公开(公告)号：US20100140515A1

公开(公告)日：2010-06-10

申请号：US12642282

申请日：2009-12-18

申请人： John A. Williams ,  John A. Martine, JR.

发明人： John A. Williams ,  John A. Martine, JR.

IPC分类号： G01T1/02

CPC分类号： A61L2/28 ,  A61L2/087 ,  A61L2/24 ,  A61L2202/122 ,  A61L2202/14 ,  A61L2202/24

摘要： An apparatus, system and method for verifying the achievement of a desired sterility assurance level (SAL) for components manipulated within a low-energy electron beam sterilization chamber. The components are preferably pre-sterilized and connected together in an assembly fashion which creates and maintains the sterility of the connection by subjecting the components to low-energy (less than 300 KeV) electron beam radiation. The verification is completed by measuring the sterilization dose delivered to a sensor, also known as a dosimeter, positioned within the sterilization process to simulate the components.

摘要翻译： 一种用于验证在低能量电子束灭菌室内操作的组件达到期望的无菌保证水平（SAL）的装置，系统和方法。 这些部件优选地被预先灭菌并以组装方式连接在一起，通过使部件经受低能量（小于300KeV）的电子束辐射而产生并保持连接的无菌性。 通过测量放置在灭菌过程中的传感器（也称为剂量计）的灭菌剂量来完成验证，以模拟组件。

公开(公告)号：US08022375B2

公开(公告)日：2011-09-20

申请号：US12642282

申请日：2009-12-18

申请人： John A. Williams ,  John A. Martine, Jr.

发明人： John A. Williams ,  John A. Martine, Jr.

IPC分类号： G01N21/64 ,  G01T1/02 ,  G01N21/75 ,  G01N23/00

CPC分类号： A61L2/28 ,  A61L2/087 ,  A61L2/24 ,  A61L2202/122 ,  A61L2202/14 ,  A61L2202/24

摘要： An apparatus, system and method for verifying the achievement of a desired sterility assurance level (SAL) for components manipulated within a low-energy electron beam sterilization chamber. The components are preferably pre-sterilized and connected together in an assembly fashion which creates and maintains the sterility of the connection by subjecting the components to low-energy (less than 300 KeV) electron beam radiation. The verification is completed by measuring the sterilization dose delivered to a sensor, also known as a dosimeter, positioned within the sterilization process to simulate the components.

摘要翻译： 一种用于验证在低能量电子束灭菌室内操作的组件达到期望的无菌保证水平（SAL）的装置，系统和方法。 这些部件优选地被预先灭菌并以组装方式连接在一起，通过使部件经受低能量（小于300KeV）的电子束辐射而产生并保持连接的无菌性。 通过测量放置在灭菌过程中的传感器（也称为剂量计）的灭菌剂量来完成验证，以模拟组件。

公开(公告)号：US07641851B2

公开(公告)日：2010-01-05

申请号：US10745466

申请日：2003-12-23

申请人： John A. Williams ,  John A. Martine, Jr.

发明人： John A. Williams ,  John A. Martine, Jr.

IPC分类号： A61L2/00 ,  A61N5/00 ,  G01N21/00 ,  G01N31/00

CPC分类号： A61L2/28 ,  A61L2/087 ,  A61L2/24 ,  A61L2202/122 ,  A61L2202/14 ,  A61L2202/24

摘要： An apparatus, system and method for verifying the achievement of a desired sterility assurance level (SAL) for components manipulated within a low-energy electron beam sterilization chamber. The components are preferably pre-sterilized and connected together in an assembly fashion which creates and maintains the sterility of the connection by subjecting the components to low-energy (less than 300 KeV) electron beam radiation. The verification is completed by measuring the sterilization dose delivered to a sensor, also known as a dosimeter, positioned within the sterilization process to simulate the components.

摘要翻译： 一种用于验证在低能量电子束灭菌室内操作的组件达到期望的无菌保证水平（SAL）的装置，系统和方法。 这些部件优选地被预先灭菌并以组装方式连接在一起，通过使部件经受低能量（小于300KeV）的电子束辐射而产生并保持连接的无菌性。 通过测量放置在灭菌过程中的传感器（也称为剂量计）的灭菌剂量来完成验证，以模拟组件。

公开(公告)号：US07358505B2

公开(公告)日：2008-04-15

申请号：US10744946

申请日：2003-12-23

申请人： Archie Woodworth ,  William Reed ,  David J. Adams ,  John A. Martine, Jr. ,  Jeffery Smith ,  Michael Steeber ,  Kim Korzeniewski

发明人： Archie Woodworth ,  William Reed ,  David J. Adams ,  John A. Martine, Jr. ,  Jeffery Smith ,  Michael Steeber ,  Kim Korzeniewski

IPC分类号： A61L2/08

CPC分类号： A61J1/2089 ,  A61J1/10 ,  A61J1/1406 ,  A61J1/1475 ,  A61J1/201 ,  A61J1/2013 ,  A61J1/2051 ,  A61J1/2055 ,  A61L2/00 ,  A61L2/087 ,  A61L2202/23 ,  A61M39/18 ,  A61M2039/1027 ,  A61M2039/1077

摘要： What is disclosed is an apparatus and method for assembling a reconstitution assembly (1) having a reconstitution device (10) having a first end connected to a flexible diluent container (12), the reconstitution device (10) having a second end connected to a drug vial (14). The reconstitution device (10) and containers, such as drug vials (14) or diluent bags (12), are loaded onto positioning assemblies (27) on a conveyor (90). The positioning assemblies (27) are conveyed to sterilization booths (270). Sterilization fields are generated within the sterilization booths (270), and the containers are sterilely connected to the reconstitution device (10) within the sterile fields.

摘要翻译： 所公开的是用于组装具有重构装置（10）的重构组件（1）的装置和方法，所述重构装置具有连接到柔性稀释剂容器（12）的第一端，所述重构装置（10）的第二端连接到 药瓶（14）。 重建装置（10）和诸如药物小瓶（14）或稀释袋（12）的容器被装载到传送器（90）上的定位组件（27）上。 定位组件（27）被输送到灭菌室（270）。 消毒场在灭菌室（270）内产生，容器与无菌区内的重建装置（10）无菌连接。