OverviewStability and photostability test chamber for ICH Q1A (stability) and ICH Q1B (photostability) testing, Series C/T and LHC/T. Designed to deliver controlled temperature, humidity and ICH‑certified illumination for pharmaceutical product stability studies. Available with touchscreen or dual‑display controllers, advanced programming and integrated data logging. Options include connectivity (USB, RS232/RS485, Ethernet, Wi‑Fi) and compliance modules.
Key features- Compliance: ICH Q1A, ICH Q1B; suitable for GMP/GLP environments.
- Temperature range: −25°C to +70°C with advanced control and programmable ramps.
- Humidity control: 10–90% RH (±3% indicated on tag); ultrasonic humidification and dehumidification options down to 2% available.
- Illumination: ICH‑certified LED lamps, vertical or horizontal arrangement; intensity up to 13,000 lux and UV‑A up to 8 W/m² for Q1B photostability tests.
- Controllers: stillFACE (separate displays for T and RH) and revoFACE (programmable colour touchscreen, up to 10 programs × 50 segments).
- Programming: up to 10 programs with 50 segments each; ramps, dwell times and transitions programmable; cycle times from 1 min to 999 h.
- Data logging & connectivity: integrated data logging, USB export; optional RS232/RS485, Ethernet, Wi‑Fi and mobile app for remote monitoring.
- Validation & regulatory options: IQ/OQ documentation available; CFR21 Part 11 compliant controller option for electronic signatures, audit trail and user management.
- Accessories: IQ/OQ certification, ventilation filters, cable ports, glass/Lexan door, internal power outlet, locking castors, water filtration system, CO2 control, 16 L demineralized water tank for humidification.
- Construction & warranty: Made in Italy, ISO 9001 certified, 24‑month warranty.
Specification tableVolume: 140 – 2300 L
Temperature range: −25°C / +70°C
Humidity: 10 – 90% RH
Temperature uniformity: ±0.5 – 2.5°C
ICH lamps: LED, up to 13,000 lux / UV‑A up to 8 W/m²
Lamp arrangement: vertical or horizontal
Controller: revoFACE / stillFACE touchscreen
Programs: 10 programs, 50 segments
Connectivity: USB, RS232, Ethernet, Wi‑Fi
GMP option: CFR21 Part 11 available
Compliance: ICH Q1A, ICH Q1B, ISO 10977, GMP/GLP
Technical features / Specifications- Series: C/T and LHC/T (configurations for specific ICH tests).
- Selectable internal volume: from 140 L up to 2300 L.
- Temperature control: −25°C to +70°C with typical uniformity ±0.5 – 2.5°C depending on configuration and volume.
- Humidity control: operational range 10–90% RH, active humidity management and advanced dehumidification options (down to 2%).
- Lighting system: ICH‑certified LED lamps with measurable/tracable spectrum and intensity for photostability testing; typical values up to 13,000 lux and up to 8 W/m² UV‑A.
- Lighting types available: ICHlamp for photostability tests; Xenon for UV‑VIS solar simulation; specific alternatives for plant/insect studies available.
- Controller & programming: stillFACE (dual channel display) for manual control/constant monitoring; revoFACE (7" colour touchscreen) programmable with 10 programs × 50 segments, ramps and transitions. Event log and setpoint history, USB and network export.
- Integrability & connectivity: USB export, RS232/RS485, Ethernet, Wi‑Fi, mobile app for remote monitoring.
- Regulatory options: CFR21 Part 11 module for electronic signature, audit trail and user management; IQ/OQ documentation available.
- Accessories & configurations: glass/Lexan doors, internal sockets, cable ports, ventilation filters, locking castors, 16 L demineralized water tank, CO2 system, IQ/OQ certification on request.
- Standards & certifications: ICH Q1A/Q1B compliance, ISO 10977 reference spectrum, ISO 9001, CE marking.