Chapter IV of the quality management standard for the preparation of medical institutions equipment

Article 26 The selection and installation of equipment should meet the preparation requirements, easy to clean, disinfect or sterilize, easy to operate, repair and maintenance, and can prevent errors and reduce pollution.

Article 27 The preparation, storage and distribution of purified water, water for injection should be able to prevent the growth of microorganisms and pollution. Storage tanks and delivery piping materials used should be non-toxic, corrosion-resistant, piping design and installation should avoid dead ends, blind pipes.

Article 28 The surface of the equipment in direct contact with the drugs should be clean, smooth, easy to clean or disinfect, corrosion-resistant; no chemical changes with the drugs and adsorption of drugs. Lubricants and coolants used in the equipment shall not cause contamination of drugs and containers.

Article 29 The preparation and testing of preparations should be prepared with the preparation of varieties of equipment, facilities and instruments.

Article 30 for the preparation and testing of instruments, meters, gauges, scales, etc., their scope and precision should be in line with the preparation and testing requirements, should be calibrated regularly, and have a qualified mark. Calibration records should be kept for at least one year.

Article 31 The establishment of equipment management rules and regulations, the development of standard operating procedures. Equipment should be managed by specialized personnel, regular maintenance, maintenance, and records.