Brief description of cartridge leakage performance and sliding performance tester

The cartridge bottle is also known as a borosilicate glass sleeve for pen-type syringes. The front of the bottle is equipped with an injection needle protected by a rubber seal, the bottle mouth is sealed with a rubber stopper and an aluminum cap, and the tail is sealed with a rubber piston.

Shanghai Chengwei is designed and manufactured in accordance with the relevant standards of ISO7886 "Single-Use Sterile Syringes". GB 15810-2019/Appendix E Body Tightness GB 15810-2019/Appendix C, D Body Tightness

The cartridge leakage performance and sliding performance tester is designed and manufactured in full compliance with relevant standards such as YBB00152004-2015 "Chlorobutyl rubber piston and gasket for pen syringes", YBB00162004-2015 "Brominated butyl rubber piston and gasket for pen syringes", and YBB00112004-2015 "Prefilled syringe assembly (with injection needle)".

Execution standard reference:

YBB00162004-2015 "Brominated butyl rubber pistons and gaskets for written test syringes"

Experimental items: leakage test, piston sliding test

standard requirement

Leakage test: Take 10 pen-type syringe sleeves with inner surfaces treated with silicone oil, fill them with water, install the test piston and gasket, add aluminum caps, and seal them. Install one pen-type syringe sleeve in the pen-type syringe sleeve holder (with a flat surface in contact with the piston), apply a force of 60N±3N to the piston, and keep it for 1 minute. After the test, check the leakage of the piston and gasket. The same operation is performed on the remaining pen-type syringe sleeves. There should be no liquid leakage in the piston and gasket.

Piston sliding test: Take 10 pen-type syringe barrels with inner surfaces treated with silicone oil, fill them with water, install the test pistons and gaskets, add aluminum caps, and seal them. Install a pen-type syringe sleeve on the pen-type syringe sleeve holder (there is a flat surface in contact with the piston, and the holder must ensure that it can puncture the gasket installed on the pen-type syringe sleeve. The injection needle is a subcutaneous needle with a blade at both ends, with an outer diameter of 0.4mm. When the piston moves, the water in the sleeve should be able to be discharged through the needle), move the piston downward at a speed of 40mm/min±3mm/min, pause for 5 seconds when it moves half the distance in the pen-type syringe sleeve, and then press the piston completely to the bottom. The remaining pen-type syringe sleeves are operated in the same way. Record the *force to start the piston in each test, and take the average of 10 *values ​​as the "starting force", which should not exceed 30N; record the force required to keep it moving after starting in each test, and take the average of 10 values ​​as the "continuous driving force", which should not exceed 15N; record the *force to push the piston again after pausing for 5 seconds in each test, and take the average of 10 *values ​​as the "restarting force", which should not exceed 30N; and check that there is no "tremor" (referring to the irregular movement of the piston) during continuous movement.