Injector and method of assembly
An injector may include a container having a wall with an interior surface defining a closed sterile reservoir filled with a drug product. The injector may also include a fluid delivery system comprising a sterile container needle that is in fluid communication with the container in a delivery state, but may or may not be in fluid communication with the container in a storage state. Further, the injector 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:
filling a sterile reservoir of a container with a drug product under sterile conditions, the reservoir defined by an interior surface of a wall of the container and a seal assembly;
attaching a sterile fluid delivery system to the container under sterile conditions in a first assembly space, the fluid delivery system including a container needle having a point, an injection needle, and a flexible conduit connecting the container needle and the injection needle, the container needle and the injection needle being separate needles, the fluid delivery system in fluid communication with the reservoir via the container needle in a delivery state and either in fluid communication or not in fluid communication with the reservoir in a storage state, the sterile fluid delivery system being attached to the container in the first assembly space such that the point of the container needle is disposed adjacent to or within the seal assembly and the container needle is not in fluid communication with the reservoir; and
after attaching the sterile fluid delivery system to the container under sterile conditions, assembling the fluid delivery system with a remainder of the injector in a second assembly space, wherein the first assembly space has a higher level of cleanliness than the second assembly space.
2. The method of claim 1 , wherein assembling the fluid delivery system with the remainder of the injector comprises attaching the fluid delivery system to an actuator, the actuator adapted to change the state of the fluid delivery system from the storage state to the delivery state.
3. The method of claim 1 , wherein an interior surface of the seal assembly and the interior surface of the wall of the container define the reservoir, and the container needle has the point disposed only partially through the seal assembly in the storage state and disposed through the interior surface of the seal assembly into the reservoir in the delivery state.
4. The method of claim 3 , wherein the wall of the container defines a bore having a first end and a second end, an opening is formed in the wall of the container at the first end of the bore, the seal assembly is disposed across the opening and fixedly attached to the wall of the container, and the container includes a stopper that is disposed within the second end of the bore and is moveable along the bore.
5. The method of claim 3 , wherein the seal assembly comprises a first wall with an interior surface that defines the interior surface of the seal assembly and a second wall disposed exterior to the first wall to define an enclosed space between the first wall and the second wall, and the point of the container needle is disposed through the second wall into the enclosed space in the storage state.
6. The method of claim 5 , wherein the wall of the container defines a bore having a first end and a second end, an opening is formed in the wall of the container at the first end of the bore, the first wall of the seal assembly is disposed across the opening and fixedly attached to the wall of the container, and the container includes a stopper that is disposed within a second end of the bore and is moveable along the bore.
7. The method of claim 1 , wherein prior to assembly with the remainder of the injector in the second assembly space, the container needle and the injection needle having a straight configuration, and wherein after assembly with the remainder of the injector in the second assembly space, the container needle and the injection needle have a non-straight configuration.
8. The method of claim 1 , comprising, prior to assembling the fluid delivery system with the remainder of the injector, covering the point of the injection needle with a shield to inhibit contamination of an internal fluid flow path of the fluid delivery system.
9. The method of claim 1 , wherein:
the seal assembly includes a first wall and a second wall,
the reservoir is defined at least by the interior surface of the wall of the container and a first surface of the first wall of the seal assembly,
an enclosed clean space is defined at least by a second surface of the first wall of the seal assembly, the interior surface of the wall of the container, and the second wall of the seal assembly, and
the container needle has the point disposed through the second wall of the seal assembly into the enclosed space in the storage state and disposed through the first wall of the seal assembly into the reservoir in the delivery state.
10. 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 an interior surface of a wall of the container and a seal assembly and attached to a sterile fluid delivery system under sterile conditions in a first assembly space prior to filling, the fluid delivery system including a container needle having a point, an injection needle, and a flexible conduit connecting the container needle and the injection needle, the container needle and the injection needle being separate needles, the fluid delivery system in fluid communication with the reservoir via the container needle in a delivery state and either in fluid communication or not in fluid communication with the reservoir in a storage state, the sterile fluid delivery system being attached to the container in the first assembly space such that the point of the container needle is disposed adjacent to or within the seal assembly and the container needle is not in fluid communication with the reservoir; and
after filling the sterile reservoir of the container with the drug product under sterile conditions, assembling the fluid delivery system with a remainder of the injector in a second assembly space, wherein the first assembly space has a higher level of cleanliness than the second assembly space.
11. The method of claim 10 , wherein assembling the fluid delivery system with the remainder of the injector comprises attaching the fluid delivery system to an actuator, the actuator adapted to change the state of the fluid delivery system from the storage state to the delivery state.
12. The method of claim 10 , wherein an interior surface of the seal assembly and the interior surface of the wall of the container define the reservoir, and the container needle has the point disposed only partially through the seal assembly in the storage state and disposed through the interior surface of the seal assembly into the reservoir in the delivery state.
13. The method of claim 12 , wherein the wall of the container defines a bore having a first end and a second end, an opening is formed in the wall of the container at the first end of the bore, the seal assembly is disposed across the opening and fixedly attached to the wall of the container, and the container includes a stopper that is disposed within the second end of the bore and is moveable along the bore.
14. The method of claim 12 , wherein the seal assembly comprises a first wall with an interior surface that defines the interior surface of the seal assembly and a second wall disposed exterior to the first wall to define an enclosed space between the first wall and the second wall, and the point of the container needle is disposed through the second wall into the enclosed space in the storage state.
15. The method of claim 14 , wherein the wall of the container defines a bore having a first end and a second end, an opening is formed in the wall of the container at the first end of the bore, the first wall of the seal assembly is disposed across the opening and fixedly attached to the wall of the container, and the container includes a stopper that is disposed within a second end of the bore and is moveable along the bore.
16. The method of claim 10 , wherein prior to assembly with the remainder of the injector in the second assembly space, the container needle and the injection needle having a straight configuration, and wherein after assembly with the remainder of the injector in the second assembly space, the container needle and the injection needle have a non-straight configuration.
17. The method of claim 10 , comprising, prior to assembling the fluid delivery system with the remainder of the injector, covering the point of the injection needle with a shield to inhibit contamination of an internal fluid flow path of the fluid delivery system.
18. The method of claim 10 , wherein:
the seal assembly includes a first wall and a second wall,
the reservoir is defined at least by the interior surface of the wall of the container and a first surface of the first wall of the seal assembly,
an enclosed clean space is defined at least by a second surface of the first wall of the seal assembly, the interior surface of the wall of the container, and the second wall of the seal assembly, and
the container needle has the point disposed through the second wall of the seal assembly into the enclosed space in the storage state and disposed through the first wall of the seal assembly into the reservoir in the delivery state.
19. A method of assembling an injector, the method comprising:
attaching a fluid delivery system to a container in a first assembly space, the container having a reservoir defined by an interior surface of a wall of the container and a seal assembly, the fluid delivery system including a container needle having a point, an injection needle, and a flexible conduit connecting the container needle and the injection needle, the container needle and the injection needle being separate needles, the fluid delivery system in fluid communication with the reservoir via the container needle in a delivery state and either in fluid communication or not in fluid communication with the reservoir in a storage state, the sterile fluid delivery system being attached to the container in the first assembly space such that the point of the container needle is disposed adjacent to or within the seal assembly and the container needle is not in fluid communication with the reservoir; and
after attaching the sterile fluid delivery system to the container, assembling the fluid delivery system with a remainder of the injector in a second assembly space, wherein the first assembly space has a higher level of cleanliness than the second assembly space.
20. The method of claim 19 , the first assembly space being operated under sterile conditions.