Support System for Flexible Lyophilization Containers

• US 20080119818A1
• Filed: 08/12/2005
• Published: 05/22/2008
• Est. Priority Date: 08/13/2004
• Status: Active Grant

• Current Assignee: Henry M Jackson Foundation For The Advancement of Military Medicine Incorporated
• Original Assignee: Henry M Jackson Foundation For The Advancement of Military Medicine Incorporated
• Inventors: O'Sullivan, Anne-Marie, Hmel, Peter, Wilder, Donna, Bakaltcheva, Irina, Ketchum, Lloyd
• Granted Patent: US 8,053,248 B2
• Time in Patent Office: Days
• US Class Current: 604/403
• CPC Class Codes: A01N 1/02 Preservation of living parts
• CPC Class Codes: A01N 1/0263 Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving, e.g. cool boxes, blood bags or "straws" for cryopreservation
• CPC Class Codes: Y10T 436/2525 Stabilizing or preserving

Abstract

A suitable container for plasma lyophilization has been designed for lyophilization (lyo-bag), storage, reconstitution and administering of blood products. A rigid support frame for use with a lyo-bag with sidewalls was designed as an external removable supportive system was designed, which provides the necessary stability for the flexible container during lyophilization. A removable bottom wall support sheet was designed for use with any flexible container for lyophilization.

Claims

1. A support structure for lyophilizing a fluid comprising:

a rigid frame that supports side walls of a flexible lyophilization container; and

a support sheet for reducing flexibility of a bottom wall of the flexible lyophilization container to allow for successful lyophilization of said fluid.

2. The support structure of claim 1, wherein the support sheet is removable.

3. The support structure of claim 1, wherein the support sheet comprises double-sided tape affixed to the support sheet.

4. The support structure of claim 3, wherein the double-sided tape is a thermo- stable tape.

5. The support structure of claim 1, wherein the support sheet is a magnetic sheet.

17. The method of claim 11, wherein successful lyophilization involves prevention of folding of the bottom wall.

6. A support structure for lyophilizing a fluid comprising:

a support sheet for reducing flexibility of a bottom wall of a flexible lyophilization container to allow for successful lyophilization of said fluid.

7. The support structure of claim 6, wherein the support sheet is removable.

8. The support structure of claim 6, wherein the support sheet comprises double-sided tape affixed to the support sheet.

9. The support structure of claim 8, wherein the double-sided tape is a thermo-stable tape.

10. The support structure of claim 6, wherein the support sheet is a magnetic sheet.

11. A method of providing support to a flexible lyophilization container during the process of lyophilizing a biological solution in the flexible lyophilization container comprising:

securing a side or top wall of the flexible lyophilization container to a support frame; and

affixing a bottom wall of the flexible lyophilization container to a support sheet that allows for successful lyophilization.

12. The method of claim 11, wherein the support frame is removable.

13. The method of claim 11, wherein securing is achieved by pins connecting said flexible lyophilization container to said support frame.

14. The method of claim 11, wherein affixing is achieved by double-sided tape.

15. The method of claim 14, wherein the double-sided tape is thermally conductive.

16. The method of claim 11, wherein the support sheet is magnetic.

18. A support system for lyophilizing a biological solution in a lyophilization container comprising:

a flexible lyophilization container;

a hydrophobic protective porous membrane attached at a top surface of an outward directed plastic strip of the flexible lyophilization container; and

a support sheet affixed to a bottom wall of the flexible lyophilization container.

19. The support system of claim 18, wherein the hydrophobic protective membrane is a GORE-TEX™

or Tyvek™

membrane.

20. A method of providing adequate support to a flexible lyophilization container during the process of lyophilizing a biological solution in the flexible lyophilization container comprising:

providing a flexible lyophilization container having a top flexible membrane and an inward directed plastic strip to which the top flexible membrane is attached;

removing the top flexible membrane along with the inward directed plastic strip;

attaching an outward directed plastic strip to a top edge of the flexible lyophilization container to serve as a platform for a replacement top flexible membrane;

affixing a replacement top flexible membrane to the top edge of the flexible lyophilization container;

affixing a bottom wall of the lyophilization container to a support sheet; and

placing the support sheet on a tray.

21. The method of claim 20, wherein the replacement top flexible membrane is a GORE-TEX™

or Tyvek™

membrane.

22. The method of claim 20, wherein the support sheet is magnetic.

23. The method of claim 20, wherein affixing is achieved with double-sided tape.

24. The method of claim 23, wherein the double-sided tape is thermally conductive.