In recent years, due to the occurrence of various drug incidents, my country's drug regulatory system and production enterprises have paid more and more attention to the production of sterile drugs, especially the new version of GMP is basically consistent with EU regulations, and the requirements for production equipment have also been further improved. Generally speaking, the production of sterile raw materials is usually completed by combining the final product refinement and aseptic process in the production process as a one-step operation unit in the production process. Sterility and contamination of insoluble particles are the two main characteristics that distinguish sterile APIs from non-sterile APIs, so the "three-in-one" equipment for filtering, washing, and drying sterile APIs (the functions of the original multiple equipment are concentrated and optimized to One piece of equipment to complete multiple processes) is directly related to the production process and quality of the product, and is the guarantee for the production of sterile raw materials.
In order to cope with this new opportunity and challenge, the engineer team of Wuxi ZhangHua Machinery Co., Ltd. has carried out a lot of design and development work, and finally successfully developed the SR-tubular-cone reaction filtration and drying multifunctional machine, the invention patent number: ZL201721560677.6. And with Many well-known domestic pharmaceutical companies have reached strategic partnerships, and users have created good economic benefits.
The working principle and process flow of the filtering, washing and drying three-in-one equipment used in the production of barrel-cone sterile raw materials
Advantages of three-in-one equipment for filtering, washing and drying used in the production of aseptic raw materials
How to ensure that the production system meets the cleanliness requirements and maintains a sterile state before use in the production process of sterile raw materials is a key issue in the production of sterile raw materials.
The aseptic production process usually has more variable factors than the terminal sterilization process, such as the air cleanliness, temperature and humidity of the production environment, the aseptic operation habits of the operator, the sterilization of packaging materials and sterile clothing, etc. These factors have added a lot of difficulty to the aseptic production process.
In the non-closed production process, materials have several links exposed outside the equipment and need to be processed manually. Once pollution occurs, it is quite difficult to find and confirm which link caused the pollution. Therefore, in the production process of sterile raw materials, the use of fully enclosed equipment production mode is better than other non-closed production methods.
1. Reduce the chance of contamination and help ensure the sterility of the product
Multiple processes such as washing, filtering, and drying are placed in a closed device to complete multiple operations, reducing the risk of pollution transferred between different devices. Protective gases such as N 2 can also be passed through the device to isolate contact with the external environment. It greatly reduces the probability of product contamination, which is conducive to the guarantee of product sterility.
2.The cylinder-cone filter, washing and drying three-in-one equipment developed and produced by Wuxi ZhangHua Machinery has changed the disadvantages of the original centrifuge, filter or oven and other equipment that are not suitable for online cleaning and sterilization; it can be installed by installing spray balls and connecting pure steam. If necessary, add cleaning solvent to achieve most of the parts in the equipment
The cleaning and sterilization functions are automatically completed without disassembly, which provides equipment guarantee for aseptic production.
3.The cylinder, cone, filter, washing and drying 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 medicines by impurities brought into the sampling tool.
4. Wuxi ZhangHua three-in-one equipment for cylinder, cone, filter, washing and drying has helped many well-known domestic pharmaceutical companies improve production efficiency and save operating costs. The work that originally required multiple processes and multiple equipment operations has been replaced by one equipment, reducing operating time. , shorten the production cycle. At the same time, the clean area is saved on site
It takes up space, reduces construction costs, and also saves operating costs such as air conditioning and refrigeration, which has certain effects on reducing costs, increasing efficiency, and saving energy.
5. Save 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 the probability of contamination in the operation of the staff are also reduced, which is conducive to the uniform and stable quality of medicines between batches.
6. In line with the development trend of clean production. 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 can The most effective way to ensure the quality of pharmaceuticals, and the production has the least impact on the environment.
This production method is in line with the development trend of cleaner production.