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公开(公告)号：US06773898B1
公开(公告)日：2004-08-10
申请号：US10238436
申请日：2002-09-09
IPC分类号： C12Q122
CPC分类号： A61L2/28
摘要： A process challenge device and method of using the same is presented for testing the efficiency of various sterilization procedures on objects to be sterilized. The device is assembled from two tapered end portions having opposite open ends and an open pathway extending therethrough. A central chamber in the open pathway receives a Biological Indicator for testing the efficiency of the sterilization process. The device is ideal for testing a sterilization process on elongated objects such as tubing, at any point along their length. The coupling structures on the end portions provide the device with single-use security.
摘要翻译： 提出了一种过程挑战装置及其使用方法，用于测试对待消毒物品的各种灭菌程序的效率。 该装置由具有相对开口端的两个锥形端部和延伸通过其的开放通道组装。 开放通道中的中央室接收用于测试灭菌过程效率的生物指示器。 该设备非常适用于在细长物体（如管道）上沿着其长度的任何点测试灭菌过程。 端部上的耦合结构为设备提供一次性安全性。
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公开(公告)号：US06653096B1
公开(公告)日：2003-11-25
申请号：US09379682
申请日：1999-08-24
IPC分类号： C12Q122
CPC分类号： C12Q1/22 , Y10S435/808
摘要： A process challenge device tailored to mimic the resistance of a particular product-package combination to a particular biological inactivation, disinfection, or sterilization process. The device is used to challenge the process, thus providing a means to validate the efficacy of the process. In one embodiment, the process indicator includes a biological indicator organism stored on a carrier enclosed within a chamber formed by a barrier film material. The specific indicator organism and carrier substrate are chosen for their appropriateness for a given process. The materials comprising the barrier film material of the process challenge device are chosen for the materials' specific resistance to the given process. The process challenge device may also comprise a separate second chamber filled with an appropriate culture medium or enzyme substrate that is separated from the chamber containing the process indicator by a separation means, such as a valve, a clip, or a frangible separation. The separation means between the two chambers is capable of being removed on demand after completion of the process thus allowing the culture medium or enzyme substrate to contact the process indicator.
摘要翻译： 定制的过程挑战装置，以模拟特定产品包装组合对特定生物灭活，消毒或灭菌过程的抵抗力。 该装置用于挑战该过程，从而提供了验证该过程的功效的手段。 在一个实施例中，过程指示器包括存储在封装在由阻挡膜材料形成的腔室内的载体上的生物指示器生物体。 选择具体的指示剂生物体和载体底物适合给定的过程。 选择包含过程挑战装置的阻挡膜材料的材料用于材料对给定工艺的特异性抗性。 过程攻击装置还可以包括填充有合适的培养基或酶底物的单独的第二室，其通过分离装置（例如阀，夹子或易碎分离）与包含过程指示器的室分离。 两个室之间的分离装置能够在完成该过程之后根据要求去除，从而允许培养基或酶底物与过程指示剂接触。
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公开(公告)号：US06528277B1
公开(公告)日：2003-03-04
申请号：US09698573
申请日：2000-10-27
IPC分类号： C12Q122
CPC分类号： C12Q1/22 , A61L2/28 , C12Q1/32 , G01N31/229 , Y10S435/807 , Y10S435/81
摘要： This invention relates to a container and method for detecting a specific environmental parameter or combination of parameters, or for determining the effectiveness of a sterilization procedure. The invention relates to test indicators containing controlled volumes of compressed, gas-permeable materials, and modified caps comprising one or more apertures, sterilant permeable inserts, protruding members, or a combination thereof, and to methods for using test indicators for determining the efficacy of different types of sterilization processes. If proper sterilization conditions are not met, the interactive enzyme system remains active, and a color product forms upon the addition of the remaining components of the enzyme system. If the proper sterilization conditions are met, the sterilant destroys the interactive enzymes and no color product is formed. Inactivation of the enzyme system parallels the inactivation of bacterial spores subjected to the sterilization process. Results are available in from a few seconds to a few hours. The test indicator can also be placed into a container with material such that the design simulates an environmental parameter test of the sterilization process.
摘要翻译： 本发明涉及用于检测特定环境参数或参数组合或用于确定灭菌程序的有效性的容器和方法。 本发明涉及含有受控体积的压缩气体可渗透材料和包含一个或多个孔的改进盖的测试指示剂，消毒剂可渗透插入物，突出构件或其组合，以及使用测试指示剂来确定 不同类型的灭菌过程。 如果不符合适当的灭菌条件，则互动酶系统保持活性，并且在添加酶系统的剩余组分时形成着色产物。 如果满足适当的灭菌条件，灭菌剂会破坏相互作用的酶，不会形成颜色产物。 酶系统的失活与灭菌过程中细菌孢子的失活相平行。 结果可以从几秒到几个小时。 测试指示器也可以放置在具有材料的容器中，使得设计模拟灭菌过程的环境参数测试。
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4.发明授权Testing for bacterial sterilizing effectiveness, and test indicator manufacture and use 失效测试细菌消毒效果，测试指标的制作和使用公开(公告)号：US06455272B1
公开(公告)日：2002-09-24
申请号：US09928626
申请日：2001-08-13
申请人： John R. Gillis
发明人： John R. Gillis
IPC分类号： C12Q122
CPC分类号： A61L2/28
摘要： Multiple early-load-release evaluations of sterilizing effectiveness for both “dry” and “wet” sterilizer loads, are made available by selective spectroscopic quantitative measurements of peak absorption of electromagnetic radiation, in selected UV and visible-light wavelength spectra developed for evaluating thermally-responsive change, in a fluid-state indicator material, which is correlated with the sterilizing effect of a selected cycle on bacterial spores of a sterilizer load. Biological evaluation of sterilizing effectiveness is made available with the same test devices, free of the risk of contamination, by measuring peak absorption of electromagentic radiation at developed wavelength spectra which evaluate pH change, if any, due to spore-growth, or the absence thereof, following a predetermined spore incubation period subsequent to completion of the thermal sterilizing cycle.
摘要翻译： 通过选择性光谱定量测量电磁辐射的峰值吸收，在为热评估开发的选定的紫外和可见光波长光谱中，可以对“干”和“湿”灭菌器负载进行多次早期负荷释放评估 在流体状态指示剂材料中的反应性变化，其与选定循环对杀菌剂负载的细菌孢子的灭菌效果相关。 通过测量开发的波长光谱下的电磁辐射的峰值吸收，评估杀菌效果的生物学评价，没有污染的风险，其评估由于孢子生长导致的pH变化（如果有的话），或不存在 在热灭菌循环完成之后经过预定的孢子孵育期。
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5.发明授权公开(公告)号：US06436659B1
公开(公告)日：2002-08-20
申请号：US09699728
申请日：2000-10-27
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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公开(公告)号：US06566090B2
公开(公告)日：2003-05-20
申请号：US10016007
申请日：2001-12-06
IPC分类号： C12Q122
CPC分类号： A61L2/28 , C12Q1/22 , C12Q2334/22 , Y10S435/81
摘要： A sterilization indicator is useful for testing the effectiveness of sterilization procedures that disinfect objects by contacting them with a liquid sterilization procedure. The indicator includes an outer container having an open end and a cover material associated with the open end that is impermeable to liquids and bacteria. An enzyme-gel matrix is coated on a surface within the outer container that comprises a biologically inert polymeric gel and a source of an active enzyme dispersed within the gel. The enzyme has an activity that is correlated with the survival of at least one test microorganism that is commonly used to monitor the effectiveness of a sterilization procedure. A breakable ampoule within the outer container contains a substrate that is capable of reacting with any active enzyme remaining after the indicator has been subjected to a sterilization procedure to provide a detectable indication that the sterilization procedure was ineffective.
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公开(公告)号：US06458554B1
公开(公告)日：2002-10-01
申请号：US10090057
申请日：2002-02-27
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.
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公开(公告)号：US06355448B1
公开(公告)日：2002-03-12
申请号：US09228712
申请日：1999-01-12
IPC分类号： C12Q122
CPC分类号： G01N31/226 , A61L2/28 , C12Q1/22
摘要： A sterilization indicator for testing the effectiveness of a sterilization procedure comprises a source of an enzyme, a sterilant-resistant chemical associated with the enzyme, and a substrate that reacts with the enzyme to form a detectable enzyme-modified product that provides an indication of the failure of the sterilization procedure. The sterilant-resistant chemical may be a polyglycerol alkyl ester, polyglycerol alkyl ether, an ethoxylated polyhydric alcohol ester, or a polyhydric alcohol ether. The indicator may be used to test the effectiveness of a hydrogen peroxide plasma sterilization procedure and may be provided with a non-challenge test pack or a lumen-challenge test pack.
摘要翻译： 用于测试灭菌程序的有效性的消毒指示剂包括酶的来源，与酶相关的杀菌剂抗性化学品，以及与酶反应形成可检测的酶修饰产物的底物，其提供 灭菌程序失败。 杀菌剂抗性化学品可以是聚甘油烷基酯，聚甘油烷基醚，乙氧基化多元醇酯或多元醇醚。 该指示剂可用于测试过氧化氢等离子体灭菌方法的有效性，并且可以提供非挑战性测试包或流明挑战测试包。
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公开(公告)号：US06352837B1
公开(公告)日：2002-03-05
申请号：US09255240
申请日：1999-02-22
IPC分类号： C12Q122
CPC分类号： A61L2/28 , C12Q1/22 , C12Q2334/22 , Y10S435/81
摘要： A sterilization indicator is useful for testing the effectiveness of sterilization procedures that disinfect objects by contacting them with a liquid sterilization procedure. The indicator includes an outer container having an open end and a cover material associated with the open end that is impermeable to liquids and bacteria. An enzyme-gel matrix is coated on a surface within the outer container that comprises a biologically inert polymeric gel and a source of an active enzyme dispersed within the gel. The enzyme has an activity that is correlated with the survival of at least one test microorganism that is commonly used to monitor the effectiveness of a sterilization procedure. A breakable ampoule within the outer container contains a substrate that is capable of reacting with any active enzyme remaining after the indicator has been subjected to a sterilization procedure to provide a detectable indication that the sterilization procedure was ineffective.
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