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Medical Device Sterilisation : Key Essentials, Options And
Challenges
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Dr. V K Tikku
Apar Industries Ltd.
Khatalwada,Taluka Umbergaon-96171. Gujarat |
Electron
Beam Sterilisation Of Medical Products
• The process is environmentally friendly,
exceptionally convenient and offers fast turn-around
times.
• Unlike the other alternatives, Electron Beam
processing does not make use of any hazardous or
radioactive materials.
Introduction
The sterilisation of
Medical Products using Electron Beam Processing is one
of the most effective methods available to the Medical
Device manufacturing industry and is successfully used
commercially for sterilising a wide variety of medical
products. The process is environmentally friendly,
exceptionally convenient and offers fast turn-around
times. |
 Medical
devices can be exposed to the beam after final packaging
because the electrons have the ability to penetrate
through the packaging to sterilise them. This allows the
package to remain intact and guarantees that the product
will remain sterile until required for use.
The Electron beam
inactivates microorganisms either by causing microbial
death as a direct effect of the destruction of a vital
molecule or by an indirect chemical reaction, thereby
rendering a product sterile. This is the same mechanism as
in other methods of radiation sterilisation, and the dose
required is the same. For many materials, Electron Beam
processing results in less material degradation than with
other methods of radiation sterilisation such as Gamma
irradiation.
Currently, most
disposable medical products are sterilised with EtO gas,
or Gamma rays. Various difficulties with these methods
have led to increased interest in Electron Beam
sterilisation. Much of the interest has been fuelled
by environmentally friendliness of Electron Beam
processing when compared to these other methods. Unlike
the other alternatives, Electron Beam processing does not
make use of any hazardous or radioactive materials.
 Facility
And The Process
The facility includes an
Electron Accelerator of energy 3.0 MeV with 100 Kw power,
trolley conveyor and shielded room and has been installed
by APAR INDUSTRIES LTD, Khatalwada , Taluka Umbergaon,
Dist Valsad, Gujarat.
The product to be processed
is placed on the Trays of the Trolley conveyor, and then
treated as the trolley conveyor passes through the
Electron Beam. The speed of the Trolley conveyor, Electron
Beam parameters and the height of the beam from the
product surface determines the dose delivered to the
product. The flexible height of the beam from the trolley
conveyor allows many configurations to suit various
product types.
Conclusion
There are many
considerations when sterilisation is the required outcome:
product characteristics, packaging, density, volume and
more. It is best to collaborate with sterilisation experts
to ensure your unique product goal is achieved. We invite
you to Contact Apar Industries Ltd. to learn more
about Electron Beam sterilisation.
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