GMP requirements for pharmaceutical water preparation equipment

At present, although the scale, variety and output of pharmaceutical machinery production have considerable strength and level, and become a larger professional product industry in China, with the integration of economic and trade with the world and the internationalization of GMP norms, pharmaceutical manufacturers have an urgent need for the GMP concept of pharmaceutical equipment and more perfect functions, which makes the GMP of equipment increasingly become the one in domestic and foreign trade A hot spot of technology and competition GMP has the following requirements for the preparation of pharmaceutical water: 1 The structure design should be simple, reliable and easy to disassemble 2 In order to facilitate disassembly, replacement and cleaning of parts, standardized, universal and systematic parts shall be used as far as possible in the design of actuator 3 The internal and external surfaces of the equipment shall be smooth and flat without dead angle, easy to clean and sterilize The surface of parts shall be treated with chrome plating to prevent corrosion and rust Avoid paint on the outside of the equipment to prevent peeling 4 Low carbon stainless steel or other materials verified not to pollute water quality shall be used for the preparation of purified water equipment The equipment for preparing purified water shall be cleaned regularly and the cleaning effect shall be verified 5 The materials in contact with water for injection must be low carbon stainless steel (such as 316L stainless steel) or other materials that are verified not to pollute the water quality The equipment for preparing water for injection shall be cleaned regularly and the cleaning effect shall be verified 6 The storage period of purified water should not be more than 24 hours, and its storage tank should be made of stainless steel or other materials that are verified to be non-toxic, corrosion-resistant and free of polluting ions A hydrophobic filter shall be installed to protect the vent of the filter The inner wall of the tank shall be smooth, and there shall be no dead angle and sand hole in the connecting pipe and weld Sensors showing parameters such as liquid level, temperature and pressure that will not form stagnant water pollution shall be used The storage tank shall be cleaned, disinfected and sterilized regularly, and the cleaning and sterilization effect shall be verified 7 Delivery of pharmaceutical water 1) purified water and pharmaceutical water should be delivered by stainless steel pump which is easy to disassemble, clean and disinfect In the case of purified water and injection water delivered by compressed air or nitrogen pressure, the compressed air and nitrogen shall be purified 2) purified water should be transported by circulation pipeline The pipeline design shall be simple and avoid blind pipe and dead angle Stainless steel pipes or other pipes verified to be non-toxic, corrosion-resistant and free of pollution ions shall be used The valve should be sanitary valve without dead angle, and the flow direction of purified water should be indicated 3) the pipeline and pump for transporting purified water and injection water shall be cleaned, disinfected and sterilized regularly, and can be put into use only after passing the verification 8 The design of pressure vessels shall be undertaken by the 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 and Technical Supervision Regulations for pressure vessels".