Medical stoppers are an important category of pharmaceutical packaging materials that can be used in conjunction with pharmaceutical packaging or medical devices such as vials, syringes, infusion bags, infusion bottles, and vacuum blood collection tubes. For medical stoppers, due to differences in molecular structure, composition, and production processes, in addition to safety and drug resistance, physical and mechanical properties such as sealing performance and puncture resistance cannot be overlooked. If the puncture resistance of a stopper is too high, requiring excessive force to puncture it, it may cause the needle to bend, creating inconvenience for medical staff during procedures such as medication extraction and blood drawing. Additionally, if the puncture resistance of a medical stopper is poor, it may easily generate debris after puncture, which, if it enters the medication, can severely endanger the safety of patients.

Therefore, appropriate puncture resistance and good puncture performance are essential properties that medical stoppers should possess.

What testing instrument is used for evaluating the puncture resistance of medical stoppers?

Stopper Puncture Tester, also known as the Stopper Puncture Strength Tester or Stopper Puncture Force Tester, is developed and produced by Shandong Paratronix. The Stopper Puncture Tester PMT-C is used to perform puncture force tests on materials such as pharmaceutical butyl rubber stoppers, silicone rubber stoppers, infusion bag caps, oral liquid caps, and combination caps. This equipment is widely used in quality inspection institutions, drug testing institutes, pharmaceutical factories, pharmaceutical packaging material enterprises, and other organizations.

Stopper Puncture Tester

Main Parameters of Stopper Puncture Tester PMT-C

Measuring Range: 5kg (other ranges optional)
Units: N, kg, lb
Accuracy: Grade 0.5
Test Stroke: ≤450mm
Test Mode: Puncture Force Measurement
Test Speed: 1-500mm/min, steplessly adjustable
Dimensions: 470 (L) x 450 (B) x 970 (H) mm
Weight: Approx. 60kg
Power Supply: AC220V±22V, 50Hz
Standard Configuration: Main unit, puncture force fixture (puncture needle optional)

Principle of Stopper Puncture Testing
The puncture force of a stopper refers to the maximum force required to puncture it. The Stopper Puncture Tester is equipped with upper and lower fixtures. The upper fixture can move up and down at a set speed and is fitted with a force sensor. During the test, the puncture needle is installed in the upper fixture and moves downward at the set speed to puncture the sample. The force sensor measures and displays the force in real time, thereby determining the puncture resistance of the sample.

Standards for Stopper Puncture Testing
YBB00012002-2015 "Low-Density Polyethylene Infusion Bottles"
YBB00022002-2015 "Polypropylene Infusion Bottles"
YBB00342002-2015 "General Rules for Multi-Layer Coextruded Infusion Films and Bags"
YBB00102005-2015 "Three-Layer Coextruded Infusion Films (Ⅰ) and Bags"
YBB00112005-2015 "Five-Layer Coextruded Infusion Films (Ⅰ) and Bags"
YBB00042005-2015 "Halogenated Butyl Rubber Stoppers for Injections"
YBB00052005-2015 "Halogenated Butyl Rubber Stoppers for Sterile Powder Injections"
YBB00232004-2015 "Pharmaceutical Synthetic Polyisoprene Gaskets"
YBB00222004-2015 "Silicone Rubber Stoppers and Gaskets for Oral Preparations"
YBB00092004-2015 "Stainless Steel Needles for Prefilled Syringes"
YBB00322004-2015 "Test Method for Puncture Force of Stoppers and Gaskets for Injections"

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