CZGY GY-160YPZ Drug Stability Testing Chamber
| Brand | CZGY |
|---|---|
| Origin | Jiangsu, China |
| Manufacturer Type | Direct Manufacturer |
| Model | GY-160YPZ |
| Capacity | 160 L |
| Temperature Range | 0–65°C (dark), 10–50°C (with illumination) |
| Humidity Range | 30–95% RH |
| Temperature Uniformity | ±1.5°C |
| Temperature Fluctuation | ≤±0.5°C |
| Humidity Fluctuation | ±5% RH |
| Temperature Resolution | 0.1°C |
| Illumination | Six-level adjustable LED lighting, ≥10,000 lx (triple-side illumination) |
| Control System | True-color touchscreen controller with programmable logic (5 programs × 30 segments max, 999 h/min per segment) |
| Data Logging | Built-in real-time recording with USB data export (U-disk storage) |
| Refrigeration | Dual independent hermetic compressors with auto-switching logic |
| Humidity Control | 15 L integrated humidifier with auto-fill and dry-run protection |
| Safety | Independent over-temperature cutoff, power-loss memory, automatic recovery on power restoration |
| Compliance Support | Designed to meet ICH Q1A(R2), Q5C stability protocol requirements |
Overview
The CZGY GY-160YPZ Drug Stability Testing Chamber is an ICH-aligned environmental simulation system engineered for long-term and accelerated stability studies of pharmaceutical products in accordance with ICH Q1A(R2), Q5C, and regional regulatory expectations (e.g., USP , FDA Guidance for Industry on Stability Testing). It operates on a dual-mode thermal-hygrometric control architecture—employing balanced heating/cooling and precision steam-based humidification—to maintain stable, reproducible conditions across defined temperature (0–65°C in dark mode; 10–50°C under illumination) and relative humidity (30–95% RH) setpoints. Unlike generic climate chambers, the GY-160YPZ integrates pharmaceutical-grade design features: a 304 mirror-finish stainless steel interior with radius-corner construction to prevent microbial harborage, chromium-plated stainless steel shelves for corrosion resistance, and a double-door structure with tempered glass viewport to minimize thermal load disturbance during access. Its mechanical architecture—including Danfoss-derived refrigeration logic, electronic expansion valve modulation, and redundant compressor staging—ensures uninterrupted operation over extended test durations (≥6 months), critical for ICH Stage 1 (long-term) and Stage 2 (accelerated) protocols.
Key Features
- True-color 7-inch programmable touchscreen interface supporting both constant-value and multi-segment profile control (up to 5 programs × 30 segments, each configurable for duration up to 999 hours or minutes)
- Dual independent hermetic refrigeration system with automatic load-balancing and failover—enabling continuous operation even during compressor maintenance cycles
- Integrated 15 L capacity humidifier with float-controlled auto-refill, anti-dry-burn protection, and PID-driven steam output regulation
- Triple-side LED illumination array delivering uniform ≥10,000 lx intensity across six adjustable brightness levels—fully compliant with ICH Q1B photostability testing tier requirements
- Real-time data acquisition engine logging temperature, humidity, and illumination status at user-defined intervals; exportable via USB flash drive in CSV format for traceable archival
- Comprehensive safety architecture: independent mechanical high-limit thermostat, voltage fluctuation compensation, brownout recovery, and non-volatile memory retention for all active parameters
Sample Compatibility & Compliance
The GY-160YPZ accommodates standard pharmaceutical packaging formats—including blister packs, HDPE bottles, amber vials, and secondary cartons—within its 550 × 450 × 700 mm working chamber. Its stainless steel interior and smooth-welded seams support routine cleaning validation per EU Annex 1 and USP . The chamber is designed to facilitate compliance with multiple regulatory frameworks: it meets the physical specification thresholds required for ICH Q1A(R2) long-term (25°C ± 2°C / 60% RH ± 5% RH) and accelerated (40°C ± 2°C / 75% RH ± 5% RH) storage conditions; supports photostability testing per ICH Q1B Option 2 (near-UV and visible light exposure); and provides the hardware foundation for 21 CFR Part 11-compliant data integrity when integrated with validated third-party software or optional embedded thermal printer (Model PRT-200, sold separately). All firmware logs include timestamped event records (door openings, alarm triggers, parameter changes) suitable for GLP audit trails.
Software & Data Management
The onboard controller runs embedded Linux-based firmware with dual-language UI (English/Chinese) and supports RS232 and RS485 serial communication for SCADA or LIMS integration. Data logging occurs continuously at 1-minute intervals by default, storing up to 30 days of full-resolution time-series data internally. USB export generates ISO 8601-formatted CSV files containing columnar fields: Timestamp (YYYY-MM-DD HH:MM:SS), Chamber Temp (°C), Setpoint Temp (°C), Chamber RH (%), Setpoint RH (%), Illumination Level (0–6), Compressor Status (ON/OFF), Humidifier Status (ON/OFF), and Alarm Code (if active). Optional add-ons—including GPRS remote alerting (SMS notification on deviation >±1.0°C or >±8% RH), 22 mm test port for external probe insertion, and UV-C germicidal lamp (254 nm, 30 W)—extend operational flexibility without compromising chamber integrity.
Applications
- ICH-compliant long-term stability monitoring of APIs and finished dosage forms (tablets, capsules, injectables, topicals)
- Accelerated degradation profiling to estimate shelf-life under stressed conditions
- Photostability assessment per ICH Q1B using calibrated visible/near-UV LED arrays
- Excipient compatibility screening under controlled hygrothermal stress
- Reference standard storage verification per USP and Ph. Eur. 2.2.45
- Biologics stability evaluation at refrigerated (2–8°C) and ambient conditions, with humidity control to assess moisture-mediated aggregation
FAQ
Does the GY-160YPZ comply with ICH Q1A(R2) long-term storage specifications?
Yes—the chamber achieves and maintains 25.0°C ± 0.5°C and 60% RH ± 3% RH under steady-state conditions, verified per internal calibration protocol traceable to NIST-certified reference sensors.
Can the unit operate unattended for 6-month accelerated studies?
Yes—its dual-compressor redundancy, electronic expansion valve modulation, and uninterruptible power management enable continuous operation; mean time between failures (MTBF) exceeds 12,000 hours per ASME BPE-2023 reliability modeling.
Is data export compatible with electronic lab notebooks (ELN) or LIMS platforms?
CSV-formatted logs are natively ingestible by most ELN/LIMS systems; RS485 Modbus RTU implementation allows direct register-level polling for automated ingestion pipelines.
What validation documentation is provided with the system?
Factory-issued IQ/OQ documentation package includes installation checklist, sensor calibration certificates (temperature/humidity/illumination), performance qualification report (PQ) executed at 25°C/60%RH and 40°C/75%RH, and firmware version audit log.
Can the illumination system be disabled for dark-condition testing?
Yes—LED arrays are fully de-energizable via software command or hardware interlock; chamber remains certified for ICH Q1A dark-storage protocols when illumination is off.
