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, comprising:
a front surface;
a back surface;
a non-breathable section;
a breathable section including a breathable membrane; and
an occlusion zone forming 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, and wherein a position of the occlusion zone is indicated by a smooth region of the occlusion zone including a surface texture that is smooth relative to a texture of an adjacent material.
2. The multi-part lyophilization container of claim 1 , wherein the smooth region comprises front surface material and back surface material which are a same material.
3. The multi-part lyophilization container of claim 1 , wherein the smooth region comprises material which is dissimilar to material of the non-breathable section and the breathable section.
4. The multi-part lyophilization container of claim 1 , wherein the smooth region comprises material having an appearance which is dissimilar to an appearance of material of the non-breathable section and of the breathable section.
5. The multi-part lyophilization container of claim 4 , wherein the dissimilar appearance is a dissimilar color.
6. A multi-part lyophilization container, comprising:
a front surface;
a back surface;
a non-breathable section;
a breathable section including a breathable membrane; and
an occlusion zone forming 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, and wherein a position of the occlusion zone is indicated by a textured region of the occlusion zone including a surface texture that is rough relative to a texture of an adjacent material.
7. The multi-part lyophilization container of claim 6 , wherein the textured region comprises front surface material and back surface material which are a same material.
8. The multi-part lyophilization container of claim 6 , wherein the textured region comprises material which is dissimilar to material of the non-breathable section and the breathable section.
9. The multi-part lyophilization container of claim 6 , wherein the textured region comprises material having an appearance which is dissimilar to an appearance of a material the non-breathable section and of the breathable section.
10. The multi-part lyophilization container of claim 9 , wherein the dissimilar appearance is a dissimilar color.
11. The multi-part lyophilization container of claim 9 , wherein the dissimilar appearance comprises lines that demarcate the occlusion zone.
12. The multi-part lyophilization container of claim 6 , wherein the smooth region indicates boundaries of the occlusion zone.
13. The multi-part lyophilization container of claim 6 , wherein the non-breathable section comprises a section of clear material.
14. The multi-part lyophilization container of claim 1 , wherein the smooth region indicates boundaries of the occlusion zone.
15. The multi-part lyophilization container of claim 1 , wherein the non-breathable section comprises a section of clear material.
16. The multi-part lyophilization container of claim 4 , wherein the dissimilar appearance comprises lines that demarcate the occlusion zone.
17. A multi-part lyophilization container, comprising:
a front surface extending a length from a first end of the multi-part lyophilization container to a second end of the multi-part lyophilization container;
a back surface extending the length;
a non-breathable section disposed adjacent the first end of the multi-part lyophilization container;
a breathable section disposed adjacent the second end of the multi-part lyophilization container, the breathable section comprising a breathable membrane; and
an occlusion zone disposed along the length between the first end of the multi-part lyophilization container and the second end of the multi-part lyophilization container, the occlusion zone forming a portion of the multi-part lyophilization container bridging the non- breathable section and the breathable section, wherein a position of the occlusion zone along the length is indicated by a region of the occlusion zone including a surface texture that is different from a texture of an adjacent material.
18. The multi-part lyophilization container of claim 17 , wherein the surface texture is rough relative to the texture of the adjacent material.
19. The multi-part lyophilization container of claim 17 , wherein the surface texture is smooth relative to the texture of the adjacent material.
20. The multi-part lyophilization container of claim 17 , wherein region indicates boundaries of the occlusion zone.