Photo Stability Test Chambers

Our LABTOP ® Photo Stability Test Chamber is designed in strict compliance with the International Conference on Harmonization (ICH) guidelines. These guidelines demand photo stability conditions with white fluorescent illumination of 1.2 million LUX hours and UV rays exposure of 200W hours/sq. meter. Our photo stability chambers are also in accordance with international standardizations made by various international organizations like WHO, ICH, and USFDA. These chambers are well equipped with distinctive features like printer interface for LUX & UV meters, and auto shut off facility after a specified exposure level.

Cabinet Construction and Refrigeration System
The cabinet of our photo stability test chamber is insulated with a high density chlorofluorocarbon or CFC free poly urethane foam. The interior of this chamber is fabricated from grade 304 SS stainless steel which is 0.8mm in thickness. The exterior portion of this equipment is manufactured from mild steel which is coated with white powder and is 1.0mm thick. The cooling inside the chamber is done by an imperviously sealed high quality compressor.

Special Features of Photo Stability Test Chambers

• Even distribution of humidity and temperature is taken care by a specially designed airflow system.
• Formed- in-place PUF insulation ensures balanced temperature and power saving.
• Use of CE approved PID controller (auto tuning type), which is based on micro controller helps in regulating the temperature and humidity in a precise and flawless manner.
• An efficient time delay enabled refrigeration system with CFC free compressor and R-134a environment-friendly refrigeration.
• Display of set value and process value.
• Fitted with casters, which enable easy mobility.

Optional Accessories

Standby Refrigeration System: A ready to use standby refrigeration system which proves beneficial in case of frequent system failures. This system is composed of compressor, condensers, evaporator, and other accessories.

Safety controller : This safety controller is equipped with dedicated sensors which keep a close watch over the temperature change and switch off the power supply in case of temperature overshoot and undershoot. The safety controller also gives an audiovisual alarm before cutting the power.

Data scanner : A 4 point temperature and 4 point humidity or 8 point temperature 8 point humidity data scanner, complete with hi-tech sensors, printer interface, and data storage space.

Printer Interface : Facility to store and print records on printer with preset denomination, process values, and date and time with changeable print time interval. Data storage facility for online and offline printing of data, appropriate for 80 column dot matrix printer.

Software : A web based communication software which is CFR 21 Part 11 compliant and meant for data management. This software is complete with RS 485 multi dropping to monitor multiple chambers to one software.

PC Inter face and data management : PC interface communication enables the controlling of chamber by means of remote monitoring and data logging. It also acts as a web-based software having tabular as well as graphical format reports.

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

PLC system : This system is perfectly suitable for carrying on the job of automatic switching of standby systems as well as miscellaneous event management tasks. It is equipped with a security lock enabled LCD touch screen measuring 3.8”. Besides displaying the equipment functioning details, this LCD screen prevents unauthorized tampering.

US FDA 21 CFR Part 11 FEATURES

• Facility of setting and viewing control parameters.
• US FDA 21 CFR Part 11 compliance.
• Different access levels with access control.
• Multiple users can be created and individual username and password can be assigned to each user.
• Database protection, backup and restore facility.
• Facility of generating chamber wise reports and printing facility reports. The reports so generated can be exported to other file formats like excel and PDF.
• Analysis of the stored data can be done.
• Alarm acknowledgment with user comments.
• Auto logout and account locking facility for the protection of account against any possible threats.
• Mandatory reconfirmation of username and password is required for the modification of crucial parameters like the alphanumeric password.
• Password aging in accordance with US FDA 21 CFR Part 11 date and time stamp audit trails.

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

Calibration
Master calibrator has been used for calibrating the equipment. The master calibrator is certified for its exactness by the Govt. of India recognized Electronics Regional Testing Laboratory (ERTL West). The same certification is in verifiable reference with the National Physical Laboratories (NPL), situated in U.K.