Drugs packed by original natural rubber stoppers are completely changed to packaging materials of butyl rubber stoppers based on relative documents from SFDA. Cleanliness, biologic properties, aging property and self- tightness of butyl rubber are better than natural rubber, but its elasticity is worse. After suing butyl rubber stoppers, needling desquamation and needle-out leakage often appear during use in clinic. Uneven quality of podermic needle is a key factor, structure of needle head, sharpness of chamfer as well as angle of puncture all greatly affect needling desquamation.
It is investigated by Jiangsu Province Hospital that transfusion preparations are usually made up and dissolved by needle with side openings, which overcomes rubber desquamation, particle pollution resulted in dosage with traditional entry needle as well as adverse phenomenon caused by particles jammed in the entry needle. If multiple drugs shall be made up into one bottle of transfusion, don't pull the needle with side openings for the first time out but continuous feeding (domestic metal needle with side openings can satisfy the market needs). Besides, the most important is only one puncture or twice at most are allowed at the dosage needling circle on surface of crown of rubber stopper; repeated needling is forbidden as dosage needling circle of each rubber stopper is clear. This is the best way to avoid needling desquamation (both pharmaceutical enterprise and rubber stopper manufacturer shall make proper instructions to nurses). In the world, needle with straight openings is not used any longer in clinic.
Every batch of our rubber stoppers are distributed to many users, in which uniform formula and production process control are applied, and we haven't received any complaint for needling desquamation from other pharmaceuticals except this batch supplied to you. Maybe it is an accident, effect factors are complex, while solid puncture outfit with allowable desquamation range ≤20 is required in domestic legal standards.
Actually, such needling desquamation won't affect safety of drug users even though it is resulted in drug loading as barrier film is mounted on ultimate filter of infusion apparatus before drug liquid flows into veins of human beings.
Note: repeated needling at the same puncturing position, otherwise it may be broken, which may easily cause needling desquamation and leakage. We suggest adding a reminder to clearly mark in user manual.
江苏华兰药用新材料股份有限公司
