Ampoule Break Force Tester


Ampoule Break Force Tester is an equipment suitable for determining the force required to separate the ampoule stem from the body and for assessing whether a clean break is obtained.

A glass ampoule is broken at the constriction area by the medical practitioner before usage.
A good ampoule should break clean and should not leave any sharp glass fragments upon breaking.
This breaking action is usually done with bare hands or wearing thin rubber gloves. Hence, a poor quality ampoule which does not break cleanly or needs very high breaking force, can easily cause injury to the medical practitioner and possibly contaminate the drug too.

ISO 9187 specifies the minimum breaking force to be 30N and the maximum breaking force to be 80N, 90N, and 100N for ampoules of <5ml, 10ml and >20ml respectively.

The Ampoule Break Force Tester can be used to test : OPC, CBR and SR type ampoules.

Confirms to : ISO 9187


Ampoule Break Force Tester
Variable Speed Model with Stepper Drive
Computer Controlled Model with facility to capture test data on to the PC directly through the software and generate PDF test reports.
Digital Model with Backlit LCD Display for easy readability.
With Peak hold facility.
Motorised operation with Ball screw mechanism for extra smooth operation.
Not dependent on operator skill.
Confirms to ISO 9187-1 with a Test Speed 10mm/min
Faster return / jog speed to save time.

Model: ABF-20-DS-DX          Capacity:         20 Kg with least count of 2 gm.

Includes :       Serial Port (9 Pin DB Connector) + Data Cable + Software for Windows 10 or higer
Excludes :      Desktop PC (with Serial Port) and Laser / Inkjet Printer 

Note : The Software (Vantage ABF) is 21-CFR-11 compliant.

To know about the features of the software CLICK HERE.

Optional Fixtures / Attachments :

  1. Ampoule Break Force Test Fixtures (to be ordered with the machine)
    • Top Wedge (common for all ampule sizes)
    • Acrylic Guard (common for all ampule holders)
    • Ampoule Holder
      • Universal Holder (1-5 ml)
      • Universal Holder (>10 ml)
      • Dedicated Holder (for each ampule size) with auto-centering.

Note : You have to order either 1 – 2 Universal Holders or multiple Dedicated Holders for your different ampule sizes.

Utilities Required for Ampoule Break Force Tester :

  • Power : 230/110 Volts A.C., 50/60 Hz. Clean power.
  • Calibration weights : 5 Kg (in any combination)
  • Desktop PC or Laptop PC
    • Processor Type :   Intel Core I3 or better. (Preferably Core I5 or Higher)
    • Memory :              4 GB RAM or better
    • Space :                  50 GB free HDD space           (minimum)
    • Monitor :               17” or larger Monitor with 1080p (FHD) resolution
    • Operating System: Windows 10 or higher (with latest updates & patches)
    • Supporting Software :       Adobe Acrobat Reader and Microsoft Dot Net Framework           (Latest Version)
    • Printer :                 Laser or Inkjet Printer.

DQ/IQ/OQ Documentation Set available for Pharmaceutical companies

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