Production method of sterile water for injection

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...

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.