Single-Use pH Sensor Connector With Retractable Wet Storage
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Solution Overview
Problem
Conventional pH sensors are not compatible with single-use bioreactor systems, as they require sterilization methods that can damage their components and need two-point calibration, leading to performance degradation and a short shelf life, which is inadequate for the longer usage requirements in single-use bioprocessing.
Innovation Solution
A single-use pH sensor designed for compatibility with Gamma irradiation sterilization, featuring a retractable fluid chamber for wet storage of sensing components, eliminating the need for two-point calibration and extending shelf life to two years with high accuracy and stability, and a fixed position sensor with no O-ring connection for downstream applications to maintain functionality under high pressures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional pH sensors are sterilized using autoclaving, steam-in-place, or clean-in-place procedures, then they can be used in bioreactor systems, but they require two-point calibration which adds complexity and they have a one-year shelf life due to glass aging
Solution Approach 1:
The sensor is pre-calibrated during manufacturing before sterilization and packaging. This preliminary calibration eliminates the need for two-point calibration by the end user, reducing operational complexity while maintaining measurement accuracy. The sensor arrives ready-to-use with factory-set calibration parameters.
Solution Approach 2:
The sensor includes an integrated storage solution with buffer solution that maintains the sensing glass in optimal condition automatically. This self-maintenance mechanism preserves calibration accuracy over time without requiring external intervention or complex calibration procedures by the user.
2Reliability
If conventional pH sensors are sterilized using autoclaving, steam-in-place, or clean-in-place procedures, then they can be used in bioreactor systems, but the sterilization processes damage sensing components and lead to performance degradation
Solution Approach 1:
The sensor is designed to withstand Gamma irradiation sterilization (25-50 kGy) which operates at different physical parameters (ionizing radiation) compared to thermal sterilization methods. This parameter change in sterilization approach eliminates thermal damage to the sensing glass and other components while achieving effective sterilization.
Solution Approach 2:
The sensor is designed as a single-use disposable component that is pre-sterilized via Gamma irradiation. This eliminates the need for repeated sterilization cycles that would damage the sensor, as each sensor is used once and then disposed of, ensuring consistent performance without exposure to damaging sterilization processes after manufacturing.
3Duration of action of moving object
If conventional pH sensors are used in single-use bioreactor systems, then they can monitor pH in bioreactors, but they have a one-year shelf life which is inadequate for longer usage requirements in downstream applications
Solution Approach 1:
The sensor is pre-filled with buffer solution in a retractable storage chamber before sterilization and packaging. This preliminary preparation ensures the sensing glass is immediately protected upon activation, preventing drying and degradation during storage and handling, thereby extending functional shelf life to match or exceed the two-year requirement for downstream applications.
Solution Approach 2:
The buffer solution in the storage chamber continuously maintains the sensing glass in a hydrated, stable state throughout the sensor's shelf life. This continuous protective action prevents glass aging and performance degradation, enabling the sensor to maintain reliability for two years or longer, matching the shelf life requirements of single-use bioprocessing systems.
Data Source
AI summary
A process fluid connector for a single-use process fluid sensing system is provided. The process fluid connector includes a pair of process fluid connections, each process fluid connection being configured to couple to a cooperative process fluid coupling. A process fluid conduit section is operably coupled to each of the process fluid connections. A sensor attachment port is coupled to the process fluid conduit section and is configured to receive and mount a process fluid sensor. A retractable fluid chamber is coupled to the process fluid conduit section and configured to provides wet storage for sensing component(s) of the process fluid sensor. A process fluid sensing system using the process fluid connector is also provided.