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Photo Stability Test Chambers

PHOTO STABILITY TEST CHAMBERS are design to provide high intensity lighting system to comply with ICH guide lines for photo stability conditions with white fluorescent exposure of 1.2 million LUX hours and ultra violet energy exposure of 200 W hours/sq. meters. LABTOP chambers conform to International Standards such as ICH, WHO Guideline, and USFDA requirements. printer interface for LUX & UV meter, automatic shut off after specified exposure level.

Cabinet Construction and Refrigeration System
The cabinet of Labtop Chambers are insulated with high density CFC free Poly Urethane Foam. Interior of chamber is mirror finish stainless Steel (304 SS, 0.8 mm thick). The exterior is white powder coated (1.0 mm thick) mild steel and the door has a magnetic door gasket with a keyed door lock. Stainless steel trays are provided for storage inside. The cooling is effected by a hermitically sealed compressor of high quality. GMP models are in total stainless steel (Inside S. S 316 with mirror finished and outside. S 304 dull finish.) is also manufactured by Labtop Instruments Pvt Ltd.

Special Features

• Unique airflow system ensures even distribution of humidity and temperature.
• Formed - in - place PUF insulation ensures temperature stability and reduced energy consumption.
• Precise control of temperature and humidity by using CE approved micro controller based PID controller (Imported, Auto tuning type).
• Refrigeration system with CFC free compressor and R-134a ECO-friendly refrigeration system with time delay.
• Display of set value and process value.
• Castor wheels for ease of mobility.

OPTIONAL ACCESSORIES
Stand by Refrigeration system Ready to use stand by refrigeration system in case of regular system fails. This includes Compressor, Evaporator, condensers and other accessories.

Safety Controller
Dedicated safety controller with separate sensor to switch off the power supply in case of overshoot and undershoot of temperature giving audio visual alarm.

Data Scanner
Data Scanner 4 point temperature and 4 point humidity or 8 point temperature 8 point humidity complete with Sensors and printer interface and data storage facility.

Printer Interface
Facility to store, print records on printer with set values, Process values, date and time with variable print time interval. Data storage facility to print the data online and off line, suitable for 80 col. Dot matrix printer. printer interface for LUX & UV meter automatic shut off after specified exposure level

Software
CFR 21 Part 11 compliance web based communication software for data management. Complete with RS 485 multi dropping to monitor multiple chambers to one software.

P C Inter face and data management
PC Interface communication allows remote monitoring and data logging to control the chamber. Web based software having reports in tabular as well as graphical form.

Temperature & Humidity sensor
Electronic capacitance type Temperature & humidity sensors, which will avoid wick, cup and water.

PLC system
For auto changeover of standby systems and other event managements with3.8" LCD display with touch screen, security lock for prevention of unauthorized tampering.

US FDA 21 CFR Part 11 FEATURES

• Set and view control parameters
• Complying US FDA 21 CFR Part 11
• Access control and different access levels
• Multi user with individual user name and password
• Database protection, backup and restore facility
• Online and Offline trends
• Chamber wise report / trend generation, printing facility reports can be export to other formats (PDF, Excel)
• Analysis of stored data
• Alarm acknowledgement with user comments
• Auto logout and account lockout facility for security reasons
• Access control with unique username and password
• Reconfirmation of username and password for change of critical parameters Alphanumeric password.
• Password aging Complying US FDA 21 CFR Part 11 Date and time stamp audit trails User, Equipment
• Alarm, SMS audit trails Separate alarm and log data recording SOP for installation, backup, restore, software operation.

Documentation : For GMP complaint models LABTOP offers DQ IQ, OQ and PQ validation with documentation, reports, calibration and test certificates.

Calibration : The equipment is calibrated with the help of master calibrator, which is certified for its accuracy by Electronics Regional Testing Laboratory (ERTL West) Government of India recognized testing laboratory with traceable reference to National Physical Laboratories (NPL).

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