制药用水热原的去除（Removal of pyrogen from pharmaceutical water）.docVIP

制药用水热原的去除（Removal of pyrogen from pharmaceutical water） Removal of pyrogen from pharmaceutical water Removal of pyrogen is one of the most important targets in the design and construction of pharmaceutical water system. Since the beginning of the pretreatment of water, until the water for injection use, many processes of water treatment are considered pyrogen removing requirements, such as activated carbon filtration, organic matter removal, reverse osmosis, ultra filtration and distillation. Chinese and current U.S. Pharmacopoeia, the purified water is not within the control of the standard, but in the European Pharmacopoeia 2000 edition, has made the provisions of the bacterial endotoxin was lower than that of the 0.25EU/mL, which means to pharmaceutical water control will be more stringent endotoxin. As for the water for injection, the control standards for bacterial endotoxins in Chinese Pharmacopoeia and European Pharmacopoeia have been completely identical. A brief introduction is made to the common methods for removing pyrogen in pharmaceutical water system. 1, reverse osmosis The pore size of the reverse osmosis membrane is minimal, and the molecular weight of the blocked contaminants (including pyrogen) is generally between 100~200. Because the molecular weight of pyrogen is more than 5 * 104, its diameter is generally between 1~50 and m, so it can be removed effectively. The United States Pharmacopoeia regards reverse osmosis as a means of producing water for injection, which means the maturation of reverse osmosis technology in the removal of pyrogen. 2, ultra filtration Microporous membrane filtration has some effect on the removal of pyrogen. It uses sieving, electrostatic adsorption and bridging to make use of microporous membrane to block the larger part of the pyrogen substance. It should be pointed out that this removal is not complete, pyrogen microporous membrane with small diameter by 0.22 m, the tiny pyrogen through 0.025 U M filter, pyrogen min