KX2-500 Purified Water Equipment GMP Biopharmaceutical Equipment

KX2-500 Purified Water Equipment GMP Biopharmaceutical Equipment

GMP certified pharmaceutical water requirements

1： GMP requirements for pharmaceutical water preparation equipment

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 materials. The equipment for preparing purified water should be cleaned and validated for cleaning.

5. The material in contact with injection water is low-carbon stainless steel (such as 316L stainless steel) or other materials that have been verified not to pollute water quality. The equipment for preparing injection water should be cleaned and validated 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 use stainless steel pipes. 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 must be cleaned and verified to be qualified before they can be put into use.

Our company is a professional manufacturer of purified water equipment and high-purity water equipment. Production of Class 1, 2, and 3 purified water equipment, secondary reverse osmosis+EDI purified water equipment, high-purity water equipment for the new energy industry, laboratory water treatment equipment, ultra pure water equipment for the electronics industry, automotive urea high-purity water equipment, pure water equipment, secondary reverse osmosis purified water equipment, GMP purified water equipment, pharmaceutical purified water equipment, air conditioning circulating cooling water, reclaimed water treatment equipment, electroplating high-purity water equipment.

Our company has professional engineering designers and after-sales service team. We welcome new and old customers to consult and purchase.

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