Abstract: Provided herein is a fluid pathway connection assembly, e.g., for connecting a fluid flowpath within a drug delivery device for delivery of a medicament to a target site. The fluid pathway connection assembly comprises a hollow needle piercing member, a sleeve fixedly engaged with the piercing member and a pierceable seal configured to sealingly engage the piercing member or the sleeve. Upon, sealing engagement, the piercing member or the sleeve and the pierceable seal form a volume within which a portion of the piercing member is disposed. The fluid pathway connection assembly is activated by relative movement between the piercing member and the pierceable seal and activation causes the piercing member to pierce the pierceable seal, thereby establishing a fluid flowpath through the pierceable seal. Upon incorporation of the assembly into a sealed fluid flowpath, the volume is isolated from the environment and maintains the sterile condition of the portion of the piercing member disposed therein.

Abstract: A treatment apparatus for a mixing device having a concentric barrel configuration. The treatment apparatus includes a manifold including an input end and an output end. The treatment apparatus also includes a conduit body having a manifold end and a nozzle end. The manifold end is connected to the output end of the manifold, and the conduit body includes at least one nozzle at the nozzle end of the conduit body opposite the manifold. At least one fluid pathway is formed between the input end of the manifold, the conduit body, and the at least one nozzle.

Abstract: Apparatus and methods for establishing sterile or disinfected/decontaminated connections or conduits between separate fluid path sub-assemblies. Each section of the fluid path to be connected include one or multiple heatable or heating surfaces, and a sterile volume or chamber defined by at least one of the heatable or heating surfaces. Prior to establishing a sterile access or connection between separate sections of a fluid path, the heatable or heating surfaces are sterilized or disinfected/decontaminated by means of heat. Such means may include ohmic resistive heating, inductive heating, and/or self-heating through an exothermic reaction. All surfaces establishing the connection or conduit are therefore sterile or disinfected/decontaminated, and a sterile connection or conduit is established.

Abstract: A fill-finish cartridge includes a carrier, a fluid pathway connection, a needle insertion mechanism, and a drug container. The cartridges enable drug containers to be filled with pharmaceutical treatments using standard filling equipment and process systems, while maintaining the sterility and container integrity of the fluid pathway. The fill-finish cartridges of the present invention can be nested or removably housed in fill-finish trays for batch filling in standard operating processes. As such, the adaptable fillfinish cartridges of the present invention may be flexibly inserted, attached, mounted, or otherwise removably positioned in fill-finish trays. These embodiments, accordingly, may provide novel and cost-efficient assemblies and cartridges which are readily integrated into drug filling processes. Methods of assembly, manufacture, and use are also provided.

Abstract: Provided herein is a fluid pathway connection assembly, e.g., for connecting a fluid flowpath within a drug delivery device for delivery of a medicament to a target site. The fluid pathway connection assembly comprises a hollow needle piercing member, a sleeve fixedly engaged with the piercing member and a pierceable seal configured to sealingly engage the piercing member or the sleeve. Upon, sealing engagement, the piercing member or the sleeve and the pierceable seal form a volume within which a portion of the piercing member is disposed. The fluid pathway connection assembly is activated by relative movement between the piercing member and the pierceable seal and activation causes the piercing member to pierce the pierceable seal, thereby establishing a fluid flowpath through the pierceable seal. Upon incorporation of the assembly into a sealed fluid flowpath, the volume is isolated from the environment and maintains the sterile condition of the portion of the piercing member disposed therein.

Abstract: A treatment apparatus for a mixing device having a concentric barrel configuration. The treatment apparatus includes a manifold including an input end and an output end. The treatment apparatus also includes a conduit body having a manifold end and a nozzle end. The manifold end is connected to the output end of the manifold, and the conduit body includes at least one nozzle at the nozzle end of the conduit body opposite the manifold.