Biocontainer Temperature Sensing for Uniform Biomaterial Freezing
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Solution Overview
Problem
Current cryopreservation methods for biopharmaceutical materials face challenges such as non-uniform freezing rates leading to denaturation and lack of real-time temperature monitoring during freezing, thawing, and transit, which can result in material degradation and loss of efficacy.
Innovation Solution
Integration of a pre-sterilized temperature sensor within biopharmaceutical containers using Silicon on Insulator (SOI) technology, capable of wireless data transmission and storage, to monitor and ensure uniform temperature profiles during freezing, thawing, and transit, with a sensor attachment mechanism that maintains sterility and flexibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If biopharmaceutical materials are frozen using traditional cryopreservation methods, then degradation and microbial contamination are reduced, but non-uniform freezing rates cause denaturation and aggregation of the material
Solution Approach 1:
The patent implements feedback control by placing temperature sensors within or adjacent to biocontainers to monitor temperature in real-time. The freezer system uses this feedback data to adjust cooling rates dynamically, ensuring uniform freezing throughout the sample and preventing denaturation caused by non-uniform temperature distribution.
Solution Approach 2:
The patent changes the freezing parameters by controlling the cooling rate to fall within a specific range (e.g., 0.1-10°C per minute) based on the physical and chemical properties of the biopharmaceutical material. This optimized parameter control prevents both rapid freezing (which causes ice crystal formation) and slow freezing (which causes solute diffusion and pH shifts).
2Measurement precision
If custom freezers with integral temperature sensors are used, then temperature monitoring during freezing is improved, but system cost and complexity increase
Solution Approach 1:
The patent divides the monitoring function into independent modular temperature sensors that can be attached to individual biocontainers. Each sensor operates independently and can communicate wirelessly, allowing precise monitoring of each container without requiring a complex centralized control system for the entire freezer.
Solution Approach 2:
The patent uses universal temperature sensors that can be applied to multiple different types of biocontainers regardless of size or shape. These sensors serve multiple functions including temperature monitoring, data logging, and wireless communication, eliminating the need for different sensor types for different container configurations.
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 provides real-time monitoring and ensures the integrity of biopharmaceutical materials by maintaining uniform temperature profiles, reducing denaturation and aggregation, and enabling validation of freezing and thawing processes, thus enhancing the stability and efficacy of biopharmaceuticals.
Implementation Method 1
a pre-installed and pre-sterilized temperature sensor
Implementation Method 2
The preservation of biopharmaceutical materials is essential in the manufacture and storage of these productions. One traditional method used to preserve these pharmaceutical materials is through freezing
Data Source
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.