Reliable, well sealed, compact structure and small size are the most basic requirements for the vacuum pump in the pharmaceutical industry to facilitate operation, cleaning and maintenance. At the same time, there is no experience in the use of the same type of pump and materials. The pump used to transport liquid medicine, intermediates, pure water and other media shall provide relevant test data to determine that the use of the pump and materials does not affect the quality of the drug. If the flow passage parts are made of new synthetic plastics, the test report allowed by the relevant health department to be used in the pharmaceutical production shall also be provided. Due to the particularity of the medical environment, it is required that in order to facilitate comprehensive cleaning, the active connection should be used between the pump and the pipeline, and the foot support should be used for the base to separate the base from the ground.
I. structural requirements of vacuum pump in pharmaceutical industry:
1. The surface of pump overflow parts shall be smooth, free of dead angle, easy to clean and corrosion resistant. Castings shall be free of sand holes, dents and cracks that are difficult to clean.
2. On the premise of ensuring performance and reliability, the structure of the pump shall be simplified as much as possible, and the installation and disassembly shall be simple, so as to facilitate cleaning treatment and maintenance.
3. CIP and sip technology are preferred.
II. Material requirements for vacuum pump in pharmaceutical industry
1. The metal materials for the flow passage parts shall be able to prevent chemical reaction, abrasion, corrosion, oxidation and peeling with the liquid medicine.
2. The materials of pump overflow parts are usually austenitic stainless steel, fluoroplastics, ultra-high molecular weight polyethylene, ceramics, glass lining, etc. For pumps in contact with highly clean materials (such as distilled water), the flow passage parts shall be made of ultra-low carbon austenitic stainless steel. The nonmetallic materials used to make the flow passage parts shall not have chemical reaction with the liquid medicine, can coexist with the conveying medium, and shall work for a long time without the release substance.
3. Generally, the auxiliary sealing materials for pumps can be PTFE or PTFE coating materials.
4. It is forbidden to use asbestos fiber materials for medical pumps.
5. When transporting organic solvents, rubber materials are strictly prohibited.
6. For the pump used in the clean area, its non overflow parts are not allowed to be painted, so the non rusting materials shall also be used.
III. precautions in actual use
1. Distinguish the use range of pump, i.e. in clean area or in non clean area.
2. According to the medium delivered by the pump, the common water pump, hot water pump, condensate pump and the pump of the waste water treatment system used in the public works are distinguished from the pumps delivering process medium such as medicine liquid, intermediate, pure water, acid and alkali. The former can be treated as the pump of the general chemical plant, but the requirements for its shaft seal are properly raised to meet the strict requirements of the medical plant for the environment. Pumps for delivering process media such as liquid medicine, intermediates, pure water, acid and alkali shall meet the requirements of pumps for pharmaceutical devices.
Of course, due to the characteristics of the industry, the sealing performance of the vacuum pump is required to be particularly high. It is thought that the leakage of the pump required by the shaft seal will reduce the cleanliness requirements of the plant floor, which will not meet the requirements of GMP, and will cause corrosion of the equipment and the floor, causing damage to the environment. Therefore, when choosing the pump, we should consider the sealing performance of the pump, especially the requirements of the shaft seal.