METTLER TOLEDO iSense Asset Intelligent Sensor Asset Management Software

Overview

iSense Asset is a dedicated sensor lifecycle management software platform developed by METTLER TOLEDO for intelligent, data-driven stewardship of ISM® (Intelligent Sensor Management) electrodes—primarily pH and dissolved oxygen (DO) sensors—used in regulated bioprocessing, pharmaceutical manufacturing, food & beverage production, and water treatment applications. Built on the ISM digital ecosystem, iSense Asset captures, stores, and interprets real-time and historical sensor metadata—including calibration history, usage time, diagnostic status, temperature exposure, cleaning cycles, and electrochemical performance trends. Unlike conventional logbook-based or manual tracking methods, iSense Asset leverages embedded microelectronics within ISM electrodes to enable traceable, timestamped, and tamper-evident digital records. This architecture supports process analytical technology (PAT) frameworks and aligns with ICH Q8/Q9/Q10 principles by transforming sensor maintenance from reactive replacement to predictive, risk-informed decision-making.

Key Features

• Digital Electrode Identity & Traceability: Each ISM electrode carries a unique electronic ID chip storing manufacturer, model, serial number, production date, and firmware version—automatically read and archived upon USB connection.
• Real-Time Health Monitoring: Displays dynamic indicators such as electrode slope (%), asymmetry potential (mV), response time (t₉₀), and glass membrane resistance—enabling immediate assessment of functional integrity prior to critical measurements.
• Predictive End-of-Life Analytics: Algorithms analyze cumulative exposure metrics (e.g., total hours in process, number of calibrations, thermal stress cycles) to estimate remaining service life and recommend timely replacement—reducing unplanned outages and measurement drift risks.
• Calibration Workflow Integration: Guides users through standardized, audit-ready calibration procedures with configurable pass/fail criteria per USP , EP 2.2.46, or internal SOPs; automatically logs operator ID, ambient conditions, buffer lot numbers, and deviation flags.
• Secure Data Export & Audit Trail: Generates PDF or CSV reports compliant with FDA 21 CFR Part 11 requirements, including electronic signatures, immutable timestamps, and full change history for all sensor-related actions.

Sample Compatibility & Compliance

iSense Asset is exclusively compatible with METTLER TOLEDO ISM-enabled pH and DO sensors—including InPro™ 3250, InPro™ 3100, InPro™ 6950, and VisiFerm® DO Arc series. It supports both standard and high-temperature variants rated for SIP (Steam-in-Place) up to 135 °C and CIP (Clean-in-Place) with aggressive caustic or acidic agents. The software enforces compliance with ISO/IEC 17025 (for testing laboratories), ASTM D1293 (pH of water), and USP Analytical Instrument Qualification. All data handling adheres to GLP and GMP documentation standards, with configurable user roles, password policies, and session timeouts aligned with Annex 11 and EU GMP Annex 11 expectations.

Software & Data Management

The application runs on Windows 10/11 (64-bit) and connects via standard USB 2.0 to ISM electrodes equipped with integrated USB interface modules. No additional hardware drivers are required. Sensor data is stored locally in an encrypted SQLite database with optional synchronization to network file shares or validated LIMS environments via secure SFTP. Version-controlled backups, automatic daily archiving, and granular permission settings (e.g., “View Only”, “Calibrate”, “Admin”) ensure operational continuity and regulatory readiness. Software updates are distributed through METTLER TOLEDO’s validated release channel and include full validation documentation packages (IQ/OQ protocols, URS mapping, and change control records).

Applications

• Bioreactor pH and DO monitoring in monoclonal antibody (mAb) and vaccine manufacturing
• In-line quality control during fermentation, cell culture, and downstream purification
• Environmental monitoring in wastewater treatment plants with fluctuating organic loads
• Batch release testing in sterile injectables where sensor reliability directly impacts product safety
• Technology transfer activities requiring harmonized sensor qualification across multiple sites

FAQ

Is iSense Asset compatible with non-ISM electrodes?
No. iSense Asset requires the embedded electronics and communication protocol of METTLER TOLEDO ISM-certified electrodes. Conventional analog sensors cannot be retrofitted or supported.
Does the software support multi-user environments with role-based access?
Yes. Administrators can define custom roles with configurable permissions for calibration execution, report generation, database backup, and system configuration.
Can sensor data be integrated into a corporate MES or SCADA system?
Via standardized CSV export or OPC UA-compliant middleware (available as an optional add-on module), subject to site-specific validation protocols.
What validation support is provided for regulated industries?
METTLER TOLEDO supplies a complete Validation Support Package including Installation Qualification (IQ), Operational Qualification (OQ), User Requirements Specification (URS), and Risk Assessment documentation—all aligned with GAMP 5 guidelines.
Is cloud deployment supported?
iSense Asset is designed for on-premise installation only; cloud-hosted instances are not offered due to data sovereignty, cybersecurity, and regulatory constraints in pharmaceutical and biotech operations.