Introduction of the characteristics and trial cond

2022-08-01
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Introduction to the characteristics and trial conditions of dryers in the pharmaceutical industry

the pharmaceutical industry has developed rapidly. In the past 20 years, with the process of reform and opening up, the pharmaceutical machinery industry has also shown a great situation of letting a hundred flowers bloom. The author has the honor to have applied the above drying devices for work reasons. Due to limited knowledge, there are many good dryers that have not been introduced, such as disc dryers, spouted bed dryers, flash dryers Microwave series dryer, etc. The dryer shall be selected according to the characteristics of drugs and the ideal state of waste products, especially the material and sterility guarantee of sterile API drying equipment. The drying equipment of Sinopharm has developed rapidly in Jiangsu area. There are many professional drying equipment factories. Their products are universal and have their own characteristics, which provides conditions for the localization of imported equipment for drying bulk drugs and the selection of GMP ideal dryers in line with the good manufacturing practice for drugs

China's accession to the WTO has brought opportunities to the pharmaceutical industry. Chinese APIs and pharmaceutical intermediates (hereinafter referred to as APIs) occupy an important position in the international market with their low prices. It also brings new challenges to the pharmaceutical industry. For various purposes, in the past two years, various API importing countries have put forward higher requirements for the production process and society of China's pharmaceutical enterprises. Therefore, various certifications have been rapidly launched in the pharmaceutical industry. At the same time, China's GMP certification of the good manufacturing practice of drugs is also accelerating. The key points of these certifications are concentrated on the posts of refining, drying and packaging for API, and the reasonable selection of dryer is particularly important. The drying device must comply with GMP requirements to ensure that the drug production process is reasonable, the product is uniform, and there is no accumulated material It can meet the cleaning inplac CIP requirements, and the drying device used for sterile API should also meet the sterilization requirements (sterilizinginplac SIP requirements. At present, there are many types of API dryers in China, including vacuum drying oven, vacuum rotary dryer, three in one, airflow dryer, spray dryer, fluidized bed, fluidized bed, freeze dryer, etc. the following is a brief discussion on their respective characteristics and applicable conditions.

1 vacuum drying oven

the box is divided into several layers by the heating plate. The heating plate is filled with hot water or low-temperature water As the heating medium, the vacuum drying oven is also an old drying device that the market pays attention to the technical innovation of graphene. Place the material tray to be dried on the heating plate, close the box door, and vacuum the box with a vacuum pump. The heating plate will heat the medicine to the specified temperature in the circulating flow of the heating medium, and the water will begin to evaporate and gradually be pumped away with the vacuum pumping. This equipment is easy to control and can condense and recover the evaporated solvent. The drugs are not easy to be polluted during the drying process. It can be used for drug drying, packaging material sterilization and heat treatment. In the 1980s, this equipment was often used as the main dryer in the API industry. However, due to the difficulty in cleaning and sterilizing the material tray, the drying speed was slow, and the labor intensity of workers was high. In addition, in order to achieve the uniformity of drugs, the dried drugs had to be mixed by a powder mixing device. At present, this equipment has been rarely used in the large-scale production of API, and it is mostly used in medium-sized and small-scale pilot production or packaging material heat treatment

2 vacuum rotary dryers

are mostly cylindrical bodies with two conical ends. Vacuum rotary dryers are derived from double cone mixers. Also commonly known as double cone dryer. There are two hollow suspended shafts in the middle of the cone, which are used for equipment rotating support and vacuum and hot water channels. The drugs rotate while drying in the dryer, which can ensure the homogeneity of the whole batch of drugs. The hot medium enters the jacket through the hollow pipe at one end, and the hot gas in the device is discharged with the exhaust pipe in the hollow pipe at the other end, and the volatile solvent is recovered through condensation. This equipment was developed by Shanghai Pharmaceutical Industry Research Institute in the 1980s. The company successfully tried penicillin production, and soon promoted it in the national antibiotic industry. At present, there are many domestic manufacturers. Later, the single axis rotary dryer, multi-dimensional rotary dryer, inclined rotary dryer and other similar products appeared. It can be seen that the fixture is important in the experimental machine. The equipment is equipped with vacuum system, solvent recovery system, cleaning and sterilization system, etc. Because this equipment is easy to operate, easy to adjust intermittent production, and can be cleaned and sterilized, it has become the preferred dryer for small and medium-sized antibiotic API enterprises, such as penicillin, lincomycin, chlortetracycline, caffeine, etc. The concentricity of the two hollow shafts and the sealing of the hollow shaft are mainly considered when selecting the equipment. In order to ensure the smooth operation of the equipment, the concentricity requires that the runout of the shaft end is less than 0.01mm. The sealing effect of the hollow shaft is mainly to prevent the lubricant or filler from polluting the drugs

3 three in one equipment

the pharmaceutical industry is very representative. Three in one refers to the three processes of filtration, washing and drying in the same equipment. This kind of equipment has developed rapidly since the 1990s. It can be divided into belt type, tank type and centrifugal type

it is mainly due to the different advance modes of the filter belt. There are two types of belt type three in one: step type and continuous type. The work flow is exactly the same. The materials are evenly laid on the filter belt by the feeder, and the filter belt is dragged by the transmission device to move in the dryer. The washing and suction filtration sections are used for solvent washing, and the solvent mother liquor is recovered by vacuum cold pumping; The hot air in the drying section enters, is evacuated and condensed to recover the solvent. It is used for mass production. It is suitable for drying granular materials with good air permeability. The waste products are dried evenly. It is widely used in vitamin C and penicillin industries in China. Due to the poor airtightness of this equipment, cleaning and sterilization cannot be well arranged, so it is only suitable for the drying of non durable bacteria free API and pharmaceutical intermediates. The feeder and filter belt deviation correction device of the equipment play a key role in the normal operation of the equipment. In addition, supporting facilities such as heater and vacuum system also have a great impact on the productivity of the equipment. Such equipment used in the pharmaceutical industry is mainly imported or self-assembled with imported main components. Domestic such equipment is only used in chemical, food and traditional Chinese medicine industries. In recent years, some companies have imitated it in the pharmaceutical machinery industry, but successful applications in the pharmaceutical industry are rare

the tank is similar to a large suction filter, and the tank type is three in one. The chassis is a combination of metal sintered plate filter, support plate and heating plate. The tank body is equipped with a jacket for heating and cooling. The tank is equipped with an agitator that can move up and down. The agitator is a hollow structure, and the medium is introduced for heating and cooling. The drying stage plays a major role. After entering the equipment, the materials shall be subject to suction filtration, and then added with washing medium to soak for a certain time. The materials shall be subject to cold pumping or pressurized suction filtration to a certain level. The mixing, chassis and jacket shall be filled with heating medium at the same time. At the same time, the materials shall be vacuumized for drying. The drying shall be stopped after the sampling is qualified according to the experience, and the materials shall be discharged from the outlet. The mixing seal and sintering plate of this equipment are the most critical. The supporting equipment includes hydraulic system, vacuum system, heating and cooling unit, etc. Since the equipment is fully enclosed, if an automatic discharge system is added, The equipment can be completely cleaned (CIP and sterilized (SIP is very suitable for the production of sterile API. In recent years, such equipment has been widely used in the production of penicillin sodium salt and semi synthetic antibody. In the 21st century, with the acceleration of GMP certification, the national pharmaceutical machinery industry has vigorously developed or imitated similar imported equipment. However, due to the differences in processing accuracy and process control, the domestic three in one equipment is mainly used in the production of non sterile API.

the base of vertical filter centrifuge On this basis, the function of hot air drying is added, and the centrifugal three in one. There are many forms such as filter bags or metal filter plates. The production process is basically the same as that of the tank type three in one. The only thing is to change the pumping dry into centrifugal drying, which can greatly reduce the production time of a single batch of materials. However, due to the volume limitation of the centrifuge silo, the production capacity of a single batch is limited, which is more suitable for the production of medium and small batches of sterile APIs. Since the equipment can put the silo and the transmission device in the sterile room and outside respectively, the equipment maintenance does not need to enter the sterile room, which is very convenient for production and use. In recent years, joint ventures in the domestic API industry have introduced such equipment, and imitations have also come out in China in recent years

4 airflow drying device

can quickly remove material moisture (mainly surface moisture). In airflow drying, airflow drying is applicable to granular and powdery materials that are easy to dehydrate. Because the material stays in the dryer for a short time, the quality of the dried product is best controlled. The wet materials are fully mixed with the hot air flow through the feeder. While drying, they enter the drying pipe under the suction of the wind for further uniform drying. The wet heavy particles that cannot be attracted by the wind will continue to be impacted, broken and dried in the dryer until they can be sucked up by the wind and enter the drying pipe. The end of the drying pipe is a cyclone separator. This equipment is mainly used in the production of oxytetracycline and local health products in the pharmaceutical industry

5 the hot air generated by the spray dryer

is filtered in several stages (selected according to the drug grade) and then enters the drying chamber through the spiral case channel on the top of the drying chamber through the hot air distributor. The material is filtered through a centrifugal atomizing disc or pressure nozzle. The drying process of this equipment is similar to air drying. The air is heated by the heater after primary filtration. Dispersed and fine material mist occurs. The material mist contacts with swirling hot air, and the water evaporates rapidly. The material is dried in a very short time. This equipment is suitable for drying liquid materials with good fluidity such as solutions, emulsions, suspensions and pastes. The company has been using this equipment to produce streptomycin since the 1950s. Now this equipment can be used for drying streptomycin, gentamicin and various biological extracts in the API industry

6 boiling bed

hot air is blown in from the bottom, and the medicine of this equipment is added from the upper part of the bed. Through the porous distribution plate, it contacts with the materials with a certain thickness of the material layer. The materials are in the state of fluidization and boiling. The air flow flips up and down, mixes and collides with each other. The contact area between gas and solid is large, and intense heat and mass transfer is carried out, which greatly improves the drying speed and drying efficiency. It is an ideal drying equipment. Some wetter materials can be dried at one time to reach the required moisture index. High thermal efficiency in fluidized boiling state. The residence time can be adjusted, and it is easy to get waste products with low moisture content. The large and small particles can be graded on the bed surface, the coarse particles can be discharged from the bed, and the fine powder is discharged from the dust collector. For some materials, bag dedusting can be used in the main machine (built-in) to save floor space, with simple structure and less investment. This equipment is suitable for drying powder, granule, silk and strip materials. It is fully enclosed and can be cleaned and sterilized. It is widely used in the production of antibiotics and semi synthetic antibiotics in the pharmaceutical industry

7 fluidized bed

vibrating fluidized bed is mostly used for drug drying due to the influence of fluidity. The dryer is vibrated by the exciting force generated by the vibrating motor. The equipment includes fluidized bed and vibrating fluidized bed. The material jumps forward under the excitation force in the given direction. At the same time, the hot air is input at the bottom of the bed to make the material in a fluidized state. The material particles are in full contact with the hot air to carry out an intense heat and mass transfer process. At this time, the thermal efficiency is the highest. The upper chamber is in a slight negative pressure state, the wet air is led out by the induced draft fan, and the dry material is discharged from the discharge port, so as to achieve the ideal drying effect. The equipment has uniform fluidization, no dead angle, uniform temperature distribution and high thermal efficiency. It is suitable for drying granular, powder, strip and silk like materials, such as Lake

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