YSEI SHH-2000SD-2TA Drug Stability Testing Chamber
| Brand | YSEI |
|---|---|
| Origin | Chongqing, China |
| Manufacturer Type | Manufacturer |
| Product Category | Domestic |
| Model | SHH-2000SD-2TA |
| Pricing | Upon Request |
Overview
The YSEI SHH-2000SD-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 implements precise, long-term control of temperature (typically 25°C ±2°C, 30°C ±2°C, 40°C ±2°C) and relative humidity (60% RH ±5%, 75% RH ±5%) to support long-term, accelerated, and intermediate stability protocols mandated for registration dossiers and shelf-life determination. The chamber utilizes dual independent PID-controlled refrigeration and humidification subsystems, coupled with high-stability PT100 sensor arrays and air-jacketed insulation architecture to ensure spatial uniformity (±0.5°C across working volume) and temporal stability (±0.3°C over 24 h). Its structural design prioritizes thermal inertia minimization and moisture retention integrity—critical for maintaining ICH-defined test conditions over durations spanning months to years.
Key Features
- Dual-door configuration: Tempered glass inner door minimizes thermal/humidity disturbance during observation; outer door equipped with dual mechanical locks and optional access-log-enabled electronic lock for GMP-grade security.
- Triple-tier user permission management: Administrator, supervisor, and operator roles with granular rights assignment for parameter modification, data export, and alarm acknowledgment—fully auditable per ALCOA+ principles.
- Comprehensive audit trail: System records all user actions (login/logout, setpoint changes, calibration events), real-time environmental readings, and alarm triggers—including timestamps, user IDs, and contextual metadata. Logs are immutable and searchable by date range, user, or event type.
- Redundant data logging: Internal 4GB flash memory (circular buffer) + removable SD card storage; configurable sampling interval from 1 sec to 60 min; supports 10-year continuous recording at 1-min intervals with non-volatile backup—even during power loss.
- Multi-device centralized monitoring: Up to 30 units synchronizable via Ethernet or Wi-Fi using YSEI Sims software; enables remote commissioning, real-time parameter adjustment, and cross-chamber comparative analysis from a single workstation.
- Integrated safety architecture: Independent overtemperature cutoff (separate from main controller), low-water shutoff for humidifier, compressor overload protection, and optional SMS alert module for out-of-specification excursions or power failure.
Sample Compatibility & Compliance
The SHH-2000SD-2TA accommodates standard ICH-compliant stability storage configurations—including open trays, sealed containers, and blister-packed samples—within its internal volume (2000 L net). Its chamber geometry and airflow distribution meet ISO 14644-1 Class 8 (100,000) cleanroom-compatible particulate control standards when operated under validated conditions. All firmware and software components comply with FDA 21 CFR Part 11 requirements for electronic records and signatures, including role-based authentication, electronic audit trails, and record retention integrity. IQ/OQ validation documentation packages—including protocol templates, test scripts, and executed reports—are supplied as part of delivery, supporting GLP/GMP facility audits and regulatory submissions.
Software & Data Management
The embedded controller runs on a Linux-based RTOS with TLS 1.2-secured web interface and native OPC UA server support. YSEI Sims software (Windows/macOS compatible) provides full visualization, trend analysis, deviation reporting, and automated PDF report generation aligned with Annex 11 and WHO TRS 996 expectations. Data export options include CSV, PDF, and XML formats—with metadata embedding for traceability. Optional integration with LIMS or MES platforms is supported via RESTful API and HL7 v2.x messaging. All exported files retain digital signatures and hash verification to satisfy data integrity requirements under EU GMP Annex 11.
Applications
- ICH Q1A(R3) long-term stability testing (25°C/60% RH, 30°C/65% RH)
- ICH Q1B photostability pre-screening (when integrated with optional UV/visible light modules)
- Accelerated stability assessment (40°C/75% RH) per Q1A(R3) and USP
- Intermediate condition studies (30°C/65% RH) for tropical climate labeling
- Forced degradation studies requiring controlled humidity ramping
- Reference standard storage under defined climatic conditions
FAQ
Does the SHH-2000SD-2TA support 21 CFR Part 11 compliance out of the box?
Yes—the system ships with pre-validated electronic signature workflows, audit trail functionality, and role-based access controls meeting all technical and procedural requirements of 21 CFR Part 11 Subpart B.
Can historical data be retrieved after a power outage?
Yes—non-volatile internal memory retains all logged parameters and events during extended power loss; SD card backup ensures zero data loss across unplanned interruptions.
Is IQ/OQ documentation included with the instrument?
Yes—YSEI provides complete, editable IQ/OQ protocols and execution records compliant with ISO/IEC 17025 and ASTM E2500-13, along with on-site or remote validation support services.
What is the maximum number of chambers manageable through one Sims workstation?
A single Sims installation can monitor and control up to 30 SHH-series chambers simultaneously, with synchronized alarm routing and consolidated reporting capabilities.
How is temperature and humidity uniformity verified during qualification?
Uniformity mapping follows ISO 14644-3 and ASTM E2297-03 methodologies using NIST-traceable 9-point sensor arrays; results are documented in the OQ report with pass/fail criteria per ICH Q1A(R3) Annex 1.
