医用纯水设备
Medical pure water equipment
一、GMP 对工艺用水的要求:
1、 GMP requirements for process water:
药品生产企业的工艺用水主要是指制剂生产中洗瓶、配料等工序以及原料药生产的精制、洗涤等工序所用的水。水的名称应避免和水的制造过程有关,如去离子水、除盐水、蒸馏水这样的名称,即水的制造过程与其名称脱钩,而是从化学和微生物的角度根据质量指标对水进行分类(如中国药典规定纯化水可以用三种不同方法制得,将来可能还会有更好得方法)。
The process water of pharmaceutical production enterprises mainly refers to the water used in the bottle washing, batching and other processes in the production of preparations, as well as the refining, washing and other processes in the production of APIs. The name of water should avoid being related to the manufacturing process of water, such as deionized water, demineralized water and distilled water, that is, the manufacturing process of water is decoupled from its name, but water is classified according to quality indicators from the perspective of chemistry and Microbiology (for example, the Chinese Pharmacopoeia stipulates that purified water can be prepared by three different methods, and there may be better methods in the future).