YSEI SHH-SD-2TA Temperature and Humidity Controlled Stability Chamber

Overview

The YSEI SHH-SD-2TA is a precision-engineered temperature and humidity controlled stability chamber designed specifically for pharmaceutical stability testing in compliance with ICH Q1–Q5 guidelines, USP , FDA 21 CFR Part 11, and Chinese Pharmacopoeia requirements. It operates on a dual-control principle—separately regulating air-jacketed heating and compressor-based cooling—to ensure thermodynamic stability across long-term, intermediate, and accelerated test conditions (e.g., 25°C/60% RH, 30°C/65% RH, 40°C/75% RH). The chamber’s robust thermal architecture minimizes thermal lag and eliminates condensation-induced humidity drift, enabling reproducible environmental profiles essential for bracketing, matrixing, and real-time stability studies mandated by regulatory submissions.

Key Features

• Air-jacketed heating system ensures rapid temperature recovery and uniform heat distribution without direct contact between heating elements and chamber walls.
• Compressor-based refrigeration delivers stable sub-ambient cooling performance down to 15°C—even at high relative humidity—without requiring supplemental dehumidification hardware.
• External humidification reservoir reduces internal contamination risk and simplifies maintenance; supports continuous operation during extended stability protocols.
• Double-glazed inner door with low-emissivity coating minimizes thermal exchange during visual inspection, preserving chamber integrity and reducing test deviation.
• Triple-tier user permission management (Administrator / Supervisor / Operator) enforces role-based access control aligned with ALCOA+ data integrity principles.
• Dual-lock outer door mechanism complies with physical security requirements for GMP-grade environments; optional door-open event logging available.

Sample Compatibility & Compliance

The SHH-SD-2TA accommodates a wide range of pharmaceutical dosage forms—including tablets, capsules, injectables, ointments, and lyophilized products—within its scalable chamber volumes (220–3000 L). All configurations meet GB/T 10586–2025 (Environmental Test Equipment General Technical Conditions) and are pre-validated to support IQ/OQ execution per ASTM E2500 and ISPE Good Practice Guide. Built-in safeguards include independent overtemperature protection, low-water cutoff for humidifier safety, and compressor overload monitoring—all documented in the factory-supplied validation protocol package. The system is fully compatible with GLP/GMP audit trails and satisfies Annex 11 (EU GMP) and FDA 21 CFR Part 11 requirements for electronic records and signatures when paired with configured audit logging.

Software & Data Management

Equipped with an embedded industrial-grade controller featuring a 7-inch capacitive touchscreen interface, the SHH-SD-2TA provides intuitive navigation and real-time parameter visualization. Data acquisition occurs at configurable intervals (1 minute minimum), with onboard 4GB circular memory supporting ≥10 years of continuous logging—even during power interruption. Raw data exports via SD card or Ethernet interface in CSV/Excel-compatible formats. Optional SIMS remote monitoring software enables centralized supervision of up to 30 units across geographically dispersed sites using secure HTTPS/TLS communication. Integrated micro-printer supports time-stamped hardcopy output with adjustable print frequency, fulfilling dual-record retention policies. All operational logs—including setpoint changes, alarm events, door openings, and user logins—are timestamped, digitally signed, and searchable by date range, operator ID, or event type.

Applications

• ICH-compliant long-term stability studies (25°C/60% RH, 30°C/65% RH)
• Accelerated stability testing (40°C/75% RH) per ICH Q1A(R2)
• Intermediate condition assessments (30°C/65% RH) for borderline formulations
• Photostability pre-screening when integrated with optional UV/visible light modules
• Excipient compatibility and degradation pathway analysis under controlled hygrothermal stress
• Biological product storage qualification and shelf-life modeling

FAQ

Does the SHH-SD-2TA support 21 CFR Part 11 compliance out of the box?
Yes—the system includes electronic signature capability, audit trail generation, and role-based access controls required for Part 11 adherence. Full validation documentation (IQ/OQ templates and test scripts) is provided upon request.
What is the maximum allowable ambient temperature for reliable operation?
The unit is rated for installation in environments with ambient temperatures between 5°C and 35°C and relative humidity ≤85% RH (non-condensing). Operation outside this range may compromise cooling efficiency and humidity control accuracy.
Can humidity be maintained at 15% RH across the full temperature range?
Yes—low-humidity operation is achieved via active dehumidification through the compressor cycle and precise proportional-integral-derivative (PID) control of steam injection rate from the external reservoir.
Is remote firmware update supported via SIMS software?
Firmware updates require local USB-based deployment for security reasons; however, remote parameter adjustment, alarm acknowledgment, and real-time data streaming are fully enabled via SIMS.
How is data integrity preserved during unexpected power loss?
All critical process data—including current setpoints, sensor readings, alarms, and user actions—are written to non-volatile flash memory within 100 ms of occurrence, ensuring zero data loss during outage events.