A vial stopper for closure of a lyophilization vial is disclosed. The vial stopper has a stopper body comprising a first circumferential sealing surface for hermetically sealing against an interior surface of a mouth of the vial in a first position of the vial stopper. The stopper body further comprises a second circumferential sealing surface for hermetically sealing against the interior surface of the mouth of the vial in a second position of the vial stopper. The second sealing surface is spaced apart from the first sealing surface in an axial direction of the stopper body. The stopper body further comprises an intermediate region in between the first and second sealing surfaces, the intermediate region having at least one venting element for venting an interior of the vial in at least one intermediate position of the stopper in between the first and second positions.

Device for blocking a fluid product reservoir with a neck, having a cap, a fixing ring to hold the cap on the neck, the fixing ring having a cylindrical structure with wall parts separated by lateral windows, each wall part having at least one inner radial projection to hold the cap in the fixing ring, each lateral window having a lower edge provided with at least one rigid lug extending radially inwards from the lower edge. The rigid lugs, in the blocking position of the fixing ring, are arranged under a neck of the reservoir, to thus fix the fixing ring on the reservoir. A blocking cover is provided having a cylindrical wall and an upper wall and arranged around the fixing ring to lock said fixing ring in its blocking position. The upper surface of the cap has a deformation profile that engages, after assembly, with the fixing ring.

Provided is a gas fill fixture for use in lyophilization, a related system and method. The gas fill fixture includes a chassis, fill indicator and a lid, such that the chassis and lid together form a cavity for receiving a flexible lyophilization container. The system includes a lyophilization container, a lyophilizer and a gas fill fixture incorporating a chassis, a fill indicator and a lid. The method includes process steps for using the system to lyophilize a fluid.

The invention relates to a locking cap for a container comprising a neck, intended to block a stopper in the neck of the container and comprising: an external body having a breakable part, a cage that is configured to fit into and lock axially in the external body, and having a breakable zone, the cage further comprising: an upper ring, a plurality n of branches that are connected to the upper ring and define therewith a generally cylindrical shape, n/2 first bridges and n/2 second bridges, each interconnecting two adjacent branches, at least one opening tab, which is supported by a second bridge, which is inclined toward the outside of the cage and is oriented toward the upper ring, the opening tab being adjacent to the breakable zone, which is located on the second bridge.

Provided is a loading tray assembly for housing a lyophilization container and a related system and method. The loading tray assembly includes a chassis including a contact void configured to facilitate direct contact between the attached lyophilization container and a lyophilizer shelf. The method includes securing a multi-part lyophilization container including a peelable seal on a lyophilization loading tray assembly, inputting a liquid into a non-breathable section of the lyophilization container, loading the tray assembly into a lyophilizer, freezing the liquid, applying heat energy and a vacuum, the vacuum causing an opening of the peelable seal and occluding the lyophilization container to isolate the frozen liquid.

Provided is a multi-part lyophilization container for lyophilizing a fluid, storing the lyophilizate, reconstituting the lyophilizate, and infusing the reconstituted lyophilizate into a patient, including a method of using same. The container includes a front surface, a back surface, a non-breathable section including a port region, a breathable section including a breathable membrane, and an occlusion zone encompassing a boundary between the non-breathable section and the breathable section. The non-breathable section is configured to accommodate any of a liquid, a solid, a gas or combination thereof. The breathable section is configured to accommodate only a gas. The method includes creating a temporary seal between the non-breathable section of the container and the breathable section, inputting a liquid into the non-breathable section, freezing the liquid, removing the temporary seal to allow vapor transport between the non-breathable section and the breathable section, and adding heat energy the frozen liquid under vacuum.

A pre-loaded container and a method of manufacturing a preloaded vial is provided wherein one or more active agents is lyophilized within the vial cap and the vial cap is then sealed onto a vial retaining a suitable diluent to form the pre-loaded vial. Lyophilizing the one or more active agents within the vial cap ensures that the one or more active agents are retained in sterile conditions, that the lyophilized one or more active agents and the diluent may be stored efficiently, and that the one or more active agents may be solubilized in a sterile and efficient manner.

A closure for dispensing one or more active agents into a container comprises a sealed or sealable chamber having a breakable wall and a hollow piston slidably mounted in a piston guide. Said hollow piston comprises an outer wall having an end in the chamber and at least one ventilation aperture. Said end has a cutting formation. Said hollow piston is slidable in the piston guide between a ventilation position in which the at least one ventilation aperture allows ventilation of the chamber and a sealed position in which the at least one ventilation aperture is sealed to prevent ventilation of the chamber and a deployed position in which the cutting formation has broken through at least a portion of the breakable wall. The outer wall has a retaining formation which engages with the piston guide to releasably resist sliding of the hollow piston between the ventilation position and the sealed position and the deployed position. The hollow piston may have an outer wall, and said outer wall has an end within the chamber, facing the breakable wall, wherein the cutting end has a first edge having a cutting formation and a gap in said cutting formation.

A closure for dispensing one or more active agents into a container comprises a sealed or sealable chamber having a breakable wall and a hollow piston slidably mounted in a piston guide. Said hollow piston comprises an outer wall having an end in the chamber and at least one ventilation aperture. Said end has a cutting formation. Said hollow piston is slidable in the piston guide between a ventilation position in which the at least one ventilation aperture allows ventilation of the chamber and a sealed position in which the at least one ventilation aperture is sealed to prevent ventilation of the chamber and a deployed position in which the cutting formation has broken through at least a portion of the breakable wall. The outer wall has a retaining formation which engages with the piston guide to releasably resist sliding of the hollow piston between the ventilation position and the sealed position and the deployed position. The hollow piston may have an outer wall, and said outer wall has an end within the chamber, facing the breakable wall, wherein the cutting end has a first edge having a cutting formation and a gap in said cutting formation.

A locking top for blocking a stopper in the neck of a vessel comprises an outer body and a cage that is configured to fit into and lock axially in the outer body. The cage comprises an upper ring, a plurality n of branches connected to the upper ring, n/2 median bridges and n/2 lower bridges arranged in alternation on the periphery of the cage, each connecting together two adjacent branches. When the top is in an intermediate holding position in which the stopper is partially pushed into the neck, the lower bridges surround, at least in part, a collar of the neck; the median bridges located, in an axial direction, between the upper ring and the lower bridges are designed to form an open space between them and the collar.