Telmisartan Material Refining and Purification Multifunctional Equipment
Keywords:Medical three-in-one filter washing and drying,Three-in-one production of sterile API,Multifunctional equipment for refining and purifying antihypertensive drugs
Telmisartan is effective in clinical trials for the treatment of mild to moderate essential hypertension and can effectively reduce systolic and diastolic blood pressure. In different clinical trials, clinical comparisons were made with placebo, calcium antagonists, β-blockers, and angiotensin transferase inhibitors. It was found that telmisartan has similar or more significant effects, and its overall The curative effect is higher than that of losartan and other early-market satan drugs. It not only effectively reduces the average pressure in 24 hours, day and night, but also effectively controls the sudden symptoms of hypertension in the early morning. In patients with mild to moderate hypertension, the combination of 40 to 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide is better than the drug alone.
Telmisartan has been widely recognized and accepted by clinicians and patients after its listing. In just a few years, sales have soared, and it has become a new force in the treatment of hypertension.
However, the traditional route for producing the drug has low yield, complicated operation, and is not conducive to cost reduction. There are three waste pollutions, which cause greater pollution to the environment. Wuxi Shuangrui Machinery Co., Ltd. has carried out a lot of design and development work, and finally developed the SR-cylinder cone reaction filter drying multifunction machine, invention patent number: ZL 20172 1560677.6. Realized Telmisartan raw material filtration washing and drying equipment The major breakthrough, and reached a strategic cooperation relationship with well-known pharmaceutical companies, has made outstanding contributions to the quality of anti-hypertensive drug equipment.
Telmisartan refining and purification multifunctional equipment Medical three-in-one filter washing and drying process:
(1) First seal the entire unit system, fill with sterile inert gas (such as N2 gas) protection, add the crystal liquid to be treated from the crystallizer to the "three in one" through the automatic valve, and close the feed valve after reaching a certain volume.
(2) Pass 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 solid-liquid separation of the crystallization liquid, the filter cake is spray washed.
(4) After the washing is completed, the stirring device is lowered by a hydraulic device for stirring, and the material layer is heated by the heating pipeline system inside the stirrer, and the temperature of the drying process is strictly controlled, otherwise it will cause the degradation of the drug. At the same time of heating and drying, the system is evacuated to quickly evaporate the solvent, and the dust collector starts to work automatically to ensure the normal ventilation of the vacuum system.
(5) After the material layer is dry and qualified (can be sampled for detection or automatic process analysis), stop the vacuum and enter the automatic discharge program.
(6) Automatic discharge: the lowering stirring device controls the stirring speed and the lowering speed of the stirring blade for scraping and feeding, so that the powdery material quickly enters the silo through the discharge valve, and stops when the scraping is close to the metal filter plate layer Stirring drops, then inert gas is instantly blown to blow all the bottom materials to the silo.
Telmisartan refining and purifying multifunctional equipment Medical three-in-one filter washing and drying Advantages and features:
Put multiple processes such as washing, filtering, and drying in a closed device to complete multiple operations, reducing the risk of pollution transferred between different devices. The equipment can also pass N2 and other protective gases to isolate the contact with the external environment, greatly Reduced the chance of product contamination, 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 centrifugal, filtration or oven that is not suitable for online cleaning and sterilization; by installing spray balls, switching on pure steam, etc., adding cleaning solvents when necessary, it can be achieved that the equipment does not need to be disassembled Under the circumstances, the cleaning and sterilization functions are automatically completed, which provides equipment protection for aseptic production. Separately packed “three-in-one” equipment is currently able to achieve CIP and SIP in some foreign countries, but it is still not available in China at present, and most of them use cleaning and sterilization after disassembly.
2. Pollution-free sampling is possible
Most of the "three-in-one" equipment is designed with safe and non-polluting sampling valve devices. When sampling, it is not necessary to open the equipment cover or cabinet door, which prevents the sampling tool from bringing impurities into the contaminated medicine.
3. Improve production efficiency and save operating costs
(1) Because the work completed by multiple processes and multiple equipment operations is completed by one equipment, the operation time is reduced and the production cycle is shortened; (2) the site saves space in the clean area and reduces construction costs; (3) It saves operating costs such as air conditioning and refrigeration, and has a certain effect on reducing costs and increasing efficiency and saving energy.
4. Save labor costs, but also help stabilize product quality
Reduces the production process, improves the degree of automation, reduces labor and labor, and also reduces the error and contamination probability of employee operations, which is conducive to uniform and stable quality between drug batches.
5. In line with the development trend of clean 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., which can most effectively ensure the quality of the medicine, and The impact of production on the environment is also minimal. This production method is in line with the development trend of clean production in the world.
The design and selection of "three-in-one" equipment mainly considers product characteristics, process routes and GMP, etc. The more functions that are not combined, the better. On the premise of fully meeting product quality and GMP requirements, transport or in closed containers or pipelines. The production of medicines is ideal. Therefore, we should also pay attention to how to choose integrated equipment according to the characteristics of the production process: in general, the above two equipments are not suitable for products with high viscosity or crushing materials that become viscous when heated; special crystal materials cannot be used when they cannot be stirred. All-in-one machine with agitation; materials with heat sensitivity or low temperature requirements can be cooled or vacuumed to dry, in addition to this, they can basically be used to improve product quality.
Shuangrui Machinery carefully studies all the details and listens to your opinions. For many situations, we have proposed the best solution. Whenever new challenges arise, we will work with you to develop suitable products.