Sterilization and aseptic operation in sterile workshop
Sterilization and aseptic operation in sterile workshop
Dry hot air sterilization in sterile workshop is sterilization with high temperature dry hot air. In a dry state, due to the weak penetration of hot air and the strong heat resistance of microorganisms, it must be heated for a long time. To achieve the purpose of sterilization, in order to ensure the sterilization effect, the general regulations are: 135...
Text label: sterile pharmaceutical cleanroom sterilization, sterile workshop design and installation, sterile workshop decoration
Sterilization and aseptic operation in sterile workshop
Dry hot air sterilization in sterile workshop is sterilization with high temperature dry hot air. In a dry state, due to the weak penetration of hot air and the strong heat resistance of microorganisms, it must be heated for a long time. To achieve the purpose of sterilization, in order to ensure the sterilization effect, the general regulations are: sterilization at 135-145 ℃ for 3-5 hours, sterilization at 160-170 ℃ for 2-4 hours, sterilization at 180-200 ℃ for 0.5-1 hours
h, the equipment can be used in a high temperature oven or a sterilization tunnel; this method is suitable for the sterilization of high temperature resistant glass and metal products, oils and fats that do not allow moisture to penetrate, and high temperature resistant powders and pharmaceutical excipients. Sterilization of rubber, plastic, etc.
Autoclave sterilization is a method of killing microorganisms by heating with high pressure saturated steam. This method uses high pressure saturated steam, superheated water spray and other means to denature the proteins and nucleic acids in the microorganisms to kill microorganisms; heat Autoclaving has the advantages of reliable sterilization, convenient operation, easy control and economy, and is the most widely used in the production of injections; the temperature and time required for autoclaving are usually 116°C*40min, 121°C*30min or 126°C ℃ * 15min, other high temperature and time parameters can also be used, but the appropriate sterilization temperature and time need to be verified through experiments. Commonly used equipment includes sterilization pot and autoclave sterilizer. Low-temperature intermittent sterilization is to heat the items to be sterilized at 60-80°C for 1 hour, after killing the microbial propagules, place them at room temperature for 24 hours to allow the spores in the objects to be sterilized to develop into propagules, then heat and sterilize and place them again. Repeated many times, this method is suitable for the sterilization of materials and preparations that are not resistant to high temperature and heat-sensitive, but the disadvantages are time-consuming and low work efficiency. Adding appropriate amount of bacteriostatic agent to the preparation can improve the sterilization effect. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for sterile workshops and sterile rooms.
Filter sterilization method, the sterilization filter should have high filtration efficiency, which can effectively remove the microorganisms in the material, the components in the filter material and the filtrate do not exchange with each other, the filter is easy to clean, and the operation is convenient; In order to effectively remove microorganisms, the pore size of the filter must be smaller than the size of spores. The sterilizing filter uses a microporous membrane with a uniform pore size distribution as the filter material. The microporous membrane is divided into hydrophilic and hydrophobic. And the selection of filtration purpose, the pore size of sterile filter membrane used in production generally does not exceed 0.22μm. The aseptic operation place is aseptic operation room, laminar flow clean workbench, aseptic operation cabinet, and the preparation of a small amount of sterile preparations. Laminar flow clean workbench is generally used for aseptic operation. The equipment has a good aseptic environment. Easy to use and reliable effect; aseptic packaging and aseptic freeze-drying are the most common aseptic production processes, and filtration sterilization must be used in the production process.
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