China's first comprehensive service provider of GMP water system net Terry you answer: pharmaceutical GMP water purification equipment selection and installation to meet the following conditions:
Article 31 of the equipment design, selection, installation should be in line with the requirements of the production, easy to clean, disinfected or sterilized, easy to operate and repair, maintenance, and can prevent errors and reduce contamination.
Article 32 of the direct contact with the drugs on the surface of the equipment should be smooth, flat, easy to clean or disinfect, corrosion-resistant and drugs do not chemically change or adsorption of drugs. Equipment used in lubricants, coolants, etc. shall not cause contamination of drugs or containers.
Article 33 and equipment connected to the main fixed pipeline should be labeled with the name of the material in the pipe, flow direction.
Article 34 purified water, water for injection preparation, storage and distribution should be able to prevent the growth of microorganisms and contamination. Storage tanks and transport piping materials used should be non-toxic, corrosion-resistant. Pipeline design and installation should avoid dead ends, blind pipe storage tanks and pipelines to provide for cleaning, sterilization cycle. Water for injection storage tanks should be installed at the air vent does not shed fibers of hydrophobic sterilization filter. Water for injection storage can be used above 80 ° C insulation, 65 ° C insulation cycle or below 4 ° C storage.
Article 35 for the production and inspection of instruments, meters, gauges, scales, etc., its scope of application and precision should be in line with the production and inspection requirements, there is a clear sign of conformity, and regular calibration.
Article 36 of the production equipment should have obvious status signs, and regular repair, maintenance and verification. Equipment installation, repair and maintenance operations shall not affect the quality of the product. Unqualified equipment should be moved out of the production area if possible, before moving out should be clearly marked.
Article 37 of the production and inspection equipment should be used, repair and maintenance records, and managed by specialized personnel.