PTBA 211E
6Pages

PTBA 211E Ampoule Breakpoint Testing Instrument The PTBA 211E ampoule breakpoint tester is design and manufactured in compliance to the EN-ISO <9187-1/2:2010> standard. According to the DIN/ISO standards Ampoule Breakpoint has to be tested in order to control the quality during production of empty ampoules and prior to the filling process. Pharma Test Apparatebau AG Siemensstr. 5 63512 HAINBURG GERMANY T: +49 6182 9532-600 F: +49 6182 9532-650 info@pharma-test.de www.pharma-test.com THE PHARMA TEST GROUP

PTBA 211E – Ampoule Breakpoint Testing Instrument The result is immediately displayed and printed to a connected dot-matrix or suitable PCL5 type Laser-Jet or a Dot-Matrix printer. Repeat this until your series has been tested, get a full print-out including each individual result, date, time, serial number of the instrument, batch number of the product tested, mean value and deviations of the test series. Operating Principle 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...

PTBA 211E – Ampoule Breakpoint Testing Instrument Validation Report

PTBA 211E – Ampoule Breakpoint Testing Instrument Entry of time and date Enter a 12 digit batch number Automatic re-start facility to speed up the testing sequence Documentation of all results using a separate Dot-Matrix or PCL5 printer Validation and calibration program for the measurement station Force curve print out Dual point adjustment of the load cell for the hardness test station Multiple point validation (calibration) Programmable print-out of force increase curve Data transfer via RS-232 interface Breakpoint testing of empty ampoules in compliance with the EN ISO <9187-1/2:2010>...

PTBA 211E – Ampoule Breakpoint Testing Instrument Standard Scope of Supply The PTBA 211E comes ready to use with the following standard scope of supply: » Standard Jaw set to allow breakpoint test of all size of ampoules up to 30ml » Broken Sample collector and protection shield » Comprehensive documentation folder including: › User manual › QC/DQ testing certificate › IQ documentation › OQ documentation › Conformity Declaration › CE/EMC Declaration › Instrument logbook Options In addition to the standard scope of supply Pharma Test offers a broad range of accessories and options including:...

PTBA 211E – Ampoule Breakpoint Testing Instrument Technical Data Parameter LED Display showing number of tests and breakpoint result Data Entry Numerical and Functional keys Standard Force Range Force Settings Linear speed or linear force increase (standard setting: 10 mm/Min) Selectable Range Parallel Interface to connect Dot-Matrix or PCL 5 Printer Calibration Guidance Built-in calibration procedures the digital load cell Two point adjustment - zero and 10kg Multiple point for load cell precision using certified weights (PTCAL15/30 and PT-CAL 50) Force Detection Reproducibility PT-MT3...