Labonce Labonce-250FC Pharmaceutical Low-Temperature Stability Chamber

Overview

The Labonce Labonce-250FC Pharmaceutical Low-Temperature Stability Chamber is an engineered environmental test system designed specifically for long-term stability testing and cold-chain storage of temperature-sensitive pharmaceuticals, biologics, reference standards, and clinical trial materials under controlled sub-zero conditions. Operating at a nominal setpoint of –25 °C ±2 °C, the chamber employs a precision-engineered forced-air circulation system combined with high-efficiency refrigeration architecture to maintain thermally stable, spatially uniform environments—critical for ICH Q5C and Q1A(R2) compliance in stability protocol execution. Unlike general-purpose freezers, the Labonce-250FC integrates pharmaceutical-grade design elements including ISO 14644-compliant cleanability, non-outgassing insulation, and audit-ready data integrity features aligned with FDA 21 CFR Part 11 and EU Annex 11 expectations for GxP-regulated laboratories.

Key Features

• High-stability refrigeration system featuring an imported hermetic industrial compressor delivering consistent cooling performance across ambient temperatures from +5 °C to +30 °C;
• Optimized air distribution ductwork ensuring temperature uniformity ≤2.0 °C and fluctuation <±0.5 °C throughout the 250 L working volume;
• Structural integrity and contamination control achieved via mirror-polished 304 stainless steel interior and electrostatically coated cold-rolled steel exterior;
• Triple-tier access-controlled color touchscreen interface supporting programmable ramp-soak profiles, real-time parameter monitoring, and tamper-evident electronic data storage;
• Redundant safety architecture including compressor overheat and high-pressure cut-off, visual/audible local alarm, and configurable remote SMS notification for temperature excursions and mains power loss;
• Pharmaceutical-optimized mechanical design: automatic defrost cycle, solid door construction, integrated test port with silicone gasket seal, adjustable stainless steel shelves (3 standard), leveling feet, and locking casters.

Sample Compatibility & Compliance

The Labonce-250FC accommodates a wide range of sample formats—including vials, syringes, trays, and secondary packaging—within its 600×500×830 mm internal cavity. Its validated thermal performance meets YY/T 0086–2020 requirements for medical refrigeration equipment and supports alignment with broader regulatory frameworks including WHO TRS 961 Annex 9 (Good Distribution Practice), USP on storage and distribution, and ICH stability guidelines for accelerated and long-term testing. The unit’s sealed insulation and non-porous interior minimize moisture ingress and condensation risk, preserving sample integrity during extended storage cycles. All materials in contact with the chamber interior are non-reactive, non-shedding, and compatible with routine disinfection using alcohol-based or hydrogen peroxide solutions.

Software & Data Management

The embedded controller provides full-cycle data logging with timestamped records for temperature, setpoint, alarm status, and operational events. Data is stored internally with ≥30 days of continuous history and exportable via USB to CSV format for traceability and review. The system enforces user role-based permissions (operator, supervisor, administrator) to prevent unauthorized configuration changes. Audit trail functionality captures all critical actions—including parameter modifications, alarm acknowledgments, and login/logout events—with immutable timestamps. When integrated into a laboratory information management system (LIMS), the Labonce-250FC supports structured metadata tagging and automated report generation compliant with GLP and GMP documentation standards.

Applications

• ICH Q1A(R2)-compliant long-term stability studies at –25 °C for biologics, mRNA formulations, and cryopreserved cell therapies;
• Cold-chain validation and qualification of storage conditions for investigational medicinal products (IMPs) in clinical trial logistics;
• Reference standard preservation requiring low-temperature inertness and minimal thermal cycling;
• Raw material and intermediate storage where moisture-sensitive or oxidation-prone compounds demand consistent sub-zero exposure;
• Regulatory submission support through documented evidence of environmental control, including IQ/OQ protocols and periodic requalification reports.

FAQ

What is the minimum temperature setpoint supported by the Labonce-250FC?
The unit is rated for operation at –25 °C ±2 °C, with stable maintenance across its full internal volume under specified ambient conditions.
Does the Labonce-250FC support 21 CFR Part 11 compliance?
Yes—the controller includes electronic signature capability, audit trail logging, and role-based access control required for Part 11 adherence when deployed within validated processes.
Is the interior lighting compatible with light-sensitive pharmaceuticals?
The chamber does not include internal illumination by default; optional LED lighting modules are available with UV-filtered diffusers upon request.
Can the Labonce-250FC be qualified for GMP use?
Yes—it is routinely deployed in GMP environments; IQ/OQ documentation templates and factory calibration certificates are provided to support qualification activities.
What maintenance intervals are recommended for sustained performance?
Compressor oil and refrigerant levels should be verified annually; air filter cleaning is recommended every 3 months; door gasket integrity and temperature sensor calibration should be assessed semiannually.