YiHeng LHH-250SD Drug Stability Testing Chamber
| Brand | YiHeng |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Direct Manufacturer |
| Model | LHH-250SD |
| Chamber Volume | 250 L |
| Temperature Range | 0–65°C |
| Humidity Range | 20–98% RH |
| Temperature Uniformity | ±0.5°C (at 25°C) |
| Humidity Uniformity | ±3% RH (at 60% RH) |
| Temperature Stability | ±0.3°C |
| Humidity Stability | ±2% RH |
Overview
The YiHeng LHH-250SD Drug Stability Testing Chamber is an ICH-aligned environmental simulation system engineered for pharmaceutical stability studies in compliance with ICH Q1A(R3), Q1B, Q5C, and the Chinese Pharmacopoeia (2020 Edition). It implements precise, independent control of temperature and relative humidity via dual PID-regulated refrigeration and steam-based humidification systems, enabling reproducible execution of long-term (25°C ±2°C / 60% RH ±5%), accelerated (40°C ±2°C / 75% RH ±5%), and intermediate (30°C ±1°C / 60% RH ±5%) storage conditions. The chamber’s air circulation architecture—featuring rear-mounted centrifugal fans and a unidirectional horizontal airflow path—ensures spatial uniformity within ±0.5°C and ±3% RH across the full 250 L working volume (measured per ISO 14644-3 and ASTM E2251-22). Its structural design adheres to GMP Annex 11 principles for computerized system validation, with embedded firmware supporting ALCOA+ data integrity requirements.
Key Features
- Dual redundant进口 compressors (Embraco or Panasonic) with automatic switchover logic—enabling uninterrupted 24/7 operation for ≥180-day accelerated trials without manual defrost cycles.
- High-stability capacitive humidity sensor (Vaisala HUMICAP® or equivalent), calibrated traceably to NIST standards, operational continuously at up to 65°C and 98% RH without drift or wick replacement.
- Microprocessor-based touchscreen controller with 100 programmable profiles (1000 segments total), real-time trend graphing, password-protected parameter locking, and P.I.D. self-tuning for dynamic load compensation.
- 304 stainless steel interior with radius-cornered construction, seamless welds, and electropolished finish—meeting USP instrument qualification criteria for cleanability and corrosion resistance.
- Dedicated 25 mm diameter test port (left-side, gasket-sealed) for external probe insertion or process monitoring without compromising chamber integrity.
- Optional integrated UV-C germicidal lamp (254 nm, 15 W) mounted on rear wall, programmable for scheduled sterilization cycles to suppress airborne and surface microbiota in accordance with ISO 14644-1 Class 8 environments.
Sample Compatibility & Compliance
The LHH-250SD accommodates primary and secondary pharmaceutical packaging configurations—including blister packs, HDPE bottles, glass vials, low-density polyethylene (LDPE) infusion bags, plastic ampoules, and ophthalmic dropper bottles—under both permeable and semi-permeable container testing protocols. It satisfies all environmental condition requirements specified in ICH Q1A(R3) Tables 1–3 and supports forced degradation studies per Q5C. Chamber validation documentation includes IQ/OQ/PQ templates aligned with ASTM E2500-22 and EU Annex 15. All temperature/humidity sensors are calibrated annually against certified reference standards (±0.1°C, ±1.5% RH uncertainty), with calibration certificates traceable to national metrology institutes. The system meets electromagnetic compatibility (EMC) per IEC 61326-1 and safety requirements per IEC 61010-1.
Software & Data Management
Data acquisition and reporting conform to FDA 21 CFR Part 11 and EU Annex 11 requirements. The controller logs timestamped temperature, humidity, and operational status (e.g., compressor duty cycle, heater output, alarm events) at user-defined intervals (1–60 min). Export formats include CSV and PDF reports with digital signatures, electronic audit trails, and immutable record retention. Optional PC software (YiHeng STS-Link) enables remote monitoring, multi-chamber synchronization, statistical process control (SPC) charting, and deviation investigation workflows. All data files carry embedded metadata including operator ID, protocol version, and environmental deviation flags—supporting full traceability during regulatory inspections.
Applications
- ICH-compliant long-term, accelerated, and stress testing of APIs and finished dosage forms (tablets, capsules, injectables, topicals).
- Stability assessment of biologics under controlled humidity conditions per ICH Q5C guidance.
- Container closure integrity evaluation for semi-permeable packaging exposed to 40°C/25% RH or 25°C/40% RH.
- Photostability screening per ICH Q1B using optional light intensity control (4500 ±500 lx, UV-A/B filtered).
- Real-time release testing (RTRT) support through integrated environmental correlation modeling.
- Environmental qualification of warehouse and logistics staging areas per WHO TRS 992 Annex 9.
FAQ
Does the LHH-250SD meet ICH Q1A(R3) temperature and humidity tolerances for long-term testing?
Yes—it maintains 25°C ±2°C and 60% RH ±5% RH over 12 months with documented uniformity and stability per internal validation reports.
Can the system operate continuously for 180 days without maintenance?
Yes—the dual-compressor architecture and frost-free humidification eliminate manual defrosting; mean time between failures (MTBF) exceeds 15,000 hours.
Is audit trail functionality included in the standard controller?
Yes—the embedded firmware records all parameter changes, user logins, alarm acknowledgments, and calibration events with timestamps and operator IDs.
What is the validation support package provided?
YiHeng supplies IQ/OQ protocols, factory acceptance test (FAT) reports, sensor calibration certificates, and a 3Q checklist compliant with ASTM E2500-22.
How is light intensity calibrated and maintained in photostability mode?
The optional light module integrates a NIST-traceable silicon photodiode sensor with auto-compensation for lamp aging; intensity is adjustable from 0–6000 lx in 10-lx increments.
