YSEI SHH-800SD-2TA Drug Stability Testing Chamber
| Brand | YSEI |
|---|---|
| Origin | Chongqing, China |
| Manufacturer Type | Direct Manufacturer |
| Product Origin | Domestic (China) |
| Model | SHH-800SD-2TA |
| Pricing | Available Upon Request |
Overview
The YSEI SHH-800SD-2TA Drug Stability Testing Chamber is an engineered environmental simulation system designed specifically for pharmaceutical stability studies in compliance with ICH Q1–Q5 guidelines, USP , FDA 21 CFR Part 11, and Chinese Pharmacopoeia requirements. It operates on a precision-controlled dual-loop climate regulation principle—integrating independent refrigeration, heating, humidification, and dehumidification subsystems—to maintain highly stable temperature (±0.3 °C) and relative humidity (±2 %RH) profiles across long-term (25 °C/60 %RH), accelerated (40 °C/75 %RH), and intermediate (30 °C/65 %RH) test conditions. The chamber’s structural integrity features double-wall insulated stainless steel construction with vacuum-sealed tempered glass inner doors, minimizing thermal bridging and moisture ingress while enabling non-intrusive sample observation. Its thermodynamic architecture supports continuous operation over 10,000+ hours without performance drift, ensuring data continuity essential for shelf-life determination and regulatory submission packages.
Key Features
- Triple-layer security architecture: Dual mechanical locks on outer door + configurable access control for door opening events (optional log generation)
- Comprehensive safety interlocks: Independent overtemperature protection in working chamber; dry-run protection for humidifier; compressor overload cutoff; power-failure alarm escalation
- Intelligent acoustic optimization: Sound-dampened refrigeration circuitry and low-noise axial fans achieving ≤52 dB(A) at 1 m distance
- Ergonomic human-machine interface: 10.1-inch capacitive touchscreen with multi-language support (English, Chinese, Spanish), real-time graphing, and intuitive parameter navigation
- Energy-efficient thermal management: Variable-speed compressors and PID-modulated PTC heaters reduce average power consumption by up to 28% versus conventional chambers under identical load conditions
Sample Compatibility & Compliance
The SHH-800SD-2TA accommodates standard ICH-compliant stability storage configurations—including open trays, sealed vials, blister packs, and primary packaging assemblies—within its 800 L internal volume (D×W×H: 850×750×1250 mm). Internal airflow is validated via ISO 14644-3 Class 5 laminar mapping to ensure uniform distribution (ΔT ≤ ±0.5 °C, ΔRH ≤ ±3 %RH across all zones). All operational protocols align with GMP Annex 15, WHO TRS 992, and EU GMP Part I Chapter 4. Full IQ/OQ documentation packages—including sensor calibration certificates traceable to NIM (National Institute of Metrology, China), installation verification checklists, and operational boundary testing reports—are supplied as standard deliverables.
Software & Data Management
Equipped with the YSEI SimsControl™ embedded controller (v4.2+), the system provides native 21 CFR Part 11 compliance through role-based three-tier user permissions (Administrator / Supervisor / Operator), electronic signatures, and immutable audit trails. All operational parameters—including setpoints, actual values, alarms, and manual interventions—are timestamped and stored at 1-minute intervals for ≥10 years within redundant media: internal 4 GB flash memory + removable industrial-grade SD card (Class 10, 32 GB minimum). Data export supports CSV, PDF, and XML formats. Remote monitoring and configuration are enabled via TLS-secured Ethernet/Wi-Fi connectivity using SimsRemote™ desktop client or browser-based web portal—scalable to networks of up to 30 units per host server. Optional USB-connected thermal printer provides time-stamped hardcopy logs with adjustable print intervals (1 min to 24 h).
Applications
- ICH Q1A(R3) long-term, accelerated, and stress testing of APIs and finished dosage forms
- Photostability assessment per ICH Q5C when integrated with optional UV/visible light modules
- Accelerated degradation kinetics modeling for forced degradation studies
- Reference standard storage under certified environmental conditions (e.g., USP Reference Standards)
- Stability-indicating method development support in QC laboratories
- Regulatory filing dossier preparation (e.g., CTD Module 3 submissions)
FAQ
Does the SHH-800SD-2TA meet FDA 21 CFR Part 11 requirements for electronic records and signatures?
Yes—the controller firmware implements full Part 11 functionality including audit trail encryption, user authentication, and electronic signature validation.
Can historical data be retrieved after a power outage?
Yes—data integrity is preserved via non-volatile memory; no loss occurs during blackout events.
Is IQ/OQ validation support included with purchase?
Yes—validated protocol templates, execution worksheets, and final signed reports are provided as part of standard delivery.
What is the maximum number of units manageable from one central PC?
Up to 30 chambers can be concurrently monitored and controlled via SimsRemote™ software.
How frequently is temperature and humidity logged by default?
Default logging interval is 1 minute; this is fully adjustable between 10 seconds and 24 hours via controller settings.
