Improved biomaterial freezing
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Solution Overview
Problem
Current cryopreservation methods for biopharmaceutical materials face challenges in uniformly monitoring temperature profiles during freezing, thawing, and transit, leading to potential denaturation and degradation due to non-uniform freezing rates and limited monitoring capabilities of existing custom freezers.
Innovation Solution
A biopharmaceutical container with an integrated pre-sterilized temperature sensor using Silicon on Insulator (SOI) technology, equipped with a wireless transmitter and processing unit, allows for real-time monitoring and storage of temperature data, ensuring proper freezing and thawing processes, and providing alerts for integrity verification.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If custom freezers with integral temperature sensors are used to monitor freezing processes, then temperature monitoring capability is improved, but system cost and complexity increase significantly
Solution Approach 1:
The patent uses disposable, inexpensive temperature sensors attached to each biocontainer rather than expensive integral sensors built into the freezer system. Each sensor is a simple, low-cost device that can be discarded after use, eliminating the need for costly, complex integral temperature monitoring systems in the freezer while still providing accurate temperature data for each container.
Solution Approach 2:
The patent introduces an intermediary temperature sensor that attaches to the exterior of the biocontainer rather than being integral to the freezer or requiring direct contact with the contents. This intermediary sensor provides temperature monitoring capability while keeping the freezer system simple and avoiding complex integration requirements.
2Measurement precision
If integral temperature sensors are placed inside or on biocontainers to monitor temperature profiles, then temperature measurement accuracy is improved, but manufacturing complexity and sterilization difficulty increase
Solution Approach 1:
The patent extracts the temperature sensor from the biocontainer manufacturing process itself, placing it on the exterior surface rather than integrating it into the container structure. This allows the sensor to be attached separately and simplifies both container manufacturing and sterilization procedures, as the sensor can be sterilized independently or replaced if needed.
Solution Approach 2:
The patent employs disposable temperature sensors that are attached to the exterior of biocontainers. These sensors are inexpensive and can be discarded after use, eliminating the need for complex, expensive integral sensors that require sophisticated manufacturing and sterilization processes. The disposable nature allows for simple attachment and removal without compromising container integrity.
3Reliability
If multiple temperature sensors are deployed across all biocontainers in a freezer, then monitoring coverage is improved, but system cost increases
Solution Approach 1:
The patent uses inexpensive, disposable temperature sensors that can be attached to every biocontainer without significantly increasing system cost. Each sensor is a low-cost device that provides reliable temperature monitoring, allowing comprehensive coverage across all containers while keeping individual sensor costs minimal and total system cost manageable.
Solution Approach 2:
The patent divides the temperature monitoring system into individual, independent sensors attached to each biocontainer rather than using a centralized, complex monitoring system. This segmentation allows each container to be monitored independently with simple, low-cost sensors, improving overall monitoring coverage while keeping the total system cost low through modular, distributed monitoring.
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 solution enables low-cost, effective monitoring of temperature profiles within each biocontainer during cryogenic processes, ensuring material integrity by preventing denaturation and aggregation, and providing validation tools for freezing profiles, thus enhancing the reliability of biopharmaceutical preservation.
Implementation Method 1
A biopharmaceutical container with an integrated pre-sterilized temperature sensor using Silicon on Insulator (SOI) technology, equipped with a wireless transmitter and processing unit, allows for real-time monitoring and storage of temperature data
Implementation Method 2
equipped with a wireless transmitter and processing unit, allows for real-time monitoring and storage of temperature data
Data Source
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AI summary
The biocontainer of the present invention provides a low cost, simple solution of many of the problems encountered during shipping, freezing and thawing of biopharmaceutical materials. The present invention enables a user to monitor the temperature profile of each biopharmaceutical container during the cryogenic process, so as to ensure the integrity of materials within each biocontainer by using a pre-installed and pre-sterilized temperature sensor. In some embodiments, the sensor assembly includes a wireless transmitter and is capable of transmitting information regarding the measured reading. In other embodiments, the sensor assembly includes a processing unit, which determines whether the temperature profile is acceptable. In a further embodiment, an indicator is included, such that the processing unit may indicate whether the biopharmaceutical material has been properly frozen. In other embodiments, the sensor assembly also includes a storage element, which is capable of storing various parameters during the freezing process.