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 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.

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.

A stopper for a container for use in freeze-drying processes, and an assembly of a stopper and a container are provided. The stopper has an insertion section configured for insertion into the container. The insertion section has a sealing section for closing the container in a fluid-tight manner in a sealing position of the stopper and a contact section which adjoins the sealing section axially from a top surface in the direction of a bottom surface, for holding the stopper in a drying position of the stopper. The contact section has at least one passage opening for a gas exchange between an interior of the container and the surroundings of the container. The stopper has a sealing body and a main body connected together, wherein the main body consists of a material which has a higher degree of hardness than a material which makes up the sealing body. Regions of a lateral surface of the insertion section in contact with an inner surface of a container wall in the drying position and/or the sealing position, are formed by outer surfaces of the sealing body in the region of the contact section, wherein the main body is configured within the sealing body in the region of the contact section.

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 a peelable region including a peelable seal encompassing a boundary between the non-breathable section and the breathable section. The method includes inputting a fluid into a non-breathable section of the container, freezing the fluid, applying, in a lyophilization chamber, vacuum pressure, opening the peelable seal using a pressure differential, applying heat energy, sublimating the fluid and creating a temporary occlusion in a peelable region of the container.

A closure stopper for pharmaceutical applications has a sealing flange seating in a sealing manner on an end face of the container's closure mouth. The sealing flange has a lower sealing surface and a boundary plane contacting an area protruding farthest downwardly and extending perpendicularly to the closure stopper's center axis. An engagement portion extending below the sealing flange is formed with a smaller radial extent than the sealing flange. Preferably a handling portion extends above the sealing flange. A circumferential sealing projection also is formed on the engagement portion and protrudes by a radial dimension with respect to an axial portion of the engagement portion initially adjoining the sealing flange from underneath and having a portion-radius. The sealing projection, at least with respect to its base portion, vertically overlaps a set-back region formed on the sealing flange and set back with respect to the contact plane.

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 vial closure assembly for sealing a container includes a ring, a cap, a shell, and an optional cover. The ring has a first top wall defining a first through-opening and a skirt extending downwardly from the first top wall that includes a plurality of locking tabs. The cover includes a second top wall defining a second through-opening, a sidewall extending downwardly from the second top wall, and an interior cavity defined by the second top wall and the sidewall. The cap includes a plurality of tabs configured to engage the first or second top wall. The shell includes a body having an inwardly radially extending upper and lower lip. The upper lip includes at least one rail for sliding contact with a top surface of either the first or second top wall.

Disclosed is a process for the treatment or processing of containers that serve for storing, or contain, substances for medical, pharmaceutical or cosmetic applications, wherein the containers are conveyed automatically, by a conveyor, past at least one processing station or pass it for the treatment or processing. In the process, a plurality of containers is conveyed by the conveyor while being held by a carrier in a regular arrangement. The containers held on the carrier are raised to a raised position for the treatment or processing at or in the respective processing station and are lowered after the treatment or processing, to be held again on the carrier in the regular arrangement. The carrier is configured such that the containers can be held on the carrier during the entire process. A negative pressure acts on the bottoms of the containers in order to lower them.

Disclosed is a process for the treatment or processing of containers that serve for storing, or contain, substances for medical, pharmaceutical or cosmetic applications, wherein the containers are conveyed automatically, by a conveyor, past at least one processing station or pass it for the treatment or processing. In the process, a plurality of containers is conveyed by the conveyor while being held by a carrier in a regular arrangement. The containers held on the carrier are raised to a raised position for the treatment or processing at or in the respective processing station and are lowered after the treatment or processing, to be held again on the carrier in the regular arrangement. The carrier is configured such that the containers can be held on the carrier during the entire process. A negative pressure acts on the bottoms of the containers in order to lower them.