Method of assembling and filling a drug delivery device
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.
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 in a first assembly space;
attaching the fluid delivery system to the filled container under clean room conditions in a second assembly space such that the point of the container needle is disposed adjacent to the seal assembly to define a storage state, wherein the second assembly space has a lower level of cleanliness than the first assembly space;
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.
2. The method of claim 1 , wherein filling the sterile reservoir with a volume of a drug product comprises filling the sterile reservoir with a volume of a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9)—specific antibody.
3. The method of claim 1 , further comprising packaging the injector.
4. The method of claim 1 , further comprising attaching a stopper to the container after filling the reservoir, thereby sealing the filler reservoir.
5. The method of claim 4 , wherein attaching the stopper to the container includes attaching the stopper to the container in a space operated as an aseptic Class 100 clean room.
6. The method of claim 1 , wherein attaching the fluid delivery system to the filled container comprises attaching the container needle such that the container needle does not penetrate a wall of the seal assembly.
7. The method of claim 1 , wherein sterilizing the container comprises (a) using e-beam technology, (b) treatment with chlorine dioxide, and/or (c) treatment with vapor phase hydrogen peroxide.
8. The method of claim 1 , wherein filling the sterile reservoir of the container includes filling the sterile reservoir in a space operated as an aseptic Class 100 clean room.
9. The method of claim 1 , prior to attaching the fluid delivery system to the container, inspecting the filled container in a space operated as an aseptic Class 10,000 clean room.
10. The method of claim 1 , prior to attaching the fluid delivery system to the container, moving the filled container to an assembly space operated as an aseptic Class 10,000 clean room.
11. The method of claim 1 , further comprising swabbing a surface of the seal assembly prior to attaching the fluid delivery system.
12. The method of claim 1 , wherein sterilizing the container comprises a radiation sterilization treatment and/or a gaseous sterilization treatment.