公开(公告)号：US20140273054A1

公开(公告)日：2014-09-18

申请号：US13832158

申请日：2013-03-15

Applicant: AMERICAN STERILIZER COMPANY

Inventor： Phillip P. Franciskovich ,  Tricia A. Cregger

IPC: C12Q1/22

CPC classification number: C12Q1/22 ,  C12Q1/001 ,  C12Q1/006 ,  G01N27/327 ,  G01N33/52 ,  G01N2400/00 ,  Y10T436/11 ,  Y10T436/25375

Abstract: A sterilization indicator system and method of using the system to determine efficacy of a sterilization process. The system includes a vial having a first compartment containing spores of one or more species of microorganism; a second compartment containing a growth medium with a disaccharide, an oligosaccharide or a polysaccharide in which the vial is free of monosaccharide; an enzyme, capable of acting upon the monosaccharide to yield reaction products and electron transfer, disposed on two or more electrodes adapted to carry an electrical signal resulting from the electron transfer, the pair of electrodes positioned to contact the combined contents of the first compartment and the second compartment during incubation; and an apparatus linked or linkable to the electrodes and adapted to detect and measure the electrical signal resulting from electron transfer when the enzyme acts upon the monosaccharide.

Abstract translation: 灭菌指示器系统和使用该系统来确定灭菌过程的功效的方法。 该系统包括具有包含一种或多种微生物孢子的第一隔室的小瓶; 第二隔室含有具有二糖的生长培养基，寡糖或多糖，其中小瓶不含单糖; 能够作用于单糖以产生反应产物和电子转移的酶，其设置在适于承载由电子转移产生的电信号的两个或多个电极上，该对电极定位成接触第一隔室的组合内容物，以及 孵化期间的第二隔室; 以及连接或可链接到电极的装置，并且适于在酶作用于单糖时检测和测量由电子转移产生的电信号。

公开(公告)号：US20140262829A1

公开(公告)日：2014-09-18

申请号：US13836787

申请日：2013-03-15

Applicant: AMERICAN STERILIZER COMPANY

Inventor： Phillip P. Franciskovich ,  Tricia A. Cregger

IPC: C12Q1/22

CPC classification number: C12Q1/22 ,  B01L2300/0609 ,  B01L2300/0816 ,  C12Q1/001 ,  C12Q1/006 ,  C12Q1/6816 ,  C12Q2527/125

Abstract: A sterilization indicator system and method of using the system to determine efficacy of a sterilization process. The system may include a vial having an optional first compartment and a second compartment comprising a growth medium comprising one or more of a disaccharide, an oligosaccharide or a polysaccharide capable of conversion to a monosaccharide by germinating spores of the one or more species of microorganism, the vial being free of the monosaccharide prior to use; a strip including two or more electrodes to oxidize the monosaccharide and to carry a resulting electrical signal, and an apparatus to detect and measure the electrical signal resulting from the oxidation. Spores of a suitable biological indicator may be disposed in the first compartment and/or on the strip.

Abstract translation: 灭菌指示器系统和使用该系统来确定灭菌过程的功效的方法。 该系统可以包括具有任选的第一隔室的小瓶和包含生长培养基的第二隔室，所述生长培养基包含一种或多种能够通过发芽一种或多种微生物的孢子转化成单糖的二糖，寡糖或多糖， 使用前小瓶不含单糖; 包括两个或更多个电极以氧化单糖并携带所得电信号的条带，以及用于检测和测量由氧化产生的电信号的装置。 合适的生物指示剂的孢子可以设置在第一隔室和/或条带上。

公开(公告)号：US08691562B2

公开(公告)日：2014-04-08

申请号：US13852435

申请日：2013-03-28

Applicant: American Sterilizer Company

Inventor： Phillip P. Franciskovich ,  Tricia A. Cregger

IPC: C12M1/34

CPC classification number: G01N21/6486 ,  C12Q1/22

Abstract: A sterilization indicator including an electronically conductive material positioned on a substrate; a biological indicator positioned on part or all of the electronically conductive material, and electronic circuitry for determining whether the membrane potential of the biological indicator changes during incubation following exposure sterilization conditions.

Abstract translation: 一种消毒指示器，包括位于基板上的电子导电材料; 位于部分或全部电子导电材料上的生物指示剂，以及用于确定在暴露灭菌条件之后孵育期间生物指示物的膜电位是否改变的电子电路。

公开(公告)号：US10011843B2

公开(公告)日：2018-07-03

申请号：US15618156

申请日：2017-06-09

Applicant: American Sterilizer Company

Inventor： Phillip P. Franciskovich ,  Tricia A. Cregger ,  William A. Yirava ,  Peter A. Burke

IPC: C12Q1/22 ,  C12Q1/34 ,  C12Q1/68 ,  C12N15/75 ,  C12M1/12 ,  C12N9/38 ,  A61L2/28 ,  C12M1/34 ,  C12Q1/6897 ,  C12Q1/689

Abstract: This invention relates to a biological indicator derived from a composition comprising: a host organism comprising a spore forming bacteria; a reporter gene for producing an indicator enzyme; a regulatory gene; and a vehicle for inserting the reporter gene and the regulatory gene in the host organism; the host organism bearing a transposable genetic element in its genome for inserting an insertion sequence in the regulatory gene; the insertion sequence comprising a transposase, a pair of terminal inverted repeat sequences, and at least one open reading frame for expressing the transposase. The vehicle may be taken up by the host organism. The insertion sequence may be inserted in the regulatory gene. The host organism may undergo sporulation to form the biological indicator. A process and an apparatus for using the biological indicator are disclosed.

公开(公告)号：US09012173B2

公开(公告)日：2015-04-21

申请号：US14180706

申请日：2014-02-14

Applicant: American Sterilizer Company

Inventor： Phillip P. Franciskovich ,  Tricia A. Cregger

IPC: C12Q1/22 ,  G01N21/64

CPC classification number: G01N21/6486 ,  C12Q1/22

Abstract: The disclosed invention relates to a method of making a sterilization indicator including depositing an electronically conductive material on a substrate using an ink jet printer and depositing a biological indicator on part or all of the electronically conductive material using the ink jet printer, and further relates to a method for monitoring a sterilization process including (A) exposing an article to be sterilized and a biological indicator to a sterilization medium during a sterilization process, the biological indicator comprising a cell with a plasma membrane in which the biological indicator is positioned on part or all of an electronically conductive material positioned on a substrate; and (B) measuring the membrane potential of the cell to detect the viability of the cell.

Abstract translation: 所公开的发明涉及一种制造灭菌指示器的方法，包括使用喷墨打印机将电子导电材料沉积在基底上，并使用喷墨打印机将生物指示剂沉积在部分或全部电子导电材料上，并且还涉及 一种用于监测消毒过程的方法，包括（A）在灭菌过程中将待灭菌的物品和生物指示剂暴露于灭菌介质，所述生物指示剂包括具有质膜的细胞，其中生物指示剂位于部分或 所有的电子导电材料都位于基底上; 和（B）测量细胞的膜电位以检测细胞的活力。

公开(公告)号：US08945837B2

公开(公告)日：2015-02-03

申请号：US13832019

申请日：2013-03-15

Applicant: American Sterilizer Company

Inventor： Phillip P. Franciskovich ,  Tricia A. Cregger ,  William A. Yirava

IPC: C12N1/20 ,  C12Q1/22 ,  C12N15/75 ,  C12N15/74

CPC classification number: C12Q1/22 ,  C12N15/74 ,  C12N15/75

Abstract: A sterilization indicator, including a first compartment containing a genetically engineered biological indicator, and a second compartment containing an enzyme substrate, the second compartment adapted to maintain the enzyme substrate separate from the biological indicator during sterilization, and to permit the enzyme substrate to contact the biological indicator after the biological indicator has been exposed to the sterilization medium; in which the genetically engineered biological indicator comprises at least one test organism and at least one reporter gene suitable for producing an indicator enzyme, the reporter gene being taken up by the test organism; and the test organism is free of any active or activatable repressor gene that would inhibit expression of the reporter gene if present in the test organism or sterilization indicator, and the indicator enzyme and the enzyme substrate are selected such that enzymatic action of the indicator enzyme upon the enzyme substrate yields a detectable signal.

Abstract translation: 灭菌指示剂，包括含有遗传工程生物指示剂的第一隔室和含有酶底物的第二隔室，所述第二隔室适于在灭菌期间将酶底物与生物指示剂分离，并允许酶底物接触 生物指示剂在生物指示剂暴露于灭菌介质之后; 其中遗传工程生物指示剂包含至少一种测试生物体和至少一种适于产生指示酶的报告基因，所述报道基因被测试生物体吸收; 并且测试生物体没有任何活性或可激活的阻遏物基因，如果存在于测试生物体或灭菌指示剂中，则抑制报告基因的表达，并且指示酶和酶底物被选择使得指示酶的酶作用 酶底物产生可检测信号。

公开(公告)号：US20140162307A1

公开(公告)日：2014-06-12

申请号：US14180706

申请日：2014-02-14

Applicant: American Sterilizer Company

Inventor： Phillip P. Franciskovich ,  Tricia A. Cregger

IPC: C12Q1/22

CPC classification number: G01N21/6486 ,  C12Q1/22

Abstract: The disclosed invention relates to a method of making a sterilization indicator including depositing an electronically conductive material on a substrate using an ink jet printer and depositing a biological indicator on part or all of the electronically conductive material using the ink jet printer, and further relates to a method for monitoring a sterilization process including (A) exposing an article to be sterilized and a biological indicator to a sterilization medium during a sterilization process, the biological indicator comprising a cell with a plasma membrane in which the biological indicator is positioned on part or all of an electronically conductive material positioned on a substrate; and (B) measuring the membrane potential of the cell to detect the viability of the cell.

Abstract translation: 所公开的发明涉及一种制造灭菌指示器的方法，包括使用喷墨打印机将电子导电材料沉积在基底上，并使用喷墨打印机将生物指示剂沉积在部分或全部电子导电材料上，并且还涉及 一种用于监测消毒过程的方法，包括（A）在灭菌过程中将待灭菌的物品和生物指示剂暴露于灭菌介质，所述生物指示剂包括具有质膜的细胞，其中生物指示剂位于部分或 所有的电子导电材料都位于基底上; 和（B）测量细胞的膜电位以检测细胞的活力。

公开(公告)号：US20130217001A1

公开(公告)日：2013-08-22

申请号：US13852435

申请日：2013-03-28

Applicant: American Sterilizer Company

Inventor： Phillip P. Franciskovich ,  Tricia A. Cregger

IPC: G01N21/64

CPC classification number: G01N21/6486 ,  C12Q1/22

Abstract: The disclosed invention relates to a method for monitoring a sterilization process. The method comprises: (A) exposing an article to be sterilized and a biological indicator to a sterilization medium during a sterilization process, the biological indicator comprising a cell with a plasma membrane in which the biological indicator is positioned on part or all of an electronically conductive material positioned on a substrate; and (B) measuring the membrane potential of the cell to detect the viability of the cell.

Abstract translation: 所公开的发明涉及一种用于监测灭菌过程的方法。 该方法包括：（A）在灭菌过程中将要灭菌的物品和生物指示剂暴露于灭菌介质，所述生物指示剂包括具有质膜的细胞，其中所述生物指示物位于电子部分或全部 位于基板上的导电材料; 和（B）测量细胞的膜电位以检测细胞的活力。

公开(公告)号：US10301631B2

公开(公告)日：2019-05-28

申请号：US16001203

申请日：2018-06-06

Applicant: American Sterilizer Company

Inventor： Phillip P. Franciskovich ,  Tricia A. Cregger ,  William A. Yirava ,  Peter A. Burke

IPC: C12Q1/22 ,  C12Q1/34 ,  C12Q1/68 ,  C12N15/75 ,  A61L2/28 ,  C12M1/34 ,  C12Q1/689 ,  C12M1/12 ,  C12Q1/6897 ,  C12N9/38

Abstract: This invention relates to a biological indicator derived from a composition comprising: a host organism comprising a spore forming bacteria; a reporter gene for producing an indicator enzyme; a regulatory gene; and a vehicle for inserting the reporter gene and the regulatory gene in the host organism; the host organism bearing a transposable genetic element in its genome for inserting an insertion sequence in the regulatory gene; the insertion sequence comprising a transposase, a pair of terminal inverted repeat sequences, and at least one open reading frame for expressing the transposase. The vehicle may be taken up by the host organism. The insertion sequence may be inserted in the regulatory gene. The host organism may undergo sporulation to form the biological indicator. A process and an apparatus for using the biological indicator are disclosed.

公开(公告)号：US10017772B2

公开(公告)日：2018-07-10

申请号：US15618158

申请日：2017-06-09

Applicant: American Sterilizer Company

Inventor： Phillip P. Franciskovich ,  Tricia A. Cregger ,  William A. Yirava ,  Peter A. Burke

IPC: C12Q1/22 ,  C12Q1/34 ,  C12Q1/68 ,  C12N15/75 ,  C12M1/12 ,  C12N9/38 ,  A61L2/28 ,  C12M1/34 ,  C12Q1/6897 ,  C12Q1/689

Abstract: This invention relates to a biological indicator derived from a composition comprising: a host organism comprising a spore forming bacteria; a reporter gene for producing an indicator enzyme; a regulatory gene; and a vehicle for inserting the reporter gene and the regulatory gene in the host organism; the host organism bearing a transposable genetic element in its genome for inserting an insertion sequence in the regulatory gene; the insertion sequence comprising a transposase, a pair of terminal inverted repeat sequences, and at least one open reading frame for expressing the transposase. The vehicle may be taken up by the host organism. The insertion sequence may be inserted in the regulatory gene. The host organism may undergo sporulation to form the biological indicator. A process and an apparatus for using the biological indicator are disclosed.