Characteristics and application scheme of multifunctional drying equipment
Abstract: starting from the shortcomings of the current drying equipment for crystalline bulk drugs, the characteristics of multifunctional drying equipment are described, and its application principle is expounded through two application schemes
key words: multifunctional drying equipment; characteristic; Application scheme
the application of drying equipment in China has a history of decades, but it has been nearly 20 years that we directly measure this signal and develop drying technology for large-scale drying. All kinds of drying devices used in drug production must meet the requirements of GMP specifications, such as ensuring the uniformity of the whole batch of drug production quality, no "material accumulation" in the equipment, CIP and sip of the equipment, and special requirements for the materials in direct contact with drugs
according to different properties and requirements, two methods can be adopted for the drying of drugs: one is to directly spray dry from aqueous solution into particles, such as streptomycin, gentamicin, etc; The other is to dry the crystals after crystallization and filtration of the solution, in which freeze-drying can be used for heat sensitive drugs (such as biological agents)
1. In the production of sterile bulk drugs, for the drying of crystalline drugs, in addition to the strict requirements of sterile and clean environment in the production process, the drying process also strictly requires sterility
among the production equipment of crystalline API, the earliest drying equipment mostly used vacuum drying oven. Due to its shortcomings such as slow drying speed and difficult cleaning of drying box, some production units have changed to rotary vacuum dryer. However, the drying of crystalline drugs also needs to go through crystallization tank, reaction tank, concentration tank, filter press, centrifuge, filter and other processes, and then gradually make the finished products through drying oven, double cone rotary drying and other equipment. A crystalline product must be processed by multiple processes and equipment, which will lead to high investment cost, cumbersome pipelines, difficult cleaning and disinfection (sterilization), high labor intensity and low safety factor
with the baptism of GMP transformation, a few years ago, our company developed a tank type "three in one" equipment that integrates filtration, washing and drying functions. In order to stabilize the voltage, the year-on-year increase of 58.3%, the connection between the power supply and the number appears faulty welding or open circuit. After the crystallization of the crystallization tank is completed, input this equipment for filtration, inject washing solution, use the mixing device for full washing, then filter, and finally dehydrate and dry. After drying, the finished product is discharged from the opening of the wall, and the paddle of the agitator plays a boosting role in the discharge of materials. "Three in one" equipment is the progress of crystalline API production equipment, which can eliminate the transmission of filter cake between the original filtration and drying two different equipment, reduce the cross pollution of products and improve the productivity, but the drawback is that the discharge is not clean
is there another device to choose from? Can there be an equipment that not only inherits the characteristics of traditional equipment, but also integrates various crystalline API production equipment? A multifunctional drying equipment recently developed by our company is the equipment to deal with the above problems, and this equipment is an attempt to reform the production equipment of crystalline API
2. Composition and characteristics of multifunctional drying equipment
2.1 composition of multifunctional drying equipment
multifunctional drying equipment consists of vacuum pumping interface, feed quick opening interface, explosion-proof box, sprinkler, sintering vacuum pumping filter rod, liner, jacket and thermal insulation materials, quick opening valve for single suction filtration, sintering for suction filtration, hot water inlet, hot water outlet 1, explosion-proof control panel 1, explosion-proof motor 1, reducer 1, pressure gauge 1, mixing blade 1, tank 1 It is composed of main shaft 1 and base support 1
2.2 characteristics of multi-functional drying equipment
(1) in the process of reaction, crystallization and concentration, the research shows that after the materials are reacted, concentrated, crystallized and processed in the multi-functional drying equipment, there is no need to enter the next process through the pipeline, which avoids the problems of drug waste, cross pollution and repeated cleaning and disinfection (sterilization) caused by cumbersome pipelines, and can prevent possible leakage Pollution or other dangerous accidents
(2) in the process of suction filtration and washing, the multi-functional drying equipment can overcome the shortcomings of low efficiency, "gross point" exceeding the standard, high operation intensity, waste of resources, difficult cleaning and disinfection (sterilization) and large land occupation caused by the suction filter, centrifuge, filter press and other equipment configured in the original process
(3) in the drying process, the multi-functional drying equipment can overcome the problems of high labor intensity, easy "caking" or "pilling" in the drying process, slow drying speed and possible "mixed batch" phenomenon of the drying oven or double cone rotary dryer configured in the original process
source: Wuxi Zhanghua Medical Equipment Co., Ltd
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