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    Ampoule Breakpoint Tester

Ampoule Breakpoint Tester

  • Breakpoint testing of empty ampoules in compliance with the DIN EN ISO <9187-1/2:2010>
  • Force standard setting: linear speed increase 10mm/min. (adjustable)
  • Automatic re-start facility to speed up the testing sequence

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The PTBA 211E ampoule breakpoint tester is designed and manufactured in compliance to the DIN EN ISO <9187-1/2:2010> standard


According to this standard the break point of ampoules has to be tested to control the quality during production of empty ampoules and prior to the filling process.


Features

  • Dual force mode instrument with linear speed increase and linear force increase modes
  • Multiple point validation procedure built-in
  • Programmable print-out of force increase curve


Advantages

  • Breakpoint testing of empty ampoules in compliance with the DIN EN ISO <9187-1/2:2010>
  • Force standard setting: linear speed increase 10mm/min. (adjustable)
  • Automatic re-start facility to speed up the testing sequence
  • Entry of time and date
  • Enter a 12 digit batch number
  • Documentation of all results using a separate PCL5 or dot-matrix printer
  • Programmable print-out of force increase curve
  • Data transfer via RS-232 interface
  • Validation and calibration program for the measurement station
  • Dual point adjustment of the load cell for the hardness test station
  • Multiple point validation (calibration)


Print-Out Results

The result is immediately displayed and printed to a connected laser printer (PCL5 capable) 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 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 1-30ml.


Included in the 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
ParameterSpecification
DisplayLED Display showing number of tests and breakpoint result
Data EntryNumerical and Functional keys
Standard Force Range5.0 to approximately 300N (optional 500N)
Accuracy< 1N
Resolution0.074N (300N model) – 0.1482N (500N model)
Force SettingsLinear speed or linear force increase (standard setting: linear speed 10mm/Min)
Selectable Range4.0 – 200 Millimeter/Minute or 5.0 – 200 N/Second
Accuracy< 2% force or < 0.1% speed
PrinterParallel Interface to connect Dot-Matrix or PCL 5 Printer
InterfaceRS232 COM port
CalibrationsMultiple point for load cell precision using certified weights (PT-CAL15/30 and PT-CAL 50)
Calibration GuidanceBuilt-in calibration procedures the digital load cell
AdjustmentsTwo point adjustment – zero and 10kg
Force Detection ReproducibilityPT-MT3 Magnetic Tablet and suitable support
Instrument HousingStainless Steel (312) to meet GLP requirements
Bench Space RequirementL 30cm x W 30cm x H 48cm (without external printer )
CertificationAll components certified to DIN EN ISO requirements
CE / EMC CertificationAll CE / EMC Certification provided
ValidationAll IQ & OQ documents included