2. 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.
3. 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
4.
India currently holds a modest 1–2% 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.
5. 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 121°C,
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.
6. APPLICATION
Temperature Monitoring in the Sterilization
Process
o
Temperature transmitter
with field housing and
PROFIBUS PA plug
connector
(patented measuring
system)
7. 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 121°C to 135°C for a period of 15- 30
minutes. The resistance thermometer based on
clamp-on
technology from LABOM accurately regulates the temperature.
8.
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.
9. 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 LABOM’s
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.
11. 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.
12. 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.
