GMP certification requirements for medical water equipment
1. The structural design should be simple, reliable, and easy to disassemble.
2. In order to facilitate disassembly, replacement, and cleaning of parts, the design of the actuator is standardized, generalized and systematic parts as much as possible.
3. The surface of the inner and outer walls of the device must be smooth and flat, without dead corners, and easy to clean and sterilize. The surface of parts should be treated with chrome plating to prevent corrosion and prevent rust. Avoid paint on the outside of the device to prevent it from peeling.
4. Preparation of purified water equipment should use low carbon stainless steel or other materials that have been verified not to pollute water quality. Equipment for preparing purified water should be cleaned regularly, and the cleaning effect should be verified.
5. The materials in contact with water for injection must be high-quality low-carbon stainless steel or other materials that have been verified not to cause water pollution. Equipment for the preparation of water for injection should be cleaned regularly and the cleaning effect verified.
6. The storage period of purified water should not be longer than 24 hours, and its storage tank should be made of stainless steel or other materials that have been verified to be non-toxic, corrosion-resistant, and not to leak out pollution ions. A hydrophobic sterilizing filter should be installed to protect the air vent. The inner wall of the storage tank shall be smooth, and there shall be no dead ends or trachoma in the connection and welds. Sensors that display parameters such as liquid level, temperature, and pressure that do not form contaminated water should be used. Storage tanks shall be regularly cleaned, disinfected and sterilized, and the cleaning and sterilization effects shall be verified.
7.Conveyance of pharmaceutical water
1) Purified water and pharmaceutical water should be transported by stainless steel pumps that are easy to disassemble, clean and disinfect. Where purified water and water for injection need to be delivered with compressed air or nitrogen pressure, compressed air and
Nitrogen must be purified.
2) The purified water should be transported by circulating pipes. The piping design should be simple, and blind pipes and dead ends should be avoided. The piping shall be stainless steel pipe or other pipes that have been verified to be non-toxic, corrosion-resistant, and not to leak out polluted ions. The valve should be a sanitary valve without dead corners. The flow direction of purified water should be indicated.
3) The pipelines and pumps that transport purified water and water for injection should be cleaned, disinfected and sterilized regularly.
8. The design of the pressure vessel must be undertaken by a licensed unit and qualified personnel, and must be handled in accordance with the relevant provisions of the People's Republic of China Standard "Steel Pressure Vessel" (GB150-80) and "Pressure Vessel Safety Technical Supervision Regulations".
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