Yiheng LHH-500GSP Pharmaceutical Stability Testing Chamber
| Brand | Yiheng |
|---|---|
| Model | LHH-500GSP |
| Origin | Shanghai, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Price | USD 9,800 (FOB Shanghai) |
Overview
The Yiheng LHH-500GSP Pharmaceutical Stability Testing Chamber is an ISO/ICH Q5A–compliant environmental simulation system engineered for long-term, accelerated, and photostability testing of pharmaceutical products in accordance with the Chinese Pharmacopoeia (2020 Edition), USP , ICH Q1A(R2), Q1B, Q5C, and GB/T 10586–2006. It employs dual-stage refrigeration with redundant compressors, precision P.I.D.-controlled humidity generation via steam humidification, and calibrated LED or fluorescent lighting arrays to maintain rigorously defined temperature (±0.5 °C stability over 24 h), relative humidity (±3 %RH uniformity across working volume), and irradiance (4500 ±500 lx, compliant with ICH Q1B Option 1). The chamber’s architecture supports continuous unattended operation for up to 12 months—critical for long-term stability studies mandated under GMP Annex 11 and FDA 21 CFR Part 11 data integrity requirements.
Key Features
- Dual independent imported compressors with automatic switchover logic—ensures uninterrupted operation during maintenance or compressor failure; eliminates manual defrost cycles and associated thermal/hygrometric drift.
- Microprocessor-based touch-screen controller (10.1″ TFT LCD) supporting 100 programmable profiles, each with up to 1000 segments and 999 loops; interface available in English and Chinese with real-time curve plotting.
- 304 stainless steel interior (radius-cornered, seamless welds), non-ozone-depleting R134a/R600a refrigerant blend, and energy-efficient insulation (≥120 mm polyurethane foam, λ ≤ 0.022 W/m·K).
- Uniform airflow distribution via rear-mounted centrifugal fan and optimized ductwork—validated per ISO 14644-1 Class 8 airflow mapping (velocity deviation ≤ ±15 % across test zone).
- Integrated UV-C germicidal lamp (254 nm, 15 W) mounted on rear wall—activated manually or scheduled to sterilize recirculated air and water reservoir vapor phase, reducing bioburden risk per EU GMP Annex 1 microbiological control principles.
- High-stability capacitive humidity sensor (operating range: 0–100 %RH, 0–80 °C), eliminating reliance on dry/wet bulb psychrometry and associated calibration drift.
- Optional photometric feedback loop: silicon photodiode sensor + dimmable ballast enables closed-loop irradiance control (4500 ±500 lx at sample level), compensating for lamp aging per ICH Q1B photostability protocol requirements.
Sample Compatibility & Compliance
The LHH-500GSP accommodates standard stability storage configurations including open trays, sealed aluminum foil-wrapped vials, blister packs, and semi-permeable containers (e.g., LDPE infusion bags, plastic ampoules, ophthalmic dropper bottles). Its internal dimensions (W×D×H: 750 × 600 × 1120 mm) support placement of ≥200 units of 2R vials (10 mL) on adjustable stainless steel shelves. All operational parameters meet ICH-defined acceptance criteria for stability chambers: temperature uniformity ≤ ±2.0 °C, humidity uniformity ≤ ±5 %RH, and light exposure compliance verified using NIST-traceable lux meter (calibration certificate included). System validation documentation (IQ/OQ/PQ protocols) is provided per ASTM E2500–13 and EU Annex 15 guidelines.
Software & Data Management
The embedded controller logs timestamped temperature, humidity, and irradiance data at user-selectable intervals (1–60 min), storing ≥3 years of records internally. RS-485 Modbus RTU and optional RS-232 interfaces enable integration with LIMS or SCADA systems. Optional Yiheng DataLink software (Windows-based) provides FDA 21 CFR Part 11-compliant audit trail, electronic signatures, role-based access control (admin/operator/user), and automated report generation (PDF/CSV) aligned with ALCOA+ principles. Raw data export supports trend analysis in JMP or Python pandas for statistical evaluation per ICH Q5C comparability protocols.
Applications
- ICH Q1A(R2)-aligned accelerated stability studies (40 °C/75 %RH, 6 months) and long-term storage (25 °C/60 %RH, 12–36 months).
- ICH Q1B photostability testing (Option 1: near-UV and visible light exposure at 4500 ±500 lx for 10 days).
- High-humidity stress testing (e.g., 40 °C/75 %RH or 30 °C/65 %RH) for hygroscopic API assessment.
- Stability evaluation of semi-permeable packaging systems (e.g., 40 °C/25 %RH per Q1A(R2) Section II.C.2).
- Real-time release testing (RTRT) support via integrated data logging for PAT-aligned quality-by-design workflows.
FAQ
Does the LHH-500GSP comply with 21 CFR Part 11 for electronic records?
Yes—the optional DataLink software includes full Part 11 functionality: audit trails, electronic signatures, and role-based permissions.
What validation documentation is supplied?
Factory-issued IQ/OQ protocols, NIST-traceable calibration certificates for temp/RH sensors, and chamber mapping reports (temperature/humidity uniformity) are included.
Can the chamber operate continuously for 365 days without defrost interruption?
Yes—dual compressor architecture and frost-free evaporator design eliminate scheduled defrost events, ensuring uninterrupted operation per ICH Q5C long-term study requirements.
Is photometric calibration performed at installation?
Yes—light intensity is measured at 5 standardized locations within the working chamber using a calibrated lux meter; report issued with commissioning documentation.
What is the maximum allowable load for humidity recovery after door opening?
Under worst-case conditions (door open 30 s at 25 °C/60 %RH), humidity recovers to setpoint within ≤12 min (per ISO 14644-1 recovery testing methodology).
