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

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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

Verbeekstraat 6C,

2332 CA Leiden, Netherlands

Ph 31 71 576 1550

Fax 31 71 576 6842CS007/LTR/6.98

SHANGHAI HEADQUARTERSCi Technologies Inc.

3C02-3C03, DongYi Bldg, No 88

Changshu Road

Shanghai, 200040, China

Ph 86-21-62490450, 62491214,

62491614 Fax 86-21-62493027

System Integration

Masibus Process Instrumentes Pvt. Ltd.

B/30, GIDC Electronics Estate, Sector 25

G a n d h i n a g a r, Gujarat 382 044

I n d i a

Tel 91 2712 24453, 26460, 32095

Fax 91 2712 25457, 25458

Email: masibus@ad1.vsnl.net.in

B l o ck diagram of temperature monitoring at Ranbaxy

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