Labonce Labonce-60000GS Walk-in Pharmaceutical Stability Chamber
| Brand | Labonce |
|---|---|
| Model | Labonce-60000GS |
| Temperature Range | 20–45°C (±0.5°C uniformity, ±1.0°C deviation) |
| Humidity Range | 20–80% RH (±3.0% RH deviation) |
| Internal Volume | 60,000 L |
| Internal Dimensions (W×D×H) | 4400 × 6400 × 2200 mm |
| External Dimensions (W×D×H) | 4600 × 6600 × 2400 mm |
| Power Requirement | 8.5 kW |
| Compliance | GB/T 10586-2006, JJF 1101-2019, ICH Q1–Q5, Chinese Pharmacopoeia 2020 Edition |
| Control System | 7-inch color programmable touchscreen with 3-tier user access, audit trail, and FDA 21 CFR Part 11–ready data export capability |
| Humidity Sensor | Imported capacitive type, maintenance-free, low-drift |
| Refrigeration | Dual redundant imported compressors |
| Safety | Key-locked door with anti-jamming mechanism, internal emergency stop button, multi-level fault protection |
| Data Logging | Onboard electronic storage + thermal printer + USB export (immutable format) |
| Optional | Networked server integration for centralized chamber fleet management |
Overview
The Labonce Labonce-60000GS Walk-in Pharmaceutical Stability Chamber is an engineered environmental test system designed specifically to meet the stringent requirements of long-term and accelerated stability testing under ICH Q1A(R3), Q5C, and Q5E guidelines. It operates on a precision-controlled air-handling principle—utilizing a high-efficiency laminar airflow system with optimized duct geometry and stainless-steel 304 internal surfaces—to ensure spatial uniformity of temperature and humidity across its 60,000-liter test volume. Unlike benchtop chambers, this walk-in platform supports full-scale packaging validation, real-time monitoring of commercial batches, and concurrent multi-condition studies (e.g., 25°C/60% RH, 30°C/65% RH, or low-humidity conditions such as 40°C/25% RH). Its architecture integrates dual-redundant refrigeration, capacitive humidity sensing, and closed-loop PID control logic—enabling continuous compliance with GLP and GMP documentation standards.
Key Features
- Stainless-steel 304 interior construction—including floor-mounted anti-slip tread plate and insulated double-glazed observation window with defrost heating
- Dual-redundant imported compressor refrigeration system with variable-frequency drive (VFD) option for >50% energy reduction per ICH-aligned operation profiles
- 7-inch full-color programmable touchscreen controller supporting ≥3 hierarchical user permissions (Administrator, Supervisor, Operator) with mandatory login authentication
- Audit trail functionality compliant with FDA 21 CFR Part 11: time-stamped records of all parameter changes, alarm events, and manual interventions—exportable via USB in tamper-evident, read-only format
- Capacitive humidity sensor (imported origin) offering ±1.5% RH accuracy over full range, drift <0.5% RH/year, zero routine calibration requirement
- Integrated thermal printer + embedded flash memory for real-time hardcopy and digital archival of temperature/humidity trends at user-defined intervals
- Multi-point environmental monitoring: factory-verified worst-case locations pre-mapped; two calibrated reference sensors installed as standard, expandable per qualification protocol
- Comprehensive safety suite: key-locked access door with mechanical anti-reverse latch, internal emergency stop button, over-temperature/over-humidity cutoffs, low-water and power-failure SMS alerts
Sample Compatibility & Compliance
The Labonce-60000GS accommodates full-size pharmaceutical cartons, palletized secondary packaging, clinical trial supply kits, and active pharmaceutical ingredient (API) drums without obstruction. Its internal layout permits flexible racking configurations and unimpeded airflow around heterogeneous load geometries. The chamber is validated per ISO 14644-1 Class 8 (cleanroom-compatible air filtration optional), and its performance verification follows ASTM E2297-22 and USP for stability-indicating environmental control. All firmware and software components are developed under a documented configuration management system aligned with Annex 11 (EU GMP) and ICH GCP. Calibration certificates traceable to NIM (National Institute of Metrology, China) accompany delivery, and IQ/OQ documentation packages are available upon request.
Software & Data Management
The embedded controller runs proprietary Labonce StabilityOS v4.2 firmware—designed for 24/7 unattended operation with automatic recovery after power interruption. Data logging resolution is configurable from 1 minute to 60 minutes; all values are stored with UTC timestamps and device ID metadata. Export options include CSV (for Excel/LabWare integration), PDF summary reports, and encrypted binary archives compatible with LIMS and ELN platforms. Optional network server deployment enables remote monitoring of multiple chambers across sites, role-based dashboard access, automated email notifications for out-of-specification excursions, and synchronized backup to secure cloud infrastructure meeting HIPAA and GDPR retention policies. Electronic signatures and change control logs satisfy ALCOA+ principles for regulated submissions.
Applications
- ICH Q1-compliant long-term (25°C/60% RH) and accelerated (40°C/75% RH) stability studies for drug substances and products
- Photostability testing support (when integrated with optional ICH Q1B-compliant light cabinets)
- Reference standard storage under controlled ambient conditions per USP
- Excipient compatibility screening across humidity gradients (e.g., 20–80% RH at fixed temperature)
- Package integrity evaluation under cyclic humidity stress (e.g., 40°C ↔ 25°C ramping with RH modulation)
- Validation of cold chain logistics by simulating transit conditions including intermediate hold points
- Biologics and mRNA vaccine formulation stability assessment requiring precise low-humidity control (e.g., 25°C/40% RH)
FAQ
Does the Labonce-60000GS support FDA 21 CFR Part 11 compliance?
Yes—the system includes electronic signature capability, audit trail with immutable export, role-based access control, and system validation documentation templates aligned with Part 11 Annex A requirements.
Can the chamber be qualified for GMP use?
Absolutely. IQ/OQ/PQ protocols are provided; installation adheres to ISO 14644-1 air cleanliness standards; all sensors are NIST-traceable and calibrated pre-delivery.
Is remote monitoring available without additional hardware?
Standard Ethernet port enables local network connectivity; optional cloud gateway module adds TLS-encrypted remote access and centralized fleet analytics.
What is the minimum temperature achievable with optional low-temperature configuration?
The unit can be modified to operate down to 2°C (±1.0°C fluctuation, ±2.0°C deviation) for cold-chain simulation or refrigerated storage validation.
How is humidity uniformity verified across such a large volume?
During factory acceptance testing, 9-point mapping per ISO 291 and ICH Q1 is performed using calibrated portable probes; worst-case locations are permanently marked and monitored during routine operation.
