From the perspective of design and water quality, biopharmaceutical factories require purified water equipment to comply with GMP certification requirements and the 2020 edition pharmacopoeia standards. The requirements of pharmaceutical factories for purified water equipment are actually the requirements of these standards for purified water 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, without dead corners, and easy to clean and sterilize. 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 the cleaning effect should be verified.
5. The material in contact with injection water must be high-quality low-carbon stainless steel (such as 316L stainless steel) or other materials that have been verified not to pollute the water quality. The equipment for preparing injection water should be regularly cleaned and the cleaning effect should be verified.
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 non-toxic, corrosion-resistant, and do not leak out pollutant ions. A hydrophobic sterilization 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, disinfect and sterilize storage tanks, and verify the effectiveness of cleaning and sterilization.
7. Transportation of pharmaceutical water
1) Purified water and pharmaceutical water should be transported using stainless steel pumps that are easy to disassemble, clean, and disinfect. 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 non-toxic, corrosion-resistant, and do not leak pollutants. Valves should be sanitary grade valves without dead corners, 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, disinfected, and sterilized before being put into use.
8. The design of pressure vessels must be undertaken by licensed units and qualified personnel, and must be handled in accordance with the relevant provisions of the national standards of the People's Republic of China, "Steel Pressure Vessels" (GB150-80) and "Safety Technical Supervision Regulations for Pressure Vessels".