INSTRUMENTATION IN PHARMACEUTICAL

INDUSTRY - TEMPERATURE MEASUREMENT

By
Johnson p savio
s7 ic
no:26
INTRODUCTION

Medicinal products require controlled storage and

transit conditions in order to ensure that their quality
is not compromised.

All distributors of drug products are required to

record storage and transportation temperatures, as
well as being licensed by the appropriate
authorities.

Temperature monitoring devices should be used to

demonstrate compliance with the records that are
kept.
 Pharmaceutical Industry Today
Indian pharmacy industry is mainly operated as well
as controlled by dominant foreign companies
having subsidiaries in India due to availability of
cheap labor in India at lowest cost

In 2002,over 20,000 registered drug manufacturers

in India sold $9 billion worth of formulations and
bulk drugs.

85% of these formulations

were sold in India
60% of the bulk drugs were
exported
 India currently holds a modest 12% share, but it
has been growing at approximately 10% per year.

The Indian pharmaceutical industry has become the

third largest producer in the world and is poised to
grow into an industry of $20 billion in 2015 from the
current turnover of $12 billion.

There are 74 US FDA-approved manufacturing

facilities in India, more than in any other country
outside the U.S, and in 2005, almost 20% of all
Abbreviated New Drug Applications (ANDA) to the
FDA are expected to be filed by Indian companies.
TEMPERATURE MEASUREMENT IN THE
PHARMACEUTICAL INDUSTRY

In order to reduce the risk of

contamination, critical hygiene
regulations, such as the regular
sterilization of the plant at
temperatures above 121C,
govern the manufacture of
drugs in the pharmaceutical industry.

The device called LABOM has been designed for

use in hygienic applications and is easy and
inexpensive to install.
APPLICATION
Temperature Monitoring in the Sterilization
Process

o Temperature transmitter
with field housing and
PROFIBUS PA plug
connector
(patented measuring
system)
MEDICINE FOR STERILIZATION PROCESSES
Non-Contact Measurement Reduces the Risk of
Contamination with Microorganisms.
In order to maintain high quality levels in automated
production processes, drug manufacture must meet
very stringent requirements that minimize the risk of
contamination by microorganisms.
The key to preventing contamination is the regular
cleaning and sterilizing of the plant.

In the SIP process (Sterilization in Process), the plant is

cleaned with vapor at 121C to 135C for a period of 15- 30
minutes. The resistance thermometer based on clamp-on
technology from LABOM accurately regulates the temperature.
 The resistance thermo-meter with clamp-on
technology from LABOM measures the pipe
temperature without having to interfere with the pipe
(this applies to pipes with outside diameters greater
than 4 mm).

The resistance signal is transmitted via a

PROFIBUS PA transmitter to a controller. The
resistance signal is transmitted via a PROFIBUS PA
transmitter to a controller.

The best installation position for the thermometer

with clamp-on technology to monitor the sterilization
process can be found by simply re-clamping it on
the pipe.
CUSTOMER BENEFITS:
Temperature can be measured by simply mounting
the device on any existing pipe system.

The temperature decoupling of the sensor from the

housing and the good heat transmission between
pipe system and sensor achieved with LABOMs
resistance thermometer with clamp-on
technology, lead to consistently good
measurements.

It is a non-contact device that does not disturb the

process.

Extremely accurate and delivers measurements

that are of a constant and verifiable quality.
ADVANTAGES
No hard-to-clean dead pockets

Very accurate

Easy to install without any welding

No process interruption
CONVENTIONAL INVASIVE METHOD OF MEASUREMENT:
Welding adapter required
Obstructed flow in pipe

High installation costs systems.

The measuring device is held in place by a
mounting device that positively guides and
presses the insert with pre-defined elastic
force against the pipe surface. Because
the insert is always kept in the same
install action position,measurements
taken are reproducible. The sensor
can be replaced without removing
the pipe collar. Since the measuring
point is mechanically unaltered by recalibration or sensor
replacement, it is an accurate, long-term measuring point.
CONCLUSION
Pharmaceutical manufacturers
require instruments that offer
the highest levels of hygiene,
accuracy and reliability, which
match the regulatory and
operational demands of the
pharmaceutical industry.

Siemens offers many differently designed resistance

thermometers and thermocouples to the
pharmaceutical industry.
Construction and materials meet FDA, EHEDG and
3A standards and are manufactured under cGMP
guidelines.