ALISN THA 760 Temperature and Humidity Controlled Environmental Test Chamber

Overview

The ALISN THA 760 is a high-stability upright environmental test chamber engineered for precise, long-duration temperature and humidity control in regulated laboratory and industrial quality assurance environments. It operates on the principle of closed-loop thermodynamic regulation—combining inverter-driven refrigeration, resistive heating, and steam-based humidification—to maintain user-defined climatic conditions within tightly bounded tolerances. Its design adheres to core requirements for stability-critical applications including pharmaceutical stability testing (ICH Q1–Q5), accelerated aging per ASTM D4332 and ISO 22309, material hygrothermal cycling, and bioburden validation studies. The chamber’s structural integrity, thermal mass optimization, and monolithic polyurethane insulation (≥120 mm) collectively minimize external thermal load interference, enabling consistent performance across ambient conditions from 5 °C to 35 °C.

Key Features

• Inverter-controlled SECOP (Danfoss) hermetic compressor and EBM axial condenser fan—enabling frost-free continuous operation, reduced energy consumption (≥40% lower than conventional units), and rapid recovery (<15 min) after door opening
• Capacitive humidity sensor from E+E Electronics and HERAEUS Pt1000 RTD temperature sensors—providing long-term drift stability, no routine calibration requirement, and traceable metrological performance
• 7-inch full-color TFT touchscreen interface with dual-language (English/Chinese) menu navigation and intuitive icon-based workflow guidance
• Multi-point temperature correction algorithm—compensating for spatial non-uniformity across the 1300 × 1180 × 500 mm working chamber without manual probe adjustment
• Dual-door structure: outer insulated door with magnetic seal and inner tempered glass door—enabling real-time visual monitoring without compromising chamber integrity
• Integrated audit trail system storing ≥16,000 timestamped entries (user actions, parameter changes, alarms) with write-once, read-many (WORM) export via USB—supporting GLP/GMP documentation workflows
• Configurable user access hierarchy with five distinct roles (e.g., Operator, Technician, QA Reviewer, Admin, Auditor)—each assignable to specific functions including setpoint modification, data export, and system configuration

Sample Compatibility & Compliance

The THA 760 accommodates diverse sample geometries and packaging formats—including blister packs, vials, trays, and bulk containers—within its 767 L stainless-steel interior (304 grade, electropolished finish). Its internal dimensions (1300 × 1180 × 500 mm) support standard ICH-compliant shelf layouts and permit installation of optional calibrated reference probes per ISO 17025 requirements. The chamber complies with electrical safety standards IEC 61010-1 and EMC directive 2014/30/EU. While not certified to UL or CSA out-of-the-box, its architecture supports third-party validation for FDA 21 CFR Part 11 compliance when deployed with ALISN’s optional secure software package (including electronic signatures, role-based audit logs, and encrypted data storage).

Software & Data Management

Data acquisition and reporting are handled entirely onboard via embedded ARM Cortex-A9 processor running a real-time Linux kernel. All environmental parameters—including chamber setpoints, actual readings, alarm states, and user activity—are logged at user-selectable intervals (1 s to 60 min) into an internal flash memory buffer. Raw datasets are exportable only via physically removable USB drives in CSV format; files are digitally signed and cryptographically hashed to prevent tampering. Historical trend visualization includes overlayable dual-axis plots (temperature/humidity vs. time), deviation heatmaps, and statistical summaries (mean, min/max, standard deviation). Optional PC-based ALISN EnviroLog™ software enables remote monitoring, automated report generation (PDF/Excel), and integration with LIMS via Modbus TCP over RS485.

Applications

• Pharmaceutical stability testing per ICH Q1A(R3), Q5C, and USP , including long-term (25 °C/60% RH), intermediate (30 °C/65% RH), and accelerated (40 °C/75% RH) conditions
• Food product shelf-life modeling under controlled moisture migration scenarios (e.g., cereal crispness retention, confectionery bloom analysis)
• Polymer and composite material conditioning prior to tensile, impact, or dielectric testing per ASTM D618 and ISO 291
• Electronics component reliability screening (e.g., IPC-J-STD-006, JEDEC JESD22-A101) involving combined thermal-hygric stress profiles
• Biological reagent and diagnostic kit storage qualification per CLSI GP35-A4 and ISO 15197:2013 Annex B
• Environmental simulation for packaging validation (ASTM D4332, ISTA 3A/3E)

FAQ

What is the recommended ambient operating environment for optimal THA 760 performance?
The chamber is rated for ambient temperatures between 5 °C and 35 °C; however, stable operation at ≤±2 °C deviation from 25 °C is advised to ensure specified temperature uniformity and humidity accuracy.
Can the THA 760 be validated for GxP-regulated environments?
Yes—the system supports IQ/OQ/PQ protocol execution. Its immutable audit trail, electronic signature-ready firmware (optional), and NIST-traceable sensor calibration paths align with FDA 21 CFR Part 11 and EU Annex 11 expectations.
Is remote monitoring or network integration supported?
Standard RS485/Modbus RTU and optional Ethernet-to-Modbus TCP gateway enable integration with building management systems (BMS) or centralized lab monitoring platforms.
How is data integrity ensured during USB export?
All exported CSV files contain SHA-256 checksums and digital signatures generated at time of export; modification invalidates the signature and triggers verification failure in ALISN EnviroLog™ software.
What maintenance is required for long-term sensor accuracy?
The E+E capacitive humidity sensor and HERAEUS RTD require no field recalibration under normal use; annual verification against NIST-traceable references is recommended per ISO/IEC 17025 clause 6.6.