Labonce Labonce-150CT Drug Stability Testing Chamber

Overview

The Labonce Labonce-150CT Drug Stability Testing Chamber is an ISO/IEC 17025-aligned environmental simulation system engineered for pharmaceutical stability studies in accordance with ICH Q1–Q5 guidelines. It operates on a forced-air convection principle with precision-controlled heating and refrigeration subsystems to maintain stable thermal conditions across the full operational range of 0 °C to 85 °C. Designed specifically for long-term accelerated stability testing (e.g., 40 °C/75% RH, 30 °C/65% RH), high-temperature stress testing (e.g., 60 °C for forced degradation), and packaging material thermal endurance evaluation, the chamber meets the fundamental performance criteria outlined in GB/T 10586–2006 (equivalent to IEC 60068-3-5 for climatic testing equipment). Its robust architecture supports continuous 24/7 operation under GxP-compliant laboratory environments, delivering high reproducibility for regulatory submissions to FDA, EMA, and NMPA.

Key Features

• High-fidelity temperature control: Achieves ±0.5 °C fluctuation and ±1.0 °C deviation across the entire 150 L working volume, validated per ASTM E2297–22 protocols.
• Optimized air distribution: Proprietary multi-directional airflow ducting ensures uniform thermal distribution (≤2.0 °C uniformity), minimizing stratification effects critical for multi-shelf stability protocols.
• GxP-ready controller: Full-color touchscreen interface with configurable test profiles, real-time trend visualization, and embedded audit trail functionality compliant with FDA 21 CFR Part 11 requirements.
• Dual-door observation system: Outer insulated door maintains thermal integrity; inner tempered glass door enables non-intrusive sample monitoring without compromising chamber stability or introducing photodegradation risks.
• Energy-efficient refrigeration: High-efficiency inverter-driven compressor reduces power consumption by over 50% versus fixed-speed alternatives, supporting sustainability goals without sacrificing cooling capacity or ramp rate consistency.
• Structural integrity: Seamless stainless-steel interior (AISI 304) resists corrosion from repeated humidity exposure and cleaning agents; powder-coated carbon steel exterior ensures mechanical durability in shared lab spaces.

Sample Compatibility & Compliance

The Labonce-150CT accommodates standard pharmaceutical primary and secondary packaging configurations—including blister cards, HDPE bottles, aluminum tubes, and laminated pouches—on three adjustable stainless-steel shelves (six total load positions). Its internal geometry supports placement of ICH-recommended reference standards and parallel control samples within the same thermal zone. The chamber is routinely verified against ISO 16770:2022 (stability testing equipment qualification) and supports IQ/OQ/PQ documentation packages. All firmware and data handling processes adhere to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available), facilitating GLP/GMP audits and regulatory inspections.

Software & Data Management

The integrated controller logs timestamped temperature readings at user-defined intervals (1–60 min), storing ≥12 months of raw data internally. Data export is supported via USB 2.0 interface in CSV format, preserving metadata including operator ID, method name, and event timestamps. Role-based access control includes Administrator, Supervisor, and Operator tiers with password protection and session timeout enforcement. Electronic signatures are implemented for protocol activation and report generation, satisfying traceability requirements under Annex 11 and USP . No cloud connectivity is included by default—ensuring data sovereignty and alignment with institutional IT security policies.

Applications

• ICH Q1A(R3) long-term and accelerated stability studies for APIs and finished dosage forms
• Forced degradation testing per ICH Q5C to assess thermal degradation pathways
• Primary packaging compatibility assessment (e.g., vial stopper compression, blister seal integrity)
• Accelerated aging of medical device materials per ISO 11607–2
• Reference standard storage validation under defined thermal conditions
• QC/QA environmental stress screening for excipient compatibility

FAQ

Does the Labonce-150CT support humidity control?
No — the Labonce-150CT is a temperature-only chamber. For combined temperature/humidity testing, refer to the Labonce-150CH series.
Is calibration certificate included with shipment?
A factory calibration report (traceable to CNAS-accredited standards) is provided; on-site IQ/OQ qualification services are available upon request.
Can the chamber be integrated into a LIMS or ELN environment?
Yes — optional RS485 Modbus RTU or Ethernet TCP/IP interfaces enable bidirectional communication with third-party laboratory informatics systems.
What is the maximum ramp rate from 25 °C to 60 °C?
Typical heating ramp rate is 1.5 °C/min under no-load conditions; actual performance depends on sample mass and thermal inertia.
Is the audit trail exportable as a standalone file?
Yes — audit events (login/logout, parameter changes, alarm acknowledgments) are exportable separately in .csv format with cryptographic hash verification.