IP Library Granted Patent US 10,973,939
Granted Patent B2
US 10,973,939 · App. 16/053,231 · Granted Apr 13, 2021

System and method for aseptic packaging of a drug delivery device components

Inventor: Ian McLaughlin (Boxboro, MA)
Assignee: INSULET CORPORATION
A61L2/206A61L2/08A61L2/26A61M5/001A61M5/002A61M5/008A61M5/14248A61M5/288A61M39/18B65B3/003B65B55/04B65B55/10A61L2202/121A61L2202/122A61L2202/23A61L2202/24
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Quick Facts
Patent No.
US 10,973,939
App. No.
16/053,231
Granted
Apr 13, 2021
Kind
B2
Abstract

A method for sterilizing a drug delivery device may comprise disposing a liquid drug container, a needle conduit and a cap in a sterilization enclosure so that a mouth portion of the liquid drug container is registered with, and spaced apart from, a circumferential lip of the cap; disposing a cover over the liquid drug container, the needle conduit, and the cap, sealing the sterilization enclosure; subjecting the interior of the sterilization enclosure to a sterilization process in which the liquid drug container, the needle conduit, and the cap are exposed to the sterilization fluid and are sterilized; and applying a downward force to the liquid drug container to move the mouth portion into engagement with the circumferential lip of the cap and to snap the cap onto the liquid drug container to seal the cap and needle conduit to the liquid drug container in an assembled configuration.

Claims (36)

1. A method for sterilizing a drug delivery device comprising:

disposing a liquid drug container, a cap, and a needle conduit, wherein the needle conduit is separate from the liquid drug container, coupled to the cap and extending from the cap in a sterilization enclosure so that a mouth portion of the liquid drug container is registered with, and spaced apart from, a circumferential lip of the cap;

disposing a cover over the liquid drug container, the needle conduit, and the cap, sealing the sterilization enclosure; and

subjecting an interior of the sterilization enclosure to a sterilization process in which the liquid drug container, the needle conduit, and the cap are exposed to a sterilization fluid.

2. The method of claim 1 , wherein the subjecting the interior of the sterilization enclosure to the sterilization process further comprises:

sterilizing respective interior portions of the liquid drug container, the needle conduit, and the cap.

3. The method of claim 1 , further comprising:

applying a downward force to the liquid drug container to move the mouth portion into engagement with the circumferential lip of the cap and to snap the cap onto the liquid drug container to seal the cap and the needle conduit to the liquid drug container in an assembled configuration.

4. The method of claim 3 , wherein the applying the downward force comprises applying the downward force to a cover disposed over the enclosure.

5. The method of claim 3 , wherein applying the downward force moves the needle conduit through a cap seal disposed in the cap, without the needle conduit being moved through a container seal disposed in the container.

6. The method of claim 3 , further comprising:

unsealing the sterilization enclosure; and

removing a fluid assembly comprising the liquid drug container, the needle conduit, and the cap.

7. The method of claim 6 , further comprising:

supplying a liquid drug to the liquid drug container.

8. The method of claim 7 , further comprising:

disposing a plunger into the liquid drug container, sealing the liquid drug within the liquid container.

9. The method of claim 1 , further comprising:

disposing a first tray into the enclosure below the cap and the liquid drug container; and

disposing a second tray into the enclosure configured to hold the liquid drug container.

10. A method for sterilizing a drug delivery device comprising:

disposing a liquid drug container, a needle conduit, and a cap in a sterilization enclosure so that a mouth portion of the liquid drug container is registered with, and spaced apart from, a circumferential lip of the cap, wherein the cap:

is coupled to the needle conduit, which extends from the cap, and is separate from the liquid drug container;

disposing a cover over the liquid drug container, the needle conduit, and the cap, sealing the sterilization enclosure;

subjecting an interior of the sterilization enclosure to a sterilization process in which the liquid drug container, the needle conduit, and the cap are exposed to a sterilization fluid; and

applying a downward force to the liquid drug container to move the needle conduit through a cap seal disposed in the cap, without the needle conduit being moved through a container seal disposed in the liquid drug container.

11. The method of claim 10 , further comprising:

disposing a first tray into the enclosure below the cap and the liquid drug container; and

disposing a second tray into the enclosure configured to hold the liquid drug container.

12. The method of claim 10 , further comprising:

unsealing the sterilization enclosure; and

removing a fluid assembly comprising the liquid drug container, the needle conduit, and the cap.

13. The method of claim 12 , further comprising:

supplying a liquid drug to the liquid drug container.

14. The method of claim 13 , further comprising:

disposing a plunger into the liquid drug container, sealing the liquid drug within the liquid drug container.

Assignments (2)
SECURITY INTEREST Recorded May 4, 2021
From: INSULET CORPORATION
To: MORGAN STANLEY SENIOR FUNDING, INC., AS COLLATERAL AGENT
Reel/Frame 056135/0974 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 21, 2018
From: MCLAUGHLIN, IAN
To: INSULET CORPORATION
Reel/Frame 046653/0427 →