YiHeng LHH-SSG Multi-Chamber Drug Stability Testing Chamber
| Brand | YiHeng |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | LHH-SSG |
| Price | USD 15,000 (FOB Shanghai) |
Overview
The YiHeng LHH-SSG Multi-Chamber Drug Stability Testing Chamber is an integrated environmental simulation system engineered for pharmaceutical stability studies in compliance with ICH Q1–Q5 guidelines. It employs a dual-chamber or multi-zone architecture—depending on configuration—to simultaneously conduct temperature-controlled, humidity-regulated, and photostability testing under defined stress conditions (e.g., ICH Q1B: photostability testing of new drug substances and products). Unlike single-zone chambers, the LHH-SSG enables independent control of temperature (±0.5 °C uniformity), relative humidity (±3% RH accuracy), and light irradiance (UV-A/visible spectrum, optional LED-based light source per ICH Q1B Option 2) across separate workspaces. This design eliminates sequential test scheduling, reduces cross-contamination risk between batches, and supports concurrent real-time monitoring of multiple formulations—critical for accelerated stability protocols (e.g., 40 °C/75% RH, 25 °C/60% RH, and photostability at 1.2 ×10⁶ lux·hr) required by regulatory submissions to FDA, EMA, and NMPA.
Key Features
- Multi-zone independent control: Each chamber operates with dedicated PID-controlled temperature, humidity, and lighting modules—enabling parallel ICH-compliant stability protocols without hardware reconfiguration.
- Stainless steel interior with seamless semi-circular corners (304 SS, electropolished finish): Complies with ISO 14644-1 Class 8 cleanroom-compatible surface requirements; facilitates cleaning validation per FDA CGMP Annex 1 and EU GMP Annex 15.
- Dual redundant refrigeration system: Two imported hermetic compressors with automatic switchover logic ensure uninterrupted operation over 10,000+ hours; eliminates downtime during maintenance or compressor failure.
- Frost-free humidification & dehumidification: Integrated ultrasonic humidifier and direct-expansion cooling coil with hot-gas bypass prevent defrost cycles—maintaining continuous ±0.3 °C/±2% RH stability during long-term studies (e.g., 6-month real-time storage).
- High-accuracy capacitive humidity sensing: Imported Vaisala HUMICAP® or equivalent sensor replaces wet-bulb psychrometry—eliminating calibration drift, wick replacement, and water-level dependency.
- Touchscreen controller with audit trail capability: 7-inch capacitive LCD interface supporting 21 CFR Part 11–compliant electronic signatures, role-based access (Administrator / Operator / Guest), and tamper-proof operation logs stored locally and exportable via USB.
Sample Compatibility & Compliance
The LHH-SSG accommodates standard pharmaceutical packaging formats—including blister packs, HDPE bottles, glass vials, and aluminum pouches—within adjustable stainless steel shelves (load capacity: up to 30 kg per chamber). Its airflow design ensures uniform thermal distribution (ASTM E2294–22 Class II air uniformity) and minimizes sample desiccation via variable-speed centrifugal circulation fans (0–100% programmable). The system meets ICH Q5C (stability of biotechnological/biological products), USP , and WHO Technical Report Series No. 992 Annex 10 requirements. Optional IQ/OQ/PQ documentation packages support GMP validation per ASTM E2500 and ISO/IEC 17025:2017 laboratory accreditation.
Software & Data Management
The embedded controller runs YiHeng’s proprietary StabilityLink™ firmware (v3.2+), enabling real-time graphing of chamber parameters (temperature, RH, light intensity), trend analysis, and deviation alerts via visual indicators and relay-triggered external alarms. All operational data—including setpoints, actual values, alarm events, user logins, and parameter changes—are time-stamped and cryptographically hashed for integrity verification. Data export conforms to CSV and PDF formats compatible with LIMS integration (e.g., LabWare, STARLIMS). Optional Ethernet/WiFi connectivity supports remote monitoring through secure TLS 1.2–encrypted web interface—fully traceable for FDA 21 CFR Part 11 audit readiness.
Applications
- ICH Q1A(R3) real-time and accelerated stability testing of APIs and finished dosage forms
- Photostability assessment per ICH Q1B (Option 1: UV + visible; Option 2: LED-based controlled irradiance)
- Excipient compatibility screening under variable hygroscopic stress conditions
- Shelf-life prediction modeling using Arrhenius kinetics (requires external software integration)
- GMP-compliant stability storage for retained samples (FDA 21 CFR Part 211.166)
- Reference standard conditioning per USP and Ph. Eur. 2.2.47
FAQ
Does the LHH-SSG support 21 CFR Part 11 compliance?
Yes—the system includes electronic signature capability, audit trail logging, role-based access control, and data immutability features required for regulated environments.
Can humidity be maintained at 5% RH for desiccated storage studies?
Yes—via integrated dehumidification mode with desiccant-assisted drying option (available as factory-installed accessory).
Is third-party IQ/OQ/PQ documentation available?
Yes—YiHeng provides vendor-qualified validation protocols and execution support; final PQ must be performed on-site by qualified personnel per local GMP requirements.
What is the maximum allowable ambient temperature for continuous operation?
The unit is rated for ambient conditions up to 32 °C and 60% RH (non-condensing); performance specifications assume installation in climate-controlled laboratories per ISO 14644-1.
How often does the humidity sensor require recalibration?
Capacitive sensors are factory-calibrated and require no routine recalibration; annual verification against NIST-traceable hygrometer is recommended per ISO/IEC 17025.
