API intermediates Conical Vertical Vacuum Dryer
The application of some new technologies and new ideas in pharmaceutical engineering also provides technical means for the fully enclosed production of raw material medicines. The new three-in-one filtration, washing and drying production 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.
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.
At present, in the production process of bulk drugs in most domestic 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 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 sterility requirements during the loading or unloading process between the transportation container (box, barrel or PE bag) and the production equipment (dryer, mixer, dispenser, etc.). Since 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 the multifunctional three-in-one equipment in the traditional production process.
API intermediates Conical Vertical Vacuum Dryer Process flow：
(1) First seal the entire unit system, fill it with sterile inert gas protection, add the crystal liquid to be processed from the crystallizer to the "three-in-one" through an 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 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, so that the solvent evaporates quickly, and the dust collector is started to work automatically, and the vacuum system is ventilated normally.
(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: lower the stirring device, control the stirring speed and the stirring and feeding action, so that the powdery material is quickly scraped through the lower speed of the mixing blade, and enters the silo through the discharge valve, when the stirring is scraped to the metal filter plate layer Stop stirring and descend at time, and then spray inert gas to blow all the bottom materials to the silo.
If high-pressure sterile inert gas is introduced near the discharge port, the silo is connected, and the vacuum is applied at the same time, and the addition of weighing can also realize the whole process of filtering, washing, drying, and packaging of medicines.
API intermediates Conical Vertical Vacuum Dryer Features
Reduce the chance and benefit the sterility of the product
How to achieve the cleanliness requirements and maintain the sterile state of the production system before use during the production of sterile APIs is a key issue in the production of sterile APIs.
Aseptic production process usually has more variable factors than final sterilization process, such as air cleanliness, temperature and humidity of the production environment, aseptic operation habits of operators, sterilization of packaging materials and aseptic clothing, etc. 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 it happens, it is quite difficult to find and confirm which link is causing it. Therefore, in the production process of sterile APIs, the production mode of fully enclosed equipment is better than other non-closed production methods. Put multiple processes such as washing, filtering, and drying in a closed device to complete multiple operations, reducing the risk of transfer between different devices. Protective gases such as N2 can also be passed through the device to isolate the contact with the external environment and greatly reduce The chance of the product being quilt is conducive to the sterility of the product.
API intermediates Conical Vertical Vacuum Dryer Function
(1) One machine with multiple functions, can complete the reaction, extraction, filtration, washing, repeated filtration and washing, drying and other operations in one machine, and directly obtain the finished product.
(2) The "three-in-one" equipment used for the production of sterile APIs is a closed system with a separate sampling system; the parts contacting the drugs are made of 316 stainless steel, and the coolant and lubricant have their own independent operating systems and drugs Separate; the shaft part is mechanically sealed with gas seal and particle collection device. Prevent particles from entering the tank or the equipment in the container; effectively reducing the probability. The design of the equipment has the function of reducing occurrence, crossover, confusion and error. It can be seen that the sampling and design of equipment materials, lubricants, coolants, etc. will not increase the impact on the product; materials entering and exiting, as well as the prevention and removal of particles from mechanical seal wear, effectively prevent particles from entering the tank or Equipment in the container, these greatly reduce the odds.
(3) The equipment is equipped with manual and automatic operation procedures, touch-type operation screen, convenient operation, automatic fault diagnosis function, easy to maintain; products with mature and stable production technology can be considered for programming control, equipped with pneumatic or electric valves, Implement one-button operation. Reduce complicated operating procedures.