System for scale-down the processes of freezing and thawing aqueous solutions of thermo-sensitive pharmaceuticals
Inventors
SILVESTRE DUARTE, Andreia Filipa • SENA REGO, Pedro Gil • DE BRITO ESTRELA, Rui
Assignees
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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.
Core Innovation
The invention relates to a scale-down system for freezing and thawing aqueous liquid mixtures of thermo sensitive substances, configured for replicating conditions of a large-scale container. The large-scale container includes a head-space and a liquid-space with a substantially constant transversal cross-section area in the liquid-space that does not change more than 20% with height, and that holds a volume of liquid at a height of liquid. The large-scale container further has a transversal cross-section area that does not change substantially with height and a lateral heat transfer area in contact with the liquid-space, with an equivalent radius (RL) defined as 2ATL/(ALL/HL).
The scale-down system comprises a scale-down container, a holder for holding the scale-down container, and an insulator, where the holder is outwardly surrounded by the insulator. The insulator insulates at least 50% of the lateral walls of the scale-down container, and heat transfer of the scale-down container is equivalent to heat transfer of the large-scale container. The scale-down container 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, holds a volume of liquid (VM) for a height of liquid (HM), and has a lateral active heat transfer area (ALM) with an insulated lateral area (ALIM).
The scale-down container has an equivalent radius (RM) defined as 2ATM/(ALM/HM) which is equal to the equivalent radius of the large-scale container, and the ALIM is equal to or greater than the ALM. The disclosed embodiments refine replication by additionally matching geometry and thermal characteristics, including optionally matching liquid heights (HM≈HL) and equivalent radii (RM≈RL).
Claims Coverage
The independent claim set centers on a single independent claim (clm-00001), which specifies a scale-down system architecture and heat-transfer equivalence to a large-scale container. Dependent claims refine this system by adding quantitative thermal-transfer constraints, specific component materials, and further matching conditions.
Scale-down system configured to replicate large-scale freezing and thawing conditions
A scale-down system for freezing and thawing aqueous liquid mixtures of thermo sensitive substances, configured for replicating conditions of a large-scale container, where the large-scale container has a head-space and a liquid-space with a substantially constant transversal cross-section area in the liquid-space that does not change more than 20% with height, holds a volume of liquid (VL) at a height of liquid (HL), and has a lateral heat transfer area (ALL) in contact with the liquid-space, with an equivalent radius (RL) defined as 2ATL/(ALL/HL).
Insulated holder achieving equivalent heat transfer between scale-down and large-scale containers
The scale-down system comprises a scale-down container, a holder for holding the scale-down container, and an insulator, where the holder is outwardly surrounded by the insulator such that the insulator insulates at least 50% of the lateral walls of the scale-down container and such that heat transfer of the scale-down container is equivalent to the heat transfer of the large-scale container.
Equivalent-radius matching using lateral active heat transfer area and insulated lateral area
The scale-down container has a head-space and a liquid-space with a substantially constant average transversal cross-section area (ATM) in the liquid-space that does not change substantially with height, holds a volume of liquid (VM) for a height of liquid (HM), has a lateral active heat transfer area (ALM) having an insulated lateral area (ALIM), an equivalent radius (RM) defined as 2ATM/(ALM/HM) which is equal to the equivalent radius of the large-scale container, and has an ALIM that is equal or greater than the ALM.
Overall, the claims cover a scale-down freezing/thawing system that replicates a large-scale container by matching head-space and liquid-space geometry and by enforcing heat-transfer equivalence through insulator placement and an equivalent-radius relationship based on lateral heat transfer areas and liquid heights.
Stated Advantages
Replicating heat-transfer conditions of a large-scale container for freezing and thawing aqueous liquid mixtures of thermo sensitive substances.
Achieving equivalent heat transfer between the scale-down container and the large-scale container by insulating and equivalence-based thermal geometry.
Documented Applications
Freezing and thawing aqueous liquid mixtures of thermo sensitive substances using a scale-down system configured to replicate a large-scale container’s conditions.
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