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What are the requirements of GMP for pure water equipment- Pure Water Equipment - Jiajie - Jiajie Pure Water Equipment Manufacturer


GMP can be understood as an industry standard, but it is not limited to one or similar industry products. Pure water equipment is within its standard range, which means it must comply with its production standards. What are the specific GMP requirements?

The overall design of pure water equipment should be simple, reliable, and easy to disassemble.

2. In order to facilitate disassembly, replacement, and cleaning of parts, the design scheme of electric actuators should use GMP standardized, practical, and professional components as much as possible.

3. The surface of the inner and outer walls of the machine equipment is specified to be smooth and level, without blind spots, making it very easy to clean and sterilize. The surface of the parts should be treated with stainless steel or other metal surfaces to resist corrosion and avoid rusting. Prevent the use of paint on the outside of machinery and equipment to prevent detachment.

4. The equipment for producing pure water should use low-carbon and environmentally friendly stainless steel plates or other raw materials that have been verified to not pollute water bodies. The machinery and equipment for producing pure water systems should be cleaned on time and the actual cleaning effect should be certified.

5. The raw materials touched by injection water must be high-quality low-carbon and environmentally friendly stainless steel plates or other materials that have been verified to cause environmental pollution due to incorrect water bodies. The machinery and equipment for producing injection water should be cleaned on time and the actual cleaning effect should be certified.

6. The storage cycle time of pure water equipment and pure water system should not exceed 24 hours. The storage tank should be made of stainless steel plate or other raw materials that have been verified to be non-toxic, corrosion-resistant, and non ionizing to prevent external environmental pollution.

7. Transportation of tap water in the pharmaceutical industry. Pure water systems and pharmaceutical tap water should be transported using stainless steel pumps that are easy to disassemble, clean, disinfect, and sterilize. In pure water systems and injection water places that require air compression or N2 compression, air compression and N2 must be cleaned and resolved.

8. The design scheme of high-pressure vessels must be undertaken by licensed enterprises and qualified personnel, and must comply with the national industry standard of the People's Republic of China, "Steel Pressure Vessels" (GB150-80) and "; Technical Supervision Specification for Safety Production Technology of GMP High Pressure Vessels; Apply for processing of relevant requirements.


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