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Brief description of heat removal by chromatography
Pyrogen is a metabolic product of microorganisms. It is a kind of endotoxin of microorganisms. Its serious component is lipopolysaccharides. The main measures to remove the pyrogen are as follows :1. In the 250 ℃ heating more than 30 minutes more. 2 acid base method. Perform with acid or alkali to destroy the heat. 3 adsorption. The adsorption treatment of activated carbon is usually 011-015%. 4 chromatography. Coax ion exchange resin or molecular sieve gel chromatography. 5. Ultrafiltration Ultrafiltration is used to assemble and remove the thermal raw material. In order to ensure compliance with regulations, it is often necessary to make several attempts to select suitable methods and to plan suitable technological paths. In the process of performing the product trial production, since the biochemical drugs and genetic engineering drugs are mostly nucleic acids (nucleotides) and proteins (peptides, amino acids), which are excellent breeding bases for microorganisms, the control of heat has become a difficult problem. The control of pyrogen may be summarized from the following aspects :1. In the whole process of reactivation, attention should be paid to controlling all levels of pyrogen in the process of reactivation. The comprehensive method of removing pyrogen is based on the fact that the pyrogen substance is at a certain level, assuming the intensity of pyrogen pollution, it will be extremely difficult to deal with. The GMP of formula production has effectively tightened the control of pyrogen in the whole production process. The control of purity degree of production environment, the control of temperature when materials are stored, etc., can be implemented strictly in the current production process, and the control of time is often careless. Level in clean environment, the environment temperature generally cried out in 18 ~ 26 ℃, settlement bacteria answer 3 P dish (30 minutes). At this temperature, proteins and nucleic acids are conducive to the reproduction of microorganisms, that is, materials that have been sterile or materials that have been sterile in the previous process, probably showing the growth of microorganisms. According to the long production experience, the material (liquid) should be treated and treated by the later sterilization and filtration, and the time should be controlled within 3 hours from the packaging of the material to the sterilization and filtration. If the material still needs to be refrigerated after treatment, the treatment process should be controlled within 2 hours. Tools are useful for cleaning up the cargo provided in general textbooks. Special attention should be paid to contaminated microorganisms or unused equipment. That is to say, a certain chemical method is used to remove the heat in the flushing process. If the solution is soaked for more than 15 minutes or 1% sodium hydroxide solution is boiled for 15 minutes (sodium carbonate is not recommended), rinse with non-thermal raw water after treatment.