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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 :
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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
energyconsumption.
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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
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.
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 with 3.7" LCD
display with touch screen security lock for prevention
of unauthorized tampering.
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)
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Stability Test Chambers