ICH Q1B-Compliant Chamber for Photostability and Stability Testing
The FitoClima 600 Photostability Chamber is a precision-engineered environmental chamber designed specifically for photostability testing of pharmaceuticals, cosmetics, and other light-sensitive products. Compliant with the ICH Q1B guideline, it enables efficient testing of both UV and visible light exposure—accurately monitored and controlled using integrated light sensors and automatic test management.
Beyond photostability, the chamber’s wide temperature and humidity range, along with a modular interior, makes it fully suitable for ICH Q1A stability testing as well. With interchangeable shelves and FDA-compliant software, it offers unmatched versatility for regulated laboratory environments.
Key Features
- Chamber Volume: 550 liters
- Temperature Range: 0 °C to 45 °C
- Humidity Range: 35 % to 95 % RH
- Temperature/Humidity Uniformity: Highly stable, ideal for long-duration tests
- Photostability Testing (ICH Q1B):
- Visible Light: ~26,000 Lux ±6% (completes Q1B test in ~48h)
- UV Light: ~30 W/m² ±10% (completes Q1B test in ~7h)
- Automatic test cutoff based on cumulative light exposure (visible and UV)
- Light sensors integrated for real-time intensity tracking
- Storage & Shelving:
- 1 UV light shelf (0.14 m²)
- 1 visible light shelf (0.14 m²)
- Shelves can be replaced with standard wire racks for conventional stability testing
- Compliance & Software:
- Fully compatible with FDA 21 CFR Part 11 for electronic records and data logging
- Delivered with IQ, OQ, PQ documentation for qualification and GMP validation
Typical Applications
- Photostability testing of pharmaceutical products (ICH Q1B)
- Light exposure testing for cosmetics, supplements, and packaging
- Stability studies under controlled temperature and humidity (ICH Q1A)
- Dual-purpose testing in one chamber: photostability + long-term storage
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