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GMP Purified water system
GMP regulations for biopharmaceutical purified water equipment, in addition to the equipment design should comply with the production and processing technology requirements, the most important standard is that the equipment should be able to avoid cross-contamination, the equipment itself does not harm product quality, and is conducive to cleaning and maintenance, The design and proper layout of the equipment can minimize the risk of leakage.
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GMP regulations for biopharmaceutical purified water equipment, in addition to the equipment design should comply with the production and processing technology requirements, the most important standard is that the equipment should be able to avoid cross-contamination, the equipment itself does not harm product quality, and is conducive to cleaning and maintenance, The design and proper layout of the equipment can minimize the risk of leakage.
1. The structure 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 should use standardized, generalized and systematic parts as much as possible.
3. The surface of the inner and outer walls of the equipment should be smooth and flat, without dead angle, easy to clean and sterilize. The surface of the parts should be treated with chrome plating to resist corrosion and prevent rusting. Avoid using paint on the outside of the equipment to prevent peeling.
4. The equipment for preparing purified water should be made of low carbon stainless steel or other materials that have been verified as not polluting the water quality. The 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 (such as 316L stainless steel) or other materials that have been verified to not pollute the water. The equipment for preparing water for injection should be cleaned regularly, and the cleaning effect should be verified.
6. The storage period of purified water should not be longer than 24 hours, and the storage tank should be made of stainless steel or other materials that have been proven to be non-toxic, corrosion-resistant and do not seep out polluting ions. To protect the vent, a hydrophobic sterilizing filter that does not shed fibers should be installed. The inner wall of the storage tank should be smooth, and there should be no dead ends and trachoma in the joints and welds. Sensors that display parameters such as liquid level, temperature and pressure that will not form stagnant water pollution should be used. The storage tank should be cleaned, disinfected and sterilized regularly, and the effect of cleaning and sterilization should be verified.
7. The design of pressure vessels must be undertaken by licensed units and qualified personnel, and must be handled in accordance with the National Standard of the People's Republic of China <Steel Pressure Vessels (GB150-80) and the relevant regulations of "Pressure Vessel Safety Technical Supervision Regulations"). .
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