|
 |
PHOTO STABILITY TEST CHAMBERS are design to provide high intensity lighting system to comply
with ICH guide lines for photo stability conditions with white
fluorescent exposure of 1.2 million 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 free Poly Urethane Foam.
Interior of chamber 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 a magnetic door gasket with a
keyed door lock. Stainless steel trays are provided for storage
inside. 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:
-
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.
-
Display of set value and process value.
-
Castor wheels for ease of mobility.
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
-
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, 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).
|
Photo Stability Test Chambers