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Medicinal spray selection consideration
2015-06-18 Reads : 38
The pharmaceutical industry, pharmaceutical production is one of its main tasks, the importance of the material nature of drugs and medicines differences, constitutes the special requirements for pharmaceutical production. Currently, drug production has already started to GMP as a system and imposing regulations to be implemented. GMP implementation involved in the design, manufacture, installation, use, management, verification and many other aspects. As one of the pharmaceutical equipment spray drier how to adapt, to take this opportunity to exchange views and what we practice is wrong please correct me, in order to jointly improve the development. One. Spray features: spray is applied by spraying a liquid material to make fine particles in the drying chamber into contact with hot air to a moisture evaporates quickly, which means direct access to powder products. This device has the following performance characteristics: 1, can be obtained directly from the liquid raw material powder products, in general, high-speed centrifugal spray-dried particle size D50 in 60 ~ 125μm (ie 250 to 120 mesh) range, pressure spray drying D50 particle size in 125 ~ 250μm (ie 120 to 60 mesh) range. 2, the drying time is very short, usually only 5 ~ 40Sec. 3, the temperature of the droplets in the drying process is not high, little thermal influence on the product, not prone to change defective protein, vitamins, and other active ingredients such as loss of oxidation, heat-sensitive materials, quality of life and drugs can basically close under vacuum dry standard. 4, the product remained spherical droplet approximation, with good dispersion, fluidity and solubility. 5, change the water content of the liquid feedstock or spray drying conditions can be adjusted residual moisture, particle size, bulk density of the product within a certain range, the production process is simplified, easy control and management. Because of these characteristics of spray drying, spray drying applications in the pharmaceutical industry are increasingly expanding. II. Material properties of drugs: drugs regardless of compound chemical drugs, biological products, or herbal, natural drugs are all strong heat-sensitive materials, relatively low hot air temperature, constituent complex, especially the material properties of herbal varieties differences, polypeptides, polysaccharide, protein, moisture absorption, viscosity, low softening point, and to ensure the active ingredient, the active ingredient is not destroyed and other characteristics of medicinal dryer put forward higher requirements. III. GMP basic requirements for the equipment: 1, layout equipment shall be compatible with the process, and batch production capacity should adapt, design and manufacture shall comply with the production process. 2, the device should be easy to operate and maintain, easy to clean and disinfect. Not only to prevent the inflow of foreign substances and bacteria also have online cleaning, sterilization function online. 3, the contact area of ??the material equipment and materials should be non-toxic, corrosion resistance, and material from a chemical reaction, without shedding of coatings, fibers and particulate matter. 4, the inner wall of the device must be smooth, no dents structure, all corners should arc transition. 5, device drivers smooth, noise, dust, sewage shall comply with the relevant provisions of the State. 6, the device itself confined good, all lubricants, coolants should be avoided with materials, containers contact. Four types and the basic functions of medicinal spray: according to the characteristics of the spray dryer; pharmaceutical material properties; and GMP requirements for equipment be considered comprehensive, most material terms: A, models: the use of open cycle, vertical drop and the flow pattern is recommended to use the high-speed centrifugal rotary spray, especially with medicine. If the requirements of dry powder particle size of 100 mesh (150μm) or more, the optional pressure nozzle type spray dryer. B, the device should have the basic functions: 1, to ensure the dried product from contamination with material, hot air the material contact parts made of stainless steel, stainless steel grades should be adapted to the pH of the drug material (PH value) requirements. 2, in order to meet the health requirements, subject to sterilization filtration of air into the tower, in addition to the purification of the injection to 100 consideration, the rest can be 100 000 ... 300 000 consideration. Drying tower should be running under a slight positive pressure state. Finished output in a drying tower cone lower part, and the finished product was collected in a clean room packaging. 3, to ensure that exhaust emission concentration comply with environmental requirements, consideration should be given two dust, carried out the first stage by a high efficiency cyclone powder recovery, the second stage can be used wet or dry bag filter dust collector tail-powder recovered. For product hygroscopic and many varieties of dryers to wet scrubber is more appropriate. 4, the device itself closed, and no contact with the material sources, wall smooth, structure as simple as possible, easy disassembly, easy to clean, smooth operation. Five medicinal spray selection and customer conditions related content: 1, the production capacity of the equipment: h water evaporation capacity index is dryer, and a direct impact on the utilization of investment size and equipment. When converted to an annual dry index, increased uptime rate should be fully dryer, try to arrange long-term continuous production, lower unit hour production requirements. Expected development of the reserves to be appropriate. 2, the drying process parameters: a) inlet air temperature: maximize material can endure under conditions, exhaust temperature to meet the requirements of the moisture content of the finished product under minimize excessively dry, into the exhaust temperature, helps improve production capacity and heat utilization. b) liquid feed solid content, improve feed concentration reduce the initial moisture content, not only in the equipment the same amount of water evaporation conditions much too dry to increase production capacity, and can make the product bulk density, increase the proportion of dry powder. 3, hot air system: Heat energy, pharmaceutical companies have steam conditions in general and drug intake air temperature is not high, can be the most economical and suitable for steam + electricity, other issues such as electricity, oil or gas fired heating stove can also be indirect, depending on the specific customers have the possibility to be. The maximum temperature limit of the hot air system should consider leaving room for a variety replace the inlet air temperature was adjusted possible, you can also take advantage of another high-temperature hot air sterilization devices, play the effect similar dry heat sterilization, taking into account HEPA filters provided to the heat temperature and reasonable economy, it is recommended to design the hot air system 2000C. 4, electrical control requirements: As a manufacturer of machine, to ensure product quality and production run fluctuations from human factors, automation should be considered necessary. a) inlet air temperature-controlled, temperature-controlled ventilation is needed, especially stable exhaust temperature stability has a direct impact on the residual moisture content of the product. As for the control precision at a set temperature conditions, inlet air temperature ± 5 ℃, the exhaust temperature of about ± 1.5-2.5 ℃ economic optimum. b) centrifugal atomizer speed control: For more variety of materials due to the viscosity of the solid content of change and conditioning products for the control of particle size, nebuliser frequency variable speed function should be considered. operation control c) into the exhaust fan: To improve the operating strength and direct and convenient, can be considered in the electrical control room remote control butterfly Laval control air flow, such as the use of frequency adjusting fan speed directly change the fan flow, the more save fan energy by 30% advantages. d) other control requires regular manual control or have higher expectations can be. 5. In order to improve the operating range, strengthen drying effect, the necessary attachments to consider: a) a cold system: design and manufacture of hot air dryers dispenser not adjusted properly, and hung overhead material vortex roll material (commonly known as the Pan-top ) have occurred, using a cold air intake system with purified air from the ventilation duct of people, but also can prevent rising cooling tower powder nebulizer, improve and solve the problem of the Pan-top, regulation and control is very convenient. b) tower wall jacket cooling system: heat denaturation for strong, low softening point of the material, such as after prolonged operation tower wall temperature is higher than the softening point of the material, dry adsorption is again melted wall, using the tower wall jacket The cooling system can tower wall overhead natural ventilation or forced ventilation cooling, the tower wall temperature is always at a temperature below the softening point of the material, the effect is obvious. c) tower wall air sweeping device: Material Since reunification electrostatic adhesion, adsorbed on the tower wall is normal, but the need for timely clean-up down, or will affect the product's color and variability, with the tower wall rapping (such as hammer, air hammer) can also be powder vibration absorption tower wall came down, but rapping area limitations, can not do a comprehensive clean air cleaning device using the tower walls, sprayed with purified air from many surrounding the tower straight cone of slow rotation of the injection tube hole blown straight for the tower cone material accumulation purge the entire area, the effect is obvious. d) pneumatic conveying system: dry powder after drying, due to higher temperatures, such as immediately bagging often condensation phenomenon of agglomeration, plus income from the cyclone powder directly by drying machine layout and structural constraints, income powder Cleanroom required very close to the dryer, which often cause inconvenience to arrange the workshop production process layout, using pneumatic conveying systems, the primary cyclone flour, to the clean room of the hopper for product packaging, use dehumidifiers thermostat air purifier While long-range transport of the product for product cooling. e) CIP cleaning system: the importance of cleaning is self-evident, the use of CIP cleaning system can be fully and effectively solve the parts in contact with the powder automatic cleaning, to ensure that materials are not cross-breed different batches mixed batch contamination and cleaning stages reliability, improve the cleaning effect, improving operating conditions. CIP cleaning system having a plurality of cleaning medium (cold water, hot water, solvent, deionized water, compressed air, low pressure steam) recycling of hot air chamber; drying tower; the main cyclone and out of the wind pipe; small whirlwind pneumatic conveying splitter and four out of the duct work area manually or by automatic operation setup. Reliable and effective. These attachments have a clear focus, we have for our customers in the dryer section is configured. Test equipment has been put into use, to achieve the desired results. Of course, these attachments need to increase energy, equipment manufacturing more difficult complex structure, the cost will increase. VI. Innovation and development of new drugs in development and production process improvement will drive the device, as a professional design and manufacturing units of the device, we must also be happy with the same people on the front pharmaceutical industry to maintain close cooperation, learn from practice, continue to industry with advanced equipment and good quality and cheap services, both for the development of their own areas of expertise, more development of the pharmaceutical industry contribute to the common.
keywords: Spray Dryer, Chang Xin Yuan machinery, dryers,
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Copyright © GuangDong ICP No. 10089450, Changzhou Xin Chang Yuan Machinery Co., Ltd. All rights reserved.
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Sie sind der 20371 Besucher
Copyright © GuangDong ICP No. 10089450, Changzhou Xin Chang Yuan Machinery Co., Ltd. All rights reserved.
Technischer Support: ShenZhen Immer Technology Development Co., Ltd
Immer Network 's Disclaimer: Die Legitimität des Enterprise Information übernimmt keine Garantie Verantwortung