METHOD OF ASSEMBLING AND FILLING A DRUG DELIVERY DEVICE

摘要

An injector may include a container having a wall with an interior surface and a seal assembly with an interior surface, the interior surfaces of the wall and the seal assembly defining a closed sterile reservoir filled with a drug product. The injector may also include a fluid delivery system comprising a clean, unsheathed, rigid container needle having a point disposed only partially through the seal assembly in a storage state, and disposed through the interior surface of the seal assembly into the sterile reservoir in a delivery state. Further, the injection may include an actuator that is adapted to move the container needle from the storage state to the delivery state.

主权项

1. A method of assembling an injector, the method comprising:
providing a container having a wall defining an interior surface and a seal assembly having an interior surface, the wall and seal assembly defining a reservoir; providing a fluid delivery system physically separate from the container, the fluid delivery system comprising a container needle having a point; sterilizing the container including the reservoir and fluid delivery system while the container and the fluid delivery system are separate from each other; filling the sterile reservoir of the container with a volume of a drug product under sterile conditions; attaching the fluid delivery system to the filled container under clean room conditions such that the point of the container needle is disposed adjacent to the seal assembly to define a storage state; attaching the container needle to an actuator, the actuator adapted to move the container needle from the storage state to a delivery state wherein the container needle is disposed through the seal assembly, into the sterile reservoir, and in fluid communication with the drug product for delivery to a patient.