Abstract: Container system and method for freezing (and subsequently thawing) a liquid such as a drug substance, such that all containers in a set have a uniform width, hence uniform freeze-path length, in the widthwise direction and perpendicular to major walls of the containers, irrespective of the particular length, height, and volumetric capacity of the various containers in the set. This leads to uniform freezing performance and thereby reduces cryoconcentration. The system also eliminates or reduces ice-bridging, and the potential for containers rupturing during freezing and thawing operations.

Abstract: A lyophilization bag is provided herein for containing a solution in a lyophilizer during lyophilization. The lyophilization bag includes a body having a flexible base member, and a flexible top member. The base member and the top member, collectively, at least partially encompass an interior volume of the body. A first portion of the interior volume is defined between at least portions of the base member and a reference plane located spaced from the at least portions of the base member, the first portion of the interior volume defining a volume corresponding to the initial volume of the solution. A second portion of the interior volume is defined between the reference plane and at least portions of the top member. At least one port defining an opening is in communication with the second portion of the interior volume.

Abstract: The phase-change accommodating rigid fluid container disclosed herein includes a variety of features that protect the container from phase changes of a fluid stored therein. As a result, the container may be in direct contact with the fluid without any flexible membrane or bag there between. For example, the fluid container may include one or more of matched pairs of recesses for physical manipulation of the container, stiffening ribs extending between the recesses, and input/output assemblies acting as inputs for fluid into the container, outputs of fluid from the container, and vents for pressure equalization of the container.

Abstract: Container system and method for freezing (and subsequently thawing) a liquid such as a drug substance, such that all containers in a set have a uniform width, hence uniform freeze-path length, in the widthwise direction and perpendicular to major walls of the containers, irrespective of the particular length, height, and volumetric capacity of the various containers in the set. This leads to uniform freezing performance and thereby reduces cryoconcentration. The system also eliminates or reduces ice-bridging, and the potential for containers rupturing during freezing and thawing operations.

Abstract: The phase-change accommodating rigid fluid container disclosed herein includes a variety of features that protect the container from phase changes of a fluid stored therein. As a result, the container may be in direct contact with the fluid without any flexible membrane or bag there between. For example, the fluid container may include one or more of matched pairs of recesses for physical manipulation of the container, stiffening ribs extending between the recesses, and input/output assemblies acting as inputs for fluid into the container, outputs of fluid from the container, and vents for pressure equalization of the container.

Abstract: The phase-change accommodating rigid fluid container disclosed herein includes a variety of features that protect the container from phase changes of a fluid stored therein. As a result, the container may be in direct contact with the fluid without any flexible membrane or bag there between. For example, the fluid container may include one or more of matched pairs of recesses for physical manipulation of the container, stiffening ribs extending between the recesses, and input/output assemblies acting as inputs for fluid into the container, outputs of fluid from the container, and vents for pressure equalization of the container.

Abstract: The phase-change accommodating rigid fluid container disclosed herein includes a variety of features that protect the container from phase changes of a fluid stored therein. As a result, the container may be in direct contact with the fluid without any flexible membrane or bag there between. For example, the fluid container may include one or more of matched pairs of recesses for physical manipulation of the container, stiffening ribs extending between the recesses, and input/output assemblies acting as inputs for fluid into the container, outputs of fluid from the container, and vents for pressure equalization of the container.