Test method of Ampoule break force tester

Keywords: Break Force, Ampoule, Breaking Strength, Medical Packaging Tester

The breaking force of ampoules is the key control point in clinical use, production and transportation of ampoules. The ampoule break force tester accurately measures the breaking force of the ampoule to help manufacturers adjust production parameters to meet the dual purposes of quality control and clinical convenience. This article introduces the test method of breaking force of ampoules.

medical packaging tester TST-01H

Test significance:

Ampoules/ampules are fusion-sealable containers used to contain injection medicines. They are generally made of glass. At present, plastic ampoules are also used, with a capacity of 1-25 mL, which are used to store vaccines, serum, oral liquids, etc.The production and method of glass ampoules is to blow the glass body into a shape and then fill the liquid, heat and fuse it with a laser or open flame.When using, use a grinding wheel to make a dent on the bottleneck, break the bottleneck on the head to open the medicine bottle.

The glass ampoules are stable in nature, difficult to react with drugs, have good barrier properties, can effectively isolate the penetration of air and moisture, and have good light transmission and high temperature resistance.However, glass ampoules are easy to break, especially in the process of opening, if the ampoules breaking force is too large or the fracture is broken, medical staff may be injured.A more serious situation is that when the fracture is broken, insoluble particles (such as glass fragments) may be generated in the fracture. If the particles enter the liquid medicine and enter the human body with the injection, it will cause harm to the human body, such as subcutaneous injection will cause nodules , Intravenous injection may cause blood clots and so on. Therefore, the breaking force of ampoules is an important performance parameter to judge the quality of ampoules.

Test Standard:

After the ampoule is broken, the section should be flat

Test Steps:

-Place the ampoule on the sample holder of the appropriate length of the fixture on the  instrument base.

-Adjust the position of the ampoule so that the color dot of the ampoule is facing downwards, and the instrument forcing device is facing the middle of the score.

-Set the test parameters and test speed (10 mm/min), and start the test. The breaking device of the instrument starts to press down at a constant speed at the test speed until the

ampoule is broken, and the test ends, and the result is displayed in the software.

-Take out the broken sample and observe whether the broken part of the ampoule is flat and whether there are cracks.

-The test is finished: After testing, the breaking force of the ampoule sample this time is 69.123 N, and there are small cracks on the surface.

Ampoule break force tester device

Conclusion:

The medical packaging tester TST-01H can accurately test the breaking force of ampoules, helping companies to effectively control the quality of ampoules and reduce the incidence of quality problems. Besides the breaking force of the ampoule, the medical packaging tester can also test the tensile performance, tearing performance, peeling performance, rubber stopper puncture force, syringe sliding performance, syringe body tightness, injection needle puncture force, injection needle needle Physical properties of medical packaging such as the connection firmness of the seat needle tube.

More pharm packaging tester, please contact Horizon tester.