The removal of pyrogens is one of the important goals of the design and construction of pharmaceutical water systems. The pretreatment of tap water begins until the point of use of the water for injection. Many processes in the water treatment consider the requirements for pyrogen removal, such as activated carbon filtration, organic matter remover, reverse osmosis, ultrafiltration and distillation. In the current edition of the Pharmacopoeia in China and the United States, there is no standard for controlling the quality of purified water. However, in the Supplement to the European Pharmacopoeia 2000, the regulation of "bacterial endotoxin below 0.25 EU/mL" has been made, which means The control of endotoxin in water will be more stringent. As for water for injection, the Chinese Pharmacopoeia and the European and American Pharmacopoeia have completely consistent control standards for bacterial endotoxin. A brief introduction to the common methods of removing pyrogens from pharmaceutical water systems is proposed.
1. The pore size of the reverse osmosis reverse osmosis membrane is small, and it is generally between 100 and 200 according to the molecular weight of the pollutants (including pyrogens). Since the molecular weight of the pyrogen is 5×104 or more, the diameter of the pyrogen is generally between 1 and 50 μm, and thus can be effectively removed. The US Pharmacopoeia uses reverse osmosis as a method of producing water for injection, which means that reverse osmosis technology is mature in removing pyrogens.
2. Ultrafiltration microfiltration membrane filtration has some effect of removing pyrogens. It uses screening, electrostatic adsorption, bridging, and uses a microporous membrane to intercept the portion of the pyrogen that is relatively large in diameter. It should be pointed out that this removal is very incomplete, the smaller diameter of the pyrogen will pass through the 0.22μm microporous membrane, the tiny pyrogen can pass through the 0.025μm filter, and the small pyrogen can be worn. Through all the microporous membranes, it pollutes the water. The higher the molecular weight of the pyrogen, the stronger the heat generation effect. Therefore, when the microfiltration membrane is used for sterilization filtration, it may objectively play a positive role in retaining pyrogens, but it cannot be used as a reliable method for removing pyrogens. The method is used alone.
In fact, ultrafiltration (Utrafiltration commonly known as ultrafiltration), microfiltration (microfiltration commonly known as microfiltration) and reverse osmosis are membrane separation technologies, there is a division of labor between them, but there is no obvious boundary. The end of the ultrafiltration membrane having a large pore size overlaps with the microporous membrane, and one end of the pore overlaps with the reverse osmosis. It can be seen from the electronic scan of the non-homogeneous ultrafiltration membrane that the ultrafiltration filter medium has a screen-like structure, and the filtration is limited to the surface of the membrane.
Unlike reverse osmosis, ultrafiltration is not separated by permeation but by mechanical means. The ultrafiltration process occurs simultaneously in three cases: adsorption retention by the separation - being blocked or trapped on the surface of the membrane and achieving sieving. The ultrafiltration membrane has a pore size of approximately 0.005 to 1 μm, and the size of the bacteria is between 0.2 and 800 μm, so that the ultrafiltration membrane can be used to remove bacteria. However, the pyrogen molecular weight of the human pyrogen effect is 800,000 to 1 million, and the naturally occurring pyrogen population is a mixture, and the small end is only 10-3 μm, so the ultrafiltration membrane for trapping the pyrogen is The molecular weight level needs to be as small as 10,000 to 80,000 to effectively remove pyrogens. The following are the effects of filters of different models and specifications to remove pyrogens. The bacterial endotoxin amount of the solution in Table 4.1 was 1 μg/ml, and the specifications of the filter were expressed by the nominal pore diameter and molecular weight, respectively.
Ultrafiltration differs from microfiltration. Microfiltration is static filtration, the solution is stirred to eliminate the concentration polarization layer; ultrafiltration is dynamic filtration, and the surface of the membrane is continuously washed by the flowing solution, so it is difficult to form a concentrated polarization layer.
Reverse osmosis, ultrafiltration, and microporous membrane filtration have similarities. They are driven by differential pressure, and use the specific properties of the membrane to separate particles such as ions, molecules, colloids, pyrogens, and microorganisms in water, but they are separated. The mechanism and objects are different. The above table lists the pore size of such membranes and the range of particle sizes of the entrapped material. It can be seen from the table that the reverse osmosis membrane only allows inorganic ions below 1 nm as its main separation object, so it has a good desalting effect, while ultrafiltration and microporous membrane filtration have no salt removal performance.
3, adsorption method In addition to the pyrogen using adsorption method can also effectively remove the pyrogen, commonly used materials are activated carbon, anion exchange resin, barium sulfate, asbestos and so on. The 24th edition of the United States Pharmacopoeia contains a method for removing pyrogens from activated carbon and macromolecular anion exchange resins. In the pharmaceutical water system, the two materials are actually used. Activated carbon adsorption is a commonly used method for removing pyrogens. It is usually used in conjunction with a membrane filter to prevent activated carbon from entering the next process. The use of a macromolecular anion exchange resin to remove pyrogens is less suitable for endotoxin contamination in the drug solution.
Because the pyrogen is not volatile. Therefore, the effective method for removing the pyrogen Zui is the distillation method. In the multi-effect distilled water machine, the purified water is distilled, and the non-volatile pyrogen remains in the purified water to become concentrated water, and is centrifuged by cyclone separation method, and the distilled water which has been removed from the pyrogen is collected, and the concentrated water having the pyrogen is collected. emission. This separation method generally reduces the contamination level of the pyrogen by 2.5 to 3 log units. Older types of distilled water machines of various types have a lower ability to remove pyrogens, but distillation is an effective method for removing pyrogens.
1. The pore size of the reverse osmosis reverse osmosis membrane is small, and it is generally between 100 and 200 according to the molecular weight of the pollutants (including pyrogens). Since the molecular weight of the pyrogen is 5×104 or more, the diameter of the pyrogen is generally between 1 and 50 μm, and thus can be effectively removed. The US Pharmacopoeia uses reverse osmosis as a method of producing water for injection, which means that reverse osmosis technology is mature in removing pyrogens.
2. Ultrafiltration microfiltration membrane filtration has some effect of removing pyrogens. It uses screening, electrostatic adsorption, bridging, and uses a microporous membrane to intercept the portion of the pyrogen that is relatively large in diameter. It should be pointed out that this removal is very incomplete, the smaller diameter of the pyrogen will pass through the 0.22μm microporous membrane, the tiny pyrogen can pass through the 0.025μm filter, and the small pyrogen can be worn. Through all the microporous membranes, it pollutes the water. The higher the molecular weight of the pyrogen, the stronger the heat generation effect. Therefore, when the microfiltration membrane is used for sterilization filtration, it may objectively play a positive role in retaining pyrogens, but it cannot be used as a reliable method for removing pyrogens. The method is used alone.
In fact, ultrafiltration (Utrafiltration commonly known as ultrafiltration), microfiltration (microfiltration commonly known as microfiltration) and reverse osmosis are membrane separation technologies, there is a division of labor between them, but there is no obvious boundary. The end of the ultrafiltration membrane having a large pore size overlaps with the microporous membrane, and one end of the pore overlaps with the reverse osmosis. It can be seen from the electronic scan of the non-homogeneous ultrafiltration membrane that the ultrafiltration filter medium has a screen-like structure, and the filtration is limited to the surface of the membrane.
Unlike reverse osmosis, ultrafiltration is not separated by permeation but by mechanical means. The ultrafiltration process occurs simultaneously in three cases: adsorption retention by the separation - being blocked or trapped on the surface of the membrane and achieving sieving. The ultrafiltration membrane has a pore size of approximately 0.005 to 1 μm, and the size of the bacteria is between 0.2 and 800 μm, so that the ultrafiltration membrane can be used to remove bacteria. However, the pyrogen molecular weight of the human pyrogen effect is 800,000 to 1 million, and the naturally occurring pyrogen population is a mixture, and the small end is only 10-3 μm, so the ultrafiltration membrane for trapping the pyrogen is The molecular weight level needs to be as small as 10,000 to 80,000 to effectively remove pyrogens. The following are the effects of filters of different models and specifications to remove pyrogens. The bacterial endotoxin amount of the solution in Table 4.1 was 1 μg/ml, and the specifications of the filter were expressed by the nominal pore diameter and molecular weight, respectively.
Ultrafiltration differs from microfiltration. Microfiltration is static filtration, the solution is stirred to eliminate the concentration polarization layer; ultrafiltration is dynamic filtration, and the surface of the membrane is continuously washed by the flowing solution, so it is difficult to form a concentrated polarization layer.
Reverse osmosis, ultrafiltration, and microporous membrane filtration have similarities. They are driven by differential pressure, and use the specific properties of the membrane to separate particles such as ions, molecules, colloids, pyrogens, and microorganisms in water, but they are separated. The mechanism and objects are different. The above table lists the pore size of such membranes and the range of particle sizes of the entrapped material. It can be seen from the table that the reverse osmosis membrane only allows inorganic ions below 1 nm as its main separation object, so it has a good desalting effect, while ultrafiltration and microporous membrane filtration have no salt removal performance.
3, adsorption method In addition to the pyrogen using adsorption method can also effectively remove the pyrogen, commonly used materials are activated carbon, anion exchange resin, barium sulfate, asbestos and so on. The 24th edition of the United States Pharmacopoeia contains a method for removing pyrogens from activated carbon and macromolecular anion exchange resins. In the pharmaceutical water system, the two materials are actually used. Activated carbon adsorption is a commonly used method for removing pyrogens. It is usually used in conjunction with a membrane filter to prevent activated carbon from entering the next process. The use of a macromolecular anion exchange resin to remove pyrogens is less suitable for endotoxin contamination in the drug solution.
Because the pyrogen is not volatile. Therefore, the effective method for removing the pyrogen Zui is the distillation method. In the multi-effect distilled water machine, the purified water is distilled, and the non-volatile pyrogen remains in the purified water to become concentrated water, and is centrifuged by cyclone separation method, and the distilled water which has been removed from the pyrogen is collected, and the concentrated water having the pyrogen is collected. emission. This separation method generally reduces the contamination level of the pyrogen by 2.5 to 3 log units. Older types of distilled water machines of various types have a lower ability to remove pyrogens, but distillation is an effective method for removing pyrogens.
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