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

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

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SKU : #PD1630-PTBA

PTBA 211E

Ampoule Breakpoint Tester

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)

 

Technical Specifications

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

 

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

 

Data Sheet Download Click here

 

Options

  • 500N (PTBA 211E-500) extended force range

  • Dot-Matrix or PCL5 Laser Printer

  • PTBA32 PC software package for instrument control and data handling

  • Recommended spare part set

  • Full range of certified validation tools available