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1. 发明授权

US06458554B1 Biological indicator for sterilization processes with double buffer system 有权
公开(公告)号：US06458554B1
公开(公告)日：2002-10-01
申请号：US10090057
申请日：2002-02-27
申请人： Henry K. Hui , Leslie A. Feldman , Richard A. Gorham
发明人： Henry K. Hui , Leslie A. Feldman , Richard A. Gorham
IPC分类号： C12Q122
CPC分类号： C12Q1/22 , A61L2/28 , G01N31/226
摘要： A method and an apparatus for preventing reversion of the color of an indicator dye in a biological indicator is disclosed. The indicator dye changes color if viable microorganisms are present after sterilization, because acidic byproducts are formed when the microorganisms metabolize the growth medium. It has been found that the dye can change color back to the original color after the completion of the sterilization due to leaching or diffusion of basic impurities into the growth medium. The method and the apparatus employ a dual buffer system with one buffer which operates at high pH to moderate pH fluctuations at the start of the sterilization and a second buffer which operates at low pH to minimize pH fluctuations after the sterilization is complete. Less high pH buffer than low pH buffer is used in order to maximize the speed and sensitivity of the biological indicator.

2. 发明授权

US06436659B1 Biological indicator for sterilization processes with double buffer system 有权
标题翻译：双缓冲系统灭菌过程的生物指标
公开(公告)号：US06436659B1
公开(公告)日：2002-08-20
申请号：US09699728
申请日：2000-10-27
申请人： Henry K. Hui , Leslie A. Feldman , Richard A. Gorham
发明人： Henry K. Hui , Leslie A. Feldman , Richard A. Gorham
IPC分类号： C12Q122
CPC分类号： C12Q1/22 , A61L2/28 , G01N31/226
摘要： A method and an apparatus for preventing reversion of the color of an indicator dye in a biological indicator is disclosed. The indicator dye changes color if viable microorganisms are present after sterilization, because acidic byproducts are formed when the microorganisms metabolize the growth medium. It has been found that the dye can change color back to the original color after the completion of the sterilization due to leaching or diffusion of basic impurities into the growth medium. The method and the apparatus employ a dual buffer system with one buffer which operates at high pH to moderate pH fluctuations at the start of the sterilization and a second buffer which operates at low pH to minimize pH fluctuations after the sterilization is complete. Less high pH buffer than low pH buffer is used in order to maximize the speed and sensitivity of the biological indicator.
摘要翻译：公开了一种用于防止生物指示剂中指示剂染料的颜色反转的方法和装置。如果活菌在灭菌后存在，则指示剂染料会变色，因为当微生物代谢生长培养基时会形成酸性副产物。已经发现，由于碱性杂质浸入或扩散到生长介质中，染料可以在灭菌完成之后将颜色改变回原色。该方法和装置采用具有一个缓冲液的双缓冲系统，该缓冲液在高pH值下操作以缓解灭菌开始时的pH波动，以及在灭菌完成后使pH波动最小的第二缓冲液。使用比低pH缓冲液低的pH缓冲液以使生物指示剂的速度和灵敏度最大化。

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