Novel aseptic processing system for crude drugs
A technology for processing systems and raw materials, applied to sanitary equipment for toilets, water supply devices, filtration, etc., can solve problems such as long time, affecting production plans, increasing costs, etc., and achieve the effect of uniform mixing
Pending Publication Date: 2018-04-06
天津梅花生物医药科技有限公司
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Problems solved by technology
But these methods have many deficiencies, many APIs are very unstable under high temperature and radioactive source radiation, and easily cause the active ingredient to decompose and fail; gas sterilization is usually carried out with toxic gas, which is easy to remain in the API and affect the activity of the API. Influenced by ingredients; the filtration and sterilization process is long and takes a long time, and after the filter device is used for a period of time, once it is blocked, it needs to be shut down for repair and replacement of the filter device, which affects the production plan and increases the cost
Method used
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Embodiment Construction
[0013] The present invention will be further described below in conjunction with drawings and embodiments.
[0014] Such as figure 1 As shown, a new type of raw material drug aseptic treatment system, including No. 1 poor solvent storage tank 1, 0.22 μm filter 2, No. 2 poor solvent storage tank 3, 0.22 μm security filter 4, raw material drug heating reflux dissolution tank (including sterile magnetic stirrer) 5. 1st grade 0.45μm filter 6. 2nd grade 0.22μm filter 7. Cooling crystallization tank (including sterile magnetic stirrer) 8. Sterile isolator 9. On-line temperature monitoring system 10 , Pure steam sterilization system 11, compressed air delivery system (including air sterilization filter) 12.
[0015] The No. 1 poor solvent storage tank 1 is connected successively with the 0.22 μm filter 2 and the No. 2 poor solvent storage tank 3 through the delivery pipeline, and the No. 2 poor solvent storage tank 3 is connected with the cooling crystallization tank 8 through the d...
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The invention relates to a novel aseptic processing system for crude drugs. The system comprises a poor solvent aseptic processing module, a crude drug aseptic processing module, a sterile crude drugoutput module, an online temperature monitoring system, a pure steam sterilizing system and a compressed air delivery system (comprising an air sterilizing filter), wherein the poor solvent aseptic processing module is composed of sequentially connecting a poor solvent storage tank No. 1, a 0.22mu m filter, a poor solvent storage tank No. 2, a 0.22mu m security filter, and conveying pipelines between all the tanks and the filters; the crude drug aseptic processing module is composed of sequentially connecting a crude drug heating reflux dissolving tank, a first stage 0.45mu m filter, a secondstage 0.22mu m filter, and conveying pipelines between all the tanks and the filters; the sterile crude drug output module comprises a cooling crystallization tank, a sterile isolator, conveying pipelines respectively arranged between the cooling crystallization tank and the sterile isolator as well as between the poor solvent aseptic processing module and the crude drug aseptic processing module,and an output pipeline of the sterile isolator.
Description
technical field [0001] The invention relates to the technical field of pharmaceutical production equipment, in particular to a system for aseptically treating raw materials in the production process of pharmaceutical preparations. Background technique [0002] In the production process of pharmaceutical preparations, the method of aseptic treatment of raw materials generally adopts moist heat sterilization, dry heat sterilization, radiation sterilization, gas sterilization and filtration sterilization. But these methods have many deficiencies, many APIs are very unstable under high temperature and radioactive source radiation, and easily cause the active ingredient to decompose and fail; gas sterilization is usually carried out with toxic gas, which is easy to remain in the API and affect the activity of the API. The ingredients are affected; the filtration and sterilization process is long and takes a long time, and after the filter device is used for a period of time, once...
Claims
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Login to View More IPC IPC(8): A61L2/07A61L2/02
CPCA61L2/0017A61L2/0023A61L2202/21
Inventor梅开忠王浩
Owner天津梅花生物医药科技有限公司