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Water for Injection

Classification:

Pharmaceutical Water System


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Description

Water for injection is used in medical equipment, biomedicine, veterinary medicine, powder injection, in vitro diagnostic reagents, clinical analysis and testing instruments, large infusion, medical sterile water and other industries. Water for injection is mainly used for the production of non-fungal drugs and cleaning of process equipment.

Quality requirements:

Items

Ch.P 2010

EP 6.7

USP 32

pH

5~7

Nitrate

≤0.000 006%

Maximum 0.2ppm

 

Nitrite

≤0.000 002%

Ammonia

≤0.000 03%

Electroconductibility

According to the specification, different temperatures correspond to different standard values.

For example,

20℃ <l.1uS/cm;

25℃ <1.3uS/cm;

70℃<2.5uS/cm;

95℃<2.9uS/cm.

According to the specification, different temperatures correspond to different standard values.

For example,

20℃ <l.1uS/cm;

25℃ <1.3uS/cm;

70℃<2.5uS/cm;

95℃<2.9uS/cm.

According to the specification, different temperatures correspond to different standard values.

For example,

20℃ <l.1uS/cm;

25℃ <1.3uS/cm;

70℃<2.5uS/cm;

95℃<2.9uS/cm.

TOC

<0.50mg/L

<0.50mg/L

<0.50mg/L

Oxidizable substances

Nonvolatile matter

L mg/100ml

Heavy metal

<0. 000 01%

Maximum 0. 1 ppm

Bacterial endotoxin

<0.25EU/ ml

<0.25EU/ ml

<0.25EU/ ml

Microbial limit

10/100ml

10/100ml

10/100ml

 

Water for injection preparation system

Water for injection is obtained by multistage distillation of purified water as raw water.

The multi-effect distilled water machine has the advantages of simple structure, easy operation, stable operation and high water quality.

Technical features of multi-effect distilled water machine:

  • Multi-stage separation technology: gravity separation + spiral separation + flash separation, effectively guarantees the quality of distilled water.
  • The first-effect evaporator, all preheaters and condensers adopt double tube sheet structure to prevent cross-contamination.
  • The online detection device, which detects water temperature, conductivity and water quality, is installed at the outlet, and the system automatically discharges unqualified distilled water through the automatic control system and valve to prevent unqualified water from entering the storage tank.
  • Keep the water temperature stable through the automatic control system. When the distilled water temperature is higher than the set value, the cooling water delivery will be automatically turned on, otherwise, the cooling water delivery will be automatically turned off.

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