IP Library › Granted Patent US 12,233,177
Granted Patent B2
US 12,233,177 · App. 17/022,695 · Granted Feb 25, 2025

Method for external sterilization of drug delivery device

Inventors: Wael Mismar (Redondo Beach, CA); Jessica Hai Liu (Agoura Hills, CA); Chia-Jung Wu (Agoura Hills, CA); Shermeen A. Abbas (Porter Ranch, CA); Shaun Devitt (King of Prussia, PA); Kenneth G. Schalhoub (Denver, CO); Anthony Bitong (Calabasas, CA); Mads Schjoth Due (Kongens Lyngby, DK); Malak Guirguis (Los Angeles, CA); Rami Saifan (Thousand Oaks, CA)
Assignee: AMGEN INC.
A61L2/20A61L2/26A61L2202/122A61L2202/21A61L2202/24
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Quick Facts
Patent No.
US 12,233,177
App. No.
17/022,695
Granted
Feb 25, 2025
Kind
B2
Abstract

A method of externally sterilizing a drug delivery device utilizing Nitrogen Dioxide (NO2) is provided, including placing the drug delivery device in a sterilization chamber, introducing into the chamber a dose of NO2 having a concentration of between about 2 and 20 milligrams per Liter by applying a vacuum level of between about 10 and 600 Torr and holding the vacuum level for a dwell time of between about 2 and 20 minutes, repeating the step of introducing into the chamber a dose of NO2 for a number of pulses between about 1 and 24, purging the sterilization chamber of at least substantially all of the NO2, and aerating the sterilization chamber.

Claims (40)

1. A method of externally sterilizing a drug delivery device utilizing Nitrogen Dioxide (NO2), comprising:

placing the drug delivery device in a sterilization chamber, wherein the drug delivery device is a syringe comprising a barrel, a flange portion, and a backstop coupled with the flange portion;

introducing into the sterilization chamber a dose of NO2 having a concentration of between about 2 and 20 milligrams per Liter by applying a vacuum level of between about 10 and 600 Torr and holding the vacuum level for a dwell time of between about 2 and 20 minutes, wherein the backstop is configured to permit or promote the NO2 to flow through a space between the backstop and the syringe when the backstop is coupled with the syringe;

repeating the step of introducing into the sterilization chamber the dose of NO2 for a number of pulses between about 1 and 24;

purging the sterilization chamber of at least substantially all of the NO2; and

aerating the sterilization chamber.

2. A method as in claim 1 , wherein the syringe is a pre-filled syringe further comprising a stopper and a plunger rod, and wherein the barrel contains a medicament.

3. A method as in claim 2 , wherein the medicament is a VEGF antagonist.

4. A method as in claim 1 , wherein the barrel is a plastic barrel.

5. A method as in claim 1 , wherein the vacuum level is between about 100 and 500 Torr.

6. A method as in claim 1 , wherein the vacuum level is between about 150 and 400 Torr.

7. A method as in claim 1 , wherein the vacuum level is between about 150 and 300 Torr.

8. A method as in claim 1 , wherein the concentration of the dose of NO2 is between about 2 and 10 milligrams per Liter.

9. A method as in claim 1 , wherein the concentration of the dose of NO2 is between about 2 and 7 milligrams per Liter.

10. A method as in claim 1 , wherein the chamber has a relative humidity is between about 70 and 90 percent.

11. A method as in claim 1 , wherein the dwell time is between about 2 and 12 minutes.

12. A method as in claim 1 , wherein the dwell time is between about 2 and 7 minutes.

13. A method as in claim 1 , wherein the number of pulses is between about 1 and 12.

14. A method as in claim 1 , wherein the number of pulses is between about 1 and 8.

15. A method as in claim 1 , wherein the number of pulses is between about 1 and 4.

16. A method as in claim 1 , wherein the number of pulses is between about 1 and 2.

17. A method as in claim 1 , wherein the step of aerating the sterilization chamber includes aerating the sterilization chamber a number of cycles between about 12 and 70 cycles to at least substantially prevent discoloration of the drug delivery device.

18. A method as in claim 1 , wherein the method of externally sterilizing the drug delivery device achieves at least a 2 logs microbial reduction.

19. A method as in claim 1 , wherein the method of externally sterilizing the drug delivery device achieves at least a 3 logs microbial reduction.

20. A method as in claim 1 , wherein the method of externally sterilizing the drug delivery device achieves at least a 4 logs microbial reduction.

21. A method as in claim 1 , wherein the method of externally sterilizing the drug delivery device achieves at least a 5 logs microbial reduction.

22. A method as in claim 1 , wherein the method of externally sterilizing the drug delivery device achieves at least a 6 logs microbial reduction.

23. A method of externally sterilizing a drug delivery device utilizing Nitrogen Dioxide (NO2), comprising:

placing the drug delivery device in a sterilization chamber, wherein the drug delivery device is a syringe comprising a barrel, a flange portion, and a backstop coupled with the flange portion;

introducing into the sterilization chamber a dose of NO2 having a concentration of between about 5 and 20 milligrams per Liter by applying a vacuum level of between about 150 and 500 Torr and holding the vacuum level for a dwell time of between about 5 and 10 minutes, wherein the backstop is configured to permit or promote the NO2 to flow through a space between the backstop and the syringe when the backstop is coupled with the syringe;

repeating the step of introducing into the sterilization chamber the dose of NO2 for a number of pulses between about 1 and 24;

purging the sterilization chamber of at least substantially all of the NO2; and

aerating the sterilization chamber a number of cycles between about 20 and 90.

24. A method of externally sterilizing a pre-filled syringe having a drug container and a medicament contained in the drug container, the method of externally sterilizing comprising the following steps:

placing the pre-filled syringe in a sterilization chamber, the pre-filled syringe comprising a flange portion and a backstop coupled with the flange portion;

introducing into the sterilization chamber a dose of Nitrogen Dioxide (NO2) having a predetermined concentration by applying a predetermined vacuum level and holding the vacuum level for a predetermined dwell time, wherein the backstop is configured to permit or promote the NO2 to flow through a space between the backstop and the pre-filled syringe when the backstop is coupled with the pre-filled syringe;

repeating the step of e introducing into the sterilization chamber the dose of NO2 for a number of pulses between about 1 and 24;

purging the sterilization chamber of at least substantially all of the NO2; and

aerating the sterilization chamber a predetermined number of cycles,

wherein the method of externally sterilizing the pre-filled syringe achieves at least a log 6 lethality target for the pre-filled syringe while realizing an ingress of NO2 gas into the drug container of less than 3.0 parts per million, as measured 30 days after externally sterilizing the pre-filled syringe.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 26, 2025
From: MISMAR, WAEL; LIU, JESSICA HAI; WU, CHIA-JUNG; ABBAS, SHERMEEN A.; DEVITT, SHAUN; SCHALHOUB, KENNETH G.; BITONG, ANTHONY; DUE, MADS SCHJOTH; GUIRGUIS, MALAK; SAIFAN, RAMI
To: AMGEN INC.
Reel/Frame 070336/0358 →
Continuity (4)
Provisional Application 62942382 · Dec 2, 2019
Provisional Application 62905341 · Sep 24, 2019
Provisional Application 62901179 · Sep 16, 2019
Related Publication 20210077645A1 · Mar 18, 2021
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