LABTOP Walk in Stability Test Chambers are especially designed to conduct stability and shelf life studies on drug and drugs substances LABTOP chambers conform to International Standards such as ICH, WHO Guideline, and USFDA requirements. Cabinet Construction and Refrigeration System The Interior of chamber is mirror finish stainless Steel (304 ). The exterior is white powder coated mild steel.. 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 Skylab.
Special Features: - Prefabricated modular type construction with high density CFC free PUF insulation
- A safety alarm system is provided in case of any emergency
- 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.
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 Multi user with individual user name and password Online and Offline trends Chamber wise report / trend generation, printing facility reports can be export to other formats (PDF, Excel) Alarm acknowledgement with user comments Auto logout and account lockout facility for security reasons Password aging Complying US FDA 21 CFR Part 11 Date and time stamp audit trails User, Equipment, 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).
