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Water production index for pharmaceutical water equipment manufacturers
- 2019-09-23-

Environmental Purified Aquatic Water Target

Chemical target: Meet the requirements of purified water for Pharmacopoeia of the People's Republic of China 2015

Hygiene inspection: microorganism 100CFU / 100ml

Endoline 0.25EU / ml conductivity ≤5.1μS / cm (25 ℃)

2. Basic equipment skills

The system adopts full active control (manual control can also be selected together), and active reverse washing and regeneration procedures can be set when the system is running; primary reverse osmosis and secondary reverse osmosis are equipped with return pipelines, and reverse osmosis equipment is equipped with chemical cleaning devices and Disinfection device; a PH conditioning device is installed between the primary reverse osmosis and the secondary reverse osmosis to ensure that the conductivity of the water produced by the purified water equipment meets the requirements of the Pharmacopoeia; the secondary reverse osmosis membrane uses a positively charged anti-pollution reverse osmosis membrane to Ensure that the reverse osmosis equipment can run stably for a long time; the primary reverse osmosis pipeline uses 304 stainless steel data, and the secondary reverse osmosis uses 316L stainless steel data; the first-stage reverse osmosis and second-stage reverse osmosis equipment are equipped with online conductivity detection instruments The conductivity of the produced water can be viewed at any time; there is a low-pressure maintenance switch before the first-grade reverse osmosis, and a low-pressure maintenance and high-pressure maintenance switch before the second-grade reverse osmosis; The recovery rate is 70% -75%, and the secondary reverse osmosis recovery rate is 85%; SUS304 pipe is used as the pipeline between the equipment. The purified water storage tank has a breathing filter, and the transportation pipeline is equipped with an ultraviolet sterilizer and a microporous filter to ensure that the pure water meets sanitary requirements.

3. Equipment planning, production, installation and operation meet GMP certification requirements

(1) Structural planning should be simple, reliable, and easy to disassemble.

(2) In order to facilitate the disassembly, replacement, and cleaning of components, the planning of the implementing agency shall use standardized, generalized and systematic components as much as possible.

(3) The appearance of the inner and outer walls of the equipment requires smooth lubrication, no dead corners, simple cleaning and sterilization. Parts should be treated with chrome plating to prevent corrosion and prevent rust. Avoid paint on the outside of the device to prevent it from falling off.

(4) Low-carbon stainless steel or other materials that have been verified not to pollute water quality should be used for the preparation of purified water equipment. Equipment for the preparation of purified water should be cleaned regularly, and the cleaning effect verified.

(5) The contact information of injection water must be high-quality low-carbon stainless steel or other materials that have been verified not to cause water pollution. The equipment for preparing injection water should be cleaned regularly, and the cleaning effect should be verified.

(6) The storage period of purified water should not be longer than 24 hours, and its storage tank should be made of stainless steel materials or other materials that have been verified to be non-toxic, corrosion-resistant, and not to leak pollution ions. Maintenance of the vent should be installed with a hydrophobic bacteria-removing filter that does not shed fibers. The inner wall of the tank should be lubricated, and the receiving and welding seams should not have dead ends and trachoma. Sensors that display parameters such as liquid level, temperature, and pressure that do not form water pollution should be selected. The storage tank shall be cleaned, disinfected and sterilized regularly, and the cleaning and sterilization effects shall be verified.

(7) Transportation of pharmaceutical water

1) Purified water and pharmaceutical water should be transported with stainless steel pumps that are easy to disassemble and clean. In the case of purified water and injection water that require compressed air or nitrogen pressure, compressed air and nitrogen must be purified.

2) The purified water should be transported by circulating pipes. Piping planning should be simple, and blind pipes and dead ends should be avoided. The piping should be stainless steel pipe or other pipes that have been verified to be non-toxic, corrosion-resistant, and not to leak out polluted ions. The valve should be a sanitary valve without dead corners. The flow direction of purified water should be indicated.

3) The pipelines and pumps for transporting purified water and injection water should be cleaned, disinfected and sterilized regularly, and they can be put into use only after passing the verification.

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