Lyophilization container and method of using same
Provided is a multi-part lyophilization container for lyophilizing a fluid, storing the lyophilizate, reconstituting the lyophilizate, and infusing the reconstituted lyophilizate into a patient, including a method of using same. The container includes a front surface, a back surface, a non-breathable section including a port region, a breathable section including a breathable membrane, and an occlusion zone encompassing a boundary between the non-breathable section and the breathable section. The non-breathable section is configured to accommodate any of a liquid, a solid, a gas or combination thereof. The breathable section is configured to accommodate only a gas. The method includes creating a temporary seal between the non-breathable section of the container and the breathable section, inputting a liquid into the non-breathable section, freezing the liquid, removing the temporary seal to allow vapor transport between the non-breathable section and the breathable section, and adding heat energy the frozen liquid under vacuum.
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
an occlusion zone encompassing a boundary bridging the non-breathable section and the breathable section,
wherein the non-breathable section and the breathable section are disposed on opposite sides of the occlusion zone.
2. The container of claim 1 , wherein the front surface and the back surface each comprise a portion of breathable section including a breathable membrane.
3. The container of claim 1 , wherein the breathable membrane comprises a continuous sheet including an isoclinal fold allowing the breathable membrane to bridge a portion of the front surface and a portion of the back surface.
4. The container of claim 1 , wherein the occlusion zone comprises material that is the same as non-breathable material of the non-breathable section.
5. The container of claim 4 , wherein the occlusion zone comprises at least two dissimilar materials positioned opposite one another across a space formed between the front surface and the back surface of the container.
6. The container of claim 1 , wherein the occlusion zone comprises a visual indicator.
7. The container of claim 1 , further comprising a Hold Open Device (HOD).
8. The container of claim 7 , wherein the HOD comprises a semi-rigid material.
9. The container of claim 7 , wherein the HOD comprises a rigid material.
10. The container of claim 9 , further comprising HOD capture voids formed in an outer perimeter weld thereof, within which the HOD is captured.
11. The container of claim 7 , wherein the HOD is coupled to the outside of the container.
12. The container of claim 1 , wherein the non-breathable section comprises polyethylene.
13. The container of claim 12 , wherein the polyethylene is a linear, low density polyethylene.
14. The container of claim 1 , wherein the breathable membrane comprises at least two layers.
15. The container of claim 14 , wherein the at least two layers of the breathable membrane comprise a breathable membrane and a reinforcing material.
16. The container of claim 15 , wherein the breathable membrane is hydrophobic.
17. The container of claim 15 , wherein the breathable membrane is an expanded polytetrafluoroethylene (PTFE).
18. The container of claim 15 , wherein the reinforcing material is a polypropylene/polyethylene blend.
19. The container of claim 1 , wherein the ratio of the surface area of the non-breathable section to the surface area of the breathable section is between 5:2 and 5:3.
20. A method of lyophilizing a fluid in a multi-part container, the method comprising:
creating a temporary seal in an occlusion zone dividing a non-breathable section of the container from a breathable section of the container;
inputting a fluid into the non-breathable section of the container;
freezing the fluid;
opening the temporary seal to allow vapor transfer between the non-breathable section of the container and the breathable section of the container; and
adding heat energy to the frozen fluid under vacuum,
wherein the non-breathable section and the breathable section are disposed on opposite sides of the occlusion zone.
21. The method of claim 20 , further comprising inputting a gas into the non-breathable section of the container to create a vapor space above the inputted fluid.
22. The method of claim 20 , further comprising inputting a pH-regulating gas into the non-breathable section of the container to regulate pH.
23. The method of claim 20 , further comprising backfilling a lyophilization chamber to a partial atmospheric pressure.
24. The method of claim 23 , wherein the backfilling of the lyophilization chamber to a partial atmospheric pressure is performed using a pH regulating gas.
25. The method of claim 24 , further comprising occluding the container in the occlusion zone.
26. The method of claim 25 , further comprising forming a permanent seam in the breathable section of the container while the interior of the non-breathable section is at partial atmospheric pressure.
27. The method of claim 26 , further comprising introducing an inert gas to raise chamber pressure to atmospheric pressure.
28. The method of claim 27 , further comprising removing the breathable section of the flexible container.