YSEI SHH-220SD-2T Drug Stability Testing Chamber
| Brand | YSEI |
|---|---|
| Origin | Chongqing, China |
| Manufacturer Type | Direct Manufacturer |
| Product Origin | Domestic (China) |
| Model | SHH-220SD-2T |
| Price Range | USD 7,000 – 11,200 |
Overview
The YSEI SHH-220SD-2T Drug Stability Testing Chamber is an engineered environmental simulation system designed exclusively for pharmaceutical stability studies in compliance with ICH Q1–Q5 guidelines, USP , FDA 21 CFR Part 11, and Chinese Pharmacopoeia (ChP) requirements. It implements precise, long-term control of temperature (±0.5 °C) and relative humidity (±3 % RH) across defined test conditions—including Long-Term (25 °C/60 % RH), Accelerated (40 °C/75 % RH), Intermediate (30 °C/65 % RH), and Low-Humidity protocols (e.g., 40 °C/20 % RH for large-volume parenterals). Its dual-door architecture, thermally insulated chamber construction, and redundant sensor feedback loops ensure minimal thermal disturbance during sample observation and high repeatability across multi-month or multi-year studies.
Key Features
- Dual-glass-door design: Inner tempered glass door enables real-time visual monitoring without compromising chamber integrity; outer keyed mechanical lock prevents unauthorized access per cGMP Annex 11 and ALCOA+ data integrity principles.
- Intelligent touchscreen controller with 64 MB internal circular buffer: Stores setpoints, actual values, timestamps, and date/time metadata; configurable sampling interval from 1 minute (10-year storage capacity) to 15 minutes (3-year retention).
- Electronic data integrity architecture: Compliant with FDA 21 CFR Part 11—supports user authentication, electronic signatures, audit trails, and immutable data export via USB or industrial-grade SD card (FAT32 formatted, ≥16 GB recommended).
- Networked remote operation: RS485 interface enables centralized control of up to 30 units on a single serial bus; optional SIMS-based cloud platform provides secure web-accessible remote monitoring, parameter adjustment, and alarm notification via SMS/email.
- Energy-efficient refrigeration & humidification: Optimized compressor cycling and PID-controlled ultrasonic humidifier reduce power consumption by ~22% vs. conventional chambers; acoustic noise level maintained below 52 dB(A) at 1 m distance.
- Comprehensive safety redundancy: Independent overtemperature cutoff, dry-run protection for humidifier reservoir, compressor overload relay, and dual-channel temperature/humidity deviation alarms with SMS alerting capability.
Sample Compatibility & Compliance
The SHH-220SD-2T accommodates standard pharmaceutical packaging formats—including blister packs, HDPE bottles, vials, syringes, and IV bags—within its 220 L working volume (D×W×H: 550 × 600 × 670 mm). Chamber airflow is calibrated to ISO 14644-1 Class 8 (100,000) cleanroom-equivalent uniformity, minimizing localized gradients. All materials in contact with the chamber interior meet USP Class VI biocompatibility standards. The system is validated per ASTM E2500-13 and supports full IQ/OQ documentation packages aligned with EU Annex 15 and WHO TRS 986, including installation qualification templates, operational qualification protocols, and traceable calibration certificates for NIST-traceable Pt100 sensors.
Software & Data Management
Pre-installed YSEI PharmaLog™ software provides compliant data lifecycle management: automated report generation (PDF/CSV), role-based access control (RBAC), version-controlled configuration backups, and time-stamped audit trail export (XML format). The system logs all user actions—including login/logout, parameter changes, alarm acknowledgments, and data exports—with cryptographic hashing to prevent tampering. Data files are digitally signed and timestamped using embedded hardware security module (HSM)-assisted signing keys. Software validation documentation includes URS, FRS, DQ/IQ/OQ/PQ evidence, and 21 CFR Part 11 readiness assessment reports.
Applications
- ICH Q1A(R3)–Q1E stability protocol execution (Long-Term, Accelerated, Stress, and Bracketing/Multipoint studies)
- Real-time and accelerated shelf-life determination for APIs, finished dosage forms, and biologics
- Photostability pre-screening (when integrated with optional ICH Q1B-compliant light cabinets)
- Transport simulation testing under variable ambient conditions
- Reference standard storage under controlled environment per USP
- Support for GMP-regulated stability programs requiring full ALCOA+ data governance
FAQ
Does the SHH-220SD-2T support 21 CFR Part 11-compliant electronic records?
Yes—the system includes built-in electronic signature workflows, audit trail logging, and data immutability features validated per Part 11 Annex A guidance.
Can multiple chambers be managed from a single workstation?
Yes—up to 30 units can be daisy-chained via RS485 and centrally monitored using YSEI PharmaLog™ or third-party SCADA systems supporting Modbus RTU.
What validation support is provided post-delivery?
YSEI supplies complete IQ/OQ documentation kits, on-site OQ execution services, and optional PQ support coordinated with qualified laboratories.
Is low-humidity operation (e.g., 40 °C/20 % RH) achievable without desiccant supplementation?
Yes—the integrated dehumidification subsystem achieves stable 20 % RH at 40 °C using chilled-mirror condensation and reheating control, verified per ISO 12099:2017 Annex B.
How is data preserved during unexpected power loss?
All critical parameters are written to non-volatile memory in real time; SD card writes occur every 15 minutes with journaling enabled to prevent file corruption.
