Vasai, Mumbai, Maharashtra, India, 401208
- - 91-250-2481431
- - 91-250-2481505
Place of Origin
100 Piece/Pieces per Month Per
Other Measuring & Analysing Instruments, Seed Germinator, LABTOP, SKYLAB INSTRUMENTS & ENGINEERING PVT LTD, India
Measurement & Analysis Instruments > Other Measuring & Analysing Instruments
Detailed Product Description
PHOTO STABILITY TEST CHAMBERS are design toprovide high intensity lighting system to comply with ICH guide linesfor photo stability conditions with white fluorescent exposure of 1.2million 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 freePoly Urethane Foam. Interior of chamber is mirror finish stainlessSteel (304 SS, 0.8 mm thick). The exterior is white powder coated (1.0mm thick) mild steel and the door has a magnetic door gasket with akeyed door lock. Stainless steel trays are provided for storage inside.The cooling is effected by a hermitically sealed compressor of highquality. GMP models are in total stainless steel (Inside S. S 316 withmirror finished and outside. S 304 dull finish.) is also manufacturedby Skylab.
- Unique airflow system ensures even distribution of humidity and temperature.
- Formed - in - place PUF insulation ensures temperature stability and reduced energy consumption.
- Precisecontrol of temperature and humidity by using CE approved microcontroller 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.
Stand by Refrigeration system Ready to use stand by refrigerationsystem in case of regular system fails. This includes Compressor,Evaporator, condensers and other accessories.
Dedicated safety controller with separate sensor to switch off thepower supply in case of overshoot and undershoot of temperature givingaudio visual alarm.
Data Scanner 4 point temperature and 4 point humidity or 8 pointtemperature 8 point humidity complete with Sensors and printerinterface and data storage facility.
Facility to store, print records on printer with set values, Processvalues, date and time with variable print time interval. Data storagefacility to print the data online and off line, suitable for 80 col.Dot matrix printer. printer interface for LUX & UV meter automaticshut off after specified exposure level
CFR 21 Part 11 compliance web based communication software for datamanagement. Complete with RS 485 multi dropping to monitor multiplechambers to one software.
P C Inter face and data management
PC Interface communication allows remote monitoring and data logging tocontrol the chamber. Web based software having reports in tabular aswell as graphical form.
Temperature & Humidity sensor
Electronic capacitance type Temperature & humidity sensors, which will avoid wick, cup and water.
For auto changeover of standby systems and other event managementswith3.8" LCD display with touch screen, security lock for prevention ofunauthorized 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, OQand PQ validation with documentation, reports, calibration and testcertificates.
Calibration : The equipment is calibrated with the help ofmaster calibrator, which is certified for its accuracy by ElectronicsRegional Testing Laboratory (ERTL West) Government of India recognizedtesting laboratory with traceable reference to National PhysicalLaboratories (NPL).
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