Sterile Sensor Calibration Packaging for Bioreactor
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Solution Overview
Problem
Bioreactor sensors require recalibration after sterilization, which complicates the process due to the need for maintaining sterility and limits calibration to one-point calibration, affecting measurement reliability.
Innovation Solution
A system comprising calibration and sensor packaging with a sterile connection allows for pre-insertion calibration of sensors using a sterile calibration liquid, enabling two-point calibration without breaching the sterile environment, using a calibration packaging with a sterile connector and an adaptor for connection to the bioreactor.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the sensor is sterilized with the bioreactor, then sterility is maintained, but the sensor calibration is affected and measurement reliability deteriorates
Solution Approach 1:
The sensor is calibrated before sterilization in a controlled environment. The calibration packaging allows the sensor to be calibrated with calibration liquid prior to being exposed to sterilization conditions, thereby preserving measurement accuracy while maintaining sterility through the sterile barrier.
Solution Approach 2:
The calibration packaging acts as an intermediary sterile barrier between the sensor and the external environment. It allows the sensor to be sterilized with the bioreactor while maintaining a controlled internal environment that preserves calibration accuracy, and enables post-sterilization calibration without breaching sterility.
2Reliability
If recalibration is performed inside the bioreactor, then sterility is maintained, but calibration capability is limited to one-point calibration
Solution Approach 1:
The system enables preliminary multi-point calibration to be performed in the calibration packaging before the sensor is inserted into the bioreactor. This preliminary calibration establishes accurate baseline measurements, and the system then allows for additional calibration points to be added after sterilization, achieving comprehensive multi-point calibration while maintaining sterility throughout the process.
3Reliability
If the sensor packaging and calibration packaging are connected through a sterile connection, then sterility is maintained, but device complexity increases
Solution Approach 1:
The sterile connection mechanism serves as an intermediary that links the sensor packaging and calibration packaging while maintaining the sterile barrier. This controlled interface allows for the necessary interactions between components without compromising sterility, and the modular design enables the complex functionality to be achieved through standardized sterile connection protocols.
Data Source
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AI summary
According to an aspect of the present inventive concept there is provided a system for calibration of a sensor for use of the sensor in a bioreactor, said system comprising: a calibration packaging adapted for carrying a sterile calibration liquid and defining a calibration space within the calibration packaging; a sensor packaging comprising a sensor carrier carrying the sensor and an enclosure enclosing a sensor packaging space in which the sensor carrier is arranged, wherein the sensor packaging and the calibration packaging are configured for allowing moving of the sensor carrier to insert the sensor from the sensor packaging space into the calibration space through a sterile connection between the sensor packaging and the calibration packaging; wherein the sensor is adapted to be subject to a calibration measurement when arranged in the calibration space.