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    Home > Active Ingredient News > Drugs Articles > Application of aseptic isolator in pharmaceutical industry

    Application of aseptic isolator in pharmaceutical industry

    • Last Update: 2019-08-17
    • Source: Internet
    • Author: User
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          Since March 1, 2011, the GMP has been officially implemented The appendix of the new GMP has greatly improved the production requirements of sterile drugs compared with the previous requirements, which indicates that the government is more strict in the quality management of sterile preparations and sterile APIs, which requires the relevant drug manufacturers to implement stricter production environment Grid standard, in hardware facilities and software management improvements In the fourth chapter of the new GMP appendix, the isolation operation technology is introduced in particular: the operation with high pollution risk should be completed in the isolation operator The isolation operator and its environment shall be designed to ensure that the air quality in the corresponding area meets the set standard The transmission device can be designed as a single door or double door, or a full sealing system connected with the sterilization equipment Special care shall be taken to prevent contamination of the entry and exit isolators Isolation technology is essentially derived from the glove box in the Second World War At that time, it was mainly used for the treatment of radioactive substances Its essence is to protect operators from the harm of radioactive substances After the war, the isolation technology applied to the nuclear industry was gradually applied to the pharmaceutical industry, food industry, medical field, electronic industry, aerospace industry and many other industries The application of isolation technology in pharmaceutical industry is mainly used in aseptic production process control and biological experiments of drugs The application in pharmaceutical industry not only meets the needs of product quality improvement, but also can be used to protect operators from harmful substances and toxic substances in the production process, reducing the operation cost of pharmaceutical industry With the rapid development of biomedical technology, microelectronics and other technologies in the 21st century, the requirements of clean technology continue to improve, the traditional clean room (local shielding) has become increasingly unable to meet the needs of users, and the sterile isolator should be more and more popular Aseptic isolation technology is a technology that uses physical barrier to isolate the controlled space from the external environment Aseptic isolation technology breaks through the traditional clean technology and brings a highly clean and continuous effective operation space for users It can effectively reduce the pollution of microorganisms, various particles and pyrogens and realize aseptic preparation The whole process of production, the sterilization of sterile API and the aseptic control of aseptic production process The pharmaceutical industry uses isolator technology for two purposes: one is to protect products from environmental pollution, including pollution caused by operators during filtration and sealing; the other is to protect operators from harmful substances and toxic substances in the production process Compared with the traditional clean technology, the isolation technology has the following advantages: 1 Automatic gas sterilizer sterilization, time-saving and labor-saving, uniform gas distribution, good effect, easy to verify by colleagues; 2 Completely isolated from the outside, only through HEPA air exchange, and can keep the pressure in the cabin constant to prevent external pollution; 3 Adopt double door fast transfer system to ensure the transfer in sterile environment; 4 It can significantly reduce the cost of operation and maintenance The sterile isolator adopts the shielded double door isolation technology for docking, which can form a completely isolated, safe and fast transmission channel The automatic sterilization system equipped with the aseptic isolator can effectively sterilize the aseptic isolator and create a dynamic, continuous and effective space of high cleanliness; the completely isolated cabin barrier provides safe and effective protection for the operators, and liberates the operators from the traditional clean room completely; it does not need the support of the huge purification system, so as to greatly reduce the operation cost; The complete isolation inside and outside the cabin can make the sterile isolator move freely in the general clean environment A "mobile microlab" has been created for you 5 VHP sterilization can effectively inactivate virus, bacterial vegetative body, spore and fungus Sal can be up to 10-6, thus providing a more secure sterile environment and good compatibility for various devices, electronic components and building materials The decomposition products of VHP are only water and oxygen, which are relatively safe for human and environment                                            
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