Method of assembling and filling a drug delivery device

• US 10,314,976 B2
• Filed: 02/10/2016
• Issued: 06/11/2019
• Est. Priority Date: 10/14/2011
• Status: Active Grant

• Current Assignee: Amgen Inc.
• Original Assignee: Amgen Inc.
• Inventors: Tan-Malecki, Francisca, Forster, Ronald, Nunn, Scott M., Holt, Mark D., Tran, Son C., Moberg, Sheldon
• Primary Examiner(s): Gerrity, Stephen F.
• Application Number:
  US15/040,335
• Publication Number:
  US 20160199582A1
• Time in Patent Office: 1,217 Days
• Field of Search: 53426, 53471
• CPC Class Codes: A61M 2005/247 with fixed or steady piercing means, e.g. piercing under movement of ampoule
• CPC Class Codes: A61M 2005/2474 with movable piercing means, e.g. ampoule remains fixed or steady
• CPC Class Codes: A61M 2005/3114 Filling or refilling
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/148 flexible, e.g. independent bagsA61M5/155 takes precedence
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/162 Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14
• CPC Class Codes: A61M 5/1626 Needle protectors therefor in combination with syringes A61M5/3202; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/2455 with sealing means to be broken or opened
• CPC Class Codes: A61M 5/2466 by piercing without internal pressure increase A61M5/2429 takes precedence
• CPC Class Codes: A61M 5/31 Details
• CPC Class Codes: B65B 3/003 Filling medical containers such as ampoules, vials, syringes or the like
• CPC Class Codes: B65B 55/08 by irradiation
• CPC Class Codes: B65B 55/10 by liquids or gases
• CPC Class Codes: B65B 7/2821 applying plugs or threadless stoppers for bottles or jars B67B1/04

Abstract

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.

Claims

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.