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Equipment selection and installation (pharmaceutical GMP implementation and certification P168) (for pharmaceutical companies)?
Article 31 equipment design, selection, installation should be consistent with the production requirements, easy to clean, disinfect or sterilize, easy to production operation and maintenance, 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 not to chemical changes with drugs or adsorption of drugs. Lubricants, coolants, etc. used in the equipment 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 The preparation, storage and distribution of purified water, water for injection should be able to prevent microbial growth and contamination. The materials used in the storage tanks and delivery piping should be non-toxic and 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 4 ° C below 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 be obvious signs of the state, and regular repair, maintenance and verification. Equipment installation, repair and maintenance operations shall not affect the quality of the product. Unqualified equipment, if possible, should be moved out of the production area, and should be clearly marked before not moved out. Article 37 production and inspection equipment should be used, repair and maintenance records, and managed by a person.