Medical rubber stoppers are critical pharmaceutical packaging materials, compatible with vials, syringes, vacuum blood collection tubes and other pharmaceutical packages or medical devices. Apart from safety and drug resistance, their physical and mechanical properties including sealing performance and puncture resistance are also essential. Excessively high puncture force of rubber stoppers requires substantial force for needle penetration, which may bend the puncture needle and bring inconvenience to medical operations such as drug extraction and blood collection. In addition, poor puncture resistance of medical rubber stoppers tends to generate particulates after puncture. Once these particulates fall into medicinal products, they will seriously endanger patients\u2019 medication safety. Therefore, appropriate puncture force and excellent puncture resistance are key required properties for medical rubber stoppers.
4015 test method for puncture force of rubber stoppers and gaskets for injections
1.Definition of puncture force: Puncture force refers to the maximum force (in Newtons, N) exerted by the puncture assembly to penetrate the rubber stopper or gasket during the puncture test. This method applies to the determination of puncture force of rubber stoppers and gaskets for injections.
4016 test method for puncture particulates of rubber stoppers and gaskets for injections
1.Definition of puncture particulates: Puncture particulates refer to the number of visible debris generated when the puncture assembly penetrates the rubber stopper or gasket in the puncture test, observable without magnification. The result is expressed as the particulate count. This method applies to the determination of puncture particulates of rubber stoppers and gaskets for injections.
ZEALWAY Instruments keeps pace with industry standards, adheres to independent R&D and continuous innovation. For pharmaceutical packaging material testing, we have developed dedicated control software for sterilization testing of pharmaceutical packaging materials: YA Special Software and YB Special Software for Pharmaceutical Packaging Materials, together with dedicated modules complying with the European Pharmacopoeia (EP) standards for pharmaceutical packaging materials.
Supported test items:
\uf0b7Test Method for Water Resistance of Glass Granules at 121 \u2103
\uf0b7Internal Surface Water Resistance Test
\uf0b7Puncture Force Test for Rubber Stoppers and Gaskets for Injections
\uf0b7Puncture Particulate Test for Rubber Stoppers and Gaskets for Injections
\uf0b7Sterilization Resistance and Coating Adhesion Test of Aluminium Caps for Pen-type Syringes
\uf0b7Special sterilization process requirements for thermal stability testing of soda-lime glass infusion bottles, low-borosilicate glass infusion bottles and medium-borosilicate glass infusion bottles
ZEALWAY Instruments has developed the back-pressure function and super cooling system to meet the requirement of cooling down to room temperature within 30 minutes for puncture force and puncture particulate tests. The back-pressure function prevents negative pressure inside the chamber during rapid cooling. Even when the liquid load exceeds 80% of the chamber volume, overflow of sterilized liquid will not occur during sterilization.<\/p>","protected":false},"excerpt":{"rendered":"
Medical rubber stoppers are critical pharmaceutical packaging materials, compatible with vials, syringes, vacuum blood collection tubes and other pharmaceutical packages or medical devices. Apart from safety and drug resistance, their physical and mechanical properties including sealing performance and puncture resistance are also essential. Excessively high puncture force of rubber stoppers requires substantial force for needle […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":true,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"acf":[],"yoast_head":"\n