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1. 发明申请

US20210052816A1 PREFILLED SYRINGE AND METHOD OF STERILIZING A PREFILLED SYRINGE 有权
公开(公告)号：US20210052816A1
公开(公告)日：2021-02-25
申请号：US16966500
申请日：2019-02-01
申请人： F. HOFFMANN-LA ROCHE AG
发明人： Neil B. CAMMISH , Markus HEMMINGER , Cyrille BLINTZ , Mayumi BOWEN , Joshua HORVATH
IPC分类号： A61M5/315 , A61M5/31
摘要： A prefilled syringe is disclosed that includes a barrel, a stopper displaceable within and defining a sealed chamber in an interior of the barrel, a liquid filled in the chamber of the barrel, and a plunger extending within the barrel. The stopper expels the liquid out of the barrel via an orifice when being forwarded towards the orifice by the plunger such that a volume of the chamber is reduced. The plunger includes a proximal portion, a distal portion and a rod portion extending between the proximal portion and the distal portion. The plunger is shaped to form a pathway between an opening of the barrel and a segment where the proximal portion of the plunger is neighboring the stopper such that a sterilizing agent can be provided through the opening of the barrel to the segment where the proximal portion of the plunger is neighboring the stopper.

2. 发明公开

US20230310681A1 PREFILLED SYRINGE AND METHOD OF PREPARING A PREFILLED SYRINGE 审中-公开
公开(公告)号：US20230310681A1
公开(公告)日：2023-10-05
申请号：US18330083
申请日：2023-06-06
申请人： F. HOFFMANN-LA ROCHE AG , GENENTECH, INC.
发明人： Markus HEMMINGER , Ulla GRAUSCHOPF , Frank BAMBERG , Mayumi BOWEN , Robert MÜLLER , Flora FELSOVALYI , Denny CHRISTENSEN
IPC分类号： A61L2/20 , A61M5/00 , A61M5/31 , A61M5/315 , A61M5/32 , B65B3/00 , B65B7/28 , B65B55/10
CPC分类号： A61L2/206 , A61M5/001 , A61M5/002 , A61M5/3129 , A61M5/315 , A61M5/3202 , B65B3/003 , B65B7/2821 , B65B55/10 , A61L2202/23 , A61M2005/3114 , A61M2205/0238 , A61M2207/10 , A61M2207/00 , A61L2202/24 , A61M5/31513 , A61M2005/3104 , B65B55/02
摘要： A method of preparing a prefilled syringe (1), comprises (i) obtaining a syringe barrel (11) having an open end (111) and a tip (112) with an orifice (113) essentially opposite to the open end (111), and a needle adaptor cap (12) assembled on the tip (112) of the syringe barrel, wherein the needle adaptor cap (12) has a rubber element (121) tightly sealing the orifice (113) of the tip (112) of the syringe barrel (11) and the syringe barrel (11) together with the needle adaptor cap (12) assembled on the tip (112) of the syringe barrel (11) is sterilized by a first sterilizing comprising a main step of exposing the syringe barrel (11) together with the needle adaptor cap (12) assembled on the tip (112) of the syringe barrel (11) to ethylene oxide for about 5 hours to about 60 hours at a relative humidity of about 40% to about 100% and at a temperature of about 30° C. to about 60° C.; (ii) filling a drug substance (14) through the open end (111) of the syringe barrel (11) into an interior of the syringe barrel; (iii) sealing the interior of the syringe barrel (11) by advancing a rubber stopper (13) through the open end (111) of the syringe barrel (11); (iv) packaging the syringe barrel (11) together with the rubber stopper (13) sealing the interior of the syringe barrel (11) and the needle adaptor cap (12) assembled on the tip (112) of the syringe barrel (11); and (v) second external surface sterilizing the packaged syringe barrel (11) together with the rubber stopper (13) sealing the interior of the syringe barrel (11) and the needle adaptor cap (12) assembled on the tip (112) of the syringe barrel (11). The rubber element (121) of the needle adaptor cap (12) and the rubber stopper (13) are made of a rubber material having a comparably low oxygen transmission rate such as, at 1 atmosphere, of not more than 64 cubic centimeter per square meter and day. The second external surface sterilizing comprises a main step of exposing the packaged syringe barrel (11) together with the rubber stopper (13) sealing the interior of the syringe barrel (11) and the needle adaptor cap (12) assembled on the tip (112) of the syringe barrel (11) to ethylene oxide for about 3 hours to about 30 hours at a relative humidity of about 40% to about 100% and at a temperature of about 25° C. to about 45° C. At least one of the duration, the relative humidity and the temperature of the second external surface sterilizing is essentially lower than the respective duration, relative humidity or temperature of the first sterilization.

3. 发明申请

US20200297919A1 PREFILLED SYRINGE AND METHOD OF PREPARING A PREFILLED SYRINGE 审中-公开
公开(公告)号：US20200297919A1
公开(公告)日：2020-09-24
申请号：US16651440
申请日：2018-09-28
申请人： F. HOFFMANN-LA ROCHE AG , GENENTECH, INC.
发明人： Markus HEMMINGER , Ulla GRAUSCHOPF , Frank BAMBERG , Mayumi BOWEN , Robert MÜLLER , Flora FELSOVALYI , Denny CHRISTENSEN
IPC分类号： A61M5/00 , A61M5/31 , A61M5/32 , A61L2/20 , B65B3/00 , B65B55/02
摘要： A method of preparing a prefilled syringe is disclosed that includes obtaining a syringe barrel and a needle adaptor cap assembled on the tip of the syringe barrel, wherein the needle adaptor cap has a rubber element tightly sealing the orifice of the tip of the syringe barrel and the syringe barrel together with the needle adaptor cap assembled on the tip of the syringe barrel is sterilized by a first sterilizing. Filling a drug substance into an interior of the syringe barrel and sealing the interior of the syringe barrel. Packaging the syringe barrel with a rubber stopper sealing the interior thereof and the needle adaptor cap assembled on the tip of the syringe barrel. Providing a second external surface sterilizing of the packaged syringe barrel with the rubber stopper sealing the interior thereof and the needle adaptor cap assembled on the tip of the syringe barrel.

4. 发明申请

US20200282130A1 PREFILLED SYRINGE AND METHOD OF PREPARING A PREFILLED SYRINGE 审中-公开
公开(公告)号：US20200282130A1
公开(公告)日：2020-09-10
申请号：US16651444
申请日：2018-09-28
申请人： F. HOFFMANN-LA ROCHE AG , GENENTECH, INC.
发明人： Markus HEMMINGER , Ulla GRAUSCHOPF , Frank BAMBERG , Mayumi BOWEN , Robert MÜLLER , Flora FELSOVALYI , Denny CHRISTENSEN
IPC分类号： A61M5/00 , A61M5/31 , A61M5/315 , A61M5/32 , A61L2/20
摘要： A method of preparing a prefilled syringe is disclosed that includes obtaining a syringe barrel and a needle adaptor cap assembled on the tip of the syringe barrel, wherein the needle adaptor cap has a rubber element tightly sealing the orifice of the tip of the syringe barrel and the syringe barrel together with the needle adaptor cap assembled on the tip of the syringe barrel is sterilized by a first sterilizing. Filling a drug substance into an interior of the syringe barrel and sealing the interior of the syringe barrel. Packaging the syringe barrel with a rubber stopper sealing the interior thereof and the needle adaptor cap assembled on the tip of the syringe barrel. Providing a second external surface sterilizing of the packaged syringe barrel with the rubber stopper sealing the interior thereof and the needle adaptor cap assembled on the tip of the syringe barrel.

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