PHOTOSTABILITY CHAMBER

Product Details :

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 3” Thick PUF insulation
• Inside Stainless steel 304 Mirror Finish & outside Stainless steel 304
• Fluorescent Tubes for day light effect and UV tubes for ultra violet ray in accordance to the ICH guidelines requirement of a lighting energy for 1.2 mil lux hours and UV-A light for 200 watt hours/m2
• Complete with standby refrigeration system in case the regular system fails
• Inside observation glass door with foam type neoprene gasket
• Data logging of UV and LUX Readings in the PLC along with date, time, temperature (and humidity if selected)
• Automatic switch off of UV and fluorescent light when the test is over giving alarm.
• UV light will be switched OFF when the door is open
• 1 No. Stainless Steel perforated tray and 1 no. Light Bank
• U shaped S.S. Nichrome wire air heaters
• Compressor with CFC Free R 134 A / R 404 (Eco Friendly) refrigerant
• PLC based control system with 7” colour HMI.
• Safety controller sensor to cut off the supply in case of overshoot and undershoot of temperature giving audio visual alarm
• Complete with IQ, OQ, PQ, Documents, Operations and Maintenance manuals
• Works on 230 V AC single phase 50 Hz

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 scanner complete with sensors and printer interface and data storage facility. (4 point Humidity optional)
• Door Access Security system
• Mobile Alert system

Specifications:

• Standard Model(S) : Inside S.S. 304 & outside mild steel powder coated
• GMP Model(G) : Inside S.S. 304 & outside S.S. 304
• Temperature Set Point : 25 °C or
• 25 °C & 60% RH (Optional)
• Temperature Accuracy : ± 0.2 °C
• Temp Uniformity : ± 2 °C

Documentation:

• Complete with IQ, OQ, PQ documents
• Operation and Maintenance manuals
• Training to end users