Pharmaceutical Industry Conical Vacuum Dryer
Generally speaking, the production of aseptic raw materials usually combines the final product refining and aseptic process in the production process as a one-step operation unit in the production process. Contamination of sterile and insoluble particles is the two main characteristics that distinguish sterile APIs from non-sterile APIs. Therefore, the "three-in-one" equipment for sterile APIs (the functions of the original multiple devices are concentrated and optimized to one device The equipment used to complete multiple tasks is directly related to the production process and quality of the product, and is the main equipment guarantee used in the production of sterile APIs.
All-in-one equipment Pharmaceutical Industry Conical Vacuum Dryer Introduction
Filtration, washing, and dryer are commonly called "three-in-one" equipment. They are commonly used key equipment in the production of raw materials. The tank body of the tank-type "three-in-one" equipment is similar to a large suction filter, and the chassis is made of metal sintered plates. Filter screen (mainly made of stainless steel and titanium), support plate and heating plate. The tank body has a jacket for heating and cooling. The tank has a stirrer that can move up and down. The stirrer has a hollow structure. The medium is passed in for heating and cooling. It plays a major role in the drying stage. The container can be protected by inert gas, which is composed of "input/output" interface system, working system, sampling system, CIP and SIP system.
Vertical Conical Vacuum Dryer Working Process
(1) Seal the entire unit system first, fill it with sterile inert gas (such as N2 gas) for protection, add the crystal solution to be processed to the "three in one" from the crystallizer through an automatic valve, and close the feed valve when it reaches a certain volume.
(2) Pass in inert gas to pressurize, and realize the solid-liquid separation of crystal liquid through the large metal filter plate at the bottom.
(3) After the solid-liquid separation of the crystalline liquid, the filter cake is sprayed and washed.
(4) After washing, the stirring device is lowered by the hydraulic device for stirring, and the heating pipeline system inside the stirring is used to heat the material layer, and the temperature of the drying process is strictly controlled, otherwise it will cause the degradation of the medicine. During heating and drying, the system is vacuumed to quickly evaporate the solvent, and the dust collector is started to work automatically to ensure the normal ventilation of the vacuum system.
(5) After the material layer is qualified (can be sampled and tested or automatic process analysis), stop the vacuum and enter the automatic discharge program.
(6) Automatic discharging: The lowering stirring device controls the stirring speed and the lowering speed of the stirring blade to scrape and feed the material, so that the powdery material quickly enters the silo through the discharge valve, and stops when the stirring is close to the metal filter layer. Stir down, and then instantly spray inert gas to blow all the bottom materials to the silo.
If high-pressure sterile inert gas (such as N2 gas) is introduced near the discharge port, the silo is connected, and the vacuum is pumped at the same time, and the addition of weighing can also realize the whole process of filtering, washing, drying and dispensing the medicine
The advantages of Vertical Conical Vacuum Dryer in the Pharmaceutical Industry
How to ensure that the production system meets the cleanliness requirements and maintains a sterile state during the production of sterile APIs is a key issue in the production of sterile APIs.
Aseptic production processes usually have more variable factors than terminal sterilization processes, such as the air cleanliness, temperature and humidity of the production environment, aseptic operation habits of operators, and sterilization of packaging materials and aseptic clothing. These factors add a lot of difficulty to the aseptic production process. In the non-closed production process, materials have several links that are exposed to the equipment and need to be processed manually. Once pollution occurs, it is very difficult to find and confirm which link caused the pollution. Therefore, in the production process of sterile raw materials, the production mode of fully enclosed equipment is more effective than other non-closed production modes to avoid product pollution from the external environment. In theory, the "three-in-one" fully enclosed production system has no open links in the entire production system except for the import of raw materials and the export of finished products. Therefore, it has the following advantages:
1. Reduce the chance of contamination and help ensure the sterility of the product
Multiple processes such as washing, filtering, and drying are placed in a closed device to complete multiple operations, reducing the risk of pollution transferred between different devices. Protective gases such as N2 can also be passed into the device to isolate the contact with the external environment. It reduces the chance of product being contaminated and helps ensure the sterility of the product.
2. It can realize online CIP and SIP, easy to clean and sterilize or clean and sterilize after disassembly
The current "three-in-one" equipment has changed the disadvantages of centrifugation, filtration or ovens that are not suitable for online cleaning and sterilization; by installing spray balls, turning on pure steam and other methods, adding cleaning solvents when necessary, the equipment does not need to be disassembled In the case of automatic cleaning and sterilization, it provides equipment guarantee for aseptic production. The "three-in-one" equipment that is packaged is currently capable of CIP and SIP in some foreign countries, but it is still not available in China. Most of them are cleaned and sterilized after disassembly.
3. Pollution-free sampling can be realized
"Three-in-one" equipment is mostly designed with a safe and pollution-free sampling valve device. When sampling, it is not necessary to open the equipment cover or cabinet door, so as to avoid the contamination of drugs with impurities from sampling tools.
4. Improve production efficiency and save operating costs
(1) As the work completed by multiple processes and multiple equipment operations becomes one device to complete, the operation time is reduced and the production cycle is shortened; (2) The clean area is saved on site and the construction cost is reduced; (3) Also It saves operating costs such as air conditioning and refrigeration, and has a certain effect on reducing costs, increasing efficiency, and saving energy.
5. It saves labor costs and also contributes to stable product quality
Reduced the production process, improved the degree of automation, reduced labor, and also reduced the error and pollution in the operation of employees, which is conducive to the uniformity and stability of drug batches.
6. In line with the development trend of cleaner production in the world
The fully enclosed production process in pharmaceutical production has always been the best production method pursued by pharmaceutical manufacturers. In this way, the pharmaceutical production process is not affected by external or man-made impurities, pollution, etc., and can most effectively guarantee the quality of the drug, and Production has the least impact on the environment. This production method is in line with the development trend of cleaner production in the world.
The "three-in-one" equipment of filtering, washing and drying replaces the original filtering equipment, which can complete the washing operation and realize the function of drying; there is also the "three-in-one" equipment for sub-packaging to realize crushing, sieving and weighing The continuous operation function of sub-packaging in a closed system fully reflects the practical significance of the "three in one" equipment.
The All-in-one equipment Pharmaceutical Industry Conical Vacuum Dryer produced by Shuangrui Machinery is a closed system with a separate sampling system; the parts contacting the medicine are made of 316 stainless steel, and the coolant and lubricant have their own independent operating system and the medicine is completely separated; the shaft part Mechanical seals have gas seals and particle collection devices or lip seals imported from the United States. Prevent particles from entering the tank or container from polluting the equipment; effectively reducing the probability of contamination. The design of the equipment has the function of reducing the occurrence of pollution, cross-contamination, confusion and errors; the material of the equipment, the lubricants, and coolants used will not increase the pollution of the product; the in and out of materials, sampling, design and mechanical seal wear In terms of particle prevention and exclusion, it effectively prevents particles from entering the tank or container and contaminating the equipment; greatly reducing the probability of contamination.
Keyword:Conical Vacuum Dryer,All-in-one equipment ,"three-in-one" equipment,Pharmaceutical Industry ,sterile APIs.