YSEI SHH-SD-2TA Series Drug Stability Testing Chamber
| Brand | YSEI |
|---|---|
| Origin | Chongqing, China |
| Manufacturer Type | Direct Manufacturer |
| Product Origin | Domestic (China) |
| Model | SHH-SD-2TA Series |
| Pricing | Upon Request |
Overview
The YSEI SHH-SD-2TA Series Drug Stability Testing Chamber is a precision-engineered environmental simulation system designed explicitly 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-controlled temperature and humidity regulation to maintain highly 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’s thermodynamic architecture integrates high-efficiency refrigeration compression, ultrasonic humidification with auto-refill reservoir monitoring, and insulated double-glass observation doors—ensuring minimal thermal/hygrometric perturbation during sample access. Its structural design conforms to GB/T 10586–2025 (Environmental Test Equipment – General Technical Conditions), supporting GLP- and GMP-aligned validation workflows from installation qualification (IQ) through operational qualification (OQ).
Key Features
- Dual-door configuration: Outer security door with dual-lock mechanism and optional access-log audit trail; inner tempered glass door for non-intrusive sample observation without compromising chamber integrity
- Triple-tier user permission management: Role-based account control (Administrator / Technician / Viewer) with configurable privilege scopes and password-protected parameter modification
- Comprehensive audit trail: Full timestamped logging of all operational events—including setpoint changes, door openings, alarm triggers, and user logins—stored internally with ISO 27001-aligned encryption
- Redundant data retention: 4GB internal cyclic memory + removable SD card export; 1-minute sampling interval supports ≥10 years of continuous environmental data archiving with power-fail resilience
- Multi-device centralized monitoring: Up to 30 units networkable via Ethernet or Wi-Fi; remote commissioning, real-time graphing, and alarm push notifications enabled via YSEI Sims software platform
- Integrated safety interlocks: Independent overtemperature cutoff, humidifier dry-run protection, compressor overload shutdown, and SMS-based alerting for temperature/humidity excursions or mains power loss
Sample Compatibility & Compliance
The SHH-SD-2TA accommodates standard pharmaceutical packaging formats—including blister packs, vials, ampoules, and sachets—within its uniformly conditioned workspace. Chamber uniformity meets ICH-defined tolerances: ±0.5°C temperature deviation and ±3% RH variation across the working volume under steady-state operation. All firmware and software components support 21 CFR Part 11 compliance through electronic signature capability, immutable audit logs, and attribute-based access control. Validation documentation packages—including IQ/OQ protocols, traceable calibration certificates, and risk assessment reports—are provided as part of standard delivery.
Software & Data Management
The embedded controller runs a deterministic real-time OS with configurable data acquisition frequency (1–60 minutes). Local touchscreen interface (7-inch capacitive LCD) enables intuitive navigation, trend visualization, and manual override. Simultaneous data streams are routed to external PCs via USB, RS485, or TCP/IP for integration into LIMS or ELN systems. Optional thermal printer provides tamper-evident hardcopy records with adjustable print intervals. All exported datasets comply with ASTM E2500-13 (Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems) metadata requirements.
Applications
- ICH Q1A(R3) long-term and accelerated stability testing of active pharmaceutical ingredients (APIs) and finished dosage forms
- Photostability assessment per ICH Q5C when integrated with optional UV/visible light modules
- Excipient compatibility screening under controlled hygrothermal stress
- Shelf-life prediction modeling using Arrhenius kinetics and moisture sorption isotherms
- Regulatory submission support for ANDA, NDA, and MA applications requiring documented environmental consistency
FAQ
Does the SHH-SD-2TA Series support 21 CFR Part 11-compliant electronic records?
Yes—full audit trail, role-based e-signature enforcement, and data immutability are natively implemented per FDA guidance.
What is the maximum allowable ambient operating environment?
Chamber performance is guaranteed at ambient temperatures between 5°C and 35°C, with relative humidity ≤85% RH.
Can historical data be exported in CSV or PDF format?
Yes—data export via SD card or network connection supports both CSV (for statistical analysis) and PDF (for audit-ready reporting).
Is IQ/OQ documentation included with shipment?
Yes—validated protocols, calibration records, and execution templates are supplied; on-site OQ support is available upon request.
How is humidity accuracy maintained during extended 40°C/75% RH testing?
Ultrasonic humidification combined with dew-point referenced feedback control ensures ±2.5% RH accuracy over 90-day continuous operation.
