A device is for sterilization by electron beam irradiation of flexible bags, in particular flexible bags of the type that can contain solutions of human plasma proteins for therapeutic use. A sterilization method includes irradiating flexible bags by electron beam irradiation. An in-line method for filling flexible can use the sterilization device and method.

A measuring tool (1) for measuring a delivered dose of radiation emitted by at least one electron beam emitter (2a-b) in an irradiation area (2) used to sterilise packaging material to be later formed into a package is provided. The measuring tool (1) comprises: at least one transducer (3) configured to convert a characteristic of the delivered dose of radiation to another characteristic; a frame (5) configured to hold the at least one transducer (3) and insert the at least one transducer (3) into the irradiation area (2); and at least one connector (7) configured to allow signal transfer from the at least one transducer (3) to a read-out system (9) remote of the irradiation area (2). Use of said tool and a method for calibrating a radiation dose emitted by at least one electron beam emitter (2a-b) in an irradiation area (2) used to sterilise packaging material to be later formed into a package are also provided.

A measuring tool (1) for measuring a delivered dose of radiation emitted by at least one electron beam emitter (2a-b) in an irradiation area (2) used to sterilise packaging material to be later formed into a package is provided. The measuring tool (1) comprises: at least one transducer (3) configured to convert a characteristic of the delivered dose of radiation to another characteristic; a frame (5) configured to hold the at least one transducer (3) and insert the at least one transducer (3) into the irradiation area (2); and at least one connector (7) configured to allow signal transfer from the at least one transducer (3) to a read-out system (9) remote of the irradiation area (2). Use of said tool and a method for calibrating a radiation dose emitted by at least one electron beam emitter (2a-b) in an irradiation area (2) used to sterilise packaging material to be later formed into a package are also provided.

In combination a spouted pouch to be filled with a flowable product by a filling machine, a plug, and a cap. The interference fit plug is releasably mounted over the top end of the neck of the spout body and hermetically seals the product passage of the spout body. The plug is adapted to be removed by the filling machine and to be replaced by pressing the plug onto the neck after filling of the pouch. The plug removal, filling, and replacing of the plug are preferably performed in an aseptic environment. The cap is after the filling of the pouch and the replacing of the plug onto the neck. The capping is preferably performed by a capping machine in a non-aseptic environment.

In combination a spouted pouch to be filled with a flowable product by a filling machine, a plug, and a cap. The interference fit plug is releasably mounted over the top end of the neck of the spout body and hermetically seals the product passage of the spout body. The plug is adapted to be removed by the filling machine and to be replaced by pressing the plug onto the neck after filling of the pouch. The plug removal, filling, and replacing of the plug are preferably performed in an aseptic environment. The cap is after the filling of the pouch and the replacing of the plug onto the neck. The capping is preferably performed by a capping machine in a non-aseptic environment.

The present application is directed to a packaging bag including a transparent body having a first film composition; and a tearable or peelable header comprising a second film composition, wherein the first film composition and the second film composition are different, wherein a component of the first film composition is bonded to the second film composition.

The present application is directed to a packaging bag including a transparent body having a first film composition; and a tearable or peelable header comprising a second film composition, wherein the first film composition and the second film composition are different, wherein a component of the first film composition is bonded to the second film composition.

A shielding member for use in sterilizing drug container assemblies includes a housing. The housing includes a first shielding portion and a second shielding portion. The first shielding portion includes a first and second surfaces and a plurality of first bore portions extending between. The second shielding portion having a first and second surfaces and a plurality of second bore portions corresponding to and aligned with the plurality of first bore portions. The first and second bore portions cooperate to form a plurality of receptacles including a plurality of openings in the first surface of the first shielding portion of the housing. The receptacles are sized and configured to receive drug container assemblies, each comprising a container with a container contact region and a seal member disposed adjacent the container contact region to seal the contents of the container at a sealing interface, such that each drug container assembly is exposed out of the housing through one of the openings.

A shielding member for use in sterilizing drug container assemblies includes a housing. The housing includes a first shielding portion and a second shielding portion. The first shielding portion includes a first and second surfaces and a plurality of first bore portions extending between. The second shielding portion having a first and second surfaces and a plurality of second bore portions corresponding to and aligned with the plurality of first bore portions. The first and second bore portions cooperate to form a plurality of receptacles including a plurality of openings in the first surface of the first shielding portion of the housing. The receptacles are sized and configured to receive drug container assemblies, each comprising a container with a container contact region and a seal member disposed adjacent the container contact region to seal the contents of the container at a sealing interface, such that each drug container assembly is exposed out of the housing through one of the openings.

In one general aspect, a method for filling multiple containers with a pharmaceutical product is disclosed, which comprises decontaminating sealed nested materials in a transfer chamber, removing from the sealed nested materials one or both of a container nest holding the multiple containers and a closure nest holding multiple closures, transferring from the transfer chamber to a controlled environment enclosure the removed nest, aseptically filling the containers with the pharmaceutical product, and closing the containers with the multiple closures. The nests are configured to allow multiple closures and containers to be simultaneously aligned concentrically, and closed simultaneously. Spring-loaded retaining structures on the closure nest allow it to releasably retain multiple closures above the corresponding multiple containers. In some embodiments the spring-loaded features are monolithically integrated with the closure nest. The product may be lyophilized in partially sealed containers while the sealing closures are releasably retained by the closure nest.