Method of assembling and filling a drug delivery device

Patent metadata

Field	Value
Publication number	US-2016199583-A1
Application number	US-201615047815-A
Country	US
Kind code	A1
Filing date	Feb 19, 2016
Priority date	Oct 14, 2011
Publication date	Jul 14, 2016
Grant date	—

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, including a granulocyte colony-stimulating factor (G-CSF). 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.

First claim

We claim:

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, the drug product comprising a granulocyte colony-stimulating factor (G-CSF); 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.

2 . The method of claim 1 , further comprising packaging the injector.

3 . The method of claim 1 , further comprising attaching a stopper to the container after filling the reservoir, thereby sealing the filler reservoir.

4 . 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.

5 . The method of claim 1 , wherein sterilizing the container comprises (a) using e-beam technology, (b) treatment with chlorine dioxide, (c) treatment with vapor phase hydrogen peroxide, and/or (d) treatment with a currently-known sterilization method.

6 . 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.

7 . 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.

8 . 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.

9 . 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.

10 . The method of claim 1 , further comprising swabbing a surface of the seal assembly prior to attaching the fluid delivery system.

Assignees

• Amgen Inc

Inventors

• Tan-Malecki Francisca
• Forster Ronald
• Nunn Scott M
• Tran Son C
• Moberg Sheldon
• Holt Mark D

Classifications

• B65B3/003

  Filling medical containers such as ampoules, vials, syringes or the like · CPC title

• A61M2005/247

  with fixed or steady piercing means, e.g. piercing under movement of ampoule · CPC title

• B65B55/10

  by liquids or gases · CPC title

• A61M2207/00

  Methods of manufacture, assembly or production · CPC title

• A61M5/14244

  adapted to be carried by the patient, e.g. portable on the body · CPC title