公开(公告)号：WO2005065624A3

公开(公告)日：2005-10-13

申请号：PCT/US2004040305

申请日：2004-12-01

Applicant: BAXTER INT ,  WOODWORTH ARCHIE ,  REED WILLIAM ,  ADAMS DAVID J ,  MARTINE JOHN A JR ,  SMITH JERRY ,  STEEBER MICHAEL ,  KORZENIEWSKI KIM

Inventor： WOODWORTH ARCHIE ,  REED WILLIAM ,  ADAMS DAVID J ,  MARTINE JOHN A JR ,  SMITH JERRY ,  STEEBER MICHAEL ,  KORZENIEWSKI KIM

IPC: A61J1/00 ,  A61J1/05 ,  A61J1/10 ,  A61J1/14 ,  A61J1/20 ,  A61L2/00 ,  A61L2/08 ,  A61M39/18 ,  B29C65/00 ,  B29C65/02 ,  B29C65/04 ,  B29C65/10 ,  B29C65/48 ,  B65B35/30

CPC classification number: 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

Abstract: 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 seond 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.

Abstract translation: 公开了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）具有连接到 药瓶（14）。 重构装置（10）和诸如药瓶（14）或稀释剂袋（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）被传送到消毒室（270）。 消毒室在消毒室（270）内产生，并且容器在无菌区域内无菌地连接到重构装置（10）。

公开(公告)号：WO9011095A3

公开(公告)日：1991-08-08

申请号：PCT/US9001182

申请日：1990-03-05

Applicant: BAXTER INT

Inventor： MINSHALL BILLY W ,  PUROHIT KAILASH ,  NYGARD JOHN E ,  SINTIM-DAMOA KWAME ,  GIESLER RICHARD ,  WOODWORTH ARCHIE

IPC: A61L2/00 ,  A61L2/04 ,  A61L2/08 ,  A61L2/20 ,  A61M1/02 ,  A61L

CPC classification number: A61L2/20 ,  A61L2/0023 ,  A61L2/08 ,  A61M1/0209

Abstract: A sterile product and a method for sterilizing and assembling such a product are disclosed wherein the product has two or more portions, such as a medical fluid containing portion (12) and a flow control apparatus portion (14), which are mutually incompatible with regard to the method of sterilization. The sterile product is preferably produced by exposing one portion of the product, e.g., the flow control apparatus (14), to a first form of sterilization such as an electron beam, while shielding the other portion of the product, e.g., the medical fluid containing portion (12), from the first form of sterilization. The product may be integral, with the step of sterilizing the first portion occurring while the other product portion remains attached in close association therewith. The present invention has particular application in association with a product having first and second incompatible portions (12 and 14) which are joined by a flow path. In such a product, each product portion and its respective flow path portion may be sterilized in the appropriate manner. The flow path may then be isolated from the respective product portion and the flow paths joined together. Subsequent to joinder, the isolated portion of the flow path may be sterilized, as by electron beam, while any product portion incompatible with such form of sterilization is shielded from the effects of the sterilization.

公开(公告)号：WO0062820A3

公开(公告)日：2001-03-08

申请号：PCT/US0009751

申请日：2000-04-12

Applicant: BAXTER INT

Inventor： BILSTAD ARNOLD C ,  BUCHANAN BRADLEY H ,  MARTTILA ALAN W ,  WOODWORTH ARCHIE

IPC: A61L2/24 ,  A61L2/00 ,  A61L2/08 ,  A61L2/10 ,  A61L2/14 ,  A61L2/20 ,  A61M39/18 ,  B29C65/00 ,  B29C65/02 ,  B29C65/04 ,  B29C65/10 ,  B29C65/48 ,  B67C7/00 ,  B65B55/02

CPC classification number: A61L2/00 ,  A61L2/08 ,  A61L2/087 ,  A61L2/14 ,  A61L2/208 ,  A61L2202/23 ,  A61L2202/24 ,  A61M39/18 ,  B29C65/02 ,  B29C65/04 ,  B29C65/103 ,  B29C65/4895 ,  B29C66/0018 ,  B29C66/1142 ,  B29C66/5221 ,  B29C66/5229 ,  B29C66/52293 ,  B29C66/52298 ,  B29C66/73921 ,  B29C66/81431 ,  B29C66/83221 ,  B29C66/857 ,  B29L2023/007 ,  B67C7/0073

Abstract: The connection, assembly, or fill of two or more pre-sterilized components having at least one terminal end each for attachment to another component, and an apparatus for performing such a connection, while maintaining the sterility of the components is disclosed. The resulting connection is made permanent by bonding the contacting components together using either a solvent bonding technique, a radio frequency sealer, a heat sealer, or any other suitable process. The connection is preferably made within an active sterile field. Using a low-voltage electron beam instrument, such as the MIN-EB , a suitable sterile field sphere can be created. The terminal ends of the multiple components remain withing the sterile field sphere until the possibility of contamination within the sealed components is significantly reduced to industry acceptable standards.

Abstract translation: 公开了两个或更多个预灭菌组件的连接，组装或填充，其具有至少一个终端，用于附接到另一组件，以及用于执行这种连接的设备，同时保持组件的无菌性。 通过使用溶剂粘合技术，无线电频率封隔器，热封机或任何其它合适的工艺将接触部件粘合在一起，使得到的连接永久化。 连接优选在活性无菌区域内进行。 使用诸如MIN-EB TM的低电压电子束仪器可以产生合适的无菌场球。 多个部件的末端保留无菌场球，直到密封部件内污染的可能性显着降低到工业上可接受的标准。

公开(公告)号：WO2005065623A2

公开(公告)日：2005-07-21

申请号：PCT/US2004040303

申请日：2004-12-01

Applicant: BAXTER INT ,  WOODWORTH ARCHIE ,  REED WILLIAM ,  ADAMS DAVID J ,  MARTINE JOHN A JR ,  SMITH JERRY ,  STEEBER MICHAEL ,  KORZENIEWSKI KIM

Inventor： WOODWORTH ARCHIE ,  REED WILLIAM ,  ADAMS DAVID J ,  MARTINE JOHN A JR ,  SMITH JERRY ,  STEEBER MICHAEL ,  KORZENIEWSKI KIM

IPC: A61J1/00 ,  A61J1/20 ,  A61L2/00 ,  A61L2/08 ,  A61M5/00 ,  A61M39/18 ,  B65B35/30 ,  A61J

CPC classification number: A61M5/008 ,  A61J1/10 ,  A61J1/1475 ,  A61J1/201 ,  A61J1/2013 ,  A61J1/2051 ,  A61J1/2055 ,  A61J1/2089 ,  A61L2/0011 ,  A61L2/087 ,  A61L2202/122

Abstract: 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.

Abstract translation: 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。

公开(公告)号：CA2649673C

公开(公告)日：2010-06-15

申请号：CA2649673

申请日：2000-04-12

Applicant: BAXTER INT

Inventor： BILSTAD ARNOLD C ,  BUCHANAN BRADLEY H ,  MARTTILA ALAN W ,  WOODWORTH ARCHIE

IPC: A61L2/24 ,  B65B55/02 ,  A61L2/00 ,  A61L2/08 ,  A61L2/10 ,  A61L2/14 ,  A61L2/20 ,  A61M39/18 ,  B29C65/00 ,  B29C65/02 ,  B29C65/04 ,  B29C65/10 ,  B29C65/48 ,  B67C7/00 ,  B67D99/00

Abstract: A method for sterile filling a pre-sterilized container having a filling port with a bulk sterile fluid comprises the steps of, establishing an active sterile field, introducing the filling port of the pre-sterilized container into the active sterile field, transferring an aliquot of the bulk sterile fluid from a supply container to the pre-sterilized container through the filling port while in the active sterile field and removing the filling port of the pre-sterilized container from the active sterile field.

公开(公告)号：CA2365557C

公开(公告)日：2010-03-30

申请号：CA2365557

申请日：2000-04-12

Applicant: BAXTER INT

Inventor： BILSTAD ARNOLD C ,  BUCHANAN BRADLEY H ,  MARTTILA ALAN W ,  WOODWORTH ARCHIE

IPC: A61L2/24 ,  A61M39/18 ,  A61L2/00 ,  A61L2/08 ,  A61L2/10 ,  A61L2/14 ,  A61L2/20 ,  B29C65/00 ,  B29C65/02 ,  B29C65/04 ,  B29C65/10 ,  B29C65/48 ,  B65B55/02 ,  B67C7/00

Abstract: The connection, assembly, or fill of two or more pre-sterilized components having at least one terminal end each for attachment to another component, and an apparatus for performing such a connection, while maintaining the sterility of the components is disclosed. The resulting connection is made permanent by bonding the contacting components together using either a solvent bonding technique, a radio frequency sealer, a heat sealer, or any other suitable process. The connection is preferably made within an active sterile field. Using a low-voltage electron beam instrument, such as the MIN-EB.TM., a suitable sterile field sphere can be created. The terminal ends of the multiple components remain withing the sterile field sphere until the possibility of contamination within the sealed components is significantly reduced to industry acceptable standards.

公开(公告)号：AU760376B2

公开(公告)日：2003-05-15

申请号：AU4455600

申请日：2000-04-12

Applicant: BAXTER INT

Inventor： BILSTAD ARNOLD C ,  BUCHANAN BRADLEY H ,  MARTTILA ALAN W ,  WOODWORTH ARCHIE

IPC: A61L2/24 ,  A61L2/00 ,  A61L2/08 ,  A61L2/10 ,  A61L2/14 ,  A61L2/20 ,  A61M39/18 ,  B29C65/00 ,  B29C65/02 ,  B29C65/04 ,  B29C65/10 ,  B29C65/48 ,  B67C7/00

Abstract: The connection, assembly, or fill of two or more pre-sterilized components having at least one terminal end each for attachment to another component, and an apparatus for performing such a connection, while maintaining the sterility of the components is disclosed. The resulting connection is made permanent by bonding the contacting components together using either a solvent bonding technique, a radio frequency sealer, a heat sealer, or any other suitable process. The connection is preferably made within an active sterile field. Using a low-voltage electron beam instrument, such as the MIN-EB(TM), a suitable sterile field sphere can be created. The terminal ends of the multiple components remain within the sterile field sphere until the possibility of contamination within the sealed components is significantly reduced to industry acceptable standards.

公开(公告)号：DE60043813D1

公开(公告)日：2010-03-25

申请号：DE60043813

申请日：2000-04-12

Applicant: BAXTER INT

Inventor： BILSTAD ARNOLD C ,  BUCHANAN BRADLEY H ,  MARTTILA ALAN W ,  WOODWORTH ARCHIE

IPC: A61L2/00 ,  A61L2/24 ,  A61L2/08 ,  A61L2/10 ,  A61L2/14 ,  A61L2/20 ,  A61M39/18 ,  B29C65/00 ,  B29C65/02 ,  B29C65/04 ,  B29C65/10 ,  B29C65/48 ,  B67C7/00

Abstract: The connection, assembly, or fill of two or more pre-sterilized components having at least one terminal end each for attachment to another component, and an apparatus for performing such a connection, while maintaining the sterility of the components is disclosed. The resulting connection is made permanent by bonding the contacting components together using either a solvent bonding technique, a radio frequency sealer, a heat sealer, or any other suitable process. The connection is preferably made within an active sterile field. Using a low-voltage electron beam instrument, such as the MIN-EB(TM), a suitable sterile field sphere can be created. The terminal ends of the multiple components remain within the sterile field sphere until the possibility of contamination within the sealed components is significantly reduced to industry acceptable standards.

公开(公告)号：AT457184T

公开(公告)日：2010-02-15

申请号：AT00925941

申请日：2000-04-12

Applicant: BAXTER INT

Inventor： BILSTAD ARNOLD C ,  BUCHANAN BRADLEY H ,  MARTTILA ALAN W ,  WOODWORTH ARCHIE

IPC: A61L2/24 ,  A61M39/18 ,  A61L2/00 ,  A61L2/08 ,  A61L2/10 ,  A61L2/14 ,  A61L2/20 ,  B29C65/00 ,  B29C65/02 ,  B29C65/04 ,  B29C65/10 ,  B29C65/48 ,  B67C7/00

Abstract: The connection, assembly, or fill of two or more pre-sterilized components having at least one terminal end each for attachment to another component, and an apparatus for performing such a connection, while maintaining the sterility of the components is disclosed. The resulting connection is made permanent by bonding the contacting components together using either a solvent bonding technique, a radio frequency sealer, a heat sealer, or any other suitable process. The connection is preferably made within an active sterile field. Using a low-voltage electron beam instrument, such as the MIN-EB(TM), a suitable sterile field sphere can be created. The terminal ends of the multiple components remain within the sterile field sphere until the possibility of contamination within the sealed components is significantly reduced to industry acceptable standards.

公开(公告)号：MXPA03008079A

公开(公告)日：2004-03-10

申请号：MXPA03008079

申请日：2002-03-06

Applicant: BAXTER INT

Inventor： WOODWORTH ARCHIE

IPC: A61L2/08 ,  A61L2/26 ,  A61M5/28 ,  B65B55/08 ,  A61L2/00 ,  B65B3/00 ,  B65B3/02

Abstract: La presente invencion reivindica un metodo para producir cuerpos de jeringa esteriles, prellenados. El metodo comprende los pasos de proveer un cuerpo de jeringa. Los cuerpos de jeringa son esterilizados y transferidos a un entorno esteril. Mientras se mantienen los cuerpos de jeringa en una condicion esterilizada, son transferidos al entorno esteril. Se provee una sustancia fluida y se la introduce dentro del cuerpo de jeringa, mientras el cuerpo de jeringa se encuentra en el entorno esteril. Tambien se sella la sustancia fluida dentro del cuerpo de jeringa, mientras el cuerpo de jeringa se encuentra en el entorno esteril.