Description
The storage and distribution of purified water and water for injection is a key part of the entire water system, mainly for supplying workshop water and ensuring water quality.
Quality requirements for distribution system:
Same as preparation system requirements.
|
检验项目 |
Ch.P 2010 |
EP6.7 |
USP 32 |
|
性状 |
无色的澄清液体；无臭，无味 |
无色的澄清液体 |
无色、无臭的澄清液体 |
|
酸碱度 |
应符合规定 |
- |
- |
|
氯化物、硫酸盐与钙盐 |
- |
- |
- |
|
硝酸盐 |
≤0.000006% |
0.2ppm |
- |
|
亚硝酸盐 |
≤0.000002% |
- |
- |
|
氨 |
≤0.00003% |
- |
- |
|
二氧化碳 |
- |
- |
- |
|
易氧化物 |
总有机碳（0.5mg/L)或易氧化物 |
总有机碳（0.5mg/L)或易氧化物 |
总有机碳（0.5mg/L) |
|
不挥发物 |
≤1mg/100ml |
- |
- |
|
重金属 |
≤0.00O01% |
≤0.1 ppm（药典规定：如果电导率符合注射用水的要求，此项可以不做) |
- |
|
电导率（见备注) |
应符合规定 |
应符合规定 |
应符合规定 |
|
微生物限度 |
细菌、霉菌和酵母菌总数：≤100个/ml(一般营养琼脂、玫瑰红钠琼脂培养基) |
- |
- |
|
- |
好氧菌总数：≤100个/ml（琼脂培养基S在30~35℃培养5天
|
菌落总数100cfu/ ml。【高营养培养基（TGYA、m-HPC琼脂），30~35℃培养48~72小时。低营养培养基（R2A 琼脂、HPCA）20 ~ 25℃更长时间（可延至l4天）】，也可进行一些控制菌的检查 |
Technical features of the storage and distribution system for purified water and water for injection:
- Purified water is distributed and cooled with limited temperature, and the microorganisms in the system are well controlled.
- Purified water distribution is regularly pasteurized to effectively reduce costs.
- The cold spot of the distribution system for water-for-injection adopts various methods such as SUP-LOOP/single-point cooling/tube-in-tube heat exchanger cooling, etc., to cooperate with the system for optimal design.
- The distribution of water for injection is sterilized by superheated water, which is easy to operate.
- On-line sterilization of water-for-injection dispensing respirator, effectively controlling the pollution risk of water-for-injection dispensing respirator replacemen.
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