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Preparation method of high-cleanness pre-filled syringe

A technology with high cleanliness and syringes, applied in syringes, infusion sets, medical containers, etc., can solve the problem of no independent production of syringes, achieve the effects of improving utilization, reducing residual volume, and ensuring dimensional accuracy

Active Publication Date: 2015-04-29
SHANDONG PHARMA GLASS
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  • Summary
  • Abstract
  • Description
  • Claims
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Problems solved by technology

But so far, this kind of syringe has not been produced independently in our country, and the market demand is also concentrated on high-end products
It has become the main form of drug packaging in the next few years. Its unparalleled packaging method and drug storage method, but due to design reasons, the prefilled syringes in the current market have a certain gap with the requirements of the international pharmaceutical industry in terms of drug residues and cleanliness.

Method used

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  • Preparation method of high-cleanness pre-filled syringe

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Experimental program
Comparison scheme
Effect test

Embodiment

[0025] The manufacturing method of the syringe includes the following steps: 1) syringe production; 2) RTF treatment; 3) ETO sterilization; 4) acceptance, packaging and storage.

[0026] Syringe production includes the following steps in a clean environment: glass forming, printing, baking siliconization, needle assembly and locking cone interface assembly. The unique baking siliconization process is adopted to improve the cleanliness of the syringe, which can effectively prevent the syringe barrel and the filled liquid from reacting and contaminate the medicine.

[0027] Glass forming includes the following steps: upper tube → fixed length → heating → cutting → heating → cone forming → heating → crimping preforming → heating → trimming → heating → trimming → blanking → inspection and packaging → storage. The key to the control of heating quality is to control the flame temperature of each station by adjusting the pressure of natural gas and oxygen to improve the quality of glass f...

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Abstract

The invention discloses a high-cleanness pre-filled syringe, which belongs to the field of production of medicinal packing materials. The syringe is characterized in that: a method for manufacturing the syringe comprises the following steps of: 1) producing the syringe; 2) performing rich text format (RTF) treatment; 3) performing ethylene oxide (ETO) sterilization; and 4) accepting, packing and warehousing. Through the syringe, the residue amount of liquid medicine of the prefilled syringe is effectively reduced and the utilization ratio of a medicament is improved while the dimensional accuracy is guaranteed. Particularly, the advantage of the syringe that waste of high-value medicaments is avoided is brought into full play in the fast-developing biological and immunologic preparation industry.

Description

Technical field [0001] The invention belongs to the field of pharmaceutical packaging materials, and specifically relates to a preparation method of a high-cleanliness prefilled syringe. Background technique [0002] As a new type of special medicinal packaging form for injection, prefilled syringe has the following characteristics: it eliminates the transfer of liquid medicine from glass packaging to the syringe, reduces the waste of medicine due to adsorption, and is especially suitable for freeze-dried powder . It is also very important for expensive biochemical preparations and vaccine products that are not easy to prepare; it can prevent cross-infection or secondary contamination during injection. It also reduces operational errors, such as dosage, and possible clinical errors; the operation is simple, and it saves general time in clinical than using ampoules, which is especially suitable for emergency patients; it is convenient for patients to administer by themselves. Ac...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61M5/178A61J1/05
Inventor 张军田德合弋康锋毛剑薛为革
Owner SHANDONG PHARMA GLASS
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