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In the fourth chapter of the new GMP Appendix* section, the isolation operation technique is specifically introduced:
Operation with high risk of contamination should be done in an isolating operator. The isolation operator and its environment should be designed to ensure that the quality of the air in the corresponding area meets the set standards. The transfer device can be designed as a single or double door or as a fully sealed system connected to the sterilization equipment.
Special care should be taken to prevent contamination when items enter and exit the isolation operator.
Isolation technology is essentially a glove box from the Second World War. It was mainly used for the treatment of radioactive materials. The essence is to protect operators from radioactive substances. After the war, this isolation technology for the nuclear industry was gradually applied to many industries such as the pharmaceutical industry, food industry, medical field, electronics industry, and aerospace industry. The application of isolation technology in the pharmaceutical industry is mainly used for the aseptic production process control and biological experiments of pharmaceuticals. The application in the pharmaceutical industry not only satisfies the need for product quality improvement, but also protects the operator. The damage caused by harmful substances and toxic substances in the production process reduces the operating costs of the pharmaceutical industry.
With the rapid development of biomedical technology, microelectronics and other technologies in the 21st century, the requirements for clean technology are constantly improving, and the traditional clean room (partial shielding) has become increasingly unable to meet the needs of users. The aseptic isolator should be changed. More and more popular.
Aseptic isolation technology is a technology that uses physical barriers to isolate the controlled space from the external environment. The sterile isolators use sterile isolation technology to break through the traditional clean technology and provide users with a high degree of cleanliness. Continuous and effective operation space, it can greatly reduce the pollution of microorganisms, various particles and pyrogens, realize the whole process of aseptic preparation and aseptic control of sterilization and aseptic production of aseptic bulk drugs.
The pharmaceutical industry uses isolator technology for two purposes. One is to protect the product from environmental pollution, including contamination from the operator during filtration and sealing; the other is to protect the operator from the production process. Harmful substances and toxic substances.
Isolation technology has the following advantages over traditional clean technology:
1. Automatic gas sterilizer sterilization, saving time and effort, uniform gas distribution, good effect, easy to verify by colleagues;
2. Completely isolated from the outside world, only through HEPA for air exchange, and can constantly isolate the pressure inside the cabin to prevent external pollution;
3. The use of a two-door rapid transfer system ensures delivery in a sterile environment;
4. Can significantly reduce the cost of operation and maintenance.
The sterile isolators are mated with a shielded double door isolation technology to create a completely isolated, safe and fast transfer path. The sterile sterilizer is equipped with an automatic sterilizing system that effectively sterilizes the sterile isolators to create a dynamic, continuous and effective high cleanliness space; the fully isolated cabin barrier provides safe and effective protection for the operator And the operator is completely freed from the traditional clean room; no need for huge purification system support, which greatly reduces operating costs; complete isolation inside and outside the cabin allows the sterile isolator to move freely in a generally clean environment. Created a "mobile micro lab" for you.
VHP sterilization can effectively inactivate viruses, bacterial vegetative and spores, and fungi. The SAL is 10-6, providing a more secure aseptic environment with good compatibility with a wide range of devices, electronic components and building materials. VHPzui's final decomposition products are only water and oxygen, which are relatively safe for people and the environment.
Hangzhou Tailin Technology, the main manufacturer of aseptic isolators, currently produces soft cabin aseptic isolator. The company's finished isolator products are mainly available in three models, and can also be customized according to the actual situation of the user to provide a production isolation system. product. The company's isolators have the following main features:
1) The completely shielded double-door transfer technology solves the problem that the 100-level cleanliness of the traditional sterile room cannot be effectively maintained, making the experimental operation more convenient, free and more efficient.
2) Built-in stealth aseptic detection system. The cabin is designed with a sterile inspection system that can be completely hidden when not in use.
3) The remote control system realizes the intelligent and digital control of the environment in the aseptic cabin, and can realize remote control within 1km.
4) The sterilization method is advanced, the cost is low, and the “automatic sterilization without consumption and pollution†is realized.
5) The application of universal wheel and double-sided operation on the HTY biological isolation compartment makes the isolation compartment an active “sterile roomâ€, which is more convenient and flexible.
6) The size, appearance and configuration of the compartment can be customized according to user requirements.
7) The product has applied for one national invention patent and utility model patent, and the company has independent intellectual property rights.
See the application of aseptic isolators in the pharmaceutical industry from the requirements of the new GMP for sterile drugs
Since March 1, 2011, the "Good Manufacturing Practices (2010 Revision)" (GMP) has been officially implemented. The new GMP Appendix* has a larger requirement for the production of sterile drugs than the previous requirements. The increase indicates that the government's quality management of aseptic preparations and aseptic bulk drugs is becoming more stringent. This requires relevant pharmaceutical manufacturers to implement more stringent standards for the production environment and improve hardware facilities and software management.