ALISN THA-250 Temperature and Humidity Controlled Environmental Chamber

Overview

The ALISN THA-250 is a precision-engineered upright temperature and humidity controlled environmental chamber designed for long-term stability-critical applications in pharmaceutical stability testing, food shelf-life validation, polymer aging studies, electronics reliability assessment, and regulatory-compliant material qualification. It operates on the fundamental principle of dual-loop feedback control—separately regulating refrigeration capacity, electric heating output, and steam-based humidification—while maintaining strict thermodynamic equilibrium within the test chamber. Its architecture adheres to ISO 14644-1 cleanroom-compatible airflow design principles, with laminar air distribution ensuring uniform thermal and hygroscopic conditions across the full 250 L working volume. The chamber meets baseline requirements for ICH Q1A(R2), USP , and ASTM E145-22 test environments, supporting both static and dynamic stress protocols under GLP and GMP-aligned operational frameworks.

Key Features

• High-fidelity dual-sensor system: HERAEUS platinum resistance thermometers (Pt100) and E+E capacitive relative humidity sensors ensure traceable, drift-free measurement across the full operating range.
• Variable-speed SECOP (Danfoss) compressor and EBM-Papst EC condenser fan enable precise cooling modulation—eliminating frost accumulation and reducing energy consumption by >40% versus fixed-speed counterparts.
• Monolithic polyurethane foam insulation (≥120 mm thick, closed-cell density >35 kg/m³) delivers superior thermal resistance (U-value ≤0.25 W/m²·K), minimizing ambient heat infiltration and stabilizing internal gradients.
• True-color 7-inch TFT touchscreen with intuitive icon-driven navigation supports multi-segment programmable profiles (up to 99 cycles, 24 steps per cycle), real-time deviation monitoring, and graphical trend overlays.
• Dual-door structure: outer insulated door with magnetic seal and inner tempered glass viewport enables visual inspection without compromising chamber integrity or thermal recovery time (<3 min to re-stabilize after 30-sec door opening at 40 °C/75 % RH).
• Comprehensive safety architecture includes redundant over-temperature cutoffs, refrigerant pressure monitoring, automatic water-level detection, and configurable alarm escalation via relay outputs.

Sample Compatibility & Compliance

The THA-250 accommodates standard ISO/IEC 17025-compliant sample racks (three stainless-steel shelves included; load capacity: 30 kg per shelf). Its interior chamber—constructed from electropolished 304 stainless steel—resists corrosion from saline mists, organic solvents, and high-humidity condensate. All materials in contact with the test environment comply with USP Class VI biocompatibility standards. The system supports 21 CFR Part 11–ready operation when integrated with validated third-party LIMS or EMS platforms via its native RS485 Modbus RTU interface. Calibration certificates for temperature and humidity sensors are provided with NIST-traceable documentation, and the unit is pre-configured for IQ/OQ protocol execution per Annex 15 of the EU GMP Guidelines.

Software & Data Management

Data integrity is enforced through hardware-enforced write-once logging: all temperature/humidity readings (recorded at user-selectable intervals from 1 s to 60 min), operator actions, alarm events, and system diagnostics are stored in encrypted, non-volatile memory. The audit trail retains 16,000 chronological entries—including timestamps, user IDs, parameter changes, and acknowledgment status—with cryptographic checksums preventing tampering. Raw datasets export exclusively via USB flash drive in CSV format, retaining original timestamps and metadata tags. Optional ALISN-ChamberLink software (Windows-based) enables remote monitoring, automated report generation (PDF/Excel), and electronic signature workflows compliant with ALCOA+ data governance principles.

Applications

• Pharmaceutical: Accelerated stability testing per ICH Q1A(R2) (e.g., 40 °C/75 % RH for 6 months), photostability screening (when paired with optional UV lamp module), and excipient compatibility studies.
• Food & Beverage: Real-time shelf-life modeling under variable humidity conditions (e.g., 25 °C/60 % RH for baked goods, 30 °C/90 % RH for tropical fruit packaging).
• Materials Science: Thermal cycling of composites, moisture absorption kinetics in hygroscopic polymers (ASTM D5229), and glass transition mapping via controlled ramp-and-soak protocols.
• Electronics: Burn-in testing of PCB assemblies under combined thermal-hygric stress (JEDEC JESD22-A110), conformal coating adhesion validation, and solder paste storage conditioning.
• Academic Research: Reproducible climate simulation for entomology (insect development thresholds), mycology (spore germination assays), and plant physiology (controlled drought stress trials).

FAQ

What is the recommended calibration interval for the THA-250?
Per ISO/IEC 17025 and manufacturer guidance, temperature and humidity sensors should be verified annually using NIST-traceable reference standards; field checks with portable calibrated probes are advised quarterly.
Can the THA-250 operate continuously at −10 °C and 98 % RH simultaneously?
No—maximum humidity is limited to ~85 % RH at −10 °C due to physical dew-point constraints; the control system enforces thermodynamically feasible setpoint combinations automatically.
Is the USB data export function compliant with 21 CFR Part 11?
The local USB export itself is not Part 11–compliant; however, when connected to a validated enterprise system with electronic signatures, role-based access, and audit trail integration, full compliance is achievable.
Does the THA-250 support external humidity control via dry-air purge?
Not natively—the system relies solely on steam humidification and refrigerative dehumidification; dry-air purging requires third-party integration via the RS485 interface and custom logic programming.
What is the maximum allowable ambient temperature for safe operation?
The specified ambient operating range is 5–35 °C; sustained operation above 35 °C may degrade compressor efficiency and extend recovery times, particularly at high-humidity setpoints.