testo 190-T2 CFR-Compliant Temperature Data Logger with Rigid Long Probe

Overview

The testo 190-T2 is a purpose-built, CFR-compliant temperature data logger engineered for rigorous thermal validation and monitoring in regulated pharmaceutical manufacturing environments. Designed in accordance with the requirements of FDA 21 CFR Part 11 for electronic records and signatures, this device employs high-stability Pt1000 resistance thermometry to deliver traceable, auditable, and highly reproducible temperature measurements across critical processes—including autoclave sterilization, depyrogenation tunnels, lyophilizer chamber mapping, and stability chamber qualification. Its rigid, 115 mm stainless steel probe (Ø3 mm) enables precise insertion into narrow vessels such as glass vials, ampoules, and stainless steel cans—ensuring representative core temperature acquisition without mechanical deflection or thermal lag. The compact cylindrical form factor (Ø20 × 59 mm) and IP68-rated hermetic sealing allow reliable operation under extreme conditions: immersion in steam, exposure to saturated humidity, and repeated autoclaving cycles up to +140 °C. All internal electronics are fully encapsulated within a passivated stainless steel housing with PEEK polymer end caps, eliminating ingress pathways and ensuring long-term metrological integrity.

Key Features

• CFR-ready architecture: Fully compliant with FDA 21 CFR Part 11 when used with the dedicated testo 190 CFR software—supporting electronic signatures, audit trails, user access control, and data integrity safeguards.
• Rigid probe design: 115 mm length, 3 mm diameter stainless steel probe optimized for insertion into narrow containers and dense product loads; minimizes conduction error and ensures spatial repeatability during qualification studies.
• High-precision Pt1000 sensor: Certified accuracy of ±0.1 °C from –40 to +140 °C and ±0.2 °C at cryogenic temperatures down to –50 °C; resolution of 0.01 °C supports tight process tolerances required by USP , ISO 11137, and EU Annex 1.
• Tool-free battery replacement: Rotational threaded battery cap enables rapid, repeatable, and fully sealed battery exchange—even after hundreds of sterilization cycles—without compromising IP68 integrity or requiring calibration revalidation.
• Configurable sampling interval: Programmable from 1 second to 24 hours via testo 190 CFR software; ideal for both fast-transient events (e.g., steam penetration) and long-duration stability runs.
• Dual battery option: Supports both standard and extended-life lithium 1/2 AA cells; larger cell extends operational life to 2,500 hours under typical sterilization-cycle logging (10 s interval at +121 °C).

Sample Compatibility & Compliance

The testo 190-T2 is validated for direct contact measurement in liquid-filled and dry-load configurations typical of pharmaceutical sterilization validation (e.g., ANSI/AAMI ST79, ISO 17665-1). Its rigid probe maintains mechanical stability inside glass vials (2 mL to 100 mL), stainless steel trays, and aluminum foil-wrapped biological indicators—enabling accurate placement at geometrically defined worst-case locations (e.g., coldest point, center of load). The device meets IEC 60529 (IP68), EN 61000-6-3 (EMC), and RoHS directives. It carries CE marking per EU Medical Device Regulation (MDR) Annex XVI for non-invasive monitoring devices used in GMP environments. All units ship with individual factory calibration certificates traceable to NIST and DKD standards, including as-found/as-left data for IQ/OQ documentation.

Software & Data Management

Data acquisition, configuration, and analysis are performed exclusively through the testo 190 CFR software—a validated application developed to meet ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available). The software supports multi-unit batch programming and parallel readout of up to eight testo 190-T2 loggers via the included multifunctional docking station—eliminating the need for serial interfaces or proprietary readers. Audit trail functionality logs all user actions (e.g., parameter changes, start/stop commands, export events) with timestamps and operator IDs. Export options include CSV, PDF reports with embedded calibration metadata, and XML formats compatible with LIMS and MES integration. Electronic signature workflows comply with 21 CFR Part 11 Subpart B requirements, including role-based permissions and two-factor authentication.

Applications

• Sterilization process validation (steam, dry heat, ethylene oxide)
• Autoclave chamber mapping per ISO 13485 and FDA Guidance for Industry
• Lyophilizer shelf and condenser temperature profiling
• Stability testing chambers (ICH Q1, Q5)
• Cold chain validation for frozen drug products (–50 to –20 °C)
• Depyrogenation tunnel qualification (250–350 °C ramp-down monitoring)
• Media fill simulation temperature monitoring

FAQ

Is the testo 190-T2 suitable for use inside autoclaves during full-cycle sterilization?

Yes. Its stainless steel/PEEK construction, IP68 rating, and validated performance up to +140 °C make it appropriate for direct placement in autoclave loads, including porous and liquid cycles.
Does the device require recalibration after each battery replacement?

No. The hermetically sealed design ensures metrological stability; battery swap does not affect sensor calibration or require requalification.
Can the testo 190-T2 be used for cryogenic applications below –40 °C?

Yes. It maintains ±0.2 °C accuracy down to –50 °C, supporting validation of ultra-low temperature freezers and cold chain logistics.
Is the testo 190 CFR software included with the hardware?

No. The software is sold separately and must be licensed per workstation; it is mandatory for CFR-compliant operation and data evaluation.
What documentation is provided with each unit?

Each testo 190-T2 ships with a factory calibration certificate (traceable to national standards), CE declaration of conformity, user manual, and validation support documentation for IQ/OQ protocols.