Lyophilization container fill fixture, system and method of use

1. A gas fill fixture for use in lyophilization, the gas fill fixture comprising:

a chassis;

a fill indicator; and

a lid,

wherein the chassis and lid together form a cavity that receives a flexible lyophilization container placed along a longitudinal axis of the cavity, and wherein the fill indicator raises and lowers with the lid to indicate a fill condition of the flexible lyophilization container.

2. The gas fill fixture of claim 1 , wherein the chassis comprises Acrylonitrile Butadiene Styrene (ABS), wherein the fill indicator is attached to the lid.

3. The gas fill fixture of claim 1 , wherein the fill indicator is a mechanical indicator attached to a bottom side of the lid.

4. The gas fill fixture of claim 3 , wherein the mechanical indicator is a linear indicator.

5. The gas fill fixture of claim 4 , wherein the linear indicator uses multiple colors to indicate a proper fill condition and an overfilled condition.

6. The gas fill fixture of claim 1 , wherein the fill indicator comprises at least one sensor.

7. The gas fill fixture of claim 6 , wherein the at least one sensor is selected from among optical sensors, inductive sensors and capacitive sensors.

8. The gas fill fixture of claim 1 , wherein the lid is connected to the chassis with at least one hinge.

9. The gas fill fixture of claim 8 , wherein the at least one hinge is a pivot hinge.

10. The gas fill fixture of claim 1 , further including a handle that cooperates with the flexible lyophilization container to secure the flexible lyophilization container.

11. A system for lyophilizing a fluid, the system comprising:

a lyophilization container;

a lyophilizer; and

a gas fill fixture, the gas fill fixture including:

a chassis,

a fill indicator, and

a lid, wherein the fill indicator raises and lowers with the lid to indicate a fill condition of the lyophilization container.

12. The system of claim 11 , further comprising a lyophilization loading tray.

13. The system of claim 11 , wherein the fill indicator is a mechanical indicator.

14. The system of claim 13 , wherein the mechanical indicator is a linear indicator.

15. The system of claim 14 , wherein the linear indicator uses multiple colors to indicate a proper fill condition and an overfilled condition.

16. A method of lyophilizing a fluid, the method comprising:

inputting the fluid into a lyophilization container;

inputting a portion of the lyophilization container into a gas fill fixture;

inputting a gas into the lyophilization container;

determining an appropriate gas fill volume based on an indication from a fill indicator of the gas fill fixture;

loading the lyophilization container into a lyophilizer; and

lyophilizing the fluid.

17. The method of claim 16 , further comprising placing the lyophilization container on a lyophilization loading tray.

18. The method of claim 16 , wherein the lyophilization container is a flexible, multi-part lyophilization container including a breathable section and non-breathable section.

19. The method of claim 18 , wherein the inputting of the fluid into the lyophilization container comprises inputting the fluid into the non-breathable section.

20. The method of claim 16 , wherein the fill indicator is a linear indicator.

21. The method of claim 20 , wherein the linear indicator uses multiple colors to indicate a proper fill condition and an overfilled condition.

22. The method of claim 16 , wherein the lyophilizing the fluid comprises the steps of:

freezing the fluid;

removing an occlusion from the lyophilization container; and

applying heat energy and vacuum.

23. The method of claim 16 , further comprising occluding the lyophilization container between breathable and non-breathable sections.

24. The method of claim 16 , further comprising placing part of the lyophilization container over a lid of the gas fill fixture and into cooperation with a handle of the gas fill fixture.