Multi-part lyophilization container and method of use

1. A multi-part lyophilization container, the container comprising:

a front surface;

a back surface;

a non-breathable section including a port region;

a breathable section including a breathable membrane; and

a peelable region including a peelable seal, the peelable region encompassing a boundary bridging the non-breathable section and the breathable section,

wherein the peelable seal is configured to open in response to a pressure differential created between an inside and an outside of the non-breathable section of the multi-part lyophilization container.

2. The multi-part lyophilization container of claim 1 , wherein the front surface and the back surface each comprise a portion of the breathable section including a breathable membrane.

3. The multi-part lyophilization container of claim 1 , wherein the peelable region comprises dissimilar materials.

4. The multi-part lyophilization container of claim 1 , wherein the peelable region comprises materials having dissimilar textures.

5. The multi-part lyophilization container of claim 1 , wherein at least one material of the peelable region comprises an additive.

6. The multi-part lyophilization container of claim 1 , wherein the peelable region comprises a visual indicator.

7. The multi-part lyophilization container of claim 1 , wherein the peelable region has a width of approximately 0.95 cm.

8. The multi-part lyophilization container of claim 1 , further comprising a Hold Open Device (HOD).

9. A method of lyophilizing a fluid in a multi-part container including a peelable seal, the method comprising:

inputting the fluid into a non-breathable section of the multi-part container;

freezing the fluid;

applying, in a lyophilization chamber, vacuum pressure;

opening the peelable seal using a pressure differential created between an inside and an outside of the non-breathable section of the multi-part container;

applying heat energy;

sublimating the fluid; and

creating a temporary occlusion in a peelable region of the multi-part container.

10. The method of claim 9 , further comprising inputting a gas into the non-breathable section of the multi-part container to create a vapor space above the inputted fluid.

11. The method of claim 9 , further comprising backfilling the lyophilization chamber to a partial atmospheric pressure.

12. The method of claim 9 , further comprising creating a permanent seal dividing a breathable section from the non-breathable section of the multi-part container.

13. The method of claim 12 , further comprising removing the breathable section of the multi-part container.

14. The method of claim 13 , further comprising removing a tear away tail from the breathable section of the multi-part container.

15. The method of claim 14 , further comprising attaching the tear away tail to the non-breathable section of the multi-part container.

16. The method of claim 9 , wherein the fluid is selected from among blood plasma, a cell suspension, a fluid containing cryoprecipitate and a fluid containing platelet lysate.

17. The method of claim 9 , wherein the multi-part container further includes a Hold Open Device (HOD).

18. A method of manufacturing a peelable seal in a multipart lyophilization container, the method comprising applying heating elements of a heat-sealing machine to opposing materials of the multi-part lyophilization container at a continuous temperature of approximately 64° C. for approximately 40 seconds.

19. The method of claim 18 , further comprising applying the heating elements to the opposing materials of the multi-part lyophilization container using a clamping force of approximately 50 Psi.

20. The method of claim 18 , wherein the opposing materials are dissimilar.

21. The method of claim 18 , wherein the opposing materials comprise dissimilar textures.

22. The method of claim 18 , wherein the peelable seal has a width of approximately 0.95 cm.