Analysis of GMP Requirements for Pharmaceutical Water Preparation Equipment

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

2. To facilitate disassembly, replacement, and cleaning of parts, the actuator design should utilize standardized, universal, and systematic components as much as possible.

3. The inner and outer surfaces of the equipment should be smooth, flat, and free of dead corners, facilitating cleaning and sterilization. Parts should undergo surface treatments such as chrome plating to resist corrosion and prevent rust. Avoid using paint on the exterior of the equipment to prevent peeling.

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

5. Materials in contact with water for injection must be high-quality low-carbon stainless steel or other materials proven not to contaminate water quality. Equipment for preparing water for injection should be cleaned regularly, and the cleaning effect should be verified.

6. The storage period for purified water should not exceed 24 hours. Storage tanks should preferably be made of stainless steel or other materials proven to be non-toxic, corrosion-resistant, and not leach contaminating ions. The vents should be protected with hydrophobic, non-shedding bactericidal filters. The inner wall of the storage tank should be smooth, and there should be no dead corners or pinholes in the pipes and welds. Sensors that display parameters such as liquid level, temperature, and pressure should be used, as they will not cause stagnant water contamination. The storage tank should be cleaned, disinfected, and sterilized regularly, and the effectiveness of the cleaning and sterilization should be verified.

7. Transportation of Pharmaceutical Water:

1) Purified water and pharmaceutical water should preferably be transported using easily disassembled, cleanable, and sterilizable stainless steel pumps. In cases where purified water and water for injection require compressed air or nitrogen pressurization, the compressed air and nitrogen must be purified.

2) Purified water should preferably be transported using circulating pipelines. The pipeline design should be simple, avoiding blind pipes and dead corners. Pipelines should be made of stainless steel or other materials that have been verified to be non-toxic, corrosion-resistant, and do not leach contaminating ions. Valves should preferably be sanitary valves without dead corners, and the flow direction of purified water should be clearly marked.

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

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