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

Select from below options to generate the correct product code (SKU) and click on “Request for Quote” to send us an enquiry.

Description

Ampoule Break Force Tester

Ampoule Break Force Tester is used to determine the force required to separate the ampoule stem from the body and for assessing whether a clean break is obtained.

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.

Ampule Break Force Tester              
Variable Speed Model with Stepper Drive
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.

Test Speed :                            10 mm/min.
Pre/Post Test Speed :             250mm/min

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

Ampoule Break Force Tester accessories / fixtures :          

  • Top Wedge (common for all ampule sizes) INCLUDED with machine.
  • Acrylic Guard (common for all ampule holders up to 20 ml) INCLUDED with machine.
  • Ampoule Holder NOT INCLUDED with machine.
    • Universal Holder (1-5 ml)
    • Universal Holder (>10 ml)
    • Dedicated Holder (for each ampule size) with auto-centering.

Utilities Required :

  • Power Supply (Current : Max 5 Amps) :
    1. For India (Domestic Model) : 230 Volts A.C., 50 Hz. Clean power.
    2. For Outside India (Export Model) : As per your country’s power rating.
  • Calibration weights : 5 Kg (2 + 2 + 1 Kg)
  • Desktop PC (Core i3, 4 GB RAM, 500 GB HDD, RS-232 port, 1080p HD Monitor).

DQ/IQ/OQ Documentation is supplied with the equipment.

Software Options :     Regular Software / 21-CFR-11 Compliant Software (Vantage).

RS-232 Data Cable with USB-Serial Convertor is supplied with all models / SKUs.

Warranty :                  12 Months (Ex-Factory)

Below Fixtures are INCLUDED in the machine by default.

Sr Item Name Description
1 Top Wedge Common for all ampoule sizes.
2 Acrylic Guard Common for 1-20 ml ampoules.

Note : If your ampoule size is >20 ml, you will need to order special Acrylic Guard for the same at additional cost.

Below Fixtures need to be selected and ordered with the basic machine.

Sr Item Name Description
1 Universal

Ampoule Holder

Adjustable Height Type.

  1. Universal Ampoule Holder for 1-5 ml.
  2. Universal Ampoule Holder for >10 ml.
or
2 Dedicated

Ampoule Holder

Dedicated Holder for every specific ampoule size.
Provided with 1 end dead stop for quick and easy ampoule placement / alignment. Easier to use.Note :

  1. Every specific ampoule will need a specific / dedicated adopter.
  2. This is made as per the stem and body dia of the sample you will provide.
  3. If you have 2 different volume ampoules with same stem and body dia but different length, it will be considered as 1 holder.
  4. If you have 2 same volume ampoules but with different stem and body dia, they will be considered as 2 separate holders.

Download Ampoule Break Force Tester Datasheet

Video of Ampoule Break Force Tester

Additional information

Region

India, Outside India

Industry

Pharmaceutical

Series

ABF20

Software

Regular Software, 21-CFR-11 Compliant Software

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