公开(公告)号：WO1990011095A2

公开(公告)日：1990-10-04

申请号：PCT/US1990001182

申请日：1990-03-05

Applicant: BAXTER INTERNATIONAL INC.

Inventor： BAXTER INTERNATIONAL INC. ,  MINSHALL, Billy, W. ,  PUROHIT, Kailash ,  NYGARD, John, E. ,  SINTIM-DAMOA, Kwame ,  GIESLER, Richard ,  WOODWORTH, Archie

IPC: A61L0

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：WO2005065623A3

公开(公告)日：2005-07-21

申请号：PCT/US2004/040303

申请日：2004-12-01

Applicant: BAXTER INTERNATIONAL INC. ,  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: B65B35/30

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.

公开(公告)号：WO2005065624A2

公开(公告)日：2005-07-21

申请号：PCT/US2004/040305

申请日：2004-12-01

Applicant: BAXTER INTERNATIONAL INC. ,  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

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: 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）具有连接到 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：WO2002072157A1

公开(公告)日：2002-09-19

申请号：PCT/US2002/006991

申请日：2002-03-06

Applicant: BAXTER INTERNATIONAL INC.

Inventor： WOODWORTH, Archie ,  FALZONE, John ,  DARVASI, John ,  GILLUM, Amy, W. ,  KAMIENSKI, James ,  BARNATO, Margaret, J. ,  GLINIECKI, Robert, L.

IPC: A61L2/00

CPC classification number: A61L2/087 ,  A61L2202/23 ,  B65B55/08

Abstract: The present invention claims a method of producing sterile prefilled syringe bodies. The method comprises the steps of providing a syringe body. The syringe bodies are sterilized and transferred to a sterile environment. While the syringe bodies are maintained in a sterilized condition as they are transferred to the sterile environment. A fluid substance is provided and introduced into the syringe body while the syringe body is within the sterile environment. The fluid substance is also sealed within the syringe body while the syringe body is within the sterile environment.

Abstract translation: 本发明要求生产无菌预充式注射器体的方法。 该方法包括提供注射器主体的步骤。 注射器体被灭菌并转移到无菌环境中。 当注射器体在转移到无菌环境时保持在灭菌状态。 当注射器体处于无菌环境中时，提供流体物质并将其引入注射器主体。 当注射器体处于无菌环境中时，流体物质也被密封在注射器主体内。

公开(公告)号：EP0425602B1

公开(公告)日：1995-09-06

申请号：EP90904574.2

申请日：1990-03-05

Applicant: BAXTER INTERNATIONAL INC.

Inventor： MINSHALL, Billy, W. ,  PUROHIT, Kailash ,  NYGARD, John, E. ,  SINTIM-DAMOA, Kwame ,  GIESLER, Richard ,  WOODWORTH, Archie

IPC: A61L2/00

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：EP1365825A1

公开(公告)日：2003-12-03

申请号：EP02723354.3

申请日：2002-03-06

Applicant: Baxter International Inc.

Inventor： WOODWORTH, Archie ,  FALZONE, John ,  DARVASI, John ,  GILLUM, Amy, W. ,  KAMIENSKI, James ,  BARNATO, Margaret, J. ,  GLINIECKI, Robert, L. ,  McCLELLAND, Deborah

IPC: A61M5/31 ,  A61M5/315 ,  C08F232/08

CPC classification number: A61M5/31511 ,  A61L2/10 ,  A61L2/26 ,  A61M5/001 ,  A61M5/3129

Abstract: A syringe having a syringe body of a norbornene and ethylene copolymer, the body defining a chamber for containing water and having an opening, a plunger seal of a halobutyl-based elastomer sealing the opening; and wherein the syringe meets all requirements of the United States Pharmocopoeia for sterile water for injection.

公开(公告)号：EP1368066A1

公开(公告)日：2003-12-10

申请号：EP02723355.0

申请日：2002-03-06

Applicant: Baxter International Inc.

Inventor： WOODWORTH, Archie ,  FALZONE, John ,  DARVASI, John ,  GILLUM, Amy, W. ,  KAMIENSKI, James ,  BARNATO, Margaret, J. ,  GLINIECKI, Robert, L.

IPC: A61L2/00 ,  A61L2/08 ,  B65B3/00 ,  B65B3/02

CPC classification number: A61L2/087 ,  A61L2202/23 ,  B65B55/08

Abstract: The present invention claims a method of producing sterile prefilled syringe bodies. The method comprises the steps of providing a syringe body. The syringe bodies are sterilized and transferred to a sterile environment. While the syringe bodies are maintained in a sterilized condition as they are transferred to the sterile environment. A fluid substance is provided and introduced into the syringe body while the syringe body is within the sterile environment. The fluid substance is also sealed within the syringe body while the syringe body is within the sterile environment.

公开(公告)号：EP1171167A2

公开(公告)日：2002-01-16

申请号：EP00925941.7

申请日：2000-04-12

Applicant: Baxter International Inc.

Inventor： BILSTAD, Arnold C. ,  BUCHANAN, Bradley H. ,  MARTTILA, Alan W. ,  WOODWORTH, Archie

IPC: A61L2/00

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-EBTM, 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：EP1171167B1

公开(公告)日：2010-02-10

申请号：EP00925941.7

申请日：2000-04-12

Applicant: Baxter International Inc.

Inventor： BILSTAD, Arnold C. ,  BUCHANAN, Bradley H. ,  MARTTILA, Alan W. ,  WOODWORTH, Archie

IPC: A61M39/18 ,  A61L2/08

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-EBTM, 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：EP1701886A2

公开(公告)日：2006-09-20

申请号：EP04812749.2

申请日：2004-12-01

Applicant: Baxter International Inc.

Inventor： WOODWORTH, Archie ,  REED, William ,  ADAMS, David, J. ,  MARTINE, John, A., Jr. ,  SMITH, Jerry ,  STEEBER, Michael ,  KORZENIEWSKI, Kim

IPC: 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.