Sterile Grade Multifunctional Conical-Cylindrical Dryer Introduction
The application of some new technologies and new ideas in pharmaceutical industry also provides technical means for the fully enclosed production of raw material medicines.Our Multifunctional Conical-Cylindrical Dryer process is not affected by external or man-made impurities, pollution, etc., can effectively ensure the quality of medicines, and the production has the least impact on the environment. This production method is in line with the development trend of GMP cleaner production.
General production process of raw material medicine fine baking bag
Generally, the final drug crystal is obtained through the crystallization process after the crude drug is refined or synthesized. The crystalline suspension containing bulk drug crystals is first filtered to realize the solid-liquid separation between the crystals and the mother liquor to obtain the filter cake layer, and then use the washing device to spray the lotion to soak or rinse the filter cake to perform certain process requirements. After washing times, the mother liquor is separated again, and then the crystals are dried (usually vacuum heating or vacuum freeze-drying). After drying for a certain period of time, samples are taken for inspection, and it becomes a finished drug product after being qualified. Finally, unloading, transportation, quantitative packaging or sub-packaging.
In the production process of raw materials for most pharmaceutical companies, the overall production process system has not been fully and reliably connected and optimized. Especially for the transportation and conveying process of powdered pharmaceutical materials, there has been no good connection and conveying method in actual production. The material movement mostly adopts the bulk material transportation or the transportation method of the barrel. Manual handling. In this transfer method, materials generally need to span multiple purification rooms, which may easily cause secondary pollution of materials during the transfer process. If a fully enclosed conveying system is adopted, the above problems can be completely avoided, making the production process more in line with cGMP requirements.
The traditional bulk material transportation method is difficult to strictly guarantee the sterility requirements during the loading or unloading process between the transportation container (box, cylinder or PE bag) and production equipment (dryer, mixer, dispenser, etc.). As the requirements for sanitation, environmental protection, and cleanliness levels in pharmaceutical companies are very strict, especially in the production of sterile preparation products or products containing certain active ingredients in the pharmaceutical industry, this requirement is even more stringent. How to choose a suitable feeding and unloading method is very important. Therefore, to realize the fully enclosed production process of the raw material medicine drying package, it is the key to change Sterile Grade Multifunctional Conical-Cylindrical Dryer in the traditional production process.
Sterile Grade Multifunctional Conical-Cylindrical Dryer Technical characteristics
1. The production system process is fully enclosed
Due to the innovative application of the fully enclosed material conveying system, a fully enclosed production process from the beginning of crystallization to the end of packaging can be fully realized. The fully enclosed three-in-one filtration, washing and drying equipment dedicated to the fine drying of APIs is a fully enclosed operating system, and the production process is more in line with cGMP requirements.
2. Safety and environmental protection
Due to the fully enclosed operation of the production system, it can completely avoid the pollution of the operating environment by solvents during the production process, and at the same time reduce the occurrence of operator poisoning accidents due to contact with toxic substances. This advantage is even more important today when the calls for environmental protection and labor protection are increasing.
3. High finished product yield and complete solvent recovery
Because the entire production system is a fully enclosed system operation, materials and solvents can be nearly 100% completely recovered, avoiding waste caused by material omissions, residues and solvent volatilization, and has great economic benefits, especially in handling materials and using This is especially true when the solvent value is higher.
4. High degree of automation and easy to master
Each process is carried out in stages, and safety measures are complete. Operators can complete the operation after simple training, and the work intensity is greatly reduced.
5. Can complete the thorough cleaning of materials
Because this equipment can re-stir and suspend the filter cake during the washing operation, the filter cake can be thoroughly cleaned.
6. Use the same system to complete all operations
Filtration, washing, drying, transportation, weighing, and packaging can be completed in the same system. The connection of each stage is very natural and smooth, and the space has been maximized.
7. Clean production
This Multifunctional Conical-Cylindrical Dryer can be operated in a sealed manner, and is equipped with a dust trap to completely collect the dust generated after drying, which can meet the requirements of high cleanliness production operations.
Sterile Grade Multifunctional Conical-Cylindrical Dryer Working Process
1. First seal the entire unit system, fill it with sterile inert gas (such as N2 gas) for protection, add the crystal solution to be processed from the crystallizer to the three-in-one 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 the crystallization 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, use the hydraulic device to lower the stirring device for stirring, and at the same time use the heating pipeline system inside the stirring to heat the material layer, and strictly control the temperature of the drying process, 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 has passed the drying process (sample testing or automatic process analysis PAT can be used), stop the vacuum and enter the automatic discharge program.
6. Automatic discharge
Inject high-pressure sterile inert gas near the discharge port, while vacuuming on the side of the silo, then lower the stirring device, control the stirring speed and the falling speed of the stirring blade to scrape and feed, so that the powdery material can quickly pass through the discharge valve Enter the silo, when the stirring is scraped to the metal filter plate layer, stop the stirring and descending, and then spray inert gas instantly to blow all the bottom materials to the silo.