Welcome to the official website of Shandong Eagle Pharma Machinery Co.,Ltd.!
Service Hotline：+86-536-8800237
14
2022
-
11
GMP requirements for WFI water for injection preparation equipment
1. The design, selection, and installation of WFI water for injection for home user equipment should meet production requirements, be easy to operate, repair, and maintain, and be able to prevent errors and reduce pollution.
2. Material: All parts in contact with WFI water for injection for home users and secondary steam must be made of specified stainless steel. Non-metallic materials should be non-toxic, corrosion-resistant, free of particle precipitation, not dissolved by high-purity water, and not deformed at high temperatures.
3. The WFI water for injection for home user equipment should have a simple structure, and the surface in contact with pure water, distilled water, and pure steam should be smooth and smooth, easy to clean, disinfect, sterilize and withstand the specified pressure, and meet the requirements of online cleaning CIP and online sterilization SIP.
4. The coolant and lubricant used in the WFI water for injection for home users shall not pollute pure water, distilled water, and pure steam.
5. The pipes, fittings, and valves configured with WFI water for injection for home users meet hygienic requirements, and the instruments configured should meet the production and inspection requirements in their scope of application and precision.
Related News