Abstract: Systems and methods are provided for monitoring a gas sterilization environment. The sensor assembly includes a housing that defines an internal chamber and a sensing volume that is in fluid communication with the gas sterilization environment. A gas concentration sensor and at least one environmental sensor positioned within the internal chamber and operably coupled to the sensing volume. A sensor-assembly controller is configured to execute a set of operations that control the sensors to monitor the gas sterilization environment over a sterilization period of between six hours and 48 hours.

Abstract: A method for monitoring a gas sterilization process can be performed via a sterilization monitoring system that includes a system controller and a set of sensor assemblies that can be spaced apart within a sterilization environment. Each sensor assembly is configured to record a set of signals from a gas concentration sensor and an environmental sensor associated with the sterilization environment at a set of sampling intervals during a sterilization period. Each sensor assembly is associated with a sensor spatial coordinate corresponding to a position of the sensor assembly within the sterilization environment. The recorded set of signals is received from each sensor assembly. A process variable is determined for each sampling interval and for each sensor assembly based, at least in part, on the corresponding set of signals. A graphical representation of the process variable during the sterilization period is produced.

Abstract: Systems and methods are provided for monitoring a gas sterilization environment. The sensor assembly includes a housing that defines an internal chamber and a sensing volume that is in fluid communication with the gas sterilization environment. A gas concentration sensor and at least one environmental sensor positioned within the internal chamber and operably coupled to the sensing volume. A sensor-assembly controller is configured to execute a set of operations that control the sensors to monitor the gas sterilization environment over a sterilization period of between six hours and 48 hours.

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.