As per ICH-Q1B For Confirmatory studies, sample should be exposed to light providing an overall illumination of not less than 1.2 million lux hours and an integrated near ultraviolet energy of not less than 200 watt hour/square meter to allow direct comparison to be made between drug substance & drug product.
Online and actual study of UV & LUX Exposure.
Automatic cycle cutoff after complete the study / test of UV & LUX.
Constructed and fabricated on fully automatic CNC machines.
Chamber interior is designed with dull or mirror finish stainless steel.
Fluorescent Tubes for daylight effect and UV tubes for ultraviolet ray in accordance with the ICH guidelines.
External finish manufactured with Stainless Steel for GMP model and G.I powder coated for the standard model.
The internals of the chamber is water and vapor tight.
Seams are arc-welded for strength & durability.
Chambers are regulated with air circulation, heating & cooling, & humidity generator system.
Double Door system with outer door insulation. The inner door offers full internal visibility. Doors sealed with silicone gasket along with Lock & key feature.
Easily accessible Control Panel with electrical & refrigeration switchgear mounted on top.
Mounted on heavy castor wheels for easy movement.
Adjustable Stainless Steel electro polished wire mesh type trays; Easy to clean.
Software (21 CFR PART-11 Compliance)
Stand by Cooling System
Stand by Humidity System
Scanner (4 Temp. +4 RH for Online Monitoring Purpose)
Mobile Alert System
Security Alarm System
OPTION 1 (PID CONTROLLER BASED)
Microprocessor based PID controller with auto tuning for accurate control of temperature and humidity conditions.
Rotronic make 4-20mA sensors for better accuracy/ Pt100 Sensor for Temperature & Direct % RH electronic capacitor type humidity.
Data Storage unit facility taao store data and to print directly on printer or transfer to software with Date, Time, SV, PV, Door Open/ Close, Power On/Off remarks.
Safety: Temperature & Humidity High / Low Alarm, Temperature very High / Low cut off, Water level low cut off.
OPTION 2 (HMI + PLC CONTROLLER BASED)
4.3″ HMI with TFT LCD Colour touch screen with password protection for all parameter actual status monitoring of utilities like Sensor, Heating & Cooling System, Humidity System).
Rotronic make 4-20mA sensors for better accuracy.
PLC with auto tuning facility for accurate control of temperature and humidity conditions.
PLC system for an auto changeover of standby systems.
Data Storage unit facility to transfer the data to software via Ethernet for web based online remote monitoring with Date, Time, SV, PV, Door Open/ Close, Power On/Off remarks.
Safety/Alert: Temperature & Humidity High / Low alarm, Temperature & Humidity High / Low cut off, Low water level cut off, Auto change over for standby systems.