Labonce Labonce-80000GS Walk-in Pharmaceutical Stability Chamber
| Brand | Labonce |
|---|---|
| Model | Labonce-80000GS-FC |
| Temperature Range | 20–45°C (±0.5°C uniformity, ±1.0°C deviation) |
| Humidity Range | 20–80% RH (±3.0% RH deviation) |
| Internal Volume | 80,000 L |
| Internal Dimensions (W×D×H) | 5800 × 6400 × 2200 mm |
| External Dimensions (W×D×H) | 6000 × 6600 × 2400 mm |
| Power Requirement | 10.5 kW |
| Compliance | GB/T 10586-2006, JJF 1101-2019, ICH Q1–Q5, Chinese Pharmacopoeia 2020 Edition |
| Control System | 7-inch color touchscreen with triple-level user authentication, audit trail, and FDA 21 CFR Part 11–compliant data management options |
| Refrigeration | Dual redundant imported compressors with inverter-driven FC-series energy-saving configuration (≥50% reduction vs. conventional units) |
| Humidity Sensor | Imported capacitive RH sensor (low drift, maintenance-free) |
| Safety | Keyed door lock with anti-jamming mechanism, internal emergency stop button, multi-layer fault protection, remote SMS alerts for deviation, power loss, and low water level |
| Data Output | Built-in thermal printer + internal electronic storage + USB export (immutable file format) |
| Monitoring Points | ≥2 validated critical monitoring locations (temperature & humidity worst-case mapping) |
Overview
The Labonce Labonce-80000GS Walk-in Pharmaceutical Stability Chamber is an engineered environmental test system designed specifically for long-term, real-time stability studies of pharmaceutical products under ICH Q1A(R3), Q5C, and Q5E guidelines. It operates on the principle of precision-controlled convective air circulation within a thermally insulated, stainless-steel-lined chamber, utilizing dual-stage refrigeration, PID-driven humidification/dehumidification, and high-fidelity feedback loops to maintain rigorously defined temperature and relative humidity setpoints. With a nominal internal volume of 80,000 liters and fully validated spatial uniformity across its 5.8 m × 6.4 m × 2.2 m workspace, this chamber supports full-scale stability batches—including palletized cartons, clinical trial supply kits, and secondary packaging—without requiring sample rotation or repositioning. Its architecture complies with GMP Annex 15 requirements for qualification (IQ/OQ/PQ), and all control logic is traceable to documented calibration standards per JJF 1101-2019 and GB/T 10586-2006.
Key Features
- Stainless steel 304 interior construction with anti-slip textured floor plating and double-glazed, heated observation windows to prevent condensation during low-RH operation
- Inverter-driven FC-series refrigeration system delivering ≥50% energy reduction versus fixed-speed equivalents while maintaining ≤±0.5°C temperature uniformity and ≤±3.0% RH deviation across the entire working volume
- 7-inch industrial-grade color touchscreen controller with role-based access control (three-tier permissions), encrypted login, and time-stamped audit trail meeting FDA 21 CFR Part 11 and EU Annex 11 expectations
- Imported capacitive humidity sensors calibrated to NIST-traceable standards, offering <0.5% RH long-term drift over 5 years and zero routine maintenance requirements
- Dual-redundant compressor architecture with automatic failover, ensuring uninterrupted operation during scheduled maintenance or unexpected component failure
- Comprehensive alarm infrastructure: local audible/visual alerts, remote SMS notifications for out-of-spec conditions (temperature/humidity deviation, power interruption, low reservoir level), and configurable email escalation protocols
- Integrated safety systems including keyed entry with anti-lockout function, internal emergency stop button, over-temperature/over-humidity cutoffs, and electrical ground-fault protection
Sample Compatibility & Compliance
The Labonce-80000GS accommodates diverse pharmaceutical product formats—including blister packs, vials, syringes, bottles, sachets, and bulk containers—without compromising environmental integrity. Its large internal footprint allows for stratified placement according to ICH Q5C recommendations, enabling simultaneous evaluation of multiple formulations or packaging configurations. The chamber has been pre-qualified against ISO 14644-1 Class 8 cleanroom-compatible airflow patterns and supports post-installation validation per ASTM E2297-22 (Standard Guide for Validation of Environmental Chambers). All firmware and calibration documentation are structured to satisfy regulatory submissions to the US FDA, EMA, PMDA, and NMPA. Optional network server integration enables centralized fleet management across multiple chambers while retaining individual device-level compliance with 21 CFR Part 11 electronic record and signature requirements.
Software & Data Management
Data integrity is maintained through a dual-path architecture: real-time thermal printing provides immediate hardcopy records, while embedded flash memory stores second-by-second temperature and humidity logs for ≥12 months at default sampling intervals (adjustable from 1 s to 60 min). Export functionality supports USB transfer of tamper-evident .csv or .pdf files with digital signatures and SHA-256 hash verification. The controller firmware includes built-in GLP/GMP mode, which enforces mandatory field entries (user ID, reason for change, timestamp) for all parameter modifications. Audit trail entries capture operator identity, action type (e.g., setpoint adjustment, calibration initiation), pre-change and post-change values, and contextual metadata—retained indefinitely unless purged via administrator override with dual-approval workflow. Optional cloud-based data archiving modules provide TLS 1.2–encrypted transmission and role-based web portal access compliant with HIPAA and GDPR data residency rules.
Applications
- ICH-compliant long-term and accelerated stability testing (e.g., 25°C/60% RH, 30°C/65% RH, 40°C/75% RH) for drug substances and products
- Photostability assessment when integrated with optional UV/visible light arrays conforming to ICH Q1B
- Excipient compatibility screening under controlled hygroscopic stress conditions (e.g., 25°C/40% RH, 40°C/25% RH)
- Reference standard storage under pharmacopeial conditions (e.g., USP , EP 2.1.12)
- Process validation support for lyophilization cycle development and cold chain logistics simulation
- Regulatory submission-ready data generation for ANDA, NDA, MAA, and CTD Module 3 dossiers
FAQ
Does the Labonce-80000GS support IQ/OQ/PQ documentation packages?
Yes—comprehensive qualification templates aligned with ASTM E2500 and ISPE GAMP5 are provided, including protocol templates, acceptance criteria checklists, and raw data log examples.
Can the chamber be configured for cold-chain validation (2–8°C)?
Yes—custom low-temperature variants (Labonce-80000GS-CR) are available with extended refrigeration capacity, enhanced insulation, and ±1.0°C temperature uniformity at 2–8°C per WHO Technical Report Series No. 961 Annex 9.
Is remote monitoring supported without compromising 21 CFR Part 11 compliance?
Yes—the optional network server module delivers real-time dashboards, automated report generation, and electronic signature workflows validated to Part 11 Annex A requirements.
What validation services does Labonce offer?
Factory acceptance testing (FAT), site acceptance testing (SAT), and third-party certified IQ/OQ/PQ execution by ISO/IEC 17025-accredited partners are available upon request.
How is humidity sensor accuracy maintained over time?
The capacitive RH sensors are factory-calibrated to NIST-traceable hygrometers and require no field recalibration; drift performance is verified annually during preventive maintenance using saturated salt solutions per ISO 12048.
