Pre treatment of 2T purified water equipment

The equipment design, production, installation, and operation of Kaixu Company comply with GMP certification requirements

(1) The structural design should be simple, reliable, and easy to disassemble.

(2) For the convenience of disassembly, replacement, and cleaning of parts, the design of the actuator should use standardized, universal, and systematic components as much as possible.

(3) The inner and outer wall surfaces of the equipment should be smooth, flat, and easy to clean. The surface of the parts should be treated with chrome plating or other surface treatments to resist corrosion and prevent rusting. Avoid using paint on the outside of the equipment to prevent peeling.

(4) The preparation of purified water equipment should use low-carbon stainless steel or other materials that have been verified to not pollute water quality. The equipment for preparing purified water should be regularly cleaned and validated for cleaning.

(5) The material in contact with injection water is low-carbon stainless steel or other materials that have been verified not to pollute water quality. The equipment for preparing injection water should be regularly cleaned and verified for cleaning.

(6) The storage period of purified water should not exceed 24 hours, and its storage tank should be made of stainless steel material or other materials that have been verified to be corrosion-resistant and do not leak out pollutant ions. A hydrophobic filter with non shedding fibers should be installed to protect its ventilation port. The inner wall of the storage tank should be smooth, and there should be no dead corners or sand holes in the connecting pipes and welds. Sensors that do not cause stagnant water pollution and display parameters such as liquid level, temperature, and pressure should be used. Regularly clean the storage tank and verify the cleaning.

(7) Transportation of pharmaceutical water

1) Purified water and pharmaceutical water should be transported using easy to disassemble and clean stainless steel pumps. In situations where purified water and injection water require compressed air or nitrogen pressure delivery, the compressed air and nitrogen must be purified.

2) Purified water should be transported through a circulating pipeline. The pipeline design should be concise and avoid blind pipes and dead corners. The pipeline should be made of stainless steel pipes or other pipes that have been verified to be corrosion-resistant and do not leak out pollutant ions. Sanitary valves should be used, and the flow direction of purified water should be indicated.

3) The pipelines and pumps used for transporting purified water and injection water should be regularly cleaned and verified to be qualified before they can be put into use.