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1. 发明授权

US4883641A Closure and container assembly for biological sterility indicator 失效
标题翻译：用于生物不育指标的闭合和容器装配
公开(公告)号：US4883641A
公开(公告)日：1989-11-28
申请号：US249982
申请日：1988-09-27
申请人： James H. Wicks , William E. Foltz
发明人： James H. Wicks , William E. Foltz
IPC分类号： A61L2/28 , B65D51/24 , C12Q1/22
CPC分类号： A61L2/28 , B65D51/241 , C12Q1/22 , Y10S435/81
摘要： A closure and container assembly biological sterility indicator having a container, a closure, test spores, growth and indicator media, and a frangible barrier for separating the growth medium from the test spores is shown. The closure is moveable in the container between open and closed positions. When in the open position, sterilant may flow into and out of the container via a tortuous pathway defined by the interior surface of the container or the exterior surface of the closure. The tortuous pathway may also include one or more openings in the wall of the closure. When the closure is in the closed position, the container is sealed. The sterility indicator may be assembled with the test spores impregnated on a spore strip which is placed in close proximity to the closure.
摘要翻译：示出了具有容器，封闭物，测试孢子，生长和指示剂介质以及用于将生长培养基与测试孢子分离的易碎屏障的封闭和容器组合生物不育指示器。封闭件可在容器中在打开和关闭位置之间移动。当处于打开位置时，消毒剂可以通过由容器的内表面或封闭件的外表面限定的曲折路径流入和流出容器。曲折路径还可以包括在封闭件的壁中的一个或多个开口。当封闭件处于关闭位置时，容器被密封。无菌指示剂可以与浸在放置在封闭物附近的孢子带上的测试孢子组装。

2. 发明申请

US20110211991A1 PROCESS CHALLENGE DEVICE AND METHOD 审中-公开
标题翻译：过程挑战性设备和方法
公开(公告)号：US20110211991A1
公开(公告)日：2011-09-01
申请号：US13128093
申请日：2009-11-05
申请人： William E. Foltz , Chad M. Herrlein , Joshua M. Schmitz , Barry W. Robole , Kelvin J. Witcher , Paul N. Holt
发明人： William E. Foltz , Chad M. Herrlein , Joshua M. Schmitz , Barry W. Robole , Kelvin J. Witcher , Paul N. Holt
IPC分类号： A61L2/28 , A61L2/16
CPC分类号： A61L2/28
摘要： A sterilization process challenge device comprising a first container comprising walls which define a first space within the first container; a process indicator within the first space; at least one sterilant access for a sterilant to enter the first space within the first container; wherein at least one of the walls which defines the first space is a flexible wall; and wherein the walls are impervious to the sterilant; a method of using the device; and a kit including the device are disclosed.
摘要翻译：一种灭菌过程挑战装置，包括：第一容器，其包含限定所述第一容器内的第一空间的壁; 第一空间内的过程指示器; 消毒剂进入第一容器内的第一空间的至少一种灭菌剂通路; 其中限定所述第一空间的壁中的至少一个是柔性壁; 并且其中所述壁对所述灭菌剂是不透水的; 使用该装置的方法; 并且公开了包括该装置的套件。

3. 发明授权

US07045343B2 Sterilization indicator test packs 有权
公开(公告)号：US07045343B2
公开(公告)日：2006-05-16
申请号：US10372993
申请日：2003-02-24
申请人： Kelvin J. Witcher , William E. Foltz , Sailaja Chandrapati , Thomas T. Rosenlund , Robert A. Asmus , Ronald G. Lulich
发明人： Kelvin J. Witcher , William E. Foltz , Sailaja Chandrapati , Thomas T. Rosenlund , Robert A. Asmus , Ronald G. Lulich
IPC分类号： C12M1/34
CPC分类号： C12Q1/22 , A61L2/28 , G01N31/226
摘要： Sterilization indicator test packs for testing the effectiveness of a sterilization procedure are provided. Both non-challenge and challenge-type test packs are disclosed. The non-challenge test packs include generally comprise a tray for holding a sterilization indicator the tray containing an elevated rim surface defining the perimeter of the tray and a recessed trough for receiving a sterilization indicator. The rim surface includes a plurality of spaced-apart grooves along its length extending through the rim to the recessed trough; a sterilization indicator within the recessed trough of the tray; and a lid that forms a plurality of channels with the grooves in the tray such that sterilant can enter the tray through the channels and contact the sterilization indicator.The challenge-type test packs generally include a tray for holding a sterilization indicator, the tray comprising a substantially planar surface, a recessed trough for receiving a sterilization indicator, and a recessed groove of a defined length and cross-sectional area extending through the recessed trough and penetrating the edge of the tray; a sterilization indicator within the recessed trough of the tray; and a lid forming a substantially sterilant-impermeable seal with the planar surface of the tray and forming a lumen path with the recessed groove in the tray.

4. 发明申请

US20130273593A1 STERILIZATION INDICATORS INCLUDING A NEUTRALIZER AND METHODS 有权
公开(公告)号：US20130273593A1
公开(公告)日：2013-10-17
申请号：US13995524
申请日：2011-12-20
申请人： William E. Foltz , Francois Ahimou , G. Marco Bommarito , Robert A. Asmus , Louis C. Haddad , Tushar A. Kshirsagar
发明人： William E. Foltz , Francois Ahimou , G. Marco Bommarito , Robert A. Asmus , Louis C. Haddad , Tushar A. Kshirsagar
IPC分类号： C12Q1/25
CPC分类号： C12Q1/22 , C12Q1/25 , G01N21/78 , G01N31/226 , G01N33/573 , G01N2021/7786 , G01N2458/00
摘要： Sterilization indicators that include a neutralizer, such indicators useful for testing the effectiveness of a sterilization procedure by measuring the activity of an active enzyme whose activity is correlated with the survival of microorganisms.

5. 发明授权

US09114186B2 Sterilization process challenge device 有权
标题翻译：灭菌过程挑战装置
公开(公告)号：US09114186B2
公开(公告)日：2015-08-25
申请号：US12991023
申请日：2009-05-05
申请人： William E. Foltz , Steven S. Kirckof , Lawrence D. Fosler , Joshua M. Schmitz , Barry W. Robole , Chad M. Herrlein
发明人： William E. Foltz , Steven S. Kirckof , Lawrence D. Fosler , Joshua M. Schmitz , Barry W. Robole , Chad M. Herrlein
IPC分类号： C12Q1/22 , A61L2/28
CPC分类号： A61L2/28 , C12Q1/22
摘要： A sterilization process challenge device comprising a solid body comprised of walls which define a space, wherein the space can fully contain a sterilization indicator and a volume of gas of at least 5 cubic centimeters and not more than 1000 cubic centimeters; a flow restrictor associated with the solid body such that any flow of the gas out of the space and any flow of a sterilant into the space is restricted; wherein the sterilization indicator indicates whether or not it has been contacted by the sterilant for a time and at a temperature sufficient to sterilize an article; and wherein the walls of the solid body are impervious to the sterilant and have a thickness of at least 0.3 centimeter, methods of using the device and a kit including the device are disclosed.
摘要翻译：一种消毒过程挑战装置，包括由限定空间的壁组成的固体，其中所述空间可以完全容纳灭菌指示剂和至少5立方厘米且不大于1000立方厘米的体积的气体; 与固体相关联的限流器，使得气体流出空间的任何流动和灭菌剂的任何流动进入空间都受到限制; 其中所述灭菌指示符指示灭菌剂是否已被灭菌剂接触一段时间并且足以对制品进行灭菌的温度; 并且其中固体的壁对消毒剂是不透水的，并且具有至少0.3厘米的厚度，公开了使用该装置的方法和包括该装置的试剂盒。

6. 发明授权

US06897059B2 Sterilization indicator with chemically stabilized enzyme 有权
标题翻译：具有化学稳定酶的灭菌指示剂
公开(公告)号：US06897059B2
公开(公告)日：2005-05-24
申请号：US10014736
申请日：2001-12-11
申请人： William E. Foltz , Robert A. Asmus , Ronald G. Lulich
发明人： William E. Foltz , Robert A. Asmus , Ronald G. Lulich
IPC分类号： A61L2/14 , A61L2/20 , A61L2/26 , A61L2/28 , C12Q1/22 , G01N31/22 , C12M1/34
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。

7. 发明授权

US06355448B1 Sterilization indicator with chemically stabilized enzyme 有权
标题翻译：具有化学稳定酶的灭菌指示剂
公开(公告)号：US06355448B1
公开(公告)日：2002-03-12
申请号：US09228712
申请日：1999-01-12
申请人： William E. Foltz , Robert A. Asmus , Ronald G. Lulich
发明人： William E. Foltz , Robert A. Asmus , Ronald G. Lulich
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。

8. 发明授权

US5418167A Rapid read-out biological indicator 失效
公开(公告)号：US5418167A
公开(公告)日：1995-05-23
申请号：US106816
申请日：1993-08-13
申请人： Richard R. Matner , William E. Foltz , Lewis P. Woodson
发明人： Richard R. Matner , William E. Foltz , Lewis P. Woodson
IPC分类号： C12Q1/22 , C12M1/40 , C12Q1/34 , C12Q1/42
CPC分类号： C12Q1/22 , Y10S435/81
摘要： A rapid method of determining the efficacy of a sterilization cycle, and an indicator adapted to perform such method, comprising subjecting to the sterilization cycle a source of active enzyme having activity which correlates with the viability of a microorganism commonly used to monitor sterilization, and incubating the enzyme source, following the completion of the sterilization cycle, with an effective amount of a substrate system capable of reacting with any residual active enzyme to produce a detectable enzyme-modified product.

9. 发明申请

US20110064606A1 STERILIZATION PROCESS CHALLENGE DEVICE AND METHOD 有权
标题翻译：灭菌过程挑战装置及方法
公开(公告)号：US20110064606A1
公开(公告)日：2011-03-17
申请号：US12991023
申请日：2009-05-05
申请人： William E. Foltz , Steven S. Kirckof , Lawrence D. Fosler , Joshua M. Schmitz , Barry W. Roboie , Chad M. Herrlein
发明人： William E. Foltz , Steven S. Kirckof , Lawrence D. Fosler , Joshua M. Schmitz , Barry W. Roboie , Chad M. Herrlein
IPC分类号： A61L2/16 , A61L2/00
CPC分类号： A61L2/28 , C12Q1/22
摘要： A sterilization process challenge device comprising a solid body comprised of walls which define a space, wherein the space can fully contain a sterilization indicator and a volume of gas of at least 5 cubic centimeters and not more than 1000 cubic centimeters; a flow restrictor associated with the solid body such that any flow of the gas out of the space and any flow of a sterilant into the space is restricted; wherein the sterilization indicator indicates whether or not it has been contacted by the sterilant for a time and at a temperature sufficient to sterilize an article; and wherein the walls of the solid body are impervious to the sterilant and have a thickness of at least 0.3 centimeter, methods of using the device and a kit including the device are disclosed.
摘要翻译：一种消毒过程挑战装置，包括由限定空间的壁组成的固体，其中所述空间可以完全容纳灭菌指示剂和至少5立方厘米且不大于1000立方厘米的体积的气体; 与固体相关联的限流器，使得气体流出空间的任何流动和灭菌剂的任何流动进入空间都受到限制; 其中所述灭菌指示符指示灭菌剂是否已被灭菌剂接触一段时间并且足以对制品进行灭菌的温度; 并且其中固体的壁对消毒剂是不透水的，并且具有至少0.3厘米的厚度，公开了使用该装置的方法和包括该装置的试剂盒。

10. 发明授权

US5252484A Rapid read-out biological indicator 失效
标题翻译：快速读出生物指标
公开(公告)号：US5252484A
公开(公告)日：1993-10-12
申请号：US748327
申请日：1991-08-21
申请人： Richard R. Matner , William E. Foltz , Lewis P. Woodson
发明人： Richard R. Matner , William E. Foltz , Lewis P. Woodson
IPC分类号： C12Q1/22 , C12M1/00 , C12M1/34
CPC分类号： C12Q1/22 , Y10S435/81
摘要： A rapid method of determining the efficacy of a sterilization cycle, and an indicator adapted to perform such method, comprising subjecting to the sterilization cycle a source of active enzyme having activity which correlates with the viability of a microorganism commonly used to monitor sterilization, and incubating the enzyme source, following the completion of the sterilization cycle, with an effective amount of a substrate system capable of reacting with any residual active enzyme to produce a detectable enzyme-modified product.
摘要翻译：确定灭菌循环功效的快速方法，以及适于进行这种方法的指示剂，包括对灭菌周期进行活性酶源，该酶活性与通常用于监测灭菌的微生物的活力相关，并且孵育在灭菌周期完成之后，酶源与有效量的能够与任何残留活性酶反应以产生可检测酶修饰产物的底物系统。

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