YiHeng LHH-UV Series Comprehensive Pharmaceutical Photostability Testing Chamber
| Brand | YiHeng |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | LHH-UV Series |
| Price Range | USD 11,200 – 14,000 |
Overview
The YiHeng LHH-UV Series Comprehensive Pharmaceutical Photostability Testing Chamber is an engineered environmental simulation system designed specifically to meet the stringent requirements of ICH Q1B (Stability Testing of New Drug Substances and Products) and the Chinese Pharmacopoeia (2020 Edition) for photostability assessment. It integrates precise temperature, humidity, and spectral irradiance control within a single chamber to replicate long-term storage and accelerated stress conditions under controlled visible and ultraviolet (UV) light exposure. The system operates on the principle of simultaneous multi-parameter environmental regulation—using dual-compressor refrigeration architecture, high-stability humidity sensing, and spectrally validated UV/visible light sources—to ensure reproducible, GLP-compliant stability studies. Unlike conventional chambers with fixed or non-monitored irradiance outputs, the LHH-UV series incorporates real-time irradiance feedback control, enabling traceable, auditable photostability testing aligned with FDA 21 CFR Part 11 data integrity expectations.
Key Features
- ICH Q1B–compliant UV and visible light source system: Includes selectable lamp configurations—single/dual-layer UV-A (320–400 nm) and visible (400–800 nm) lamp arrays—with independent on/off and intensity control per spectrum band.
- Real-time irradiance monitoring and closed-loop control: Integrated calibrated photodiode sensors (visible and UV channels) continuously measure irradiance (lux and W/m²), feeding data to the controller for dynamic lamp power adjustment to compensate for lamp aging and maintain target exposure dose (e.g., ≥1.2 × 10⁶ lux·hr total visible; ≥200 W·hr/m² near-UV).
- Dual-imported compressor redundancy: Automatic switchover ensures uninterrupted operation for extended durations (≥365 days), eliminating defrost cycles that disrupt temperature/humidity profiles during long-term stability trials.
- High-reliability UV lamp assembly: UV lamps rated for continuous operation in high-humidity environments (up to 85% RH); lamp sockets and ballasts engineered for thermal stability and spectral consistency over lifetime (>5,000 hr typical service life).
- GSP-series programmable touchscreen controller: 7-inch TFT LCD with bilingual interface (English/Chinese), supporting up to 100 programs × 1000 segments × 999 cycles; PID auto-tuning for temperature/humidity; RS-485/RS-232 communication for remote monitoring, data logging, and PC-based program editing.
- Robust chamber construction: 304 stainless steel interior with radius-corner design; uniform air distribution via optimized wind tunnel circulation; optional 25 mm test port (left side) for external sensor integration or sample access.
Sample Compatibility & Compliance
The LHH-UV chamber accommodates standard pharmaceutical packaging formats—including blister packs, amber vials, low-density polyethylene (LDPE) infusion bags, plastic ampoules, and ophthalmic containers—under defined ICH and Pharmacopoeial test conditions. It supports all mandated stability protocols: long-term (25 ± 2°C / 60 ± 5% RH or 30 ± 2°C / 60 ± 5% RH), accelerated (40 ± 2°C / 75 ± 5% RH or 30 ± 1°C / 60 ± 5% RH), and photostability (4500 ± 500 lux for 10 days; UV + visible irradiation per Q1B). For semi-permeable packaging, it delivers specified low-humidity conditions (e.g., 40 ± 2°C / 25 ± 5% RH). All operational parameters comply with GB/T 10586–2006 (Environmental Test Equipment General Technical Conditions) and support IQ/OQ/PQ validation documentation packages. Humidity sensing utilizes high-temperature-capable capacitive sensors (operable up to 85°C), eliminating wet-bulb maintenance.
Software & Data Management
The embedded controller provides full audit trail functionality—including user login timestamps, parameter change logs, alarm history, and runtime event records—meeting ALCOA+ principles for data integrity. Data export is supported via USB, RS-485, or optional Ethernet module for integration into LIMS or ELN systems. Optional printer interface enables hard-copy generation of temperature/humidity/irradiance trend curves. All firmware complies with IEC 62304 for medical device software safety classification. Third-party calibration certificates (traceable to NIM or Shanghai Institute of Measurement and Testing Technology) are available upon request, including full 3Q validation reports (IQ/OQ/PQ) compliant with EU GMP Annex 15 and USP .
Applications
- ICH Q1B photostability screening of new drug substances and products under UV and visible light stress.
- Long-term and accelerated stability studies per Chinese Pharmacopoeia 2020 and WHO TRS 953 Annex 2 guidelines.
- Comparative light-exposure testing of primary and secondary packaging materials.
- Validation of photoprotective efficacy of opaque/blister packaging designs.
- Support for regulatory submissions requiring documented environmental control, irradiance traceability, and system reliability evidence.
FAQ
Does the LHH-UV chamber meet ICH Q1B spectral irradiance requirements?
Yes—it delivers quantifiable UV-A (320–400 nm) and visible (400–800 nm) irradiance levels validated against ICH Q1B thresholds, with integrated sensors and closed-loop control ensuring dose accuracy throughout test duration.
Can irradiance be calibrated and verified independently?
Yes—optional third-party irradiance calibration services are available, including NIST-traceable photometric verification and full-spectrum radiometric characterization reports.
Is the system suitable for 24/7 unattended operation over 12 months?
Yes—the dual-compressor architecture, no-defrost design, and industrial-grade components enable continuous operation with ≤0.5% cumulative drift in temperature/humidity over 365-day cycles.
What validation documentation is provided?
Standard delivery includes factory calibration certificates; optional 3Q validation kits (IQ/OQ/PQ protocols, test scripts, and summary reports) are available for GMP-regulated environments.
How is UV lamp aging compensated during long-term testing?
Real-time photodiode feedback adjusts lamp drive current dynamically, maintaining constant irradiance output without manual intervention or scheduled lamp replacement mid-test.
