- 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 fabricated of stainless steel with dull/mirror finish & exterior is of stainless steel for GMP Model /G.I. Powder coated for standard Model.
- The inner working chamber is water & vapour tight high-grade stainless steel. All seams are arc-welded & passivity for strength & durability.
- Chambers are provide with effective air circulation system, heating & cooling systems and humidity generator system.
- Double Door : Inner full viewing glass door and outer door insulated with lock and key arrangement. Inner& outer doors are sealed with silicone sponge rubber gasket.
- Control panel with electrical switch gear and refrigeration system mounted on top for easy service accessibility.
- Equipment mounted on heavy castor wheels for easy movement.
- Heavy duty solid stainless steel duly electro polished wire mesh type trays are provide which are easy to clean, time & efforts saving, also adjustable for convenience.
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
- 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.
Temperature & Humidity High / Low alarm, Temperature & Humidity High / Low cut off, Low water level cut off, Auto change over for standby systems.
- Software (21 CFR PART-11 Compliance) :
Log data, Event data, Audit Trail data, E-Records & E-signatures, Graphical analysis& Data acquisition.