YSEI SHH-1500SD-2TD Dual-Door Pharmaceutical Stability Testing Chamber
| Brand | YSEI |
|---|---|
| Origin | Chongqing, China |
| Manufacturer Type | Direct Manufacturer |
| Product Origin | Domestic (China) |
| Model | SHH-1500SD-2TD |
| Price Range | USD 7,000 – 11,200 |
| Compliance Standards | GB/T 10586–2025, JJF 1101–2019, ICH Q1A–Q1E, USP <1150>, FDA 21 CFR Part 11 (via software validation), GMP Annex 15 (IQ/OQ support) |
| Chamber Dimensions (D×W×H) | 850 × 750 × 2350 mm |
| Operating Power Consumption | ≤2.8 kW (at 40°C / 75% RH, single compressor active) |
| Ambient Operating Conditions | 5–35°C ambient temperature, ≤85% RH |
| Data Logging Interval | Adjustable from 1 min to 24 h |
| controller internal RAM | 64 MB cyclic buffer |
| Communication Interfaces | RS485 (Modbus RTU), USB, SD card slot, optional Ethernet/WiFi via SIMS remote monitoring platform |
| Safety Protections | Independent overtemperature cutoff, humidifier dry-run protection, compressor overload protection, door-access electronic lock with key override, SMS-based alarm (power failure, temp/RH deviation) |
Overview
The YSEI SHH-1500SD-2TD Dual-Door Pharmaceutical Stability Testing Chamber is an engineered environmental simulation system designed specifically for long-term, accelerated, and intermediate stability studies in compliance with ICH Q1A(R3), Q1B, Q1C, and Q5C guidelines. It operates on a precision-controlled forced-air convection principle, integrating independent refrigeration, heating, and steam-based humidification subsystems to maintain highly stable and reproducible temperature (±0.5°C uniformity, ±0.3°C fluctuation) and relative humidity (±3% RH uniformity, ±2% RH fluctuation) profiles across its 1500 L working volume. The chamber supports critical pharmaceutical test conditions including the ICH-specified long-term (25°C/60% RH), accelerated (40°C/75% RH), and intermediate (30°C/65% RH) protocols — as well as low-humidity testing at 40°C/25% RH for large-volume parenterals and hygroscopic APIs. Its dual-door architecture — featuring an outer electro-mechanical lockable door and an inner tempered glass observation door — minimizes thermal and humidity perturbation during routine sample access while preserving experimental integrity.
Key Features
- Dual-door configuration with outer electric plug-lock and inner tempered glass door for minimal environmental disturbance during visual inspection or sample handling
- Integrated 7-inch high-resolution capacitive touchscreen controller with 64 MB internal cyclic memory; stores setpoints, real-time measurements, timestamps, and event logs
- Comprehensive electronic data recording compliant with ALCOA+ principles: 15-minute default logging interval, 3-year onboard retention (expandable via SD card or USB export), non-volatile memory backup ensuring zero data loss during power interruption
- RS485 Modbus RTU interface enabling centralized control of up to 30 units via a single PC; optional SIMS cloud platform for secure remote monitoring, firmware updates, and real-time alarm notification via SMS/email
- Multi-layer safety architecture: independent overtemperature cut-off relay, humidifier low-water auto-shutoff, compressor current-sensing overload protection, and door-open interlock logic
- Energy-optimized refrigeration design with variable-speed compressors and intelligent defrost cycle management; verified power consumption ≤2.8 kW under full-load 40°C/75% RH operation
- Factory-calibrated to JJF 1101–2019 (Calibration Specifications for Environmental Test Equipment) with traceable NIST-equivalent reference sensors
Sample Compatibility & Compliance
The SHH-1500SD-2TD accommodates standard ICH-compliant stability sample configurations — including nested trays, stacked cartons, and open shelving arrangements — within its uniformly conditioned workspace. Its interior stainless-steel construction (AISI 304) and seamless weld joints meet USP requirements for cleanroom-compatible equipment surfaces. The system fully supports GMP-regulated workflows: it ships with validated IQ/OQ documentation packages aligned with Annex 15 and includes optional PQ protocol templates. Software functionality satisfies FDA 21 CFR Part 11 requirements for electronic records and signatures when deployed with YSEI’s certified SIMS Pharma Suite — providing audit trails, user role-based access control, electronic signatures, and change history logging. All thermal and humidity performance data are generated under controlled verification per ISO/IEC 17025-accredited procedures.
Software & Data Management
YSEI’s proprietary SIMS Pharma Control Software enables full lifecycle data governance for stability programs. It supports automated import of CSV/Excel-formatted logs from SD cards or USB drives, time-synchronized multi-chamber trending, statistical process control (SPC) charting (X-bar/R, Cp/Cpk), and deviation alerting with configurable thresholds. The software generates PDF reports compliant with ICH M4 regulatory submission formats and integrates seamlessly with LIMS environments via ODBC or REST API. Electronic records include immutable metadata: operator ID, instrument serial number, calibration status, environmental deviations, and maintenance events — all retained for ≥25 years per GxP archival policy recommendations. Validation documentation includes URS, FRS, DQ/IQ/OQ/PQ protocols, and summary reports signed by qualified validation engineers.
Applications
- ICH Q1-compliant long-term (25°C/60% RH), accelerated (40°C/75% RH), and intermediate (30°C/65% RH) stability studies for small-molecule APIs, biologics, and finished dosage forms
- Low-humidity stress testing (e.g., 40°C/25% RH) for IV bags, lyophilized powders, and moisture-sensitive excipients
- Photostability pre-screening (when integrated with optional ICH Q1B-compliant light banks)
- Excipient compatibility screening under controlled humidity gradients
- Real-time stability monitoring for commercial batch release and shelf-life extension studies
- Environmental qualification of storage areas (cold rooms, warehouse zones) using chamber-derived reference profiles
FAQ
Does the SHH-1500SD-2TD comply with FDA 21 CFR Part 11 for electronic records?
Yes — when operated with the validated SIMS Pharma Suite (v3.2+), the system provides full Part 11 functionality including audit trails, electronic signatures, role-based access, and record retention controls.
Can the chamber perform 40°C/25% RH testing reliably?
Yes — its dedicated low-RH mode employs enhanced dehumidification logic and optimized airflow distribution to achieve and sustain 25% RH at 40°C with ≤±2% RH deviation over 24 h.
What validation documentation is included?
Standard delivery includes IQ/OQ protocols and executed reports per Annex 15; PQ support and site-specific execution services are available upon request.
Is remote monitoring supported out-of-the-box?
Basic RS485-to-PC connectivity is standard; SIMS cloud-based remote access requires optional Ethernet/WiFi module installation and annual service subscription.
How is data integrity ensured during power failure?
All sensor readings and controller states are written to non-volatile FRAM memory every second; SD card writes occur synchronously every 15 minutes with CRC-32 checksum verification.
