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Production method of sterile water for injection

A technology of water for injection and production method, applied in the medical field, can solve problems such as hidden safety hazards, cannot be effectively removed, and the quality of purified water cannot be strictly monitored, and achieve the effect of safety guarantee

Inactive Publication Date: 2019-02-26
JIANGSU DESANO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, in the process of producing water for injection, purified water is generally used as the basis, but the purified water is generally purchased, so the quality of purified water is not strictly monitored, and it is difficult to distinguish after the production of water for injection source of the problem
[0004] In addition, in the traditional process, the level of microbial contamination of water for injection before filling is relatively high. After filling into glass ampoules or polypropylene ampoules, and then performing final sterilization, the bacterial endotoxins (heat source ) content increases, bacterial endotoxin is higher
However, due to the particularity of the heat source, it is high temperature resistant, soluble in water, and small in size, and cannot be effectively removed when it enters the human body. According to individual differences in people, it will cause heat source reactions in people, which brings a greater safety hazard to clinical use.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0022] The present invention relates to a kind of production method of sterile water for injection, comprising the following steps:

[0023] Cleaning, passivation, disinfection, specifically for pure water tanks, distillation towers, storage tanks and connecting pipelines for pre-flushing with water for injection, lye cleaning, flushing with water for injection, passivation, re-rinsing with water for injection, pure steam disinfection and water for injection Rinse repeatedly.

[0024] Using tap water as raw material, the multi-media filter is used to remove impurities such as sediment, suspended solids, and colloids in the raw water, and the activated carbon filter is used to remove organic matter and chlorine in the water, and the anti-scaling device is used to effectively prevent salt scaling. The sterilizer performs filtration and disinfection treatment, and uses a security filter with a pore size of less than 5um to filter to effectively remove suspended solids and impurit...

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PUM

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Abstract

The invention belongs to the field of medical treatment and particularly relates to a production method of sterile water for injection. The production method comprises following steps: cleaning, passivation and disinfection are performed; tap water is taken as a raw material, pretreated and filtered by a security filter with pore diameter smaller than 5 mu m; a PH value is regulated by an automatic control dosing device and a dose metering device; the water is filtered and subjected to permeation with a three-stage reverse osmosis technology and enters a pure water tank; the water in the purewater tank is sampled and detected; after passing detection, the water enters a distillation column for repeated distillation; the distilled water obtained after distillation is cooled, then is sterilized and filtered again by a redundant filtering system and enters a storage tank; the water is subjected to sterile seal filling by a sterile automatic filling machine. The sterile water for injection is produced from the tap water, the production is controlled from the source, the production process of the sterile water for injection is strictly controlled and the water is repeatedly disinfected, and traceable sterile water with reliable quality for injection is obtained.

Description

technical field [0001] The invention belongs to the medical field, and in particular relates to a production and preparation method of water for injection. Background technique [0002] Water for injection is widely used in the medical field, and the amount of use is very large. Since water for injection is directly injected into the blood vessels of the human body, the requirements for water for injection are very high. [0003] At present, in the process of producing water for injection, purified water is generally used as the basis, but the purified water is generally purchased, so the quality of purified water is not strictly monitored, and it is difficult to distinguish after the production of water for injection The source of the problem. [0004] In addition, in the traditional process, the level of microbial contamination of water for injection before filling is relatively high. After filling into glass ampoules or polypropylene ampoules, and then performing final s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C02F9/10
CPCC02F9/00C02F1/001C02F1/008C02F1/04C02F1/42C02F1/441C02F1/66C02F2303/04
Inventor 袁桢刘少峰王雪原
Owner JIANGSU DESANO PHARMA
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