GMP biopharmaceutical purified water

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.