Brief Analysis of the Requirements of Reverse Osmosis Method for Pharmaceutical Water Equipment

1. The structure design is simple, reliable, and easy to assemble and disassemble.

2. The design adopts standardized, generalized and systematic components.

3. The inner and outer surfaces of the equipment are smooth and flat, without dead angle, easy to clean and sterilize. The surface of the part is surface treated with chrome plating to resist corrosion and prevent rust. Avoid using paint outside the equipment to prevent peeling.

4. Preparation of purified water equipment using low carbon stainless steel or other materials that have been verified to not pollute the water. Equipment for purifying water should be cleaned regularly.

5. The material in contact with water for injection must be high quality low carbon stainless steel (such as 316L stainless steel) or other materials that have been verified to be non-contaminating to water quality. Equipment for the preparation of water for injection should be cleaned regularly and verified for cleaning results.

6. The storage period of purified water should not be more than 24 hours. The storage tank should be made of stainless steel or other materials that have been verified to be non-toxic, corrosion-resistant and do not bleed out contaminated ions. The venting port should be protected by a hydrophobic sterilizing filter that does not shed fibers. The inner wall of the tank should be smooth, and the joints and welds should have no dead angles and trachoma. Sensors that display parameters such as liquid level and temperature pressure that do not form stagnant water contamination should be used. The storage tank should be cleaned, disinfected and sterilized regularly, and the cleaning and sterilization effects should be verified.

7. Delivery of pharmaceutical water

7.1. Purified water and pharmaceutical water should be transported by a stainless steel pump that is easy to disassemble and clean. Where purified water and water for injection are required to be compressed by compressed air or nitrogen, compressed air and nitrogen must be purified.

7.2. Purified water should be transported by circulating pipeline. The piping design should be simple and blind tubes and dead ends should be avoided. Pipes shall be made of stainless steel pipes or other pipes that have been verified to be non-toxic, corrosion-resistant and do not bleed out contaminated ions. The valve should be a hygienic valve with no dead angle, and the purified water should be marked with the flow direction.

7.3. Pipes and transfer pumps for conveying purified water and water for injection should be cleaned, disinfected and sterilized regularly, and can be put into use after verification.

8. The design of the pressure vessel shall be undertaken by the licensed unit and qualified personnel, and shall be handled in accordance with the relevant provisions of the People's Republic of China National Standard "Steel Pressure Vessel" (GB150-80) and "Pressure Vessel Safety Technical Supervision Regulations". .

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