Drugs and people's health are closely related to the medical device has the following specific requirements of the pump: 1. General requirements (1) For the production of pharmaceutical pumps should work reliably, well-sealed, compact, smaller size to facilitate the operation, cleaning and maintain. (2) Pumps and intermediates used to transport medicinal liquids, intermediates, pure water and other media should be provided with relevant test data to determine that the use of the pump and materials does not affect the quality of pharmaceuticals, if no experience is gained with the use of pumps and materials of the same type. If the flow of components using a new type of synthetic plastics, should also provide the health department to allow the use of pharmaceutical production test reports. (3) Pumps used for the transportation of chemicals, intermediates, pure water and other media should be sterilizable, cleaned and used for cleaning of materials. Media devices shall be guaranteed not to cause new pollution. (4) The pump used in the clean area, for easy overall cleaning, it is best to use an active connection between the pump and the pipe. The base should also preferably be supported by feet, so that the base is free from the ground. 2. Structural Requirements (1) pump over-current parts surface should be smooth, no dead ends, easy to clean, corrosion-resistant, casting should be easy to clean the trachoma, depression and cracks. (2) The structure of the pump should be as simple as possible under the premise of ensuring the performance and reliability, easy assembly and disassembly, to facilitate cleaning and maintenance. 3. Shaft Seal Requirements Medical devices are very restrictive of leaks using pumps because leaks can not only affect the cleanliness of the plant floor, failing to meet GMP requirements, but also corrode the equipment and ground and cause damage to the environment. Therefore, medical devices with high pump shaft seal, the general should be preferred mechanical seal, such as leakage higher requirements, consider the use of shielded pump and magnetic drive pump. 4. Material Requirements (1) The metal material used in the pump over-current part of the medical device shall prevent the chemical reaction with the liquid chemical, the sorption and permeation, and the oxidation and peeling phenomena. (2) Non-metallic materials used in pump overcurrent components of medical devices shall be made of materials that do not react chemically with the chemical solution, coexist with the transport medium, and do not release additives for a long period of time. In the absence of experience with the use, pumps made of non-metallic materials, such as synthetic plastics, for safety reasons, should be required by the manufacturer to provide test reports on the use of the material by the health authorities in the manufacture of pharmaceuticals. (3) Medical devices pump overcurrent components often use austenitic stainless steel, fluoroplastic (F46, Fluoroplastic alloy, PVDF) UHMWPE, ceramics, glass lined. For pumps that contact high purity materials (such as distilled water), ultra-low carbon austenitic stainless steels should be used for flow-over components. (4) pump auxiliary sealing materials generally use PTFE coated materials and pure PTFE material. (5) Materials containing asbestos fibers are strictly prohibited. (6) It is forbidden to use rubber materials when transporting organic solvents. (7) Pumps used in clean areas must also be constructed of non-corrosive materials for non-overcurrent components, and painting is not permitted.
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