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在制药用水系统中 ,存在微生物的外源性污染和内源性污染。制水系统中存在的微生物会使工艺用水的质量发生变化。水作为药品生产中的原料 ,势必会给药品生产带来不安全的风险。《药品生产质量管理规范》针对微生物污染问题对工艺用水提出下列原则性要求 :“纯化水、注射用水的?
In pharmaceutical water systems, there are exogenous and endogenous contamination of microorganisms. The presence of microorganisms in the water system changes the quality of the process water. As a raw material in the production of medicines, water is bound to bring unsafe risks to the production of medicines. The “Code of Practice for the Quality Control of Pharmaceutical Production” puts forward the following principle requirements for process water for microbial contamination: "Purified water, water for injection?