of the hardness station a certified reference weight of 10 kg is used. All calibration and validation results can be printed and countersigned. To qualify the linearity of the built-in load...

> Ampoule testing in compliance with the DIN/ISO 9187 standard > Programmable print-out of force increase curve > Built-in printer connection port to connect any Dot-Matrix or PCL5 printer > Built-in RS-232 COM port > Calibration menu for the hardness test station > LED display and keyboard > Statistical calculation of results > Print-out of PQ result data > Exchangeable ampoule supports Technical Data Display: Keyboard: Hardness: Accuracy: Measuring units: Force rate: Range: Number of tests prior to statistic: Dual Point Calibration Procedure: Validation linearity load...

Manual Ampoule Breakpoint Test Instrument - Type PTBA 211E PHARMA TEST AG Siemensstrasse 5 D-63512 Hainburg (GER) +49 6182 9532-600 +49 6182 9532-650 email@pharma-test.de www.pharma-test. com