Abstract: This disclosure describes a system for protection of the bottle or carboys during freezing, storage or transport, and thawing. The system described herein is designed to enable high heat transfer rates under certain conditions, thus enabling to freeze or thaw the biopharmaceutical solutions at optimal rates, without disassembling the protective structure. This disclosure describes a system configured to receive a bottle or carboy filled with biopharmaceutical solutions for freezing, transport and thawing. This system comprises five main parts: a lid; a top cover; a multi-shape compatible top holder; a multi-shape compatible bottom holder and a bottom cover. This system has an opening in the bottom below the container that allows air to be driven through the walls of the bottle and through a side vent. The airflow passage in the system, allows the use of the system for freezing (cold air) or thawing (hot air) while providing physical protection.

Abstract: This disclosure relates to a method and system for fast freezing of a biological product (such as blood plasma) contained in an individual bag or a plurality of bags. This disclosure relates to a method and system for freezing plasma in an individual bag or a plurality of bags, favoring bottom-up ice-growth, by implementing a differential air flow on top and bottom surfaces of a horizontally placed bag or bags filled with plasma. This disclosure relates to a method and a differential air flow system for freezing plasma, wherein the heat transfer coefficient on a bottom of a bag is at least 10 times larger than at a top. This disclosure relates to a differential air flow system and method for freezing plasma, wherein the differential air flow on top and bottom surfaces of a plasma bag is imposed by at least one fan or blower.

Abstract: This disclosure relates to a system and method to improve the uniformity of the heat transfer coefficient of containers filled with biological materials during the freezing and thawing process, in particular a system that is easily transported and incremented to other conventional freeze-thaw methods and equipment. The system includes a portable air blast system configured to receive a container filled with biological materials and to be placed in a cooling or heating chamber, for homogeneous and reproducible freezing and thawing of biological materials.

Abstract: This disclosure relates to a system for freezing, transporting, storing and thawing aqueous solutions of biological materials, in particular those used in chemical and pharmaceutical processes. In particular, this disclosure relates to ice-crust attenuator devices to prevent ice-crust formation at the top of the solution. The ice-crust attenuator devices (10) have an internal cavity comprising a phase change material to improve thermal insulation. The ice-crust attenuator device may comprise an internal wall made of a moldable material configured to attain a good thermal contact between the ice-crust attenuator device and the outer surface of the container. In another embodiment, the ice-crust attenuator device is configured to be placed in a refrigerated cavity and in contact with the upper surface of a moldable container, to keep the top of the container under insulated conditions. The ice-crust attenuator device may be connected to a holder to accommodate the moldable container.

Abstract: This disclosure relates to scale-down systems for freezing and thawing aqueous liquid mixtures of thermo sensitive substances. In at least one aspect, the system can comprise a first container that has a head-space and a liquid-space, with a substantially constant average transversal cross-section area in the liquid-space that does not change substantially with height. The first container holds a volume of liquid for a height of liquid, has a lateral active heat transfer area having an insulated lateral area ALIM, and has an equivalent radius sized to reproduce the equivalent radius of a second container. The first container further has a lateral heat transfer area in contact with the liquid-space. The first container is smaller than the second container, and the insulated lateral area is equal to or greater than the lateral active heat transfer area.

Abstract: The present disclosure provides systems and methods for use in freezing liquid mixtures or suspensions containing sensitive substances, such as biopharmaceutical materials, under sterile conditions and in small-volume containers. The disclosed device enables the control of ice nucleation of the solution minoring the layer of volume that freezes, while controlling the ice growth rate in a bottom up geometry, and comprises a heat transfer surface (101) with means to control temperature, a holder (102) for multiple containers (109), pressing means (103) to press the holder against the heat transfer surface and optionally a contact promoting material.

Abstract: This present disclosure describes an apparatus and a method for measuring degradation kinetics of a biomaterial in aqueous solution below the normal freezing temperature. Further includes new systems comprising high-pressure containers with nucleating-locks, a temperature-control holder for the high-pressure containers, a holder for the nucleating-locks and an insulated low-temperature gradient chamber. A method is described comprising several steps such as filling of the high-pressure container with the biomaterial solution to be slightly below freezing temperature, closing of the container with a nucleating-lock, which is below freezing temperature, allowing the container to reach the reaction temperature, removing the container at selected time and bringing it to above freezing temperature and opening the container to recover the biomaterial solution.

Abstract: This disclosure relates to scale-down systems for freezing and thawing aqueous liquid mixtures of thermo sensitive substances. In at least one aspect, the system can comprise a first container that has a head-space and a liquid-space, with a substantially constant average transversal cross-section area in the liquid-space that does not change substantially with height. The first container holds a volume of liquid for a height of liquid, has a lateral active heat transfer area having an insulated lateral area ALIM, and has an equivalent radius sized to reproduce the equivalent radius of a second container. The first container further has a lateral heat transfer area in contact with the liquid-space. The first container is smaller than the second container, and the insulated lateral area is equal to or greater than the lateral active heat transfer area.