testo Saveris 2-T2 WiFi Temperature Data Logger Kit for Refrigerated Storage

Overview

The testo Saveris 2-T2 WiFi Temperature Data Logger Kit is an engineered solution for continuous, compliant monitoring of temperature-critical storage environments—specifically refrigerators and cold rooms used in pharmaceutical, clinical, laboratory, and retail settings. Built upon a dual-channel architecture with two integrated NTC sensors and support for external flat-cable probes, the system operates on validated principles of resistance-based thermal measurement, delivering traceable, time-stamped temperature records aligned with regulatory expectations for cold chain integrity. Unlike manual logging or standalone loggers, the Saveris 2-T2 leverages embedded WiFi connectivity to transmit encrypted measurement data in real time to the testo Cloud—a secure, ISO/IEC 27001-certified infrastructure—enabling remote oversight without physical access to the unit. Its design prioritizes operational continuity: automatic detection of out-of-specification conditions triggers configurable email or SMS alerts, minimizing response latency during equipment failure or door-abuse events.

Key Features

• Dual-channel temperature monitoring with two pre-calibrated, flat-cable NTC probes—engineered for minimal door-gap intrusion and sustained seal integrity in refrigerator doors.
• Included glycol-filled temperature simulation bottles replicate thermal mass of stored products (e.g., vaccines, reagents, biological samples), suppressing transient spikes caused by door openings and reducing false alarms.
• IP65-rated enclosure ensures dust-tight and water-jet resistant operation—suitable for humid or splash-prone environments including pharmacy prep areas and lab cold rooms.
• EN 12830-compliant performance: meets European standard requirements for temperature recording equipment used in refrigerated transport and storage of medicinal products.
• Configurable measurement intervals (1 min to 24 h), alarm thresholds, and hysteresis logic—supporting both GxP-aligned validation protocols and routine QC workflows.
• Onboard memory stores up to 10,000 timestamped readings; local data retention persists during temporary WLAN outages, with automatic sync upon reconnection.

Sample Compatibility & Compliance

The Saveris 2-T2 is validated for use with temperature-sensitive materials requiring stable cold-chain conditions—including but not limited to pharmaceuticals (per USP , EU GDP Annex 9), diagnostic reagents, blood components, and biologics. Its NTC sensor configuration supports direct immersion into glycol simulators or surface-mounting on shelving units, ensuring representative thermal profiling rather than ambient air measurement alone. The system satisfies audit readiness requirements under FDA 21 CFR Part 11 (via optional electronic signature add-on), MHRA guidance, and WHO TRS No. 961 Annex 9. All factory calibration reports are provided with NIST-traceable documentation, and the device supports periodic user verification using certified reference sources.

Software & Data Management

Data acquisition, visualization, and reporting are managed through the web-based testo Saveris Cloud platform—accessible via desktop browser, iOS, or Android application. Users configure individual monitoring zones, define multi-level alarm hierarchies (warning/critical), and generate PDF or CSV reports compliant with internal SOPs or external auditor requests. Audit trails record all user actions—including parameter changes, alarm acknowledgments, and report exports—with immutable timestamps. An open RESTful API enables bidirectional integration with enterprise systems such as LIMS, ERP (e.g., SAP), or CMMS platforms, supporting automated data ingestion and centralized compliance dashboards. Cloud service includes free basic tier hosting (12-month data retention); extended archival and advanced analytics modules are available under subscription.

Applications

• Pharmaceutical manufacturing and distribution: continuous qualification of fridge/freezer units storing APIs, finished dosage forms, and stability study samples.
• Hospital pharmacies and central sterile supply departments (CSSD): monitoring of vaccine refrigerators, blood bank units, and cryopreserved tissue storage.
• Research laboratories: validation of low-temperature incubators, ultra-low freezers (-80 °C), and environmental chambers used in cell culture or assay development.
• Retail pharmacy and supermarket cold chains: compliance with national food safety regulations (e.g., FDA Food Code, EC Regulation 852/2004) for perishable goods.
• Clinical trial logistics: documented temperature history for investigational medicinal products (IMPs) across decentralized trial sites.

FAQ

Is the testo Saveris 2-T2 suitable for freezer applications down to -80 °C?
The logger’s operating range is -30 to +50 °C; however, its external NTC probes (model 0600 9793) maintain accuracy from -50 to +150 °C. When deployed in ultra-low freezers, ensure only the probe—not the main unit—is exposed to sub-zero temperatures.
Does the system meet FDA 21 CFR Part 11 requirements for electronic records?
Out-of-the-box, the Saveris Cloud provides ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate). Full Part 11 compliance—including electronic signatures and audit trail locking—requires activation of the optional “GxP Mode” license.
Can I export raw data directly into Excel or my LIMS without using the cloud interface?
Yes—via the testo Saveris API or scheduled automated exports (SFTP/HTTPS), raw .csv or .xlsx files can be delivered to designated network locations or third-party databases at defined intervals.
What battery type is recommended for operation below -10 °C?
Energizer Ultimate Lithium AA (L91) batteries (part no. 0515 0572) are specified for reliable performance at temperatures as low as -40 °C.
How is calibration verified during routine use?
Users may perform field checks using a calibrated reference thermometer or dry-block calibrator; testo also offers accredited annual recalibration services with full ISO/IEC 17025 certification.