Thermolab’s Photostability Chambers are developed according to the ICH 1Qb guidelines keeping in mind that light testing is an integral part of the stress testing. The chambers closely monitor temperature, Humidity (optional) and light intensity on the drug and drug substance.
Standard Features
Double walled modular structure with PUF insulation
Inside Stainless Steel and Outside Mild Steel Powder Coated OR Stainless Steel
Exposure of cool white florescent light for 1.2 mil lux hours and UV-A light for 200 watt hours per square meter on the test samples
Cool white, near-ultraviolet, full spectrum, and dual source cool white/UV banks designed to meet Options 1 and 2 of current ICH/FDA guidelines
Combined light exposure or individual light exposure with automatic light cut off system after exposure is achieved
The light exposure data is captured in the system with respect to date and time along with temperature
Shelf-mounted light tubes providing direct uninterrupted light to test samples
Interior illumination
Inside full length observation glass door with secure gasket
Racks & trays – Stainless Steel with adjustable height
U shaped S.S. Nichrome wire air heaters
Compressor with CFC Free R 134 A / R 404 (Eco Friendly) refrigerant having state of art by-pass system for continuous run of compressor
Plc control system with touch screen display coloured screen – 5.7” HMI with Ethernet
Safety controller sensor to cut off the supply in case of overshoot and undershoot of temperature giving audio visual alarm
Web based online monitoring
Complete with IQ, OQ, PQ, Documents, Operations and Maintenance manuals
Works on 23V AC single phase 50Hz
Complete safety and alarm system
Automatic door open cut off of UV light as a safety measure
Optional Features
21 CFR Part 11 compliance window based communication software for data management
Humidity system
Stand by refrigeration system & Stand by humidity system
Scanner 4 point temperature and 4 point humidity scanner complete with sensors and printer interface and data storage facility Door Access Security system
Mobile Alert system
80 Col. Dot Matrix printers along with Stainless Steel stand
Specifications
Standard Model(S) : Inside S.S. 304 with mirror polish & outside mild steel powder coated
GMP Model(G) : Inside S.S. 316 with mirror polish & outside with S.S. 304 matt buff
Temperature Range : 20 °C to 60 °C
Temperature Accuracy : ± 0.2 °C
Temp Uniformity : ± 2 °C
