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High-cleanness pre-filled syringe

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

Active Publication Date: 2011-05-25
SHANDONG PHARMA GLASS
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  • Summary
  • Abstract
  • Description
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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, and its unparalleled packaging and drug storage methods. However, 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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  • High-cleanness pre-filled syringe

Examples

Experimental program
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Effect test

Embodiment

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

[0026] Syringe production includes the following steps in a clean environment: glass molding, printing, baked siliconization, needle assembly and locking cone assembly. The unique baking and siliconization treatment process is adopted to improve the cleanliness of the syringe, which can effectively prevent the reaction between the syringe body and the filled liquid medicine and contaminate the medicine.

[0027] Glass forming includes the following steps: tube feeding→length fixing→heating→cutting→heating→cone forming→heating→curling preforming→heating→edge trimming→heating→trimming→cutting→inspection and packaging→warehousing. The key to controlling the heating quality is to control the flame temperature of each station by adjusting the pressure of natural gas and oxygen, so as to i...

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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, in particular to a high-cleanliness prefilled syringe Background technique [0002] As a new type of packaging form for special pharmaceutical injections, pre-filled syringes have the following characteristics: it saves the transfer of liquid medicine from glass packaging to syringes, reduces the waste of medicine due to adsorption, and is especially suitable for freeze-dried powders . 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 pollution during injection. It also reduces operational errors, such as dosage, and other possible clinical errors; it is easy to operate and saves time compared with using ampoules in clinical practice, and is especially suitable for emergency patients; it is convenient for patients to administer drugs by themselves. At present, prefilled...

Claims

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Application Information

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Patent Type & Authority Applications(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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