Systems and containers for sterilzing a fluid

• US 9,737,624 B2
• Filed: 02/12/2016
• Issued: 08/22/2017
• Est. Priority Date: 02/28/2012
• Status: Active Grant

• Current Assignee: Life Technologies Corporation (Thermo Fisher Scientific Incorporated)
• Original Assignee: Life Technologies Corporation (Thermo Fisher Scientific Incorporated)
• Inventors: Goodwin, Michael E., Jones, Nephi D., Buchanan, Bradley H.
• Primary Examiner(s): Chorbaji, Monzer R
• Application Number:
  US15/042,974
• Publication Number:
  US 20160158394A1
• Time in Patent Office: 557 Days
• Field of Search: 422 22, 422 24, 422 44, 250 22, 250435, 250437-438, 25045511, 250433, 21074808
• CPC Class Codes: A61L 2/007 Particle radiation, e.g. electron-beam, alpha or beta radiation
• CPC Class Codes: A61L 2/087 Particle radiation, e.g. electron-beam, alpha or beta radiation
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment

Abstract

A system for sterilizing a fluid includes a sterilization container bounding a fluid flow path that can be coupled with a fluid source. The sterilization container is comprised of one or more polymeric walls. A beam generator is configured to direct a beam of electromagnetic radiation through at least a portion of the fluid flow path of the sterilization container, the beam of electromagnetic radiation being sufficient to sterilize a fluid within the fluid flow path.

Claims

1. A system for sterilizing a fluid, comprising:

a sterilization container bounding a first fluid flow path and being configured to couple with a fluid source, the sterilization container being comprised of a polymeric first wall and an opposing polymeric second wall with the first fluid path being bounded between the first wall and the second wall, the first wall and the second wall each being comprised of a flexible polymeric film;

a support surface and an adjacently disposed retention plate, the sterilization container being sandwiched between the support surface and the retention plate so that when a fluid passes through the first fluid flow path, the support surface is held stationary relative to the retention plate; and

a first beam generator configured to direct a first beam of electromagnetic radiation through the polymeric first wall of the sterilization container and through at least a portion of the first fluid flow path, the first beam of electromagnetic radiation being sufficient to at least partially sterilize a fluid when the fluid is passing through the first fluid flow path.

2. The system as recited in claim 1, wherein the sterilization container comprises a collapsible polymeric bag formed from one or more sheets of polymeric film.

3. The system as recited in claim 1, further comprising:

a second beam generator disposed on a side of the sterilization container that is opposite the first beam generator and is configured to direct a second beam of electromagnetic radiation through the polymeric second wall of the sterilization container and through at least a portion of the first fluid flow path.

4. The system as recited in claim 1, wherein the first beam of electromagnetic radiation is an electron beam.

5. The system as recited in claim 1, wherein the sterilization container is sandwiched between the support surface and the retention plate so that when a fluid passes through the first fluid flow path, the support surface and the retention plate constantly restrain outward expansion of the sterilization container along a fixed length of the sterilization container.

6. A method for sterilizing a fluid comprising:

passing a fluid through a first fluid flow path of a sterilization container under a pressurized forced fluid flow, the sterilization container being comprised of a polymeric first wall, the first wall being comprised of a sheet of flexible polymeric film; and

applying a first beam of electromagnetic radiation to the first wall of the sterilization container so that the first beam of electromagnetic radiation passes through the first wall and through at least a portion of the fluid passing through the first fluid flow path of the sterilization container, the first beam of electromagnetic radiation at least partially sterilizing the fluid passing through the sterilization container.

7. The method as recited in claim 6, further comprising passing the fluid through a non-sterilizing, size exclusion filter before passing the fluid through the first fluid flow path of the sterilization container.

8. The method as recited in claim 6, wherein the fluid includes a biologic suitable for use in biotechnology or pharmaceutical applications.

9. The method as recited in claim 6, further comprising dispensing the fluid that passes through the sterilization container into a storage vessel.

10. The method as recited in claim 6, further comprising:

applying the first beam of electromagnetic radiation to a first side of the sterilization container; and

applying a second beam of electromagnetic radiation to a second side of the sterilization container that is opposite the first side.

11. The method as recited in claim 6, further comprising:

passing a fluid through a second fluid flow path of the sterilization container, the second fluid flow path being separated from the first fluid flow path; and

applying a second beam of electromagnetic radiation to the first wall of the sterilization container so that the second beam of electromagnetic radiation passes through the first wall and through at least a portion of the fluid passing through the second fluid flow path of the sterilization container, the second beam of electromagnetic radiation at least partially sterilizing the fluid passing through the sterilization container.

12. The method as recited in claim 6, further comprising applying means for limiting a thickness of the first fluid flow path to the sterilization container prior to passing the fluid through the first fluid flow path.

13. A container system for use in sterilizing a fluid, the system comprising:

a sterilization container having an inlet, an outlet, and a plurality of separate fluid flow paths, each fluid flow path having a first end in fluid communication with the inlet and having a second end in fluid communication with the outlet, the sterilization container being comprised of;

a first wall comprised of a polymeric material;

a second wall comprised of a polymeric material; and

a plurality of elongated baffles, spacers or seam lines formed between the first wall and the second wall, each fluid flow path being separated from the other fluid flow paths by at least one of the baffles, spacers or seam lines.

14. The container system as recited in claim 13, wherein the first wall and the second wall are each comprised of a flexible sheet of a polymeric film.

15. The container system as recited in claim 13, wherein the sterilization container has at least three fluid flow paths.

16. The container system as recited in claim 13, wherein the first ends and the second ends of the fluid flow paths are in fluid communication with each other.

17. A system for sterilizing a fluid, the system comprising:

the container system as recited in claim 13; and

a plurality of beam generators each configured to direct a beam of electromagnetic radiation through the first wall of the sterilization container and through at least a portion of a corresponding one of the plurality of fluid flow paths, the beams of electromagnetic radiation being sufficient to at least partially sterilize a fluid when the fluid is passing through the plurality of fluid flow paths.

18. A system for sterilizing a fluid, comprising:

a sterilization container bounding a fluid flow path and being configured to couple with a fluid source, the sterilization container being comprised of a flexible polymeric first wall;

a first beam generator configured to direct a first beam of electromagnetic radiation through the flexible polymeric first wall of the sterilization container and through at least a portion of the fluid flow path, the first beam of electromagnetic radiation being sufficient to at least partially sterilize a fluid when the fluid is passed through the fluid flow path; and

a first retention plate positioned over at least a portion of the flexible polymeric first wall of the sterilization container so as to restrict outward expansion of the first wall when fluid flows through the fluid flow path, an opening being formed either through the first retention plate or adjacent to the first retention plate, the first beam generator being configured to direct the first beam of electromagnetic radiation through the opening.

19. The system for sterilizing a fluid as recited in claim 18, further comprising a second retention plate positioned over a portion of the flexible polymeric first wall of the sterilization container so as to restrict outward expansion of the first wall when fluid flows through the fluid flow path, the opening being formed between the first retention plate and the second retention plate.