Labonce Labonce-250FT Precision Temperature and Humidity Controlled Stability Chamber

Overview

The Labonce Labonce-250FT is a precision-engineered temperature and humidity controlled stability chamber designed explicitly for long-term pharmaceutical stability testing in compliance with international regulatory frameworks. It operates on a dual-control principle—simultaneous regulation of air temperature and relative humidity via independent refrigeration, heating, and humidification subsystems—ensuring thermodynamic equilibrium within the test chamber under dynamic load conditions. Engineered for GMP and cGMP environments, the system meets the stringent environmental control requirements outlined in ICH Q1 series guidelines (Q1A–Q1E, 2003 revision) and the Chinese Pharmacopoeia (2020 Edition), supporting real-time monitoring, data integrity, and full traceability throughout the product lifecycle.

Key Features

• Triple-tier user access control with role-based authentication (Administrator, Supervisor, Operator), enforced via encrypted username/password login and session timeout protocols
• FDA 21 CFR Part 11-compliant audit trail functionality: all system events—including parameter changes, door openings, alarm triggers, and user logins—are timestamped, immutable, and exportable to USB in read-only PDF or CSV format
• Tri-directional bottom airflow design ensures uniform thermal and hygrometric distribution; validated temperature uniformity ≤ ±0.5 °C and humidity uniformity ≤ ±2.0 %RH across the entire 250 L working volume
• High-density polyurethane foam insulation (≥120 mm thickness, closed-cell structure) minimizes thermal bridging and moisture migration, delivering exceptional thermal retention and humidity stability
• Corrosion-resistant interior constructed entirely from mirror-finish AISI 304 stainless steel; exterior finished with electrostatically applied epoxy-polyester powder coating for durability and cleanroom compatibility
• 7-inch full-color programmable touchscreen controller with intuitive GUI, multi-segment ramp-soak programming, and real-time graphical display of setpoints vs. actual values
• Dual-door configuration: inner tempered glass door enables visual inspection without compromising chamber integrity; outer solid insulated door maintains thermal/hygrometric isolation and blocks ambient light interference
• Imported hermetic compressor with low-noise scroll technology, coupled with capacitive humidity sensors (±0.8 %RH accuracy, <0.5 %RH/year drift) for high-fidelity RH control

Sample Compatibility & Compliance

The Labonce-250FT accommodates standard pharmaceutical packaging formats—including blister packs, vials, bottles, and sachets—on three adjustable stainless-steel shelves (load capacity: 15 kg/shelf). Its internal geometry (600 × 500 × 830 mm) permits placement of ICH-specified sample arrays while maintaining required air circulation clearance. The chamber satisfies ISO 14644-1 Class 8 cleanroom compatibility when operated in controlled environments and supports validation per IQ/OQ/PQ protocols. All firmware and software components are developed in accordance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available), ensuring readiness for FDA, EMA, and NMPA inspections.

Software & Data Management

The integrated network-capable monitoring platform provides centralized remote supervision of multiple chambers via Ethernet/Wi-Fi. Data logging occurs at user-configurable intervals (1–60 min), with local storage (≥12 months’ continuous data at 1-min intervals) and automatic backup to external NAS or cloud-based servers. Electronic records include full metadata (operator ID, instrument ID, calibration status, environmental context), and support digital signature workflows. Optional 21 CFR Part 11 add-on module enables electronic signature enforcement, biometric authentication integration, and automated report generation compliant with USP , ISO/IEC 17025, and Annex 11 requirements.

Applications

• ICH Q1A(R3) accelerated and long-term stability studies (e.g., 40 °C/75 %RH, 25 °C/60 %RH, 30 °C/65 %RH)
• Photostability testing (when used in conjunction with optional UV-filtered lighting modules)
• Excipient compatibility screening under controlled hygrothermal stress
• Reference standard storage under defined climatic conditions (e.g., WHO recommended storage for biologicals)
• Method validation support for dissolution, assay, and impurity profiling under stressed storage conditions
• QC/QA batch release testing in contract manufacturing organizations (CMOs) and API manufacturers

FAQ

Does the Labonce-250FT support IQ/OQ/PQ documentation packages?
Yes—comprehensive validation documentation templates (including protocol drafts, test scripts, and summary reports) are provided as part of the standard delivery package.
Is the humidity sensor calibrated traceable to NIST or equivalent national standards?
All capacitive humidity sensors undergo factory calibration against certified reference hygrometers (NIST-traceable secondary standards); calibration certificates are included with shipment.
Can the system be integrated into an existing LIMS or MES infrastructure?
Yes—the chamber supports Modbus TCP and OPC UA communication protocols, enabling seamless bidirectional data exchange with laboratory information management systems and enterprise resource planning platforms.
What safety mechanisms prevent uncontrolled temperature excursions during power failure?
The unit features redundant overtemperature protection (independent mechanical thermostat + PID-controlled electronic cutoff), low-water cutoff for humidifier, compressor high-pressure/overheat shutdown, and battery-backed real-time clock with alarm memory retention for ≥72 hours.
Is remote firmware update capability available?
Firmware updates are performed securely via signed OTA (Over-The-Air) packages authenticated using SHA-256 digital signatures; updates require administrator-level credentials and generate corresponding audit trail entries.