Starting from March 1, 2011, the "Pharmaceutical Production Quality Management Standards (2010 Revision)" (GMP) was officially implemented, and the first part of the new version of the GMP appendix has a greater scope for the production of sterile drugs than the previous requirements The increase indicates that the government is stricter on the quality management of sterile preparations and sterile APIs, which requires relevant drug manufacturers to implement stricter standards for the production environment and improve the hardware facilities and software management.
In the fourth chapter of the first part of the new GMP appendix, the isolation operation technology is specifically introduced:
Operations with high contamination risks should be completed in isolation operators. The design of the isolation manipulator and its environment should be able 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 a double door, or it can be a fully sealed system connected to the sterilization equipment.
Special care shall be taken to prevent contamination when items enter and exit the isolation manipulator.
The isolation technology is essentially derived from the glove box of the Second World War, which was mainly used for the treatment of radioactive materials at the time, and its essence was to protect the operators from the harm of radioactive materials. After the war, this isolation technology suitable for the nuclear industry was gradually applied to many industries such as the pharmaceutical industry, food industry, medical field, electronics industry, aerospace industry and so on. The application of isolation technology in the pharmaceutical industry is mainly used for aseptic production process control and biological experiments of pharmaceuticals. The application in the pharmaceutical industry not only meets the need for product quality improvement, but also can be used to protect operators from The harm 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 continue to increase. The traditional clean room (partial shielding) has become more and more unable to meet the needs of users. Increasing popularity.
Aseptic isolation technology is a technology that uses a physical barrier to isolate the controlled space from the external environment. Aseptic isolation technology uses aseptic isolation technology to break through the traditional clean technology and bring users a high degree of cleanliness. , Continuous and effective operation space, it can minimize the pollution of microorganisms, various particles and pyrogens, to achieve the entire process of aseptic preparation production and sterilization of aseptic raw materials and aseptic control of aseptic production processes.
The pharmaceutical industry uses isolator technology for two purposes. One is to protect the product from environmental pollution, including pollution caused by the operator during filtration and sealing; the other purpose is to protect the operator from the production process. Harm caused by harmful substances and toxic substances.
Compared with traditional clean technology, isolation technology has the following advantages:
1. Automatic gas sterilizer sterilizes, saving time and effort, gas distribution is even, the effect is better, colleagues can easily verify;
2. Complete isolation from the outside world, air exchange only through HEPA, and constant pressure in the isolation compartment to prevent external pollution;
3. Adopt double-door fast transfer system to ensure the transfer in aseptic environment;
4. Can significantly reduce the cost of operation and maintenance.
The aseptic isolator adopts shielded double-door isolation technology to cooperate with each other to form a completely isolated, safe and fast transmission channel. The automatic sterilization system equipped with sterile isolators can effectively sterilize the sterile isolators, which can create a dynamic, continuous and effective high cleanliness space; the fully isolated cabin barrier provides safe and effective protection for the operators And completely free the operator from the traditional clean room; no need for huge purification system support, which greatly reduces operating costs; complete isolation inside and outside the cabin, can make the sterile isolator move freely in the general clean environment. Created a "removable microlab" for you.
VHP sterilization can effectively inactivate viruses, bacterial nutrients, spores and fungi. The SAL can reach 10 -6, which provides a more secure sterile environment and has good compatibility with various devices, electronic components, and building materials. The final decomposition products of VHP are only water and oxygen, which are relatively safe for people and the environment.
Hangzhou Tailin Technology, a major domestic manufacturer of aseptic isolators, currently mainly produces aseptic isolators for soft cabins. The company's finished isolator products mainly have three models, and can also be customized according to the actual situation of users to provide production isolation systems. product. The company's isolator products mainly have the following characteristics:
1) The fully 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 efficient.
2) Built-in invisible sterility detection system. The sterility testing system is designed and installed in the cabin, which 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 the remote control can be realized within 1km.
4) The sterilization method is advanced and the cost is low, which realizes "automatic sterilization without consumption and pollution".
5) The application of universal wheels, double-sided operation, etc. on the HTY biological isolation cabin makes the isolation cabin an active "sterile room", which is more convenient and flexible to use.
6) The size, appearance and configuration of the cofferdam can be customized according to user requirements.
7) The product has applied for one national invention patent and one utility model patent, and the company has independent intellectual property rights.
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