Systems and approaches for sterilizing a drug delivery device

Patent metadata

Field	Value
Publication number	US-11826480-B2
Application number	US-201816179399-A
Country	US
Kind code	B2
Filing date	Nov 2, 2018
Priority date	Nov 3, 2017
Publication date	Nov 28, 2023
Grant date	Nov 28, 2023

Abstract

A drug delivery sterilization system includes a housing defining at least one receptacle, a container assembly having first and second ends, an elongated portion extending therebetween, and an electron beam or x-ray generator disposed near the housing. The container assembly includes a container having a container contact region at the second end and an inner volume to contain a medicament, a seal member having a seal member contact region to form a sealing interface with the container contact region, and a coupling device adapted to sealingly couple the seal member to the container. The container assembly is at least partially disposed in the receptacle such that the second end of the container is exposed through the housing. The electron beam or x-ray generator generates a sterilizing beam that penetrates the seal member to sterilize the sealing interface.

First claim

What is claimed is:

1. A drug delivery sterilization system comprising:
a housing defining at least one receptacle, the at least one receptacle is defined by at least one blocking region;
a container assembly having a first end, a second end, an elongated portion extending between the first end and the second end, the container assembly including:
a container having a container contact region at the second end of the container assembly and an inner volume adapted to contain a medicament to be administered to a user;
a seal member having a seal member contact region adapted to be disposed adjacent to the container contact region to form a sealing interface; and
a coupling device adapted to sealingly couple the seal member to the container;
wherein the container assembly is at least partially disposed in the receptacle of the housing such that the second end of the container assembly is exposed through the housing; and
an electron beam or x-ray generator disposed near the housing, wherein the electron beam or x-ray generator is adapted to generate a sterilizing beam that penetrates the seal member to sterilize the sealing interface between the seal member contact region and the container contact region;
wherein the at least one blocking region is positioned between the sterilizing beam and at least a portion of the container assembly to restrict the sterilizing beam from contacting the elongated portion of the container or the inner volume of the container.

2. The drug delivery sterilization system of claim 1 , wherein the at least one blocking region comprises a first blocking region adjacent the second end of the container assembly and a second blocking region adjacent the first end of the container assembly, wherein the first blocking region defines a first diameter of the at least one receptacle and the second blocking region defines a second diameter of the at least one receptacle, wherein the first diameter is less than the second diameter.

3. The drug delivery sterilization system of claim 2 , wherein the second blocking region is configured to restrict the sterilization beam from progressing in a direction that is non-orthogonal to the elongated portion of the container.

4. The drug delivery sterilization system of claim 1 , wherein the second end of the container includes a shoulder region, wherein the housing forms a ledge adjacent to the shoulder region to restrict progression of the sterilization beam.

5. The drug delivery sterilization system of claim 1 , wherein the container is constructed from at least one of a glass or a polymeric material.

6. The drug delivery sterilization system of claim 1 , wherein the coupling device comprises a crimp ring adapted to compress the seal member against the container.

7. The drug delivery sterilization system of claim 1 , wherein the seal member contact region includes an angled portion that engages the container contact region.

8. The drug delivery sterilization system of claim 1 , wherein the electron beam or x-ray generator generates electronic beam irradiation or x-rays.

9. The drug delivery sterilization system of claim 1 , wherein the electron beam or x-ray generator generates a sterilizing beam having an energy level between (a) approximately 0.3 MeV and approximately 5 MeV, or (b) approximately 3 keV and approximately 50 keV.

10. The drug delivery sterilization system of claim 1 , wherein the electron beam or x-ray generator is adapted to deliver an energy level of approximately 5 kGy to approximately 50 kGy at the sealing interface.

11. The drug delivery sterilization system of claim 1 , wherein the housing is constructed from at least one of aluminum, ceramic, and polymer.

12. The drug deliver sterilization system of claim 1 , further comprising a medicament in the container.

13. A method of sterilizing a drug delivery assembly comprising:
providing a container having a first end, a second end, an elongated portion extending between the first end and the second end, a container contact region at or near the second end, and an inner volume adapted to contain a medicament to be administered to a user;
covering the container contact region with a seal member having a seal member contact region such that the seal member contact region and the container contact region form a sealing interface;
sealingly coupling the seal member to the container via a coupling device;
disposing a portion of the container into a receptacle defined by a housing such that the second end is exposed through the housing; and
sterilizing the sealing interface by generating, via a sterilizing beam positioned near the housing to penetrate the seal member;
positioning at least one blocking region of the housing between at least a portion of the container and the sterilizing beam to restrict the sterilizing beam from contacting the elongated portion of the container or the inner volume of the container.

14. The method of claim 13 , wherein providing the container comprises providing the seal member contact region with an angled portion to engage the container contact region.

15. The method of claim 13 , wherein sterilizing the sealing surface comprises generating, via an electron beam or x-ray generator, electronic beam irradiation or x-rays.

16. The method of claim 13 , wherein sterilizing the sealing surface comprises generating, via an electron beam or x-ray generator, a sterilizing beam having an energy level between (a) approximately 0.3 MeV and approximately 5 MeV, or (b) approximately 3 keV and approximately 50 keV.

17. The method of claim 13 , wherein disposing a portion of the container into a receptacle comprises disposing the second end of the container into a first portion of the housing and placing a second portion of the housing around the first end of the container.

18. The method of claim 13 , further comprising filling the container with a medicament prior to sterilizing the sealing interface.

Assignees

• Amgen Inc

Inventors

• Barbedette Loic
• Devitt Shaun
• Mismar Wael

Classifications

• A61L2103/23

  Containers other than laboratory or medical, e.g. bottles or mail · CPC title

• A61L2/087

  Particle radiation, e.g. electron-beam, alpha or beta radiation · CPC title

• A61L2/08 Primary

  Radiation · CPC title

• A61L2/081

  Gamma radiation · CPC title

• A61L2/26

  Accessories · CPC title