Freeze protective shipping units
AssigneeAmgen Inc.
InventorsHenry E. Schea, III, Kenneth M. Cleary, Jr.
Life of this patent
Estimating the term…
Abstract
Disclosed are shipping and/or storage units for containers of liquid compositions, such as solutions of biologically active proteins, which are susceptible to physicochemical change upon freezing. Preferred container holders have double sidewalls and a freeze indicator adjacent a container-accommodating cavity. A phase change material such as a carboxymethylcellulose gel is disposed in the enclosed space between sidewalls and freezes at a temperature higher than the nucleation temperature of the composition. A freeze indicator provides an irreversible visual signal upon reaching a temperature intermediate the nucleation temperature of the liquid composition and the freezing temperature of the phase change material.
Claims12
A storage unit for containers of a liquid composition susceptible to physicochemical alteration upon freezing, said unit comprising:
- a double-sidewalled container holder including,
- an inner sidewall having formed therein cavity means accommodating the disposition of at least one said container in a position secured against movement,
- an outer sidewall,
- said inner and outer sidewalls of said container holder means defining an enclosed space therebetween and adjacent at least a part of said cavity means;
- a phase change material disposed in and filling at least a portion of said enclosed space adjacent said cavity means, said phase change material having a freezing temperature which is higher than the nucleation temperature of said liquid composition in said container;
- and,
- a freeze indicator means for generating an irreversible visual signal of the attainment, adjacent said cavity means, of a temperature less than the freezing temperature of said phase change material, but no less than the nucleation temperature of said liquid composition.
A freeze protective storage unit for a plurality of containers of an aqueous solution of a biologically active protein susceptible to physicochemical alteration upon freezing, said unit comprising:
- a double-sidewall container holder including,
- an inner sidewall having formed therein a plurality of cavity means accommodating the disposition of a plurality of said containers in a position secured against movement,
- an outer sidewall,
- said inner and outer sidewalls of said container holder means defining an enclosed space therebetween and adjacent said cavity means;
- a phase change material disposed in and filling at least a portion of said enclosed space adjacent said cavity means, said phase change material having a freezing temperature which is higher than the nucleation temperature of the aqueous solution in said containers;
- and
- a freeze indicator means for generating an irreversible visual signal of the attainment, adjacent said cavity means, of a temperature intermediate the freezing temperature of said phase change material and the ice nucleating temperature of said aqueous solution.
Dependencies are inferred from the claim text.