Preparation process of polymer pre-filled syringe

Abstract

The invention belongs to the technical field of medicine package materials, and particularly relates to a preparation process of a polymer pre-filled syringe. The preparation process comprises the following steps of (1), preparing materials: selecting a syringe needle tube material and a syringe sealing piston material; (2), mold flow design: establishing a mold flow analysis model of an injectionmolding product, and optimizing mold design and formulating optimal process parameters through mold flow analysis by testing PVT parameters of a material; (3), injection molding: respectively carrying out injection molding on the syringe needle tube material and the syringe sealing piston material according to the formulated optimal process parameters to obtain a syringe needle tube and an syringe sealing piston; (4), assembling a finished product, namely assembling the obtained syringe needle tube and syringe sealing piston with a push rod and a protective cap accessory; and (5), sterilizingand packaging, namely spraying silicon on the assembled syringe, sterilizing, analyzing, detecting, checking and accepting, packaging and warehousing. According to the method, the product with high forming precision can be obtained by optimizing the mold design and formulating the optimal technological parameters.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical packaging materials, and in particular relates to a preparation process of a polymer prefilled syringe. Background technique [0002] Prefilled syringes are a new form of pharmaceutical packaging. After more than ten years of promotion and use, they have played a very good role in preventing the spread of infectious diseases and the development of medical services. Pre-filled syringes are mainly used for packaging and storage of high-grade drugs and are directly used for injection or flushing in ophthalmology, ear, orthopedics and other operations. [0003] The prefilled syringe has two functions of storing medicine and ordinary injection at the same time, and uses materials with good compatibility and stability, which is not only safe and reliable, but also minimizes the cost of The labor and cost from production to use bring many advantages to pharmaceutical companies and clinical use. ...

AI Technical Summary

Problems solved by technology

[0004] At present, the existing prefilled syringes mainly use high-quality glass and rubber components, which have good compatibility with drugs and can ensure the stability of the packaged drugs; however, the production process of glass prefilled syringes is complex, Fragile, heavy and other disadvantages, at the same time, traditional vulcanized rubber plug sealing materials have problems such as drug migration of vulcanization aids and easy chipping

In the prior art, studies have begun to apply polymer materials to prefilled syringes. However, during the preparation, the product will not meet the required performance due to the internal stress generated.

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