YSEI SHH-500SD-2TA Drug Stability Testing Chamber
| Brand | YSEI |
|---|---|
| Origin | Chongqing, China |
| Manufacturer Type | Manufacturer |
| Product Category | Domestic |
| Model | SHH-500SD-2TA |
| Pricing | Upon Request |
Overview
The YSEI SHH-500SD-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 <1150>, FDA 21 CFR Part 11, and Chinese Pharmacopoeia requirements. It implements precise, dual-channel PID-controlled temperature and humidity regulation to maintain stable test conditions across long-term (25°C/60% RH), intermediate (30°C/65% RH), and accelerated (40°C/75% RH) storage protocols. The chamber employs a robust refrigeration circuit with cascade cooling capability, stainless steel humidification reservoir with anti-scale design, and insulated double-glass observation doors to minimize thermal and moisture disturbance during sample inspection. Its architecture supports Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) workflows through hardware-enforced access control, tamper-evident logging, and deterministic data capture.
Key Features
- Triple-layer insulation with vacuum-sealed polyurethane foam (120 mm thickness) ensures thermal stability and energy efficiency
- Touchscreen HMI controller with 7-inch capacitive display, supporting multi-language UI (English, Chinese, Spanish) and intuitive navigation
- Three-tier user permission system (Administrator / Supervisor / Operator) with role-based access to settings, calibration, and data export functions
- Dual-door configuration: outer door with dual mechanical lock + electronic access log; inner tempered glass door for non-intrusive sample monitoring
- Real-time environmental monitoring at 1-minute intervals, with onboard 4GB circular memory and removable SD card (up to 128 GB) for archival export
- Integrated GSM module enabling SMS alerts for critical events — including temperature/humidity deviation, power failure, door breach, and compressor fault
- Low-noise operation (<52 dB(A) at 1 m distance) achieved via brushless DC fan motors and vibration-damped compressor mounting
- Modular controller firmware compliant with FDA 21 CFR Part 11 Annex 11 requirements, supporting electronic signatures and audit trail integrity verification
Sample Compatibility & Compliance
The SHH-500SD-2TA accommodates standard pharmaceutical packaging formats including blister packs, HDPE bottles, aluminum tubes, and vials placed on adjustable stainless steel shelves. Internal chamber volume (500 L net) allows uniform airflow distribution per ISO 14644-3 Class 8 cleanroom air exchange specifications. All materials in contact with the test environment meet USP Class VI biocompatibility standards. The system conforms to GB/T 10586–2025 (Environmental Test Equipment Technical Requirements), ICH Q1A(R3), Q5C, and EU GMP Annex 15 validation principles. Full IQ/OQ documentation packages—including traceable sensor calibration certificates, installation checklists, operational test protocols, and performance qualification reports—are provided upon request.
Software & Data Management
- SIMS (Stability Instrument Management System) software enables centralized monitoring of up to 30 units via LAN or secure cloud gateway
- Real-time data streaming to local PC with timestamped CSV/Excel export and configurable alarm thresholds
- Audit trail records all user actions: parameter changes, door openings, manual overrides, and calibration events — searchable by date range, username, or event type
- Onboard micro-printer supports configurable print intervals (1 min to 24 hrs) for hard-copy SOP compliance during audits
- Data persistence guaranteed: internal memory retains logs during power loss; SD card backup ensures continuity without reliance on network infrastructure
- Firmware update mechanism supports cryptographic signature verification to prevent unauthorized modification
Applications
This chamber is deployed across R&D laboratories, QC/QA departments, and contract testing organizations for forced degradation studies, photostability assessment (when integrated with optional UV/visible light modules), bracketing and matrixing protocols, and shelf-life estimation under ICH-aligned conditions. It supports regulatory submissions to NMPA, FDA, EMA, and PMDA by delivering reproducible, auditable environmental profiles essential for Chemistry, Manufacturing, and Controls (CMC) dossiers. Routine use includes stability testing of APIs, finished dosage forms (tablets, capsules, injectables), biologics intermediates, and excipient compatibility screening.
FAQ
Does the SHH-500SD-2TA support 21 CFR Part 11-compliant electronic records?
Yes — the controller firmware implements audit trail immutability, electronic signature enforcement, and role-based access controls aligned with FDA requirements.
Can historical data be retrieved after a power outage?
Yes — both internal 4GB circular memory and external SD card retain time-stamped logs independent of mains power.
What validation support is included with the system?
YSEI provides comprehensive IQ/OQ documentation templates, certified sensor calibration reports, and on-site or remote protocol execution services upon request.
Is remote troubleshooting supported without physical access?
Yes — SIMS software enables secure remote diagnostics, parameter adjustment, and firmware updates via encrypted TLS 1.2 connections.
How is unauthorized access prevented during unattended operation?
Dual-lock outer door, login-authenticated HMI interface, door-opening event logging, and optional SMS alerting collectively enforce physical and digital access governance.
