Injector and method of assembly
An injector ( 100 ) may include a container ( 102 ) having a wall ( 110 ) with an interior surface ( 112 ) and a seal assembly ( 140 ) with an interior surface ( 142 ), the interior surfaces ( 110 ) of the wall ( 110 ) and the seal assembly ( 140 ) defining a closed sterile reservoir ( 150 ) filled with a drug product. The injector ( 100 ) may also include a fluid delivery system comprising a clean, unsheathed, rigid container needle ( 180 ) having a point ( 182 ) disposed only partially through the seal assembly ( 140 ) in a storage state, and disposed through the interior surface ( 142 ) of the seal assembly ( 140 ) into the sterile reservoir ( 150 ) in a delivery state. Further, the injection may include an actuator ( 106 ) that is adapted to move the container needle from the storage state to the delivery state.
1. An injector comprising:
a container including a wall with a first interior surface defining a bore and an opening in fluid communication with a first end of the bore;
a stopper disposed in a second end of the bore and movable along the bore;
a seal assembly comprising
a first septum disposed across the opening and fixedly attached to the wall of the container, the first septum having a second interior surface, the first and second interior surfaces defining a closed sterile reservoir filled with a drug product, and
a second septum disposed across the opening and fixedly attached to the wall of the container, the second septum being spaced from the first septum to define an enclosed clean space between the first septum and the second septum;
a fluid delivery system comprising a clean, unsheathed, rigid container needle having a point disposed through the second septum into the clean space in a storage state, and disposed through the first septum into the sterile reservoir in a delivery state; and
an actuator that is adapted to move the container needle from the storage state to the delivery state.
2. The injector of claim 1 , wherein the wall of the container comprises a rigid wall.
3. The injector of claim 1 , wherein the wall of the container comprises a flexible wall.
4. The injector of claim 1 , wherein the first septum consists of a flexible unitary wall, the flexible unitary wall defining the second interior surface.
5. The injector of claim 1 , wherein the fluid delivery system comprises clean flexible tubing connected at a first end to the rigid container needle and a second end to a clean rigid injection needle received within a clean cover that closes off the clean rigid injection needle.
6. The injector of claim 1 , wherein the actuator is adapted to move the container needle repeatedly between the storage state and the delivery state.
7. The injector of claim 1 , wherein the actuator is adapted to delay movement of the container needle from the storage state to the delivery state after an input is received.
8. The injector of claim 1 , further comprising a mechanical, electro-mechanical, or electrical input device coupled to the actuator.
9. The injector of claim 1 , wherein the drug product comprises a volume of an erythropoiesis stimulating agent.
10. The injector of claim 1 , wherein the drug product comprises a volume of a granulocyte colony-stimulating factor.
11. The injector of claim 1 , wherein the drug product comprises a volume of a TNF blocker.
12. The injector of claim 1 , wherein the drug product comprises a volume of a pegylated granulocyte colony-stimulating factor.
13. The injector of claim 1 , wherein the drug product comprises a volume of interleukin-receptor specific antibody.
14. The injector of claim 1 , wherein the drug product comprises a volume of IGF-receptor specific antibody.
15. The injector of claim 1 , wherein the drug product comprises a volume of TGF-specific antibody.
16. The injector of claim 1 , wherein the drug product comprises a volume of PCSK9-specific antibody.
17. A method of assembling an injector, the method comprising:
filling a sterile reservoir of a container with a drug product under sterile conditions, the reservoir defined by a first interior surface of a wall of the container and a second interior surface of a first septum, the first septum being spaced from a second septum such that an enclosed clean space is defined therebetween, the first and second septums each being disposed across an opening in the container and fixedly attached to the wall of the container;
disposing a stopper within a bore of the container, the stopper being movable along the bore;
inserting a point of a clean, unsheathed, rigid container needle through the second septum into the clean space under clean room conditions subsequent to filling the sterile reservoir to define a storage state; and
attaching the container needle to an actuator under clean room conditions, the actuator adapted to move the container needle from the storage state to a delivery state wherein the container needle is disposed through the first septum into the sterile reservoir.
18. The method according to claim 17 , wherein the wall of the container is a rigid wall.
19. The method according to claim 17 , wherein the wall of the container is a flexible wall.