TX-130 Temperature & Humidity Data Logger and Impact Printer

Overview

The TX-130 Temperature & Humidity Data Logger and Impact Printer is an industrial-grade, GLP/GMP-compliant environmental monitoring solution engineered for continuous, traceable recording in regulated laboratory and manufacturing environments. Designed specifically for integration with incubators, stability chambers, drying ovens, and cleanroom HVAC systems, the device employs a calibrated digital temperature and humidity sensor—mounted externally or integrated via standard analog/digital interfaces—to capture time-stamped environmental data. Unlike thermal printers, its 8-pin bidirectional impact printing mechanism ensures archival-grade permanence using plain paper and durable ribbon media (EPSON ERC-09/ERC-22), eliminating fade, heat sensitivity, or UV degradation risks. The unit operates autonomously with internal non-volatile memory capable of storing ≥30 days of data at a default 2-minute logging interval, while supporting real-time USB/RS-232 communication for live monitoring and synchronized archiving.

Key Features

• Impact-based 8-pin dot matrix printing—no thermal paper dependency; supports long-term physical record retention compliant with FDA 21 CFR Part 11 Annex 11 requirements for audit trails.
• Configurable logging parameters: user-defined sampling intervals (1 sec to 24 hrs), alarm thresholds (high/low limits per channel), print frequency (on-change, periodic, or event-triggered), and auto-reset options.
• Modular sensor compatibility: accepts industry-standard digital (Modbus RTU over RS-485) or analog (4–20 mA / 0–5 V) inputs—enabling use with third-party probes without proprietary pairing or firmware reconfiguration.
• Customizable report header/footer: programmable fields include facility ID, instrument serial number, operator name, SOP reference, and calibration due date—ensuring full traceability per ISO/IEC 17025 and WHO TRS 961 Annex 6.
• Low-power architecture: 12 V DC input with 5 W operational draw and 1 W standby consumption—suitable for battery-backed or UPS-integrated deployments in critical infrastructure.
• Physical robustness: compact aluminum-alloy housing (114.6 × 86.6 × 188.2 mm) rated IP20 for indoor lab use; ESD-protected circuitry and optical isolation on serial interfaces.

Sample Compatibility & Compliance

The TX-130 interfaces seamlessly with all major brands of environmental chambers—including Binder, Memmert, Thermo Fisher Scientific, Angelantoni, and Yamato—via standardized analog or Modbus-compatible digital outputs. It meets essential regulatory expectations for raw data integrity under EU GMP Annex 15, USP , and ICH Q5C stability testing guidelines. All printed reports include embedded timestamps, sensor identification codes, measurement units, and uncertainty annotations where applicable. Internal memory logs retain full metadata—including power-on events, configuration changes, and alarm acknowledgments—supporting retrospective GLP audits and 21 CFR Part 11 electronic signature readiness when paired with validated LogView software.

Software & Data Management

STARiTECH LogView v4.x is a validated Windows/macOS application that provides real-time charting, multi-channel overlay analysis, export to CSV/PDF/XLSX, and hierarchical folder-based archiving with SHA-256 file hashing. The software enforces role-based access control (RBAC), audit trail generation (with immutable timestamps and operator IDs), and electronic signature workflows compliant with ALCOA+ principles. Raw binary log files are encrypted during transfer and stored with version-controlled backups. Optional FIPS 140-2 cryptographic modules are available for high-security deployments requiring NIST SP 800-53 alignment.

Applications

• Stability storage monitoring for pharmaceuticals (ICH Q1–Q5), including long-term, accelerated, and intermediate condition studies.
• Environmental validation of cleanrooms (ISO 14644-1), isolators, and aseptic processing suites per EU GMP Annex 1.
• Calibration laboratory temperature/humidity mapping per ISO/IEC 17025 Clause 5.8.2 and ASTM E2877-22.
• Biological safety cabinet and CO₂ incubator performance verification per CLSI M29-A4 and ISO 13738.
• Quality assurance documentation for medical device sterilization cycles (e.g., ethylene oxide, steam autoclave ambient hold phases).

FAQ

Does the TX-130 support wireless connectivity or cloud upload?
No. The device is intentionally designed as a closed-loop, locally auditable system to minimize cybersecurity exposure and ensure deterministic data integrity. Network connectivity is excluded by design per IEC 62443-3-3 SL2 requirements for safety-critical instrumentation.
Can the printer operate without a connected PC?
Yes. All logging, alarming, and printing functions operate fully autonomously after initial configuration via USB or front-panel buttons.
Is the internal clock battery-backed?
Yes. A replaceable CR2032 coin cell maintains real-time clock accuracy for ≥5 years, even during main power loss.
What sensor accuracy levels are supported?
Accuracy depends on the external probe selected—options range from ±0.3 °C / ±2 %RH (Class B) to ±0.15 °C / ±1 %RH (Class A) per ISO 17025-accredited calibration certificates.
How is firmware updated?
Firmware updates are performed offline via signed USB flash drive using LogView’s secure update utility, with SHA-256 hash verification and rollback capability.