Case Study Citect Used on FDA Validated Process to Monitor Reactor Profiles Ranbaxy Labs By K. Subramaniam Managing Director Masibus Process Instruments Pvt. Ltd. Masibus has installed a Citect SCADA system with a Masibus Data Logger 8030 at the Ranbaxy Labs, Ltd. bulk drug manufacturing plant at Mohali, India. The manufacturer has achieved U.S. Food and Drug Administration (FDA) process validation for confor- mance to Current Good Manufacturing Practices (CGMP) covering the manufacturing, process- ing, packing and holding of drugs. The application in question is to monitor temperature at various reactors in the process. Application of Citect SCADA Software at RANBAXY Site The Citect software acquires data from a Masibus data logger model 8030-MI for the various temperature points sensed by sensors connected to the data logger. The actual temperature is logged in the computer every ten seconds for all the channels by the Windows- based Citect software. The standard operating profiles are fed into the computer by Citect for different processing steps in terms of absolute time, intervals and temperature ranges. The upper con- trol limit and the lower control limit can be different in case of different steps. This data can be entered or modified using dbase software. This data is called the standard profile. There are six such profiles possible for a single channel. Ranbaxy Labs 5/28/98 9:20 PM Page 1
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C a s e S t u d y
Citect Used on FDA Validated
Process to Monitor Reactor Profiles
Ranbaxy Labs
By K. Subramaniam
Managing Director
Masibus Process Instruments Pvt. Ltd.
Masibus has installed a Citect
S CA DA system with a Masibus Data
Logger 8030 at the Ranbaxy Labs,
Ltd. bulk drug manufacturing plant
at Mohali, India.
The manufacturer has achieved
U. S. Food and Drug Administration
( F DA) process validation for confor-
mance to Current Good
Manufacturing Practices (CGMP)
covering the manufacturing, process-
i n g, packing and holding of drugs.
The application in question is to
monitor temperature at various
reactors in the process.
Application of Citect SCA DAS o f t w a re at RANBAXY Site
The Citect software acquires data
from a Masibus data logger model
8030-MI for the various temperature
points sensed by sensors connected
to the data logger.
The actual temperature is logged
in the computer every ten seconds
for all the channels by the Wi n d o w s -
based Citect software.
The standard operating profiles
are fed into the computer by Citect
for different processing steps in
terms of absolute time, intervals and
temperature ranges. The upper con-
trol limit and the lower control limit
can be different in case of different
s t e p s. This data can be entered or
modified using dbase software. Th i s
data is called the standard profile.
There are six such profiles possible
for a single channel.
Ranbaxy Labs 5/28/98 9:20 PM Page 1
The actual temperature trend is
plotted in real-time by Citect.
Two type of trends can be plotted.
One is simply the actual temperature
trend (process value); the other is
the actual temperature trend
(process value) superimposed on the
standard profile. These standard
profiles contain a graph for setpoint,
upper limit & lower limit. The stan-
dard profile is superimposed on the
actual process value on the printout.
This enables the operator to com-
pare the actual trend of the step
against the standard one in terms of
shape and the total time taken by the
s t e p.
There are two buttons on every
trend page for printing. Pressing
either one invokes an auxiliary soft-
ware package developed by the user
which plots the data sent by Citect.
This auxiliary software plots trends
on the screen and then on request
will give print output. One button is
for printing the [Actual + Standard]
trend, i.e actual process value with
standard profile superimposed on it,
while the other is for printing only
Actual trend.
The standard trend will be inde-
pendent of the end of the actual
process and only depends upon the
starting date, starting time and the
batch number. Multiple profiles can
be there for the same channel and
batch number.
The user can print the actual
trends along with the standard
graphs on a color inkjet printer in
different colors. The channel number
and the batch number also appear
on the screen and printer on the
t r e n d s. Tag number, batch number,
profile number, start time, start date,
end time and end date are printed on
the trend.
This trend print is submitted as
the test report of the batch.
• Masibus Process Instruments
Masibus is an ISO 9001-certified
manufacturer and distributor of
process instrumentation, and a sys-
tems integrator with a network of
suppliers throughout India. In addi-
tion to manufacturing its own brand
of data loggers, it sells an extensive
line of sensors, transmitters,
r e c o r d e r s, and analyzers, and oper-
ates a state-of-the-art calibration
laboratory (CALLAB) equipped to
issue calibration certification trace-
able to national and international
s t a n d a r d s.
2
Press to plotactual and standard trend
Press to plotactual trend only
Ranbaxy Labs 5/28/98 9:20 PM Page 2
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Ranbaxy process overview
C u s t o m i zed Citect display at Ranbaxy
Ranbaxy Labs 5/28/98 9:20 PM Page 3
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AMERICAN HEADQUARTERSCi Technologies Inc.
4828 Parkway Plaza Blvd, Suite 140
Charlotte, NC 28217-1958 USA
Ph 1 704 329 3838
Fax 1 704 329 3839
www.citect.com
ASIA/PACIFIC HEADQUARTERSCi Technologies Inc.
10–12 West Street (PO Box 174)
Pymble NSW 2073, Australia
Ph 61 2 9855 1000
Fax 61 2 9488 9164
www.cit.com.au
EUROPEAN HEADQUARTERSCi Technologies Inc.(Netherlands) Pty Ltd