公开(公告)号：WO1997007955A1

公开(公告)日：1997-03-06

申请号：PCT/US1996012756

申请日：1996-08-21

Applicant: MEDRAD, INC.

Inventor： MEDRAD, INC. ,  LAWECKI, Mark ,  GELBLUM, Eugene, A. ,  ROBINSON, Michelle ,  WOLSTENHOLME, Ralph ,  WOLSTENHOLME, Eugene, B.

IPC: B29C45/17

CPC classification number: B65B3/006 ,  B29C45/0084 ,  B29C45/1701 ,  Y10S425/815

Abstract: An apparatus and method are provided for manufacturing articles, such as syringe barrels (126), substantially free from contaminants. The apparatus is an enclosure (10) defining at least a class 100 and MCB-3 environment, and includes a molding isolation module (12) and a packaging isolation module (14). Any contaminants that may exist within the enclosure (10) are removed by the use of horizontal and vertical laminar airflows directed by air filter units (50). Further, the molding temperature may be selected such that it renders the fabricated articles substantially free from contaminants. The molding isolation module (12) and packaging isolation module (14) keep the fabricated articles substantially free from contaminants from the time the articles are molded to the time the articles are placed in sealed containers (128a, 130, 132, 134) for shipment.

Abstract translation: 提供了一种用于制造基本上没有污染物的制品例如注射器筒（126）的装置和方法。 该设备是限定至少100级和MCB-3环境的外壳（10），并且包括模制隔离模块（12）和封装隔离模块（14）。 可以通过使用由空气过滤器单元（50）引导的水平和垂直层流气流来移除可能存在于外壳（10）内的任何污染物。 此外，可以选择成型温度，使得其使制造的制品基本上不含污染物。 成型隔离模块（12）和包装隔离模块（14）在物品被放置在密封容器（128a，130,132,134）中以便装运时保持制造物品基本上不受污染物的污染 。

公开(公告)号：WO1997008054A1

公开(公告)日：1997-03-06

申请号：PCT/US1996013559

申请日：1996-08-20

Applicant: MEDRAD, INC.

Inventor： MEDRAD, INC. ,  REILLY, David, M. ,  RHINEHART, Edward, J. ,  GELBLUM, Eugene, A. ,  HITCHINS, Mark ,  ROBINSON, Michelle

IPC: B65B55/02

CPC classification number: B65B3/003 ,  Y10T29/49808 ,  Y10T29/4984

Abstract: This invention relates to a process for manufacturing prefilled syringes where at least one of the syringe components is manufactured in at least a class 100 environment. The process includes the steps of manufacturing syringe components, such as the barrel and plunger substrate, within at least a class 100 and MCB-3 environment (210-218, 242-250); manufacturing syringe components, such as the plunger cover and tip seal in an environment less clean than a class 100 environment (252-262, 222-232); decontaminating the plunger cover and tip seal (264-265, 234-236); lubricating at least one of the barrel, plunger substrate, plunger cover and tip seal (220, 266, 238); assembling the barrel and tip seal to form a barrel/tip seal combination (240); assembling the plunger cover and plunger substrate to form a plunger (268); filling the barrel/tip seal combination with a predetermined amount of fluid (276); and final assembling of the prefilled syringe by inserting the plunger into the barrel/tip seal combination (278). When the syringe components are manufactured at different locations, each component is tripled-bagged to maintain the component substantially free from contaminants, and transported to an assembly site where the components are unpackaged and assembled into the barrel/tip seal combination and plunger. When filling and final assembly of the barrel/tip seal combination takes place at a location separate from its assembly site, the barrel/tip seal combination is tripled-bagged to maintain it substantially free from contaminants, and transported to a filling and final assembling site for filling and final assembling into a prefilled syringe.

Abstract translation: 本发明涉及一种用于制造预灌装注射器的方法，其中至少一个注射器组件在至少100级环境中制造。 该方法包括在至少100级和MCB-3环境（210-218,242-250）内制造注射器部件（例如筒体和柱塞基底）的步骤; 在比100级环境（252-262,222-232）更干净的环境中制造注射器部件，例如柱塞盖和末端密封; 去除柱塞盖和顶端密封（264-265,234-236）; 润滑筒，柱塞基底，柱塞盖和末端密封件（220,266,238）中的至少一个; 组装筒和尖端密封以形成筒/尖端密封组合（240）; 组装柱塞盖和柱塞基板以形成柱塞（268）; 用预定量的流体（276）填充桶/尖端密封组合; 以及通过将柱塞插入筒/尖端密封组合（278）中来预先填充的注射器的最终组装。 当注射器组件在不同位置制造时，每个组件被三倍重装，以保持组件基本上没有污染物，并且被运输到组件的未被包装并组装到筒/尖端密封组合和柱塞中的组装位置。 当筒/尖端密封组合的填充和最终组装在与其组装位置分离的位置处发生时，筒/尖端密封组合被三倍增加以保持其基本上没有污染物，并被运送到填充和最终组装位置 用于填充和最终组装成预充式注射器。

公开(公告)号：EP0846072B1

公开(公告)日：2001-05-16

申请号：EP96929717.5

申请日：1996-08-20

Applicant: MEDRAD INC.

Inventor： REILLY, David, M. ,  RHINEHART, Edward, J. ,  GELBLUM, Eugene, A. ,  HITCHINS, Mark ,  ROBINSON, Michelle

IPC: B65B55/02

CPC classification number: B65B3/003 ,  Y10T29/49808 ,  Y10T29/4984

Abstract: This invention relates to a process for manufacturing prefilled syringes where at least one of the syringe components is manufactured in at least a class 100 environment. The process includes the steps of manufacturing syringe components, such as the barrel and plunger substrate, within at least a class 100 and MCB-3 environment (210-218, 242-250); manufacturing syringe components, such as the plunger cover and tip seal in an environment less clean than a class 100 environment (252-262, 222-232); decontaminating the plunger cover and tip seal (264-265, 234-236); lubricating at least one of the barrel, plunger substrate, plunger cover and tip seal (220, 266, 238); assembling the barrel and tip seal to form a barrel/tip seal combination (240); assembling the plunger cover and plunger substrate to form a plunger (268); filling the barrel/tip seal combination with a predetermined amount of fluid (276); and final assembling of the prefilled syringe by inserting the plunger into the barrel/tip seal combination (278). When the syringe components are manufactured at different locations, each component is tripled-bagged to maintain the component substantially free from contaminants, and transported to an assembly site where the components are unpackaged and assembled into the barrel/tip seal combination and plunger. When filling and final assembly of the barrel/tip seal combination takes place at a location separate from its assembly site, the barrel/tip seal combination is tripled-bagged to maintain it substantially free from contaminants, and transported to a filling and final assembling site for filling and final assembling into a prefilled syringe.

公开(公告)号：EP0846046A1

公开(公告)日：1998-06-10

申请号：EP96928808.0

申请日：1996-08-21

Applicant: MEDRAD INC.

Inventor： LAWECKI, Mark ,  GELBLUM, Eugene, A. ,  ROBINSON, Michelle ,  WOLSTENHOLME, Ralph ,  WOLSTENHOLME, Eugene, B.

IPC: B29C45 ,  B65B3

CPC classification number: B65B3/006 ,  B29C45/0084 ,  B29C45/1701 ,  Y10S425/815

Abstract: An apparatus and method are provided for manufacturing articles, such as syringe barrels (126), substantially free from contaminants. The apparatus is an enclosure (10) defining at least a class 100 and MCB-3 environment, and includes a molding isolation module (12) and a packaging isolation module (14). Any contaminants that may exist within the enclosure (10) are removed by the use of horizontal and vertical laminar airflows directed by air filter units (50). Further, the molding temperature may be selected such that it renders the fabricated articles substantially free from contaminants. The molding isolation module (12) and packaging isolation module (14) keep the fabricated articles substantially free from contaminants from the time the articles are molded to the time the articles are placed in sealed containers (128a, 130, 132, 134) for shipment.

公开(公告)号：EP0846046B1

公开(公告)日：2002-11-06

申请号：EP96928808.3

申请日：1996-08-21

Applicant: MEDRAD INC.

Inventor： LAWECKI, Mark ,  GELBLUM, Eugene, A. ,  ROBINSON, Michelle ,  WOLSTENHOLME, Ralph ,  WOLSTENHOLME, Eugene, B.

IPC: B29C45/17 ,  B29C45/00

CPC classification number: B65B3/006 ,  B29C45/0084 ,  B29C45/1701 ,  Y10S425/815

Abstract: An apparatus and method are provided for manufacturing articles, such as syringe barrels (126), substantially free from contaminants. The apparatus is an enclosure (10) defining at least a class 100 and MCB-3 environment, and includes a molding isolation module (12) and a packaging isolation module (14). Any contaminants that may exist within the enclosure (10) are removed by the use of horizontal and vertical laminar airflows directed by air filter units (50). Further, the molding temperature may be selected such that it renders the fabricated articles substantially free from contaminants. The molding isolation module (12) and packaging isolation module (14) keep the fabricated articles substantially free from contaminants from the time the articles are molded to the time the articles are placed in sealed containers (128a, 130, 132, 134) for shipment.

公开(公告)号：EP0846072A1

公开(公告)日：1998-06-10

申请号：EP96929717.0

申请日：1996-08-20

Applicant: MEDRAD, INC.

Inventor： REILLY, David, M. ,  RHINEHART, Edward, J. ,  GELBLUM, Eugene, A. ,  HITCHINS, Mark ,  ROBINSON, Michelle

IPC: B65B3

CPC classification number: B65B3/003 ,  Y10T29/49808 ,  Y10T29/4984

Abstract: This invention relates to a process for manufacturing prefilled syringes where at least one of the syringe components is manufactured in at least a class 100 environment. The process includes the steps of manufacturing syringe components, such as the barrel and plunger substrate, within at least a class 100 and MCB-3 environment (210-218, 242-250); manufacturing syringe components, such as the plunger cover and tip seal in an environment less clean than a class 100 environment (252-262, 222-232); decontaminating the plunger cover and tip seal (264-265, 234-236); lubricating at least one of the barrel, plunger substrate, plunger cover and tip seal (220, 266, 238); assembling the barrel and tip seal to form a barrel/tip seal combination (240); assembling the plunger cover and plunger substrate to form a plunger (268); filling the barrel/tip seal combination with a predetermined amount of fluid (276); and final assembling of the prefilled syringe by inserting the plunger into the barrel/tip seal combination (278). When the syringe components are manufactured at different locations, each component is tripled-bagged to maintain the component substantially free from contaminants, and transported to an assembly site where the components are unpackaged and assembled into the barrel/tip seal combination and plunger. When filling and final assembly of the barrel/tip seal combination takes place at a location separate from its assembly site, the barrel/tip seal combination is tripled-bagged to maintain it substantially free from contaminants, and transported to a filling and final assembling site for filling and final assembling into a prefilled syringe.