METHOD AND APPARATUS FOR CALIBRATION OF INSTRUMENTS THAT MONITOR THE CONCENTRATION OF A STERILANT IN A SYSTEM
    1.
    发明申请
    METHOD AND APPARATUS FOR CALIBRATION OF INSTRUMENTS THAT MONITOR THE CONCENTRATION OF A STERILANT IN A SYSTEM 审中-公开
    用于校准监测系统中灭菌剂浓度的仪器的方法和装置

    公开(公告)号:WO2002066973A2

    公开(公告)日:2002-08-29

    申请号:PCT/US2002/001294

    申请日:2002-01-15

    Abstract: A method and apparatus for calibrating a sensor for determination of the concentration of a sterilant, e. g., hydrogen peroxide vapor, in a sterilization system. This invention provides a method for calibrating a sensor that is used for measuring the quantity of a sterilant in a system for delivering the sterilant, the method comprising the steps of: (a) generating reference calibration data, the reference calibration data showing a mathematical relationship between a measurable parameter, e. g. voltage, and a quantity of the sterilant, e. g., parts of sterilant per million parts of air (ppm), for a plurality of sensors; (b) generating sensor calibration data, the sensor calibration data showing a mathematical relationship between the measurable parameter and the quantity of the sterilant for an individual sensor; and(c) normalizing the sensor calibration data to compensate for the difference between the measurable parameter for the reference calibration data and the measurable parameter for the sensor calibration data, whereby data obtained by the individual sensor can be used to accurately determine the quantity of sterilant in the system.

    Abstract translation: 一种用于校准用于确定灭菌剂浓度的传感器的方法和装置, 例如过氧化氢蒸汽,在灭菌系统中。 本发明提供了一种用于校准用于测量用于输送消毒剂的系统中的消毒剂的量的传感器的方法,所述方法包括以下步骤:(a)产生参考校准数据,所述参考校准数据显示数学关系 在可测量的参数之间, G。 电压和一定量的灭菌剂,例如, 例如,对于多个传感器,每百万份空气(ppm)的消毒剂的份数; (b)产生传感器校准数据,所述传感器校准数据示出了可测量参数与单个传感器的消毒剂量之间的数学关系; 和(c)对传感器校准数据进行归一化以补偿参考校准数据的可测量参数与传感器校准数据的可测量参数之间的差异,由此可以使用由各个传感器获得的数据来精确地确定灭菌剂的量 在系统中。

    ON-LINE AIR FILTER INTEGRITY TESTING APPARATUS
    2.
    发明申请
    ON-LINE AIR FILTER INTEGRITY TESTING APPARATUS 审中-公开
    在线空气过滤器完整性测试装置

    公开(公告)号:WO1996025997A1

    公开(公告)日:1996-08-29

    申请号:PCT/US1996000879

    申请日:1996-01-24

    CPC classification number: G01N15/082

    Abstract: A testing apparatus is disclosed which is useful for determining if air filters are providing clean/sterile air within acceptable aseptic processing and/or clean room operation acceptable contaminant levels. The advantage of the disclosed testing apparatus is that air filters may be tested "on-line" during a production process as opposed to the traditional testing methods which included removal of air filter for off-line testing. Less down-time is experienced using the disclosed testing system. A series of valves positioned at the outputs from the air filters, which allow communication with a particle counter, are controlled by a computer which sequentially activates the valves to test the contamination level of the air which passed through an air filter during the production process.

    Abstract translation: 公开了一种测试装置,其用于确定空气过滤器是否在可接受的无菌处理和/或洁净室操作可接受的污染物水平内提供清洁/无菌空气。 所公开的测试装置的优点在于空气过滤器可以在生产过程中“在线”地进行测试,而不是传统的测试方法,包括去除用于离线测试的空气过滤器。 使用公开的测试系统减少停机时间。 位于空气过滤器的输出端的一系列阀,其允许与颗粒计数器通信,该计算机依次启动阀门,以测试在生产过程中通过空气过滤器的空气的污染水平。

    APPARATUS AND METHOD FOR DETERMINING THE DISPERSIBILITY OF A PRODUCT IN PARTICULATE FORM
    3.
    发明申请
    APPARATUS AND METHOD FOR DETERMINING THE DISPERSIBILITY OF A PRODUCT IN PARTICULATE FORM 审中-公开
    用于确定颗粒形式的产品的不均匀性的装置和方法

    公开(公告)号:WO2002103329A2

    公开(公告)日:2002-12-27

    申请号:PCT/US2002/017566

    申请日:2002-06-04

    Abstract: A method and apparatus for determining the dispersibility grade of particulate material by means of an image processing technique that employs machine vision. In one aspect, this invention provides a method for grading the dispersibility of particulate material, the method comprising the steps of: (a) obtaining an image, in digitized form, of a sample comprising reconstituted particulate material; (b) performing a series of image processing steps to determine the presence and magnitude of blobs; (c) performing a blob analysis to obtain data relating to the distribution of the particulate material in the sample; (d) comparing the result of the blob analysis with data in a database; and (e) determining the grade of said particulate material by means of the comparison. The sample of particulate material, which is typically in the form of a powder, is reconstituted preferably by means of agitating a container filled with the sample. The database suitable for use in this invention can be established by recording the results of a large number of tests performed by a powder quality grading authority. The grade levels are ssociated with several ranges that have emerged from the statistical analysis. In another aspect, this invention provides an apparatus suitable for grading the dispersibility of particulate material.

    Abstract translation: 一种通过采用机器视觉的图像处理技术来确定颗粒材料的分散性等级的方法和装置。 一方面,本发明提供了一种用于分级颗粒材料的分散性的方法,所述方法包括以下步骤:(a)以数字形式获得包含复原颗粒材料的样品的图像; (b)执行一系列图像处理步骤以确定斑点的存在和大小; (c)进行斑点分析以获得与样品中颗粒物质的分布有关的数据; (d)将斑块分析的结果与数据库中的数据进行比较; 和(e)通过比较确定所述颗粒材料的等级。 通常为粉末形式的颗粒材料样品优选通过搅拌填充有样品的容器来重构。 可以通过记录由粉末质量分级机构进行的大量测试的结果来建立适用于本发明的数据库。 年级水平与统计分析中出现的几个范围相关。 在另一方面,本发明提供了适用于分级颗粒材料的分散性的装置。

    ULTRASOUND TRANSMISSIVE PAD
    4.
    发明申请
    ULTRASOUND TRANSMISSIVE PAD 审中-公开
    超声波传动垫

    公开(公告)号:WO1997031364A1

    公开(公告)日:1997-08-28

    申请号:PCT/US1997002471

    申请日:1997-02-18

    CPC classification number: G10K11/02 A61B8/0866 A61B8/4281 A61B8/4405 G01N29/28

    Abstract: A pad (101) for transmitting acoustical waves between an ultrasound probe (107) and a target surface (105). The pad (101) includes a first layer (102) having a first porous portion which defines first layer pores therethrough. The first layer pores have a first layer pore dimension. The pad (101) further includes a second layer (103) having a first porous portion which defines second layer pores therethrough. The second layer pores have a second layer pore dimension. The second layer (103) is attached to the first layer (102) to define a space (104) therebetween. The first porous portion of the first layer (102) overlies the first porous portion of said second layer (103). An ultrasound couplant (100) is disposed in the space (104) defined between the first (102) and second (103) layers. The ultrasound couplant (100) has a molecule size that is less than or substantially equal to the first layer pore dimension and less than or substantially equal to the second layer pore dimension.

    Abstract translation: 用于在超声波探头(107)和目标表面(105)之间传输声波的焊盘(101)。 垫(101)包括具有第一多孔部分的第一层(102),该第一多孔部分限定穿过其中的第一层孔。 第一层孔具有第一层孔尺寸。 垫(101)还包括具有第一多孔部分的第二层(103),该第一多孔部分限定穿过其中的第二层孔。 第二层孔具有第二层孔尺寸。 第二层(103)附接到第一层(102)以在其间限定空间(104)。 第一层(102)的第一多孔部分覆盖在所述第二层(103)的第一多孔部分上。 超声耦合剂(100)设置在限定在第一(102)和第二(103)层之间的空间(104)中。 超声耦合剂(100)具有小于或基本上等于第一层孔尺寸并小于或基本上等于第二层孔尺寸的分子尺寸。

    APPARATUS FOR ULTRASOUND TESTING USING LIQUID COUPLANT
    5.
    发明申请
    APPARATUS FOR ULTRASOUND TESTING USING LIQUID COUPLANT 审中-公开
    使用液体超声波超声波测试的设备

    公开(公告)号:WO1996034381A1

    公开(公告)日:1996-10-31

    申请号:PCT/US1996005109

    申请日:1996-04-12

    Abstract: The need for a highly viscous couplant gel or water spray to form an acoustical couple for ultrasound testing is eliminated by employing an ultrasound probe module. A porous membrane (83) and an ultrasound probe (80) cooperate to define a chamber (90) which contains a liquid acoustical couplant. When pressure is applied to the liquid acoustical couplant, it passes through the porous membrane (83). The porous membrane (83) and chamber (90) are disposed such that ultrasound signals going to or away from the ultrasound probe (80) pass through the liquid acoustical couplant and porous membrane (83).

    Abstract translation: 通过采用超声波探针模块,消除了需要高粘度的耦合剂凝胶或喷水以形成用于超声波测试的声学耦合。 多孔膜(83)和超声波探头(80)配合以限定含有液体声耦合剂的腔室(90)。 当液体声耦合剂施加压力时,它通过多孔膜(83)。 多孔膜(83)和室(90)被布置成使得超声波探头(80)或超出该超声波探头(80)的超声波信号通过液体声耦合剂和多孔膜(83)。

    METHOD FOR CONDUCTING AN ULTRASOUND PROCEDURE USING AN ULTRASOUND TRANSMISSIVE PAD
    6.
    发明申请
    METHOD FOR CONDUCTING AN ULTRASOUND PROCEDURE USING AN ULTRASOUND TRANSMISSIVE PAD 审中-公开
    使用超声波传输垫进行超声波程序的方法

    公开(公告)号:WO1997030750A1

    公开(公告)日:1997-08-28

    申请号:PCT/US1997002418

    申请日:1997-02-18

    CPC classification number: A61B8/4281 A61M37/0092 G10K11/18

    Abstract: A method for conducting an ultrasound procedure on an object having a target surface. The method includes the step of providing an ultrasound probe having an acoustical wave emitting end portion. A pad for transmitting acoustical waves between the ultrasound probe and a target surface of an object also is provided. The pad includes a first layer having a first porous portion which defines first layer pores therethrough. The first layer pores have a first layer pore dimension. The pad further includes a second layer having a first porous portion which defines second layer pores therethrough. The second layer pores have a second layer pore dimension. The second layer is attached to the first layer so as to define a space therebetween. The first porous portion of the first layer overlies the first porous portion of the layer. An ultrasound couplant is disposed in the space defined between the first layer and the second layer. The ultrasound couplant has a molecule size which is less than or substantially equal to the first layer pore dimension, and which is less than or substantially equal to the second layer pore dimension. The method further includes the steps of placing the first porous portion of the second layer in contact with a target surface and placing the acoustical wave emitting end portion of the ultrasound probe in contact with the first porous portion of the first layer. The ultrasound probe is then activated.

    Abstract translation: 一种用于在具有目标表面的物体上进行超声程序的方法。 该方法包括提供具有声波发射端部的超声波探头的步骤。 还提供了用于在超声波探头和物体的目标表面之间传输声波的垫。 垫包括具有第一多孔部分的第一层,其限定穿过其中的第一层孔。 第一层孔具有第一层孔尺寸。 垫还包括具有第一多孔部分的第二层,第一多孔部分限定穿过其中的第二层孔。 第二层孔具有第二层孔尺寸。 第二层连接到第一层以便在它们之间限定一个空间。 第一层的第一多孔部分覆盖在该层的第一多孔部分上。 超声耦合剂设置在第一层和第二层之间限定的空间中。 超声耦合剂具有小于或基本上等于第一层孔尺寸的分子尺寸,其小于或基本上等于第二层孔尺寸。 该方法还包括以下步骤:将第二层的第一多孔部分与目标表面接触,并将超声波探头的声波发射端部与第一层的第一多孔部分接触。 然后激活超声波探头。

    METHOD AND APPARATUS FOR ANALYZING FLOWABLE PRODUCTS
    7.
    发明申请
    METHOD AND APPARATUS FOR ANALYZING FLOWABLE PRODUCTS 审中-公开
    用于分析流动产品的方法和装置

    公开(公告)号:WO1997037217A2

    公开(公告)日:1997-10-09

    申请号:PCT/US1997004659

    申请日:1997-03-21

    Abstract: The method includes the steps of providing a means for generating and receiving ultrasonic waves, a processing unit, and a means for agitating the flowable product. The means for generating and receiving ultrasonic waves is placed in ultrasonic contact with the flowable product and ultrasonic waves are directed into the flowable product. Ultrasonic waves are received using the means for gnerating and receiving ultrasonic waves and the received waves are transmitted to the processing unit where they are processed by establishing respective vectors for a plurality of reflective contents of the flowable product and by comparing the respective vectors to a predetermined, acceptable statistical range of vectors. The system includes a means for conveying a flowable product where the means for conveying includes an agitating means for agitating the flowable product.

    Abstract translation: 该方法包括提供用于产生和接收超声波的装置,处理单元和用于搅拌可流动产品的装置的步骤。 用于产生和接收超声波的装置被放置在与可流动产品的超声波接触中,超声波被引导到可流动的产品中。 使用用于收集和接收超声波的装置接收超声波,并且通过为可流动产品的多个反射内容建立相应的矢量将接收的波发送到处理单元,在那里它们被处理,并且通过将各个向量与预定的 ,可接受的载体统计范围。 该系统包括用于输送可流动产品的装置,其中用于输送的装置包括用于搅拌可流动产品的搅拌装置。

    APPARATUS FOR ULTRASOUND TESTING USING LIQUID COUPLANT
    8.
    发明授权
    APPARATUS FOR ULTRASOUND TESTING USING LIQUID COUPLANT 失效
    DEVICE FOR超声测试中使用液体耦合

    公开(公告)号:EP0823111B1

    公开(公告)日:2002-03-20

    申请号:EP96910824.0

    申请日:1996-04-12

    Abstract: The need for a highly viscous couplant gel or water spray to form an acoustical couple for ultrasound testing is eliminated by employing an ultrasound probe module. A porous membrane (83) and an ultrasound probe (80) cooperate to define a chamber (90) which contains a liquid acoustical couplant. When pressure is applied to the liquid acoustical couplant, it passes through the porous membrane (83). The porous membrane (83) and chamber (90) are disposed such that ultrasound signals going to or away from the ultrasound probe (80) pass through the liquid acoustical couplant and porous membrane (83).

    Methods for the calibration of instruments that monitor the concentration of a sterilant in a delivery system
    9.
    发明公开
    Methods for the calibration of instruments that monitor the concentration of a sterilant in a delivery system 审中-公开
    用于监测输送系统消毒器的浓度的仪器的校准的方法

    公开(公告)号:EP1686375A3

    公开(公告)日:2006-11-02

    申请号:EP06111961.6

    申请日:2002-01-15

    Abstract: A rnethod for calibrating a portable unit for measuring the concentration of a sterilant, e.g., hydrogen peroxyde vapor, said method comprising the steps of: (a) passing a sterilant vapor through a vessel, said vessel being submerged in a water bath, said portable unit being installed within said vessel, said portable unit responsive to the concentration of sterilant, the temperature, and the relative humidity for a test run; and (b) additionally determining the concentration of said sterilant by a titration method. Furthermore, a method for verifying that a sensor for measuring the quantity of sterilant in a system for delivering said sterilant has been calibrated accurately is disclosed, wherein said sterilant delivered in a stream of flowing air, said method comprising the steps of: (a) performing at least two static and (b) at least two dynamic test runs for said sensor to obtain readings of concentration of sterilant vapor; (c) comparing the results of said at least two static and (d) at least two dynamic test runs; (e) concluding that (1) the flow rate of air has changed or (2) the rate of addition of sterilant to the system has changed or (3) said sensor is unreliable if (i) if said readings of concentration of sterilant vapor determined in said static test runs remain substantially constant, but said readings of concentration of sterilant vapor deterrnined in said dynamic test runs vary substantially or (ii) if said readings of concentration of sterilant vapor determined in said static test runs vary substantially, but said readings of concentration of sterilant vapor determined in said dynamic test runs rernain substantially constant.

    Abstract translation: 一种用于校准一个便携式单元,用于测量杀菌剂的浓度rnethod,例如,双氧水蒸气,所述方法包括以下步骤:(a)使一消毒剂蒸气通过的容器中,所述容器浸没在水浴中,所述便携式 单元是所述器皿,所述响应于消毒剂的浓度,温度,以及用于测试运行中的相对湿度便携式单元内安装; 和(b)另外确定性采矿所述杀菌剂的用滴定法的浓度。 进一步,用于验证的方法做了传感器,用于测量杀菌剂的量在一种系统,用于输送所述灭菌剂已被校准精确地设置为圆盘游离缺失,worin所述灭菌剂在流动的空气流中输送,所述方法包括的步骤:(a) 执行至少两个静态和(b)至少两个动态测试运行用于所述传感器,以获得消毒剂蒸气的浓度的读数; (C)比较所述的结果至少两个静态和(d)至少两个动态测试运行; (E)结论没有(1)的空气的流量发生了变化或者(2)除了消毒剂到该系统的速率已经改变或(3),所述传感器是不可靠的,如果(i)如消毒剂蒸气的浓度的说读数 确定在所述静态测试运行基本保持恒定,但在所说动态测试运行deterrnined消毒剂蒸气的浓度的读数变化基本上或(ii)如果在所述静态测试运行确定消毒剂蒸气的浓度的说读数有很大差异,但表示的读数 在说开采消毒剂蒸气确定性的浓度的动态测试rernain运行基本恒定。

    STERILANT MONITORING ASSEMBLY AND APPARATUS
    10.
    发明授权
    STERILANT MONITORING ASSEMBLY AND APPARATUS 有权
    监测系统监测灭菌

    公开(公告)号:EP1198260B1

    公开(公告)日:2005-07-20

    申请号:EP00952214.5

    申请日:2000-07-26

    CPC classification number: A23L3/003 A61L2/24 A61L2/28

    Abstract: A sterilant monitoring assembly including an external housing defining an inlet and an outlet, and an internal flow path extending therethrough. An internal housing is located within the external housing and substantially surrounded by the internal flow path. The internal housing defines an interior sensor chamber therein. A sterilant sensor is positioned within the interior sensor chamber and is constructed to provide output signals corresponding to detected levels of sterilant within the interior sensor chamber. In one embodiment, a sterilant monitoring assembly includes an external housing defining an inlet and an outlet, and an internal flow path extending therethrough. An internal housing is located within the external housing and substantially surrounded by the internal flow path. The internal housing defines an interior sensor chamber having a sterilant sensor positioned therein, the sterilant sensor constructed to provide output signals corresponding todetected levels of sterilant within the interior sensor chamber.

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