The application of some new technologies and new ideas in pharmaceutical engineering also provides technical means for the fully-sealed production of API fine-baking packages. Wuxi ZhangHua Machinery innovates, develops and produces a new type of barrel-cone filter, washing and drying machine that is not affected by external or man-made impurities, pollution, etc., can effectively guarantee the quality of drugs, and the production has the least impact on the environment. This production method complies with GMP clean production requirements and is the development trend of biopharmaceuticals in the future.
(Wuxi ZhangHua Machinery's new cylinder cone filter washing and drying machine: invention patent number: ZL2017 2 1560677.6.)
General production process of API raw material medicine fine-drying package equipment
Generally, the raw material drug is refined or synthesized to obtain the final drug crystal through the crystallization process. The crystalline suspension containing raw drug crystals is firstly filtered to achieve solid-liquid separation of crystals and mother liquor to obtain a filter cake layer, and then the washing device is used to spray the washing liquid to soak or rinse the filter cake to meet the certain requirements of the process. After washing times, the mother liquor is separated again, and then the crystals are dried (usually by vacuum heating or vacuum freeze-drying). After drying for a certain period of time, samples are taken for inspection. After passing the test, they become finished medicines. Finally, unloading, transportation, quantitative packaging or sub-packaging are carried out.
At present, in the production process of raw materials in most pharmaceutical factories in China, the production process system as a whole has not been relatively complete and reliable connection and optimization. Especially for the transportation and transmission process of powdery pharmaceutical materials, there has not been a good connection and transportation method in actual production. The material operation mostly adopts the transportation of bulk materials or buckets, and between the unloading and sub-packaging processes. Handling is carried out manually. In this transfer method, the material generally needs to cross multiple purification rooms, which is likely to cause secondary pollution of the material during the transfer process.
If a fully enclosed delivery system is used, the above problems can be completely avoided, making the production process more in line with cGMP requirements.
The traditional bulk material delivery method is difficult to strictly guarantee the aseptic requirements during the loading or unloading process between the transport container (box, drum or PE bag) and the production equipment (dryer, mixer, dispenser, etc.). Since the hygiene, environmental protection, and cleanliness requirements of 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 the appropriate feeding and unloading method is very important. Therefore, in order to achieve a fully enclosed production process for the fine-drying package of raw materials, it is the key to change the multi-functional three-in-one equipment in the traditional production process.
(1) The production system process is fully enclosed
Due to the innovative application of the fully enclosed material conveying system, the fully enclosed production process from the beginning of crystallization to the end of subpackaging can be fully realized.
The fully enclosed three-in-one filter washing and drying equipment for raw material medicine fine-drying package 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 this production system, it can completely avoid the pollution of the solvent to the operating environment air during the production process, and at the same time reduce the occurrence of poisoning accidents of operators caused by contact with toxic substances. This advantage is even more important today when the calls for environmental protection and labor protection are rising day by day.
(3) The yield of finished product is high, and the solvent recovery is complete
Because the entire production system is a fully closed system operation, materials and solvents can be recovered almost 100% completely, avoiding waste caused by material omission, legacy and solvent volatilization, which has great economic benefits, especially in the treatment of materials and use This is especially true at higher solvent values.
(4) High degree of automation and easy to master
Each process is carried out in stages, and the safety measures are complete. The operators can complete the operation after simple training, and the work intensity is greatly reduced.
(5) Thorough cleaning of materials can be completed
Since this equipment can re-stir and suspend the filter cake during the washing operation, the filter cake can be cleaned very thoroughly.
(6) All operations can be performed with the same system
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 is also maximized.
(7) Clean production
This multi-functional filter drying equipment can operate in a closed manner, and is equipped with a dust collector to completely collect the dust generated after drying, which can meet the production operation requirements of high cleanliness.
Process flow of new barrel-cone filter, washing and drying integrated machine for fine drying and packaging equipment of API raw materials
(1) First seal the entire unit system, fill it with sterile inert gas (such as N2 gas) for protection, add crystallization liquid to be processed from the crystallizer to the three-in-one through the automatic valve, and close the feed valve after reaching 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 crystallization liquid, spray and wash the filter cake.
(4) After washing, the stirring device is lowered by the hydraulic device for stirring, and at the same time, 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 and failure of the drug.
While heating and drying, vacuumize the system to make the solvent evaporate quickly, and at the same time start the dust collector to work automatically to ensure the normal ventilation of the vacuum system.
(5) After the material layer is dried and qualified (sampling test or automatic process analysis PAT can be used), stop the vacuum and enter the automatic discharge program.
(6) Automatic nesting
Inject high-pressure sterile inert gas near the discharge port, and at the same time vacuumize the side of the silo, then lower the stirring device, control the stirring speed and the descending speed of the stirring blade to perform scraping and feeding actions, so that the powdery material can quickly pass through the discharge valve Entering the silo, when the stirring is scraped close to the metal filter plate layer, stop stirring and descend, and then instantly spray inert gas to blow all the bottom materials to the silo.
Many well-known biopharmaceutical companies at home and abroad choose Wuxi ZhangHua Machinery to innovate, develop and produce a new type of cylinder-cone filter, washing and drying machine, and have reached a strategic partnership. If you want to know more about the new type of cylinder-cone filter, washing and drying machine, please call: 13861731823 to proceed consult