YSEI SHH-3000SD-2TA Drug Stability Testing Chamber
| Brand | YSEI |
|---|---|
| Origin | Chongqing, China |
| Manufacturer Type | Manufacturer |
| Country of Origin | Domestic (China) |
| Model | SHH-3000SD-2TA |
| Pricing | Upon Request |
Overview
The YSEI SHH-3000SD-2TA Drug Stability Testing Chamber is a precision-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 implements dual-loop PID control architecture with independent temperature and humidity regulation modules to maintain highly stable test conditions across long-term (25°C/60% RH), accelerated (40°C/75% RH), and intermediate (30°C/65% RH) protocols. The chamber utilizes high-efficiency scroll compressors, stainless-steel humidification tanks with auto-drain functionality, and insulated double-glass observation doors to minimize thermal and moisture load perturbations during routine monitoring. Its structural design adheres to GB/T 10586–2025 technical specifications for environmental test chambers, ensuring mechanical robustness and long-term operational consistency under continuous 24/7 operation.
Key Features
- Triple-tier user permission management with role-based access control (RBAC) supporting administrator, supervisor, and operator levels — configurable via intuitive 7-inch capacitive touchscreen interface
- Comprehensive audit trail system compliant with ALCOA+ principles: all parameter changes, alarm events, door openings, and calibration actions are timestamped, user-identified, and immutable
- Dual data redundancy: internal 4GB flash memory (circular buffer) + removable industrial-grade SD card; 1-minute logging resolution supports ≥10 years of continuous data retention even during power interruption
- Multi-modal data output: real-time USB/RS485 PC connectivity, optional thermal printer (adjustable print interval), and Ethernet-enabled remote access via YSEI Sims software platform
- Physical security architecture: dual-lock outer door with access log recording (optional), inner tempered glass observation window minimizing thermal leakage, and independent over-temperature protection circuitry per chamber zone
- Energy-optimized operation: variable-speed compressor control, intelligent defrost scheduling, and low-noise fan array achieving ≤55 dB(A) at 1 m distance
Sample Compatibility & Compliance
The SHH-3000SD-2TA accommodates standard ICH-compliant stability batches including blister-packed tablets, vials, ampoules, and sachets on adjustable stainless-steel shelves. Its uniformity performance meets ICH Q1A(R3) spatial tolerance requirements (±2°C temperature deviation, ±5% RH deviation across working volume). Validation documentation includes full IQ/OQ protocol packages aligned with ISO 13485 and GMP Annex 15 standards, with traceable NIST-traceable sensor calibration certificates provided. All firmware and software components undergo periodic cybersecurity assessment per IEC 62443-3-3, and electronic records satisfy FDA 21 CFR Part 11 electronic signature and audit trail requirements.
Software & Data Management
The embedded controller runs a deterministic real-time OS with deterministic sampling intervals (configurable from 10 s to 60 min). Data export supports CSV, PDF, and XML formats with embedded digital signatures. The Sims remote monitoring platform enables centralized management of up to 30 units across geographically dispersed sites via HTTPS-secured TLS 1.2 connections. Role-specific dashboards allow QA personnel to review trend reports, generate deviation investigations (OOS/OOT), and export validated PDF summaries with embedded metadata (user ID, timestamp, device serial number). All software updates follow a formal change control process documented in the system validation master plan (VMP).
Applications
- ICH Q1A–Q1E long-term, accelerated, and stress testing of active pharmaceutical ingredients (APIs) and finished dosage forms
- Photostability assessment when integrated with optional UV/visible light modules (IEC 60601-2-57 compliant)
- Excipient compatibility screening under controlled humidity gradients
- GMP-regulated stability program execution for ANDA, NDA, and MA submissions
- Real-time stability monitoring during commercial batch release and shelf-life extension studies
- Environmental qualification of cleanroom support areas (e.g., sample holding rooms)
FAQ
Does the SHH-3000SD-2TA support 21 CFR Part 11 compliance out-of-the-box?
Yes — the system ships with pre-validated electronic signature workflows, audit trail integrity checks, and role-based authentication mechanisms fully aligned with Part 11 Annex A requirements.
Can historical data be retrieved after a power failure?
Yes — non-volatile memory ensures no data loss during outage; both internal flash and SD card retain synchronized logs with millisecond-precision timestamps.
Is IQ/OQ documentation included with delivery?
Yes — a complete validation kit comprising protocol templates, executed reports, calibration certificates, and traceability matrices is supplied as part of standard delivery.
What is the maximum number of units manageable via a single Sims server instance?
Up to 30 chambers can be monitored and controlled concurrently through one Sims installation, with configurable alert routing to designated email or SMS endpoints.
How is humidity uniformity verified across the chamber volume?
Uniformity mapping is performed per ISO 16730 using nine calibrated hygrometers placed at defined geometric locations; results are documented in the OQ report with pass/fail criteria per ICH Q1A(R3) Annex 2.
