Urs and improvement of fluidized bed drying equipment

Abstract: in the production process of solid preparation, one-step granulation and fluidized bed drying equipment are often selected The fluidized bed drying equipment has also developed from horizontal vibrating fluidized bed dryer to multi-purpose one-step granulator With the application of new technologies such as material processing and intelligent control, fluidized bed drying equipment is facing new opportunities and challenges in the field of traditional domestic equipment As a user of pharmaceutical enterprises, in the new project or workshop transformation, the first consideration is to determine the selection and configuration requirements of equipment according to the production process and capacity needs, and make requirements and descriptions for the important components, options and necessary configuration of the equipment, which is conducive to the user to obtain cost-effective Zui large equipment with a small investment of Zui Urs (customer requirements) of fluidized bed drying equipment has become a technical document for selecting suppliers The equipment suppliers need to meet the configuration information and conditions proposed in the document At the same time, URS also puts forward technical improvement requirements for equipment manufacturers Specific analysis: At present, the domestic GMP requirements for DQ of equipment are very lax, and the equipment demand is a part of DQ The pre confirmation we know is only a general description of equipment selection, material and production capacity, and there is no detailed configuration requirements for equipment, which is also a main reason that the domestic equipment, including fluidized bed drying equipment manufacturing, control system and processing accuracy cannot be improved As the user of fluidized bed drying equipment, when comparing domestic equipment with imported equipment, we are also pleased to find that some domestic equipment manufacturers have begun to try to start from the detailed equipment customer demand, gradually accept the urs mode required by the US FDA, EU and who, and customize the equipment according to different products, which is the only way for the development of Chinese pharmaceutical machinery The production process of wet granulation adopts the combination of high-speed rotating wet granulation machine and fluidized bed drying equipment to form a granulation linkage line, which has been widely used in many domestic pharmaceutical enterprises According to the principle of domestic equipment selection: energy saving and environmental protection We must put forward a series of requirements for equipment selection, including technical feasibility discussion with suppliers In this paper, we will discuss several topics with reference to the US FDA's requirements for urs terms and standards for fluidized beds 1 Energy saving of fluidized bed drying equipment The basic principle of fluidized bed drying is to blow the wet particles to boiling and convective state through heated air, and hot air will take away the evaporated water or organic solvent to realize the drying of the wet particles, which involves air treatment At present, many domestic manufacturers configure air treatment units as: primary effect filter - electric heating (or steam heating) - Fan - medium effect filter - fluidized bed dryer, which is so simple Obviously, this has a great relationship with the user's needs If the user's requirements are low, then the manufacturer's configuration is also low Here, we only take the fluidized bed in GEA's granulation linkage line as an example to talk about the relationship between configuration and energy saving Configuration and parameter requirements of air treatment unit: (1) air inlet temperature and humidity can be adjusted to the parameter range required by the process, t is 80 ℃, RH is 20%; 2) cooling and dehumidification of chilled water, copper tube and aluminum rib are used as coil, and chilled water is used as chilled water of the process chilled water system, with the temperature of 7-12 ℃ (3) The heat source of the heater is industrial steam, indicating the requirements of pressure and temperature consumption; (4) the filter adopts (G4 + F8 + H13) three-level filtration, and H13 needs to be tested and verified for Pao leakage, indicating the time of detection and replacement; (5) box requirements: the inner wall of the middle rear is stainless steel plate, the middle front is galvanized steel plate, and the wall plate has the function of heat preservation and cooling prevention (6) The inlet and outlet of cold water and steam are automatically controlled by PLC electric valve or pneumatic valve according to the set temperature and humidity; (7) G4, F8, H13 have differential pressure display device, and have differential pressure alarm function in PLC (differential pressure is not displayed on PLC); (8) filter is easy to replace and disassemble (9) Equipped with surface cooler drainage trap, the water pan material is 304 stainless steel, no water leakage, smooth drainage, no water in the water pan; (10) the air outlet is equipped with electric regulating valve, the opening can be controlled by PLC This is our requirement for AHU configuration We believe that many domestic manufacturers can fully meet these requirements If domestic equipment is manufactured in accordance with this requirement, the quality risk of drug production will be reduced With detailed verification documents, the technical content of the equipment will be further improved At the same time of meeting GMP requirements, we should also take energy conservation into full consideration The energy consumption here involves defrosting preheating function section, cold water dehumidification, heating section and negative pressure maintenance in the fluidized bed cylinder According to urs, if defrosting preheating section is not needed, the setting of this function section can be cancelled, otherwise, investment, air inlet resistance and energy consumption will be increased PLC solenoid valve is used for automatic control of cold water dehumidification section and steam heater, and the temperature and humidity of air outlet are set The conventional drying parameters of fluidized bed are 11g / m3 and t 80 ℃ The relationship between the air inlet volume and exhaust volume of fluidized bed can be set by PLC for the negative pressure in the cylinder and the air inlet valve and exhaust valve automatically adjusted According to the requirements of FDA, the three-stage filter of air conditioning processing unit is very important The main reason for the greater risk of domestic equipment lies in the filter problem The filter selection is very important The specification and model of the filter must be clearly stated G4, F8 and H13 must conform to the international general standards They cannot be made of non-woven cotton at a low price Otherwise, there will be a greater risk Quality risk, of course, the standard filter will increase the resistance of air flow, but our premise is to meet the quality requirements first   During the operation of the fluidized bed, the track of particle movement is also closely related to the air heat exchange At present, the air at the bottom is usually blown up to make the particles convective The time when the particles stay in the air is the time when the water in the particles evaporates The bottom of the drying equipment of the fluidized bed manufactured by GEA adopts the Fishscale air outlet, which makes the particles spiral in the cylinder and increase effectively The length of streamline and the time of heat exchange with air are fully utilized 2 Development trend of fluidized bed drying equipment From the specific structure, fluidized bed drying equipment can be divided into cylinder part, AHU part and electrical control part At present, most domestic manufacturers can basically carry out all production and assembly From a technical point of view, it is wide but not precise Stainless steel processing can also be produced Air processing unit can also be assembled Electrical control two electricians can solve the problem They have high working efficiency, fast assembly speed and low cost Most of them imitate other people's equipment, similar in shape but different in spirit This is currently domestic The current situation of many manufacturers, lack of new product R & D investment   Many foreign advanced equipment suppliers' practices are worth our learning They divide the equipment into several parts and cooperate with each other The stainless steel production of the fluidized bed drying equipment only processes the cylinder and assembles it AHU is supplied by the professional air conditioner manufacturer, and the electrical automatic control is done by the professional personnel They do a good job in technical coordination with each other, so that they can be specialized and precise, and the technical level of the equipment will be high It will be improved, which requires us to have a good spirit of cooperation and serious work attitude While improving the product quality, the added value of the equipment will also be significantly improved As a pharmaceutical enterprise user, we will put forward detailed requirements for each specific part of the fluidized bed according to GMP requirements, to ensure that the product quality risk is reduced to Zui low, GMP pursues the repeatability and traceability of the process production process, which requires us to adjust every step of the production equipment, specify and clarify the parameter setting, and require the manufacturing of each part of the fluidized bed drying equipment Make standardization and strictly implement the design scheme, DQ and DS The supplier manufactures a set of advanced fluidized bed drying equipment, and it is very important to have a long-term technical discussion with the customer The higher the customer's demand is, the more advanced the equipment will be At present, many pharmaceutical enterprises in China have gradually approached the FDA's requirements, requiring equipment suppliers to provide a series of documents when purchasing equipment, which is just the weakness of domestic suppliers Take the fluidized bed drying equipment as an example, we need to provide: (1) mechanical design: process design, installation design, marking list, composition list, spare parts list (2) electrical design: software, distribution diagram, SDS, function diagram, function description, distribution cabinet list (3) equipment documents: operation manual, maintenance and inspection list, inspection record form, touch screen operation instructions, customer training (4) technical data and spare parts data (5) quality control documents: calibration certificate, sample retention, passivation cleaning, welding gas certificate (6) manufacturing: training, instruction and instruction of welders, filming, passivation and cleaning training (7) quality management: welding quality record, sample retention, weld number drawing, welding track output, CD-ROM (8) validation documents: quality and project plan, fat scheme, unit test inspection, sat documents In view of the above software requirements, the understanding of each manufacturer may be inconsistent, but from the perspective of users, it is exactly what our pharmaceutical enterprise GMP needs to be able to provide these comprehensive information 3 Process repeatability and traceability of fluidized bed drying equipment in actual production, the operator shall reset and modify the process parameters of each production equipment, which can not guarantee that the same products are produced with the same equipment and process parameters, so it is impossible to talk about traceability According to GMP requirements, the equipment is required to be able to store a certain amount of production process parameters to ensure the repeatability and traceability of production Each user sets according to the number of varieties Generally, fluidized bed drying equipment can store 50 kinds of production processes, but most domestic equipment can't do this at present To give a simple example, the spray system is replaced by a spray nozzle of the same specification Under the same pressure, the effect of the same adhesive is different The time and the drying time of the spray are reset This is because the nozzle is different from the nozzle produced by the machine when finishing, which requires us to strictly implement the quality standard of the sprinkler Accuracy (including accuracy), as one of the necessary conditions to ensure the reproducibility of the process, its processing accuracy shall be controlled within the range of several microns This requires us to have the rigor and strictness of equipment manufacturing, to conduct strict component inspection and acceptance according to the processing drawings, and to have sufficient data and document support The repeatability and traceability of the production process of fluidized bed drying equipment put forward certain requirements for PLC control system and mechanical actuator For example: (1) it is designed and installed in the stainless steel box with lock (2) siemens plc (S7-300) is used to control the granulation and drying process (3) it has the functions of automatic and manual granulation, drying, discharging, etc (4) be able to control and operate the following contents: air inlet and exhaust volume, control the pressure in the cylinder; control the air inlet temperature and humidity; control the water inlet and steam valves; control the discharge; control the operation of the peristaltic pump during granulation; control the feed volume; control the online cleaning (5) temperature probe shall be set in the air inlet, fluidization chamber and exhaust, and