Quality control and test method for chlorobutyl rubber piston for pen injector

Pen-type syringe with chlorobutyl rubber piston, this article will be combined with YBB30042012 to focus on the quality control and standard detection method of chlorobutyl rubber piston for pen injector.
This article will combine the National Food and Drug Administration, the national pharmaceutical packaging container (material) standard YBB30042012 pen-type syringe with chlorobutyl rubber piston and gasket standards, focusing on the interpretation of the quality of chlorobutyl rubber piston for pen injectors Control and testing methods for various indicators.



This test method is suitable for the detection of chlorinated butyl rubber pistons and gaskets for pen injectors.



The chlorinated butyl rubber piston for pen type syringes needs to be tested separately for puncture and chipping, leakage test and piston slidability test to ensure product performance and quality.



1. [leak test]



Take 10 pen-injector sleeves treated with silicone oil for internal surface treatment, fill with water, install test pistons and gaskets, add Aluminum caps, and seal. Install a pen-type syringe sleeve on the pen-type syringe sleeve holder (with plane and piston contact), apply a force of 60N ± 3N to the piston for 1 minute. After the test, check the piston and gasket. Leakage. The remaining pen-type syringe sleeves are also operated in the same way, and there must be no liquid leakage in the piston and gasket parts.



2. [piston sliding test]



Take 10 pen-type syringe sleeves with silicone oil treated inner surface, fill water, install test pistons and gaskets, add aluminum cap, and seal. Install a pen-type syringe sleeve on the pen-type syringe sleeve holder (with flat and piston contact, the holder must ensure that the spacer is mounted on the pen-type syringe sleeve, the needle is one end The subcutaneous needle with a cutting edge has an outer diameter of 0.4 mm. When the piston moves, the water in the sleeve should be able to be connected through the needle. The piston is moved downward at a speed of 40 mm/min ± 3 mm/min, in the pen injector. When moving halfway through the sleeve, pause for 5 seconds, then fully press the piston to the end, and the remaining pen injector sleeves operate the same way. Record the maximum force of the starting piston in each test, take the average of the 10 maximum values ​​as the “starting force”, and should not exceed 30N; record the force required to keep moving after starting in each test, take 10 values The average value of the “sustained driving force” shall not exceed 15N; record the maximum force of re-pushing the piston after 5 seconds of suspension in each test, and take the average value of the 10 maximum values ​​as “restarting force”. Pass 30N; and check that there is no “vibration” (referred to as irregular movement of the piston) during continuous motion.



[Using the instrument] TSL-1002 electronic tensile testing machine can meet the detection of various indicators of chlorobutyl rubber piston for pen injector. The TSL-1002 electronic tensile testing machine produced by Jinan Sike test is designed to meet the testing design of pharmaceutical packaging materials manufacturers and manufacturers. It can also meet the mechanical properties of various pharmaceutical packaging materials and packaging containers, such as aluminum parts machinery. Strength, ampoule breaking force, halogenated butyl rubber puncture force, simulated skin puncture force, tearing aluminum cover tearing force, aluminum-plastic composite cover opening force, antibiotic plastic combination cover opening force, cassette bottle piston sliding property, piston Leakage, needle-to-needle connection force, needle cap pull-out force, syringe body tightness, plate pressure leak, tearing tear force, catheter and joint release force, compression test, peel strength of packaging material, heat sealing Strength, tensile strength and other tests.



TSL-1002 electronic tensile testing machine adopts a full set of imported servo drive, high-precision screw drive, imported high-precision force measuring unit, the latest computer and embedded system composite control, the speed can be arbitrarily set from 0.01-1000mm/min, and the 1100mm long effective The stroke, multi-step test range is optional, the test process is fully automatic, and supports GB, ASTM, ISO multi-standard test methods to meet the needs of more material testing. With the SYSTESTER Tensilyst mechanical analysis system, powerful data analysis functions help data analysis and quality control of your products.



SICK test, focusing on the R&D and production of high-quality packaging testing instruments, always follows the spirit of “pursuing the ultimate user experience”, strictly abides by the brand goal of “creating high-tech art” and provides high performance for customers such as food, medicine and packaging. Intelligent and excellent products. Please call SICK test 0531-87031169 for more information on packaging inspection products, or follow the SICK website.


Http://news.chinawj.com.cn Editor: (Hardware Business Network Information Center) http://news.chinawj.com.cn

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