A method of controlling a temperature of a biopharmaceutical product during blow-fill sealing, includes developing a model based on heat transfer mechanisms that incorporates the effects of the blow-fill sealing on the biopharmaceutical product, providing a parison to a blow-fill sealing machine for accepting the biopharmaceutical product during the blow-fill sealing, predicting a temperature of at least one the biopharmaceutical product, the parison, and a component of the blow-fill sealing machine at a stage in the blow-fill sealing, and adjusting a parameter of the blow-fill sealing machine to reduce damage to the biopharmaceutical product.

Fluid delivery devices and methods are described, where the device may comprise a piezoelectric actuator operatively coupled to an ampoule with fluid, under a preloading force. The ampoule may comprise a thin-walled thermoplastic package which includes one or more apertures positioned on the wall of the ampoule. The piezoelectric actuator may be configured to clamp at least partially around the circumference of the ampoule and apply oscillations to its wall. The oscillations, typically in ultrasonic frequency, produce cycles of acoustic pressure in the fluid, leading to ejection of the fluid droplets or streams from the apertures.

A drug-filled synthetic resin ampule 1m includes an ampule main body 2m and a drug stored in the ampule main body. The ampule main body includes a distal end portion, a hollow portion having a drug storing portion, and an annular breakable portion provided between a lower portion of the distal end portion and an upper portion of the hollow portion. The ampule main body includes no inner lateral surface protrusion on an inner lateral portion thereof which is located on a side toward the distal end portion with respect to the annular breakable portion. The distal end portion is configured such that an inner top surface of the distal end portion is located near a plane defined by the annular breakable portion and an inner surface of the distal end portion is a low-drug-retention surface.

An applicator assembly, a method of assembly of the applicator and a method of use of the applicator. The applicator assembly includes a reservoir body, a neck that extends from the reservoir body and includes an exposable opening at a distal end thereof and a shroud that extends from the distal end about the exposable opening and a cap that is integrally formed with and releasably fixed to the distal end of the neck, fully encompassing the opening in the neck and sealing the reservoir body.

A method for blow-fill-seal (BFS) packaging of a product and a BFS package. The method forms a BFS package with a twist-off top, container body and information panel in a main mold. The container is filled via a fill opening located distal to the twist-off top and the fill opening is sealed with a base portion. This provides a container having a twist-off top that is more reliably secured to the container body. A plurality of containers may be attached to a single information panel. The BFS packaging system may employ a quick change insert to reduce lost production time when changing products or lots. The package includes an information panel integrally formed with a plurality of twist-off tops, each of which is removably attached to a container body whereby each container body can be removed from the package without removing the remaining container bodies from the information panel.

The present disclosure is directed to a holder. The holder includes a main body, the main body including an interior surface and an exterior surface, a film that extends around at least a portion of the circumference of a first end of the main body and covers an opening of the first end of the main body, and a sheet including a first surface and a second surface, the second surface opposed to the first surface, the first surface operably attached to the seal at at least one point, the sheet configured to extend a distance along an interior of the main body from the first end towards a second end, wherein at least a portion of the first surface of the sheet contacts the interior surface of the main body, and wherein a liquid composition contacts a second surface of the sheet.

An applicator assembly, a method of assembly of the applicator and a method of use of the applicator. The applicator assembly includes a reservoir body, a neck that extends from the reservoir body and includes an exposable opening at a distal end thereof and a shroud that extends from the distal end about the exposable opening and a cap that is integrally formed with and releasably fixed to the distal end of the neck, fully encompassing the opening in the neck and sealing the reservoir body.

A drug-filled synthetic resin ampule has an ampule body capable of standing by itself and a drug accommodated inside the ampule body. The ampule body has a tip part positioned at an upper part thereof when the ampule body stands by itself, a hollow part having a drug accommodation portion, and a breakable part provided between a lower portion of the tip part and an upper portion of the hollow part. The tip part has pressing portions, for guiding a pressing force applied thereto respectively in a predetermined direction when an operation of breaking the breakable part is performed. The hollow part has a bottom surface part for allowing the ampule body to stand by itself. The bottom surface part has extension portions extended in predetermined directions (X-direction, Y-direction) in which the pressing force applied to the pressing portions respectively is guided when the operation of pressing the pressing portion is performed to break the breakable part.

A sealing arrangement is for a container (1) and/or container part, such as a closure cap placed onto the container (1). The interior of the container (1) is used to accommodate a medium, particularly a fluid bottled in a sterile manner, which can be removed from the container (1) by a removal device such as a syringe needle. The removal device penetrates sealing material (9) connected to the container. The sealing material (9) is fixedly connected to the outside (7) of the container (1) and/or container parts facing the environment by a fused and/or adhesively bonded connection.

Methods are described for packaging a foldable container including covering a multi-monodose container in an expanded configuration with a hermetically-sealable overwrap, the multi-monodose container including a row of interconnected monodose pharmaceutical vials, each of the monodose pharmaceutical vials enclosing at least one pharmaceutical agent, the interconnected monodose pharmaceutical vials connected to one another by one or more articulating joints sufficiently flexible to form a folded configuration of the multi-monodose container; exerting a force on at least one of the monodose pharmaceutical vials; bending the one or more articulating joints to form the folded configuration of the multi-monodose container in response to the exerted force; and sealing the hermetically-sealable overwrap to form a hermetic seal around the folded configuration of the multi-monodose container.