Biopharma Freezing Holder With Heat Transfer Pockets
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Solution Overview
Problem
Current methods for freezing, storing, and thawing biopharmaceutical materials often result in container damage due to volumetric expansion, handling errors, and inadequate temperature control, leading to product loss and increased costs from using robust but expensive equipment.
Innovation Solution
A system comprising a container and holder with integrated heat transfer members that actively control temperature, using a holder with pockets to distribute heat transfer fluid and minimize pressure on flexible containers, providing structural support and protection during freezing and thawing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If flexible containers are used for freezing biopharmaceutical materials, then handling and storage flexibility is improved, but container damage risk increases due to volumetric expansion and handling errors
Solution Approach 1:
The patent applies beforehand cushioning by providing structural support to flexible containers before freezing occurs. The container support structure is designed to accommodate volumetric expansion and prevent damage before it happens, rather than trying to repair damage after it occurs. This resolves the contradiction by maintaining both handling flexibility and container integrity during the freezing process.
Solution Approach 2:
The patent utilizes flexible containers (shells and films) that can deform to accommodate volumetric expansion during freezing without rupturing. These flexible structures are designed with appropriate thickness and material properties to withstand the freezing process while maintaining containment, thus preserving both ease of operation and reliability.
2Temperature
If robust equipment is used for freezing and thawing, then temperature control is improved, but equipment cost increases significantly
Solution Approach 1:
The patent employs disposable or single-use container support structures that are inexpensive to manufacture. Rather than investing in expensive, robust, reusable equipment, the solution uses low-cost support structures that are discarded after use, thereby achieving adequate temperature control without significant capital investment.
Solution Approach 2:
The patent introduces an intermediary container support structure that mediates between the flexible container and the freezing/thawing environment. This intermediary provides the necessary structural support and temperature control interface without requiring expensive specialized equipment, thus resolving the contradiction between temperature control and equipment cost.
3Loss of substance
If rapid thawing is performed, then product loss is reduced, but temperature control difficulty increases
Solution Approach 1:
The patent applies preliminary action by providing structural support to containers before thawing begins. This pre-positioned support structure enables rapid thawing to proceed safely without requiring complex real-time temperature control systems during the thawing process itself, thus reducing product loss while avoiding increased device complexity.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system effectively prevents container damage, maintains product quality by controlling temperature, and reduces costs through the use of cost-effective, flexible holders and heat transfer members, enhancing the handling and storage of biopharmaceutical materials.
Implementation Method 1
The heat transfer member actively controls the temperature of biopharmaceutical materials held in the container
Implementation Method 2
the volumetric expansion of the biopharmaceutical materials during freezing could generate excessive pressure in an over filled bag or in a pocket of occluded liquid adjoining the bag material
Data Source
AI summary
A system for use in freezing, thawing, transporting or storing biopharmaceutical materials which includes a container, a holder and plurality of heat transfer members. The container is configured to hold biopharmaceutical materials therein. The holder has a cavity for receiving the container and includes an interior surface bounding the cavity. A plurality of pockets contact outer surfaces of the container and is received in the cavity. Each pocket of the plurality of pockets includes a pocket cavity. A heat transfer member actively controls the temperature of biopharmaceutical materials held in the container and is received in the pocket cavity.