Systems and containers for sterilizing a fluid

• US 9,289,522 B2
• Filed: 02/27/2013
• Issued: 03/22/2016
• 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:
  US14/381,551
• Publication Number:
  US 20150044093A1
• Time in Patent Office: 1,119 Days
• Field of Search: 422/22, 422/24, 422/44, 250/22, 250/435, 250437-438, 250/455.11, 250/433, 210/748.08
• US Class Current: 1/1
• 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 fluid source and a sterilization container bounding a fluid flow path that is in fluid communication with the fluid source. The sterilization container is comprised of one or more polymeric walls. An electron beam generator is configured to direct an electron beam through at least a portion of the fluid flow path of the sterilization container, the electron beam being sufficient to sterilize a fluid within the fluid flow path.

Claims

1. A system for sterilizing a fluid, comprising:

a fluid source;

a sterilization container bounding a fluid flow path that is in fluid communication with the fluid source, the sterilization container being comprised of a polymeric first wall, the first wall comprising a sheet of flexible polymeric film; and

a first electron beam generator configured to direct a first electron beam through the polymeric first wall of the sterilization container and through at least a portion of the fluid flow path, the first electron beam being sufficient to at least partially sterilize a fluid within the fluid flow path.

2. The system as recited in claim 1, further comprising a non-sterilizing filter having a cutoff of 0.5 micron or greater, the non-sterilization filter being positioned in fluid communication with a fluid line extending between the fluid source and the sterilization container.

3. The system as recited in claim 1, wherein at least a portion of the polymeric first wall of the sterilization container has a maximum thickness in a range from 0.1 mm to 2 mm.

4. The system as recited in claim 1, further comprising means for limiting a thickness of the fluid flow path.

5. The system as recited in claim 4, wherein the means for limiting the thickness of the fluid flow path comprises one or more inner seams that partition the fluid flow path within the sterilization container into a plurality of separate fluid flow paths.

6. The system as recited in claim 1, further comprising means for immobilizing the sterilization container.

7. The system as recited in claim 6, wherein the means for immobilizing includes a support on which the sterilization container rests and a plurality of fasteners securing the sterilization container to the support.

8. The system as recited in claim 6, wherein the means for immobilizing includes:

a support on which the sterilization container rests;

a plurality of spaced part posts outwardly projecting from the support; and

a plurality of spaced apart holes formed on the sterilization container, each hole having a corresponding post received therein.

9. The system as recited in claim 1, wherein the sterilization container comprises:

the first wall comprised of a polymeric material;

a second wall comprised of a polymeric material; and

a plurality of elongated spacers secured to and disposed between the first wall and the second wall so that the first wall, second wall and spacers bound a plurality of elongated fluid flow paths.

10. The system as recited in claim 1, wherein the sterilization container comprises a molded polymeric container.

11. The system as recited in claim 1, wherein the polymeric first wall comprises a primary wall portion and a secondary wall portion, the secondary wall portion being aligned with the first electron beam generator so that during operation electron beams are passed through the secondary wall portion, the secondary wall portion being thinner than the primary wall portion.

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

the sterilization container comprising a polymeric second wall opposing the first wall; and

a second electron beam generator configured to direct a second electron beam through the polymeric second wall of the sterilization container and through at least a portion of the fluid flow path, the second electron beam being sufficient to at least partially sterilize a fluid within the fluid flow path.

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

the first electron beam generator being disposed on a first side of the sterilization container;

a second electron beam generator being disposed on a second side of the sterilization container that opposes the first side and being configured to direct a second electron beam at the sterilization container, the second electron beam being aligned with the first electron beam.

14. The system as recited in claim 1, wherein the sterilization container comprises a collapsible polymeric bag formed from the polymeric first wall and an opposing polymeric second wall, the second wall comprising a sheet of flexible polymeric film.

15. 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 opposing polymeric walls that bound the plurality of separate fluid flow paths therebetween, the opposing polymeric walls comprising:

a first wall comprised of a polymeric material;

a second wall comprised of a polymeric material; and

a plurality of elongated baffles or spacers formed between the first wall and the second wall, each fluid flow path being formed between an adjacent pair of baffles or spacers.

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

17. The container system as recited in claim 15, wherein the first ends and the second ends of the fluid flow paths are in fluid communication with each other.

18. 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 opposing polymeric walls that bound the plurality of separate fluid flow paths therebetween, the opposing polymeric walls comprising:

a first wall comprised of a polymeric material;

a second wall comprised of a polymeric material; and

the first wall being secured directly to the second wall along a plurality of elongated, spaced apart seam lines, each fluid flow path being formed between an adjacent pair of seam lines.

19. The container system as recited in claim 18, wherein the first wall and the second wall are each comprised of a flexible sheet of a polymeric film.

20. A system for sterilizing a fluid, comprising:

a fluid source;

a sterilization container bounding a fluid flow path that is in fluid communication with the fluid source, the sterilization container being comprised of a polymeric first wall;

a first electron beam generator configured to direct a first electron beam through the polymeric first wall of the sterilization container and through at least a portion of the fluid flow path, the first electron beam being sufficient to at least partially sterilize a fluid within the fluid flow path; and

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

21. A system for sterilizing a fluid, comprising:

a fluid source;

a sterilization container bounding a fluid flow path that is in fluid communication with the fluid source, the sterilization container being comprised of a polymeric first wall;

a first electron beam generator configured to direct a first electron beam through the polymeric first wall of the sterilization container and through at least a portion of the fluid flow path, the first electron beam being sufficient to at least partially sterilize a fluid within the fluid flow path;

a first retention plate positioned over a portion of the flexible sheet of the sterilization container so as to restrict outward expansion of the flexible sheet when fluid flows through the fluid flow path;

a second retention plate positioned over a portion of the flexible sheet of the sterilization container so as to restrict outward expansion of the flexible sheet when fluid flows through the fluid flow path, the second retention plate being spaced apart from the first retention plate so that a gap is formed therebetween;

the first electron beam generator being configured to direct the first electron beam through the gap.