Abstract: 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.

Abstract: 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.

Abstract: A syringe pack with a prefilled syringe (1) and a packaging (2) comprises: a barrel part (11) with an orifice (113) at a proximal end and a flange portion (112) at a distal end; a plunger part (13) extending through the distal end of the barrel part (11) into the barrel part (11); a stopper (12) adjacent to a proximal end of the plunger part (13) and arranged inside the barrel part (11) such that a dosage chamber (111) is formed inside the barrel part (11); and a drug substance arranged inside the dosage chamber (111), wherein the prefilled syringe (1) is arranged in the packaging (2) and the packaging (2) is configured to allow external sterilization of the prefilled syringe (1) arranged in the packaging (2).

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: Disclosed are a closure system for an applicator attachment on a container for pharmaceutical preparations and to a use of the closure system, a syringe for medical purposes, including a container for pharmaceutical preparations and a closure system, and a method of assembling a syringe. The aforementioned operate such that splash prevention and a venting function are integrated in the closure system.

Abstract: Disclosed are a closure system for an applicator attachment on a container for pharmaceutical preparations and to a use of the closure system, a syringe for medical purposes, including a container for pharmaceutical preparations and a closure system, and a method of assembling a syringe. The aforementioned operate such that splash prevention and a venting function are integrated in the closure system.

Abstract: Double chamber container for holding and combining, e.g., a lyophilizate and a liquid reconstitution medium, comprising an integral cylindrical body (15) with a closure (20, 60) at each of the two ends (5, 70), an upper movable closure (60) to the side of the reconstitution medium and a lower closure (20) to the side of the lyophilizate, a separating stopper (40) that can be moved in the cylindrical body (15) as a seal between the upper chamber (50) and the lower chamber (30), a bypass (35), arranged below the separating stopper (40), having a length L greater than the height H of the separating stopper (40), wherein at the lower end (5) in the wall of the cylindrical body (15) or in the lower stopper (20) there are provided means (21, 25, 28) that allow connection of the interior of the cylindrical body (15) to the environment during the lyophilization.

Abstract: A double chamber container for holding and combining a solid lyophilizate and a liquid reconstituting medium, comprising a cylindrical body with a closure at each of the two ends, an upper displaceable closure at the reconstituting medium end, and a lower closure at the lyophilizate end, a separating stopper that can be pushed in the cylindrical body and act as a seal between the upper chamber and the lower chamber, and a bypass arranged underneath the separating stopper, with a length L that is preferably greater than the height H of the separating stopper, wherein at the upper end in the wall of the cylindrical body or in the separating stopper means are provided that allow partial connection of the interior of the cylindrical body to the environment during the lyophilization.

Abstract: The invention relates to a double chamber container for holding and combining two separate components, at least one of which is liquid, comprising a cylindrical body (15) with a closure (20, 60) at each of the two ends (5, 70) of the body (15), an upper closure (60) at the liquid component end and a lower closure (20) at the solid component end, and a separating stopper (40) in the cylindrical body (15) as a seal between the two chambers (30, 50), the separating stopper (40) having a height H and the upper closure (60) at the liquid component end being movable by the application of pressure, and comprising on its underside a hollow needle (45) with a length L having at least one opening (42) which is provided at the end opposite the tip, where H <L.

Abstract: A double chamber container for holding and combining a solid lyophilizate and a liquid reconstituting medium, comprising a cylindrical body (15) with a closure (20, 60) at each of the two ends (5, 70), an upper displaceable closure at the reconstituting medium end, and a lower closure (20) at the lyophilizate end, a separating stopper (40) that can be pushed in the cylindrical body (15) and act as a seal between the upper chamber (50) and the lower chamber 30), and a bypass (35) arranged underneath the separating stopper (40), with a length L that is preferably greater than the height H of the separating stopper (40), wherein at the upper end (70) in the wall of the cylindrical body (15) or in the separating stopper (40) means (75, 45) are provided that allow partial connection of the interior of the cylindrical body (15) to the environment during the lyophilization.

Abstract: The invention relates to a double chamber container for holding and combining two separate components, at least one of which is liquid, comprising a cylindrical body (15) with a closure (20, 60) at each end (5, 70), of which the closure (60) at the end of a chamber containing the liquid component (50) can be pushed, and a separating stopper (40) which can only be pushed by increased pressure, which is mounted in the cylindrical body (15), which defines the volume of the chamber (30, 50) mounted above and below, as a seal between the two chambers (30, 50), with an opening (42) running therethrough along its longitudinal axis, said opening having an upper part (42a) to the side of the chamber containing the liquid component (50) that is closed off in fluid-tight manner by a shaped member that is movable by gentle to moderate pressure (45).

Abstract: Double chamber container for holding and combining, e.g., a lyophilizate and a liquid reconstitution medium, comprising an integral cylindrical body (15) with a closure (20, 60) at each of the two ends (5, 70), an upper movable closure (60) to the side of the reconstitution medium and a lower closure (20) to the side of the lyophilizate, a separating stopper (40) that can be moved in the cylindrical body (15) as a seal between the upper chamber (50) and the lower chamber (30), a bypass (35), arranged below the separating stopper (40), having a length L greater than the height H of the separating stopper (40), wherein at the lower end (5) in the wall of the cylindrical body (15) or in the lower stopper (20) there are provided means (21, 25, 28) that allow connection of the interior of the cylindrical body (15) to the environment during the lyophilization.

Abstract: The invention relates to a double chamber container for holding and combining two separate components, at least one of which is liquid, comprising a cylindrical body (15) with a closure (20, 60) at each of the two ends (5, 70) of the body (15), an upper closure (60) at the liquid component end and a lower closure (20) at the solid component end, and a separating stopper (40) in the cylindrical body (15) as a seal between the two chambers (30, 50), the separating stopper (40) having a height H and the upper closure (60) at the liquid component end being movable by the application of pressure, and comprising on its underside a hollow needle (45) with a length L having at least one opening (42) which is provided at the end opposite the tip, where H<L.