Abstract: A formed, filled, and sealed flexible container is provided with an attached port assembly. The container is formed from film folded to define opposing sidewalls which are sealed to define a chamber for sterile fluid. A hollow, tubular port member is provided with a V-shaped saddle and is sealed to the bottom of the container. The film at the bottom of the container is received in the saddle. A unique shoulder is defined by the tubular port member. The film is sealed to the shoulder and to the saddle of the port member. A hollow penetrator element is slidably disposed within the port member and is movable between a retracted position and an advanced position to puncture the film whereby fluid can flow out of the container. Internal formations are provided to guide and to limit the movement of the penetrator element. The container film may be provided with a crease along the bottom of the container.

Abstract: A unique selectively openable seal line made between two sheets of flexible thermoplastic material is disclosed, the seal line being exceptionally resistant to unintentional opening forces but being easy to open upon the application of a specific force. The seal line may be employed in various containers, including a two chamber container for the separate storage and selective mixing of two medical substances. The container includes two sheets forming the exterior of the container and an inner, diaphgram sheet between the outer sheets. The selectively openable seal line is disposed between one of the outer sheets and the diaphragm sheet. Preferably a permanent line of securement is also included, between the other exterior sheet and the inner diaphragm sheet, extending substantially parallel to and coextensive with the openable seal line.

Abstract: The present invention provides a method and apparatus for attaching fitments to filled flexible containers. A series of interconnected filled flexible containers are conveyed between a pair of belt conveyors which limit lateral movement of the containers. A third conveyor urges fitments against the bottoms of the containers and the fitments are sealed to the containers.

Abstract: A fitment for attachment to a container having an integral body constructed from a thermoplastic foam and having an integral skin outer surface and a cellular core. The body has a top and bottom surface and includes at least one resealable port.

Abstract: A unique container is disclosed which has at least three chambers for the separate storage and selective mixing of at least two components. The container includes two outer flexible sheets and an inner, diaphragm sheet, all sealed about their peripheries in the preferred embodiment. Multiple breakable lines of securement are formed between one of the outer sheets and the inner, diaphragm sheet. Multiple permanent lines of securement are formed between the inner diaphragm sheet and the other outer sheet, extending substantially parallel to and substantially the length of the respective breakable lines of securement. Such a container structure defines two chambers which have no common boundary and an intermediate chamber. In the preferred embodiment of the invention, the intermediate chamber does not store any substance; rather, it serves as a buffer or barrier chamber and also acts as a test for seal integrity. In another embodiment of the invention, the intermediate chamber holds a third component for mixing.

Abstract: A two chamber container for the separate storage and selective mixing of two components is disclosed. The container includes two outer flexible thermoplastic sheets and an inner, diaphragm sheet. A unique seal line structure is formed between one of the outer sheets and the inner, diaphragm sheet. A peelable barrier structure such as a sheet of aluminum foil with an inner layer of adhesive is secured to the exterior surface of the exterior wall of the container at that portion of the other of the outer sheets which defines one of the chambers of the container. The peelable barrier sheet permits the use of lower cost materials for the remainder of the container structure while both (1) permitting visual inspection of the chamber contents and (2) providing high moisture, gas and light barrier properties.

Abstract: Provided is a process for preparing an aseptic container for separately storing a sterilized powdered component and a sterilized liquid component under clean conditions. The container includes two sealed chambers having a frangible, sterilized connection therebetween, one said chamber containing the liquid component, and the other said chamber including a sealed vial containing a powdered component. The vial has an outer surface that is aseptic throughout its entire surface area, and the frangible connection provides a sterile pathway, when desired, between the interior of the vial and the interior of the liquid-containing chamber.