Process characteristics and advantages of the multi-functional filter washing and drying machine in the fully enclosed production of antibiotic penicillin sodium


Penicillin sodium is suitable for infections caused by sensitive bacteria, such as swine erysipelas, anthrax, emphysematous gangrene, malignant edema, actinomycosis, equine blight, necrobacteriosis, bovine pyelonephritis, leptospirosis and mastitis, uterine Inflammation, pneumonia, sepsis, etc. It should be used in combination with tetanus antitoxin in the treatment of tetanus.

Multifunctional filter, washing and drying machine Antibiotic penicillin sodium three-in-one filter, washing and drying equipment overview

The centrifuge extraction process was used to replace the traditional tank extraction process. By investigating many factors affecting the extraction process, the parameters of the extraction process were optimized, the operating flexibility for different materials was improved, and the quality and yield of intermediates were improved.

Through the study of the crystal habit of penicillin sodium, the optimized crystallization process parameters were determined, and on this basis, the crystallization equipment was systematically transformed to solve the problems of irregular penicillin sodium crystal habit, easy breakage and non-concentrated particle size distribution. Through experiments to verify the relationship between different operating conditions and suction filtration speed, drying time and product crystal habit in the process of filtration, washing and drying, the "three-in-one" operation is optimized to solve the problem of long filtration and drying time, fine product crystal habit, To solve the problem of poor fluidity, realize the normal operation of the "three-in-one" automatic discharge and automatic packaging system. The above optimization process has been successfully applied to the production of penicillin sodium, and the actual application cases of customers have proved that: the penicillin sodium produced by the multi-function filter washing and drying machine has large crystal particle size and concentrated distribution, the product fluidity is improved, and the product quality maintains the domestic Leading level, fully adapted to the requirements of preparation packaging, the production capacity has reached and exceeded the design level, the technical indicators have been significantly improved, and the economic and social benefits have been remarkable.

Multi-functional filtering, washing and drying machine Three-in-one filtering, washing and drying process of antibiotic penicillin sodium:

(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 solution, 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 degradation and failure of the drug will be caused. 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 can be used), stop the vacuum and enter the automatic discharge program.

(6) Automatic discharge: lower the stirring device, control the stirring speed and the descending speed of the stirring blade to carry out the scraping and feeding action, so that the powdery material can quickly enter the silo through the discharge valve, and stop when the stirring is close to the metal filter plate layer Stir and descend, and then inject inert gas instantly to blow all the bottom materials to the silo.

Multi-functional filter washing and drying machine Antibiotic penicillin sodium three-in-one filter washing and drying Advantages and features:

Putting multiple processes such as washing, filtering, and drying in one airtight device to complete multiple operations reduces the risk of pollution transferred between different devices. Protective gases such as N2 can also be passed through the device to isolate contact with the external environment, greatly improving The probability of product contamination is reduced, which is conducive to the guarantee of product sterility.
1. Online CIP and SIP can be realized, which is convenient for cleaning and sterilization or cleaning and sterilization after disassembly
The current "three-in-one" equipment has changed the shortcomings of the original centrifugation, filtration or oven that are not suitable for online cleaning and sterilization; by installing spray balls, connecting pure steam, etc., and adding cleaning solvents when necessary, the equipment can be realized without disassembly Automatically complete the cleaning and sterilization functions under certain circumstances, providing equipment guarantee for aseptic production.

The "three-in-one" equipment packaged separately is currently able to achieve CIP and SIP in some foreign countries, but it is still not possible in China, and most of them are cleaned and sterilized after disassembly.

2. Pollution-free sampling can be realized
Most of the "three-in-one" equipment is designed with a safe and pollution-free sampling valve device. When sampling, it is not necessary to open the equipment cover or cabinet door, which avoids the contamination of drugs by impurities brought into the sampling tool.

3. Improve production efficiency and save operating costs
(1) Since the work completed by multiple equipment operations in multiple processes is completed by one equipment, the operation time is reduced and the production cycle is shortened; (2) The space occupied by the clean area is saved on site, and construction costs are reduced; (3) Also It saves operating costs such as air conditioning and refrigeration, and has certain effects on reducing costs, increasing efficiency, and saving energy.

4. Saving labor costs, but also conducive to stable product quality
The production process is reduced, the degree of automation is improved, the labor force is reduced, and the error and pollution probability in the operation of the staff are also reduced, which is conducive to the uniform and stable quality of the drug batches.

5. 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 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 design and selection of multi-function filter washing and drying machine equipment mainly considers product characteristics, process routes and GMP, etc. It is not that the more functions combined, the better. On the premise of fully meeting product quality and GMP requirements, in a closed container or pipeline The delivery or production of pharmaceuticals is an ideal situation. Therefore, you should also pay attention to how to choose the integrated equipment according to the characteristics of the production process: generally speaking, the above two equipments are not suitable for use when the product is relatively viscous or when crushing materials that become viscous when heated; special crystal materials cannot be used when they cannot be stirred. An all-in-one machine with stirring; materials with heat sensitivity or low temperature requirements can be cooled or vacuumed to cooperate with drying, and can basically be used to improve product quality.

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