PTBA 211E

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

PTBA 211E

Ampoule Breakpoint Tester

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.

PTBA 211E Ampoule Breakpoint Testing Instrument

PTBA 211E Ampoule Breakpoint Testing Instrument

Print-Out Results

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 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.

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

  • 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>
  • Speed increase rate factory setting: 10mm/min.
  • Force increase rate 20-200 N/s can be set alternatively

Technical Specifications

Parameter Specification
Display LED Display showing number of tests and breakpoint result
Data Entry Numerical and Functional keys
Standard Force Range 5.0 to approximately 300N (optional 500N)
Accuracy < 1N
Resolution 0.074N (300N model) – 0.1482N (500N model)
Force Settings Linear speed or linear force increase (standard setting: 10 mm/Min)
Selectable Range 5.0 – 200 N/Second or Millimeter/Minute
Accuracy < 2% force or < 0.1% speed
Printer Parallel Interface to connect Dot-Matrix or PCL 5 Printer
Interface RS232 COM port
Calibration Guidance Built-in calibration procedures the digital load cell
Adjustments Two point adjustment – zero and 10kg
Calibrations Multiple point for load cell precision using certified weights (PT-CAL15/30 and PT-CAL 50)
Force Detection Reproducibility PT-MT3 Magnetic Tablet and suitable support
Instrument Housing Stainless Steel (312) to meet GLP requirements
Bench Space Requirement L 30cm x W 30cm x H 48cm (without external printer )
Certification All components certified to USP / EP requirements
CE / EMC Certification All CE / EMC Certification provided
Validation All IQ & OQ documents included

We reserve the right to make technical changes without any prior notice.

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

Options

  • 500N (PTBA 211E-500) extended force range
  • Dot-Matrix or PCL5 Laser Printer
  • Recommended spare part set
  • Full range of certified validation tools available

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