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The LABTOP ® Stability Test Chambers are
especially designed to conduct stability and shelf life studies
on drug and drugs substances. In addition to this, Labtop
Stability Test Chambers are extensively used for seeds
testing, biological studies, testing on electronic &
mechanical components, Cement plants, packing industries
etc. LABTOP
chambers conform to International Standards such as ICH, WHO
Guideline, and USFDA requirements.
Special Features:
-
Precise control of temperature and humidity by using CE approved micro controller based
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PID controller (Imported, Auto
tuning type.).
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Direct digital read-out of % RH with a electronic capacitance type sensor. No wick, cup and water (Optional).
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Refrigeration system with CFC free compressor and R-134a ECO- friendly refrigeration system with time delay.
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PC interface with Windows based communication software. (Optional)
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Micro controller based programmable timer for chamber illumination. (Optional).
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Foamed - in - place PUF insulation ensures temperature stability and reduced energy consumption.
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Audiovisual alarm if the temperature deviates from the pre set temperature (Optional).
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Cabinet Construction and Refrigeration System
:
The cabinet of Labtop Chambers are insulated with high density
CFC free Poly Urethane Foam. Interior of chambers 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
magnetic gasket with a keyed door lock. Stainless steel trays
are provided for storage inside. The cooling is effected by
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.
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 offline, suitable for 80
col. Dot matrix printer. Printer interface for LUX & UV
meter atomatic 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
Printer Interface
:
Facility to store, print records on
printer with set values, process values, date and time
with variable print time interval. Data stoarge facility
to print the data online and offline suitable for 80 col
dot matrix printer
PC
Interface and data management
:
PC Interface with communication
allows remote monitoring and data logging to control the
chamber. Web based software having reports in tabular as
well as graphical form.
PLC system
:
For auto changeover of standby
systems and other event managements with 3.7" LCD
display with touch screen security lock for prevention
of unauthorised tampering.
Temperature & Humidity Sensor
:
Electronic capacitance type Temperature & Humidity
Sensors, which will avoid wick, cup and water
US FDA 21 CFR Part 11 Features
:
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Set and view control parameters
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Complying US FDA 21 CFR Part 11
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Access Control and different access levels
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Multi user with individual user name and password
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Database protection, backup and restore facility
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Online and offline trends
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Chamber wise report / trend generation, printing
facility reports can be export to other formats (PDF,
Excel)
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Analysis of stored data
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Alarm acknowledgment with user comments
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Auto logout and account lockout facility
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Access control with unique username and password
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Reconfirmation of username and password
for change of critical parameters alphanumeric password
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Password aging complying US FDA 21 CFR Part 11 Date and
Time stamp audit trails user equipments
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Alarms SMS audit trails seaparate alarm and log data
recording SOP for installation backup, restore, software
operation.
Documentation
:
For GMP complaint models LABTOP
offers IQ, OQ, PQ and DQ 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)
Software :
PC Interface communication hardware allows remote monitoring and data logging to control the chamber. Windows based software having reports in tabular as well as graphical form. |