1: GMP Requirements for Pharmaceutical Water Preparation Equipment

1. The structural design shall be simple, reliable, and easy to disassemble and assemble.

2. To facilitate the disassembly, replacement, and cleaning of parts, the design of the actuator shall adopt standardized, universalized, and systematized parts as much as possible.

3. The inner and outer wall surfaces of the equipment shall be smooth and flat without dead corners, and easy to clean and sterilize. The surface of parts shall be treated with chrome plating or other surface treatments to resist corrosion and prevent rusting. Paint shall be avoided on the outside of the equipment to prevent peeling off.

4. Equipment for preparing purified water shall be made of low-carbon stainless steel or other materials proven not to contaminate water quality. Equipment for preparing purified water shall be cleaned regularly, and the cleaning effect shall be verified.

5. Materials in contact with water for injection must be high-quality low-carbon stainless steel (e.g., 316L stainless steel) or other materials proven not to cause pollution to water quality. Equipment for preparing water for injection shall be cleaned regularly, and the cleaning effect shall be verified.

6. The storage period of purified water shall not exceed 24 hours, and its storage tank shall be made of stainless steel or other materials proven to be non-toxic, corrosion-resistant, and free from leaching of polluting ions. The vent of the storage tank shall be equipped with a hydrophobic sterile filter that does not shed fibers. The inner wall of the storage tank shall be smooth, and there shall be no dead corners or sand holes in the nozzles and welds. Sensors for displaying liquid level, temperature, pressure and other parameters that will not cause stagnant water pollution shall be adopted. The storage tank shall be cleaned, disinfected and sterilized regularly, and the cleaning and sterilization effects shall be verified.

7. Conveyance of pharmaceutical water

1) Purified water and pharmaceutical water shall preferably be conveyed by stainless steel pumps that are easy to disassemble, clean and disinfect. In occasions where purified water and water for injection need to be delivered by compressed air or nitrogen pressure, the compressed air and nitrogen must be purified.

2) Purified water shall preferably be conveyed by circulating pipelines. The pipeline design shall be concise, avoiding blind pipes and dead corners. Pipelines shall be made of stainless steel pipes or other pipe materials proven to be non-toxic, corrosion-resistant, and free from leaching of polluting ions. Valves shall preferably be sanitary-grade valves without dead corners, and the flow direction shall be marked for the conveyance of purified water.

3) Pipes and delivery pumps for conveying purified water and water for injection shall be cleaned, disinfected and sterilized regularly, and can be put into use only after passing verification.

8. The design of pressure vessels shall be undertaken by licensed units and qualified personnel, and shall be handled in accordance with the relevant provisions of the national standard of the People's Republic of China "Steel Pressure Vessels" (GB150-80) and the "Safety Technical Supervision Regulations for Pressure Vessels".