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GMP biopharmaceutical purified water

1、 Purified water indicators for medical devices 1. Conductivity ≤ 2 μ S/cm (resistivity ≥ 0.5 M Ω* CM) 2. Hygiene examination: Microbial 10CFU/100ml 3. Endotoxin 0.25EU/ml 2、 Technical characteristics of equipment 1. The system adopts fully automatic control (manual control can also be used), and automatic backwashing and regene...

Product details

1、 Purified water indicators for medical devices

1. Conductivity ≤ 2 μ S/cm (resistivity ≥ 0.5 M Ω* CM)

2. Hygiene examination: Microbial 10CFU/100ml

3. Endotoxin 0.25EU/ml

2、 Technical characteristics of equipment

1. The system adopts fully automatic control (manual control can also be used), and automatic backwashing and regeneration programs can be set during system operation;

2. The first and second level reverse osmosis systems are equipped with reflux pipelines, and the reverse osmosis equipment is equipped with chemical cleaning and disinfection devices;

3. A pH adjustment device is installed between the first and second level reverse osmosis to ensure that the conductivity of the produced water meets the requirements of the pharmacopoeia;

4. The secondary reverse osmosis membrane adopts a positively charged anti pollution reverse osmosis membrane to ensure the long-term stable operation of the reverse osmosis equipment;

5. The first stage reverse osmosis pipeline is made of 304 stainless steel material, and the second stage reverse osmosis is made of 316L stainless steel material;

6. Both the primary and secondary reverse osmosis equipment are equipped with online conductivity detection instruments, and the conductivity of the produced water can be observed at any time;

7. There is a low-voltage protection switch before the first level reverse osmosis, and low-voltage and high-voltage protection switches before the second level reverse osmosis;

8. The first and second level reverse osmosis water recovery rates can be adjusted, with a first level reverse osmosis recovery rate of 60% -65% and a second level reverse osmosis recovery rate of 70%;

9. All pre-treatment devices are made of original imported parts; UPVC pipes are used for the piping between pre-processing equipment.

10. The purified water storage tank is equipped with a breathing filter, and the conveying pipeline is equipped with ultraviolet sterilizers and microporous filters to ensure that pure water meets hygiene requirements.

2024新澳资料正版大全

2024新澳资料正版大全

2024新澳资料正版大全

 Pharmaceutical industry:   medicine      apparatus        oral liquid      Finished drugs     Biological agents, etc

 

2024新澳资料正版大全

2024新澳资料正版大全

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