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生物指示剂在灭菌质量控制中占有重要地位。目前,国外已在医药工业、食品工业和医院等方面广泛应用。药品生产和质量管理规范(GMP)和美国药典等都指出了应用生物指示剂的重要性并规定了有关参数。高压蒸汽灭菌质量控制方法主要分为物理、化学和生物学三大类,由于生物指示剂能较正确反映灭菌过程中有关时间和温度等情况,因此具有许多物理和化学指示法所没有的优点。
Biological indicators play an important role in the quality control of sterilization. At present, foreign countries have been widely used in the pharmaceutical industry, food industry and hospitals. The GMP and the United States Pharmacopoeia all point to the importance of applying biological indicators and setting the parameters. The quality control methods of autoclaving are mainly divided into three major categories: physics, chemistry and biology. Since biological indicators can reflect more accurately the relevant time and temperature in the sterilization process, they have many physical and chemical indicators advantage.