A thermoplastic elastomer stopper that meets the desired material properties of a stopper for a syringe assembly is disclosed. The compression set of the thermoplastic elastomer stopper of the present disclosure is ≤50% when measured at 25% compression for 22 hrs at 70 degree C. The hardness of the thermoplastic elastomer stopper of the present disclosure is 40-70 Shore A. The viscosity of a thermoplastic elastomer stopper of the present disclosure is ≥70 Pa.Math.s at 1,000 s.sup.−1 shear rate, ≥12.0 Pa.Math.s at 10,000 s.sup.−1 shear rate, and ≥3.0 Pa.Math.s at 50,000 s.sup.−1 shear rate when measured using a capillary rheometer at 205 degree C. (Die: Roundhole 20 mm length/1 mm diameter/180 degree inlet, Piston: d=15 mm, and melting time=7 min). The present non-lubricated stopper exhibits the required functional performance of a lubricated stopper.

A syringe cover device comprises a first cap with a first frame and a first seal coupled thereto, and a second cap with a second frame and a second seal coupled thereto. The first frame and the second frame are couplable to each other to form an accommodating space therebetween. The first seal and the second seal are couplable to each other to form a main seal body and disposed in the accommodating space. The main seal body has a first surface abutting against the first frame and the second frame, a second surface opposite to the first surface and an aperture formed through the first surface and the second surface. The first frame and the second frame may be attached to a syringe flange with the syringe plunger passing through the aperture to cover and seal a back opening of the syringe barrel.

Medical device assemblies capable of aspirating liquid into a syringe barrel or other medical devices while evacuating any air from the syringe are described. An exemplary medical device includes a syringe barrel, plunger rod and stopper assembly having an air permeable and liquid impermeable porous portion and structure for forming a vacuum within either the stopper or the plunger rod. Described is a medical device including a syringe barrel, plunger rod and stopper assembly having an air permeable and liquid impermeable porous portion and structure for forming a vacuum within chamber between the stopper and plunger rod wherein the plunger rod includes a sealing edge and is moveable relative to the stopper. Exemplary medical devices may include a vent for allowing air that permeates through the porous portion to escape to atmosphere. Methods for aspirating a syringe barrel with a liquid are also provided.

Laminated gasket free from liquid drug leakage. A gasket (13) for a medical syringe, with main body (14) made of elastic material, and film (15) provided on a surface of main body (14). Gasket (13) has a circumferential surface portion (17) for contact with an inner peripheral surface of a syringe barrel (11) and an annular groove (22) formed circumferentially in a surface portion of the film in the circumferential surface portion thereof. Annular groove (22) has outer edge portions (24) provided along opposite edges (23) thereof as projecting from an unprocessed surface portion of the film. Annular groove (22) has a groove formation start point and a groove formation end point connected to each other in a groove connection region. Outer edge portions (24) provided along the opposite edges of the annular groove have a maximum-to-minimum height difference of μm in the groove connection region.

A plunger seal for a drug delivery device may have a mobile and an enhanced sealing parked state. Optionally, the cartridge is stored with the plunger seal in the parked state. Optionally, drug discharge occurs with the plunger seal in the mobile state. For example in the parked state there may be increased normal force between the plunger seal and an inner wall of the cartridge. Optionally there is limited deformation of the plunger seal between the parked and mobile states. Optionally the plunger seal is biased to the parked state. Optionally, a distal force switches the plunger seal to the mobile state. For example, the plunger seal may have an inner cavity that is expanded radially by core. A biasing element optionally biases the core wedging it proximally to the parked state. A distal force on the core may push it distally to the mobile state.

A process for producing gaskets with an improved channel for use in matched syringe and plunger systems, preferably prefilled plastic syringe systems. In particular, an improved process for making and inspecting continuous channels in a gasket film by laser treatment. The gaskets are useful in matched syringe and plunger systems with high and consistent container closure integrity (CCI), and consistent break loose and glide forces over time, and sealability.

A syringe includes a barrel, a plunger, and a sealing member creating a seal between the plunger and the barrel. The barrel includes a first portion with a first inner diameter and a second portion with a second inner diameter that is larger than the first inner diameter. The sealing member engages the first portion of the barrel to give rise to a first contact pressure when the barrel is filled with product. The first contact pressure is sufficient to maintain a gas-tight seal over the expected temperature ranges −25° C. to 40° C. A first force is applied to the plunger to overcome the first contact pressure and move the plunger out of the first portion and into the second portion to dispense product. The sealing member engages the second portion of the barrel to give rise to a second contact pressure that is lower than the first contact pressure. A second force lower than the first force is sufficient to overcome the second contact pressure and move the plunger in the second portion to continue dispensing product. The syringe may include a restraining element for accommodating expansion of the product during freezing.

A system having a syringe and a connector. A proximal end of an outer housing of the connector is a specially designed female Luer element. A distal end of an outer housing of the connector is configured to connect the syringe to a component of a fluid transfer apparatus. The syringe and the connector are configured to be joined together such that they can be swiveled relative to each other around their common longitudinal axis. Once connected together, any attempt to twist the syringe or connector relative to each other in either a counterclockwise direction or a clockwise direction will result in endless swiveling about their common longitudinal axis. In other words, once the system is connected together, the syringe cannot be disconnected from the connector.

A syringe assembly and methods of producing the syringe assembly are described. The syringe assembly may include a syringe body, a plunger rod, a barrel cover, and a tamper evident device. The syringe body has a chamber configured to receive a material. The plunger rod moves within the chamber to dispense the material. The barrel cover covers the syringe body. The backstop is attached to the barrel cover to prevent a portion of the plunger rod from moving proximally through the backstop. The tamper evident device includes a tamper evident cap covering a distal portion of the syringe body, a collar attached to the barrel cover, and a frangible connection between the tamper evident cap and the collar.

Laminated gasket free from liquid drug leakage. Gasket (13) to be used for a medical syringe includes main body (14) made of an elastic material and film (15) on a surface of main body (14). Gasket (13) has a circumferential surface portion (17) that can contact an inner peripheral surface of syringe barrel (11) of the syringe, and has an annular groove (22) formed circumferentially in a surface portion of the film present in the circumferential surface portion thereof. Annular groove (22) has outer edge portions (24) provided along opposite edges (23) thereof as projecting from an unprocessed surface portion of the film. Annular groove (22) has groove formation start points and end points that are connected to each other in a groove connection region. Outer edge portions (24) along the opposite edges of the annular groove have a maximum-to-minimum height difference of ≤5 μm in the groove connection region.