Understanding Single-Use pH Sensors in Modern Bioprocessing
The biopharmaceutical industry is continuing to move toward single-use technologies (SUTs) that dramatically reduce contamination risks while increasing operational flexibility. Single-use pH sensors provide accurate pH measurement in bioprocess bags and other devices, with reliable measurement performance that helps optimize processes for the production of monoclonal antibodies, vaccines, and components for cell and gene therapies.
Unlike traditional reusable sensors that require cleaning, sterilization, and recalibration between batches, single-use pH sensors are directly integrated into the single-use process device by the device supplier and cannot be taken out and replaced. The complete SUB assembly, including the single-use pH sensor, is gamma irradiated and shipped pre-sterilized to the biopharmaceutical producer.
Why Analog Disposable pH Sensors Matter
Analog disposable pH sensors represent a critical advancement in bioprocess monitoring. These sensors must withstand gamma sterilization while maintaining measurement accuracy throughout extended batch processes. These single-use format pH sensors are designed for long-term stability in single-use bioreactor bag applications.
Traditional approaches required operators to insert reusable sensors into single-use bags, creating potential contamination points and requiring complex sterilization procedures. Single-use sensors eliminate these risks by arriving pre-sterilized and factory-calibrated, ready for immediate deployment.
Mettler Toledo's Game-Changing Solution: InSUS 310i and InSUS H30i
The InSUS 310i: First Digital Single-Use pH Sensor
The InSUS 310i from METTLER TOLEDO is the world's first disposable pH sensor in digital format. Analog, disposable pH sensors integrated into single-use bioreactors do not offer the same reliable measurement performance, convenient operation, and electronic documentation features as reusable digital sensors.
Key advantages of the InSUS 310i include:
- Extended Shelf Life: The InSUS 310 single-use pH sensor is designed for integration into single-use bags. Its 30-month shelf life enables enhanced bag inventory control at both bag manufacturer and end-user sites, compared to sensors with shorter shelf lives.
- Robust Design Protection: The glass electrodes of the sensor are shielded against damage during transport and bag preparation by round-edged protective guards. To maintain bag purity, a protective coating on the reference electrode prevents the release of electrolytes into the bag during storage and transport.
- Proven Measurement Technology: The measurement principle of the InSUS 310 single-use pH sensor is based on proven pH glass technology, offering identical reliability and accuracy as reusable pH sensors.
The InSUS H30i: Reusable Intelligence for Single-Use Applications
The InSUS H30i reusable sensor head works in conjunction with the InSUS 310i to deliver unprecedented capabilities. The reusable sensor head is operated in conjunction with the InSUS 310i and is ISM (Intelligent Sensor Management) ready. ISM is Mettler Toledo's digital sensor platform, enabling advanced diagnostics, predictive maintenance, and seamless integration with asset management systems, as well as single-use pH sensors. The sensor head has no product contact surfaces and does not require heat sterilization before being combined with an InSUS 310i sensor.
This innovative design separates the intelligent electronics from the single-use measuring element, providing:
- Seamless Integration: For standardized integration into process control equipment, the InSUS H30i offers identical connectivity options as a reusable InPro pH ISM sensor.
- Automatic Configuration: With ISM's Plug and Measure feature, the sensor head is automatically recognized for fast and trouble-free transmitter self-configuration.
- Electronic Documentation: The InSUS H30i is compatible with our ISM Core software for generating electronic documentation for InSUS 310i sensors used in your processes.
Why Operators and Quality Managers Prefer Mettler Toledo's Solution
Enhanced Signal Reliability
This digital sensor's signal is resistant to interference and noise, providing highly reliable measurements for sustaining process consistency. This combination yields a digital measurement solution that is resistant to electronic interference and noise, resulting in more accurate and reliable pH measurements.
Traditional analog sensors are susceptible to signal degradation over long cable runs and electromagnetic interference from surrounding equipment. Mettler Toledo's digital solution eliminates these concerns through robust digital signal transmission.
Intelligent Sensor Management (ISM) Technology
The true game-changer lies in Mettler Toledo's ISM technology. The solution features METTLER TOLEDO's Intelligent Sensor Management (ISM™) technology, which enables efficient sensor management and generation of electronic documentation, abilities that operators and quality managers will appreciate in the biopharmaceutical industry.
ISM provides operators with unprecedented insight into sensor performance:
- Predictive Diagnostics: ISM sensors are digital analytical sensors from METTLER TOLEDO that utilize Intelligent Sensor Management technology to provide predictive diagnostics, enhancing maintenance operations. This technology delivers a strong and reliable measurement signal to prevent interference, as well as rapid commissioning and startup, thereby reducing downtime.
- Proper Predictive Maintenance: While most digital sensors offer some diagnostics, often, these are based on counters and are not truly predictive diagnostics. ISM sensors provide diagnostic information on the remaining days, enabling maintenance teams to assess sensor health easily.
- Regulatory Compliance: ISM sensors, when used with ISM Core CFR, are fully technically compliant with 21 CFR Part 11 and EudraLex Volume 4 Annex 11.
Operational Excellence Benefits
Quality managers particularly value several key aspects:
- Inventory Management: For single-use bag manufacturers, the InSUS 310i pH sensor can be safely and easily integrated into bioreactor bags. Long sensor shelf life facilitates enhanced bag inventory control at bag manufacturer and end-user sites.
- Process Consistency: Digital sensors with ISM continuously monitor their condition and, using advanced algorithms, predict when calibration, maintenance, or replacement will be required. These diagnostic tools significantly reduce calibration and maintenance time and effort.
- Risk Mitigation: Uncertainty about whether a sensor is measuring accurately. Not knowing if a sensor is suddenly going to fail during the process. Sensor measurements that fluctuate due to electromagnetic interference from surrounding equipment. ISM technology addresses all these critical concerns.
Economic Advantages
ISM technology can have various benefits to production, including increased process reliability, reduced risks to operators, and lower overall annual costs. The combination of extended sensor life, predictive maintenance capabilities, and elimination of unplanned downtime creates substantial cost savings.
Backward Compatibility: The digital InSUS 310i is backward compatible with its analog, industry-proven version, InSUS 310. This enables an easy retrofit of your existing hardware to benefit from ISM technology.
The Future of Bioprocess Analytics
Many customers have requested a technology transfer of our digital ISM concept for reusable sensors to sensors in a single-use format. Mettler Toledo's response demonstrates their commitment to innovation in bioprocess analytics.
The InSUS 310i and H30i combination represents more than just technological advancement—it embodies a paradigm shift toward intelligent, connected bioprocessing. ISM sensors provide valuable input into Industry 4.0 and IIoT schemes and systems. Sensor diagnostic data can be sent directly to your higher-level asset management systems, driving the management of maintenance programs and the ordering of replacement equipment.
Mettler Toledo's InSUS 310i single-use pH sensor and InSUS H30i reusable sensor head combination deliver unparalleled advantages in biopharmaceutical manufacturing. From the 30-month shelf life and gamma-sterilization compatibility to the advanced ISM technology, which provides predictive diagnostics and electronic documentation, this solution addresses every primary concern of operators and quality managers.
The transition from analog to digital single-use pH measurement represents a fundamental improvement in bioprocess control, offering enhanced reliability, simplified operations, and comprehensive regulatory compliance support. For biopharmaceutical manufacturers seeking to optimize their single-use processes while maintaining the highest quality standards, Mettler Toledo's solution sets the industry benchmark.
