Study On Puncture Invagination Of Pharmaceutical Synthetic Polyisoprene Gasket In Clinical Use

The medicinal synthetic polyisoprene gasket(hereinafter referred to as the gasket)is a medicine packaging material which need be registered and managed,and is an inner cushion of a polypropylene composite cover for a plastic infusion container.During clinical use,it acts to seal and clamp the needle.There often has been a clinical appearance of a variety of insets in the gasket when the disposable infusion set(plastic puncture device)is used to puncture the combined cover.This would eventually lead to leakage of liquid medicine,not only the medicine being used was scrapped,but also the products in the entire industrial chain(such as medicine,polypropylene cover,gasket)were affected,which could cause huge economic losses.Therefore,the gasket intrusion is already an unavoidable problem that needs to be solved.In this paper,through the formulation design,production process design and technical index of the gasket,the quality control of the gasket in the production process is discussed.Parallel test,nuclear magnetic resonance,TGA analysis,analysis of variance,statistical chart and other methods are used to analyze the key factors that cause puncture retraction during clinical use.The results showed that increased when synthetic polyisoprene blended amount in gasket increased at the same filler the gasket intrusion filled in gasket.At the same kind of rubber,the gasket intrusion was more easier occurred filled with Kaolin than filled with calcium carbonate.Silicon oil on the surface of gasket could reduced gasket intrusion.When the Silicon oil amount was reduced,the gasket intrusion became seriously.High viscosity of Silicon oil could reduced the gasket intrusion,however,Silicon oil was nonuniform on the surface.We selected proper kind of steel needle infusion according to different gasket.Generally,we selected 1.2 mm steel needle infusion when the diameter of gasket was within 20 mm.The outside high and width of gasket should excessive design,which could reduce gasket intrusion.The gasket intrusion could reduce when the amount of PE and elastomer in inner cover were increased.The contact surface between inner cover and gasket was changed from circle to saw could reduce gasket intrusion.The clinical puncture techniques used by nurses were more important on gasket intrusion.