Lyophilization containers

• US 4,878,597 A
• Filed: 03/24/1988
• Issued: 11/07/1989
• Est. Priority Date: 03/24/1988
• Status: Expired due to Term

• Current Assignee: William E. Haast
• Original Assignee: William E. Haast
• Inventors: Haast, William E.
• Primary Examiner(s): Stinson, Frankie L.
• Application Number:
  US07/172,556
• Time in Patent Office: 593 Days
• Field of Search: 422/102, 220/404, 220/408, 220/410, 249/82, 249/149, 249/150, 249/153, 249/65, 249/179, 249/180, 249/181, 249/182, 249/183, 249/147, 62/340, 62/344, 62/345
• US Class Current: 34/108
• CPC Class Codes: B01L 3/5082 Test tubes per se
• CPC Class Codes: F26B 5/06 the process involving freezing
• CPC Class Codes: G01N 1/42 Low-temperature sample treatment, e.g. cryofixation

Abstract

The invention provides containers useful for freezedrying of biological and other materials which can be advantageously subjected to a lyophilization process, such materials including proteinaceous materials from which moisture is removed in order to preserve the material in a dry, shelf-stable form. The present containers allow lyophilization of the contained material with a minimum of time and energy expenditure by forming the material into a frozen shell to increase the surface area of the material and to minimize the thickness of a given quantity of material which is to be lyophilized. In a typical embodiment of the invention, a container is provided with a congruent, flexible core which is inserted into the container to force the material into the space lying between the container and the core. Expansion of the material on freezing acts to deform the flexible core rather than to break the container. The material thus frozen into a shell-like conformation within the container is then subjected to a lyophilization process after removal of the flexible core.

Claims

1. Lyophilization apparatus, comprising:

container means for receiving a lyophilizable material;

core means insertable into the container means for displacing the lyophilizable material into that space between opposed surfaces of the container means and core means, the core mean being deformable on freezing of the lyophilizable material to form a frozen shell of lyophilizable material; and

,

sheath means receivable over the core means for facilitating release of the core means from the frozen shell of lyophilizable material.

2. The apparatus of claim 1 and further comprising:

cap means attached to the core means for closing the container means.

3. The apparatus of claim 1 wherein outer surfaces of the core means are congruent with inner surfaces of the container means.

4. The apparatus of claim 1 wherein the core means is tapered in conformation.

5. The apparatus of claim 1 wherein the core means is formed of a compressible material which is continuous throughout said core means.

6. Lyophilization apparatus, comprising:

container means for receiving a lyophilizable material;

core means insertable into the container means for displacing the lyophilizable material into that space between opposed surfaces of the container means and core means, the core means being deformable on freezing of the lyophilizable material to form a frozen shell of lyophilizable material;

cap means attached to the core means for closing the container means; and

sheath means receivable over the core means for facilitating release of the core means from the frozen shell of lyophilizable material.

7. The apparatus of claim 6 wherein the core means is tapered in conformation.

8. The apparatus of claim 6 wherein the core means is hollow.

9. The apparatus of claim 6 wherein the core means is inflatable.

10. The apparatus of claim 6 wherein outer surfaces of the core means are congruent with inner surfaces of the container means.

11. The apparatus of claim 6 wherein the core means is formed of a compressible material which is continuous throughout said core means.

12. Lyophilization apparatus, comprising:

container means for receiving a lyophilizable material;

core means insertable into the container means for displacing the lyophilizable material into that space between opposed surfaces of the container means and core means, outer surfaces of the core means being congruent with inner surfaces of the container means, the core means being deformable on freezing of the lyophilizable material to form a frozen shell of lyophilizable material; and

,

sheath means receivable over the core means for facilitating release of the core means from the frozen shell of lyophilizable material.

13. The apparatus of claim 12 wherein the core means is hollow.

14. The apparatus of claim 12 wherein the core means is inflatable.

15. The apparatus of claim 12 and further comprising:

cap means attached to the core means for closing the container means.

16. The apparatus of claim 12 wherein the core means is formed of a compressible material which is continuous throughout said core means.

17. Apparatus for forming a lyophilizable material into a shell-like conformation wherein the material can be frozen in said conformation and wherein the surface area of the material frozen within the apparatus is increased without damage to the apparatus which could be occasioned by expansion of the lyophilizable material on freezing thereof, comprising:

container means for receiving a lyophilizable material;

deformable core means insertable into the container means for displacing the lyophilizable material into that space between opposed surfaces of the container means and core means, the core means being deformable on freezing of the lyophilizable material to form a frozen shell of lyophilizable material; and

,

sheath means receivable over the core means for facilitating release of the core means from the frozen shell of lyophilizable material.

18. The apparatus of claim 17 wherein the core means is tapered in conformation.

19. The apparatus of claim 17 wherein the core means is hollow.

20. The apparatus of claim 17 wherein the core means is inflatable.

21. The apparatus of claim 17 wherein the core means is formed of a compressible material which is continuous thorughout said core means.

22. The apparatus of claim 21 wherein the core means is formed of a compressible foam material.

23. The apparatus of claim 17 and further comprising:

cap means attached to the core means for closing the container means.

24. The apparatus of claim 17 wherein outer surfaces of the core means are congruent with inner surfaces of the container means.

25. Apparatus for forming a lyophilizable material into a shell-like conformation wherein the material can be frozen in said conformation and wherein the surface area of the material frozen within the apparatus is increased without damage to the apparatus which could be occasioned by expansion of the lyophilizable material on freezing thereof, comprising:

container means for receiving a lyophilizable material; and

,

deformable core means insertable into the container means for displacing the lyophilizable material into that space between opposed surfaces of the container means and core means, the core means being formed of a compressible material which is continuous throughout said core means, the core means being deformable on freezing of the lyophilizable material to form a frozen shell of lyophilizable material.

26. The apparatus of claim 25 wherein the core means is formed of a compressible foam material.

27. the apparatus of claim 25 and further comprising:

sheath means receivable over the core means for facilitating release of the core means from the frozen shell of lyophilizable material.

28. The apparatus of claim 25 and further comprising:

cap means attached to the core means for closing the container means.

29. The apparatus of claim 25 wherein outer surfaces of the core means are congruent with inner surfaces of the container means.

30. The apparatus of claim 26 wherein the core means is tapered in conformation.

31. The apparatus of claim 25 wherein the core means has a corrugated pattern formed in a surface facing a surface of the container means to increase the surface area of frozen material formed between the core means and the container means.

32. A method for forming a lyophilizable material into a frozen shell to thereby increase the surface area of the lyophilizable material and to prevent damage to a container within which the lyophilizable material is frozen, comprising the steps of:

placing a quantity of a lyophilizable material into a container within which the lyophilizable material is to be frozen;

inserting a deformable core element into the container to displace at least a portion of the lyophilizable material into that space between opposed surfaces of the container and the core element;

subjecting the assembly of container and core element to conditions sufficient to freeze the lyophilizable material, the core element being deformed on freezing of the lyophilizable material to prevent damage to the container;

removing the core element from the container while maintaining the lyophilizable material is a frozen condition; and

,

subjecting the frozen lyophilizable material to conditions sufficient to lyophilize said material.