Filtration, washing and drying three-in-one equipment realizes the fully enclosed production of sterile raw materials, which meets the requirements of CGMP

2023/04/08

Filtration, washing and drying three-in-one equipment realizes the fully enclosed production of sterile raw materials, which meets the requirements of CGMP

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 artificial impurities, pollution, etc., and the quality of pharmaceuticals can be guaranteed most effectively, and Production also has minimal environmental impact. This production method is in line with the development trend of cleaner production in the world.

The application of some new technologies and new ideas in pharmaceutical engineering also provides technical means for the fully enclosed production of drugs.

The filter washing dryer is commonly called "three-in-one" equipment, which is the key equipment commonly used in production. This article combines the development and application of some new technologies of the three-in-one unit to explain how to comprehensively utilize the new technological progress of the three-in-one unit. To realize the fully closed production process of sterile raw materials.



General production process of sterile raw materials
Generally, the final pharmaceutical crystals are obtained through the crystallization process after the aseptic bulk drug is refined or synthesized. The crystalline suspension containing drug crystals is first filtered to achieve solid-liquid separation of the crystals and the 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 perform certain washing required by the process After the number of times, the mother liquor is separated again, and then the crystal is dried (usually vacuum heating or vacuum freeze-drying). After drying for a certain period of time, a sample is taken for inspection, and it becomes a finished drug after passing the test.

Finally, unloading, transportation, quantitative packaging or sub-packaging are carried out.

At present, in the production process of sterile raw materials in most domestic pharmaceutical factories, 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 transportation 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, changing the material delivery method in the traditional production process is the key.





The fully enclosed three-in-one production system can realize complete automatic operation control. The production process of the system is introduced as follows:
1) Seal the entire unit system first, 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) The inert gas is introduced to pressurize, and the solid-liquid separation of the crystallization liquid is realized 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 the drug will be degraded and invalid. 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 dry and qualified (sampling test 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 (such as N2 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 falling speed of the stirring blade for scraping and feeding The action allows the powdery material to quickly enter the silo through the discharge valve. When the stirring is scraped close to the metal filter plate layer, it stops stirring and descends, and then instantly injects inert gas to blow all the bottom material to the silo.
7) After the material enters the silo, the material level is detected, and it is loaded into the metering silo in batches, and then quantitatively distributed through the weighing controller.

So far, the whole process of filtering, washing, drying and packaging of medicines is completed.


Features of fully enclosed three-in-one production system
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.

This set of equipment 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 in the production process to the air of the operating environment, and at the same time reduce the occurrence of poisoning accidents 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 drug yield 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) 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 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.

In view of the above advantages of the fully enclosed three-in-one production system, the production line composed of it is especially suitable for the production of sterile pharmaceutical products, so that the technical performance of the three-in-one equipment is completely integrated and optimized with the pharmaceutical process system.




At present, with the general application of GMP regulations in the pharmaceutical production process, more and more pharmaceutical companies are concerned about whether their equipment has process adaptability. Especially in the manufacturing stage of finished pharmaceutical products, the norms and standards will become more and more stringent, and the closed production and fully closed process will be the best production process. The three-in-one production system with fully enclosed material transfer function can well realize the fully enclosed production process of pharmaceutical production, and complete all functions of pharmaceutical production from crystallization-filtration-washing-drying-discharging-screening-packaging.

Therefore, it is a very good choice for the solution of the fully closed process of pharmaceutical production, and it also proves that the road to the optimization and integration of the pharmaceutical production process system through technological innovation of traditional equipment is very bright.


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