工艺流程 TECHNOLOGICAL PROCESS

原水-原水加压泵-多介质过滤器-软水器-活性炭过滤器-精密过滤器-一级RO高压泵-一级反渗透-

中间水箱-二级RO高压泵- 二级反渗透- RO水箱- EDI水泵-EID系统- 紫外线杀菌器-除菌过滤器-

纯化水箱-纯化水泵-用水点-巴氏消毒设施或臭氧灭菌设施。

Raw water-- Raw water boost pump-- Multi-media filter-- Water softener-- Active

carbon filter--Precision filter—Stage 1 high pressure pump-- Stage 1 reverse osmosis

Middle water tank--Stage 2 high pressure pump-- Stage 2 reverse osmosis --Ro

water tank-- EDI pump-- EDI system-- Ultraviolet sterilizer--Sterilizing

filter—Purified water tank-- Purified water pump--Purified water user points—Hot

sonitization equipment or ozone sterilization equipment.

GMP对制药用水制备装置的要求：

GMP requirements for pharmaceutical water preparation device:

1、结构设计应简单、可靠、拆装简便。

2、为便于拆装、更换、清洗零件，执行机构的设计尽量标准化、通用化、零部件系统化。

3、设备内外壁表面，要求光滑平整、无死角，容易清洗、灭菌。设备外面避免用油漆，以防

剥落。

4、制备纯化水设备应采用低碳不锈钢或其他经验证不污染水质的材料。制备纯化水的设备应

定期清洗或消毒，并对清洗或消毒效果验证。

5、注射用水接触的材料必须是优质低碳不锈钢（例如 316L 不锈钢）或其他经验证不对水质

产生污染的材料。制备注射用水的设备应定期清洗或灭菌，并对清洗或灭菌效果验证。

6、纯化水及注射水的循环置换速度不低于储罐容积的1-4次/小时，环路管内流速不低于

0.914m/s或雷诺系数不低于20000 。 其储罐宜采用不锈钢材料或经验证无毒，耐腐蚀，不渗

出污染离子的其他材料制作。保护其通气口应安装不脱落纤维的疏水性除菌滤器。储罐内壁

应光滑，接管和焊缝不应有死角系统应完全排净。应采用不会形成滞水污染的液位、温度压

力等参数的传感器。对储罐要定期清洗、消毒灭菌，并对清洗、灭菌效果验证。

1.Structural design should be simple、reliable、easy dismantled.

2.To convenient for disassembly, replacement, and cleaning parts, the design of

the actuator will be as possible standardization, generalization and systematic

parts

3.Equipment inside and outside surface will be demanded smooth, no dead Angle,

easy to clean and sterilize. Equipments avoid using paint to prevent peeling!

4.Preparation of purified water equipment should be low carbon stainless steel or

other materials which has been qualified no pollution for the water。Preparation of

purified water equipment should be regular cleaning or disinfection, and validate

for cleaning or disinfection effect.

5.Injection water contact materials must be high quality low carbon stainless steel

(such as 316 l stainless steel) or other materials which has been proved no

pollution for water quality. Preparation injection equipment should be periodically

cleaned or sterilized, and validate for cleaning or sterilized effect.

6.Cycle displacement speed of purified water and injection water can not be lower

than the tank volume 1-4 times per hour，speed of loop tube can not be less than

0.914 m/s or Reynolds coefficient not be less than 20000。The tank should use

stainless steel or verified non-toxic, corrosion resistance, and other materials with

no leakage pollution ions. To protect the vent, it should install un-fall fiber steam

trap filter。Tank inner surface should be smooth, splice and welding can not with

dead angle, system should be completely free. Should use the sensor which will

not take stagnant water pollution level and temperature pressure. Tank should be

regular cleaning, disinfection, sterilization, and validate for cleaning or sterilized

effect.