Method and apparatus for validation of sterilization

• US 8,022,375 B2
• Filed: 12/18/2009
• Issued: 09/20/2011
• Est. Priority Date: 12/23/2003
• Status: Expired due to Term

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Martine, John A. Jr., Williams, John A.
• Primary Examiner(s): Warden; Jill
• Assistant Examiner(s): Turk; Neil N
• Application Number:
  US12/642,282
• Publication Number:
  US 20100140515A1
• Time in Patent Office: 641 Days
• Field of Search: None
• US Class Current: 250/486.1
• CPC Class Codes: A61L 2/087 Particle radiation, e.g. electron-beam, alpha or beta radiation
• CPC Class Codes: A61L 2/24 Apparatus using programmed or automatic operation
• CPC Class Codes: A61L 2/28 Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour apparatus involving enzymes or microorganisms C12M1/34; methods involving enzymes or microorganisms C12Q1/00
• CPC Class Codes: A61L 2202/122 Chambers for sterilisation
• CPC Class Codes: A61L 2202/14 Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps

Abstract

An apparatus, system and method for verifying the achievement of a desired sterility assurance level (SAL) for components manipulated within a low-energy electron beam sterilization chamber. The components are preferably pre-sterilized and connected together in an assembly fashion which creates and maintains the sterility of the connection by subjecting the components to low-energy (less than 300 KeV) electron beam radiation. The verification is completed by measuring the sterilization dose delivered to a sensor, also known as a dosimeter, positioned within the sterilization process to simulate the components.

Claims

1. A radiation sterilization verification device comprising:

a dosimeter;

a first dosimeter block including an interior surface with a cavity defined therein, wherein the dosimeter is positioned within the cavity;

a second dosimeter block configured to operate with the first dosimeter block, the second dosimeter block including an interior surface forming a protrusion configured to abut an interior surface of the cavity of the first dosimeter block, at least one of the first and second dosimeter blocks having a radiation resistant material and a sufficient density and thickness to shield the dosimeter from indirect exposure to radiation.

2. The device of claim 1, further comprising:

a mechanism to affix the first dosimeter block to the second dosimeter block.

3. The device of claim 1, further comprising a mechanism to affix the first dosimeter block to a radiation sterilization site.

4. The device of claim 1, further comprising a mechanism to affix the first dosimeter block and the second dosimeter block to a radiation sterilization site.

5. The device of claim 4, wherein the mechanism to affix the first dosimeter block to the second dosimeter block includes the mechanism to affix the first dosimeter block and the second dosimeter block to the radiation sterilization site.

6. The device of claim 2, wherein the mechanism to affix the first the first dosimeter block to the second dosimeter block includes friction.

7. The device of claim 1, wherein the first dosimeter block includes a single cavity.

8. The device of claim 1, wherein the first dosimeter block includes a plurality of cavities, and wherein the second dosimeter block has a corresponding number of protrusions each configured to abut an interior surface of one of the cavities.

9. The device of claim 1, further comprising a passage defined within either the first or second dosimeter block to allow radiation to reach the cavity.

10. The device of claim 9, wherein a diameter of the passage is in the range of from about 4.45 mm (0.175 inch) to about 7.37 mm (0.290 inch).

11. The device of claim 10, wherein the diameter of the passage is about 5.94 mm (0.234 inch).

12. The device of claim 9, wherein a depth of the passage is in the range of from about 1.78 mm (0.070 inch) to about 4.45 mm (0.175 inch).

13. The device of claim 12, wherein the depth of each passage is about 3.15 mm (0.124 inch).

14. The device of claim 1, further comprising a plurality of passages defined within either the first or second dosimeter block to allow radiation to reach each cavity.

15. The device of claim 14, wherein a diameter of each passage is in the range of from about 4.45 mm (0.175 inch) to about 7.37 mm (0.290 inch).

16. The device of claim 15, wherein the diameter of each passage is about 5.94 mm (0.234 inch).

17. The device of claim 14, wherein a depth of each passage is in the range of from about 1.78 mm (0.070 inch) to about 4.45 mm (0.174 inch).

18. The device of claim 17, wherein the depth of each passage is about 3.15 mm (0.124 inch).

19. A radiation sterilization verification device comprising:

a plurality of dosimeters;

a first dosimeter block including an interior surface with a plurality of cavities defined therein, wherein one of the plurality of dosimeters is positioned within each cavity; and

a second dosimeter block configured to operate with the first dosimeter block, the second dosimeter block including an interior surface with a plurality of protrusions each configured to abut an interior surface of one of the plurality of cavities of the first dosimeter block, the first and second dosimeter blocks having a radiation resistant material and a sufficient density and thickness to shield the dosimeter from radiation.

20. The device of claim 19, further comprising:

a mechanism to affix the first dosimeter block to the second dosimeter block.

21. The device of claim 19, further comprising a mechanism to affix the first dosimeter block to a radiation sterilization site.

22. The device of claim 19, further comprising a mechanism to affix the first dosimeter block and the second dosimeter block to a radiation sterilization site.

23. The device of claim 22, wherein the mechanism to affix the first dosimeter block to the second dosimeter block includes the mechanism to affix the first dosimeter block and the second dosimeter block to a radiation sterilization site.

24. The device of claim 20, wherein the mechanism to affix the first the first dosimeter block to the second dosimeter block includes friction.

25. The device of claim 19, further comprising a passage defined within either the first or second dosimeter block to allow radiation to reach the cavity.

26. The device of claim 25, wherein a diameter of the passage is in the range of from about 4.45mm (0.174 inch) to about 7.37mm (0.290 inch).

27. The device of claim 26, wherein the diameter of the passage is about 5.94mm (0.234 inch).

28. The device of claim 25, wherein a depth of the passage is in the range of from about 1.78mm (0.070 inch) to about 4.45mm (0.175 inch).

29. The device of claim 28, wherein the depth of each passage is about 3.15mm (0.124 inch).

30. A radiation sterilization verification device comprising:

a dosimeter;

a first dosimeter block including an interior surface with a plurality of cavities defined therein, wherein the dosimeter is positioned within one of the plurality of cavities;

a second dosimeter block configured to operate with the first dosimeter block, the second dosimeter block including a plurality of protrusions, each protrusion configured to abut an interior surface of one of the plurality of cavities, at least one of the first and second dosimeter blocks having a radiation resistant material and a sufficient density and thickness to shield the dosimeter from indirect exposure to radiation.