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PTBA 211E Ampoule Breakpoint Tester

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Code: #22329

Supplier: Pharma Test Apparatebau AG

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

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rightMORE INFORMATION

  • 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
     

  • 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: linear speed 10mm/Min)

    Selectable Range

    4.0 – 200 Millimeter/Minute or 5.0 – 200 N/Second

    Accuracy

    < 2% force or < 0.1% speed

    Printer

    Parallel Interface to connect Dot-Matrix or PCL 5 Printer

    Interface

    RS232 COM port

    Calibrations

    Multiple point for load cell precision using certified weights (PT-CAL15/30 and PT-CAL 50)

    Calibration Guidance

    Built-in calibration procedures the digital load cell

    Adjustments

    Two point adjustment – zero and 10kg

    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 DIN EN ISO requirements

    CE / EMC Certification

    All CE / EMC Certification provided

    Validation

    All IQ & OQ documents included

  • 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)

 

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