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Medical Device Sterilisation : Key Essentials, Options And
Challenges
Gamma Radiation
Sterilisation: The Indomitable Workhorse For Terminal
Sterilisation Of Medical Products
Medical Product Categories
Routinely Radiation Processed For The Terminal
Sterilisation
Single Use Disposable
Medical Devices Hospital Supplies Family Planning
Devices Medicated/ Non Medicated, absorbent / non
absorbent gauge dressings Medicated Ointments Medical
Accessories Burn dressings Absorbent/Nonabsorbent
Sutures Petri dishes for the pharmaceutical industry
Containers and Closures Orthopedic Implants Drugs and
Chemicals Cosmetics Ayurvedic Raw Materials Silver
Agitated Antimicrobial Dressings 70% V/V Iso Propyl
Alcohol Pre Pads Elastics for Sports wear X Rays
protection gloves
Merits Of The Radiations
Sterilisation Technology
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Products of any shape can be
sterilised because powerful gamma rays penetrate right
through the package and the product.
-
Being a cold process, heat
sensitive plastic medical devices and pharmaceutical
products can safely be sterilised.
-
Flexibility in packaging as
the products can be packed individually in sealed bags and
sterilised in the fully packaged form.
-
Since sterilisation is
effected after final packaging (Terminal Sterilisation)
product sterility is retained indefinitely as long as the
packaging integrity is not at risk.
-
This is a continuous, fully
automated process with a single parameter to be
controlled, namely the time of exposure. Steam
sterilisation and ETO apart from being batch processes;
require more than one parameter to be controlled.
-
Radiation Sterilisation
enlarges the market for ready to use pre-packaged
products. The process does not result into residual
toxicity of any form in the product.
-
Products sterilised by this
process do not become radioactive and are safe for use.
Limitations Of Radiation
Sterilisation Technology
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Radiation sensitivity of
polymeric compositions.
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Aqueous pharmaceutical
preparations have poor radiation compatibility.
-
Single use disposable syringes
have compatibility issues with radiation sterilisation.
-
The continuous decay of the
Cobalt 60 radioactive source puts a continuous product
load demand at the contract radiation service providers
end.
Future Promises:
The market for the terminal
sterilisation of single use disposable medical devices
along with other medical products using gamma radiation
has been witnessing a phenomenal growth in the recent
years amidst the global awareness in the healthcare
industry with respect to residual toxicity issues
intrinsic to the ethylene oxide sterilisation.
Incidentally , indigenous technical knowhow fuelled by
self reliance attained by BRIT, DAE Government of India
with respect to the complete life cycle of the Cobalt 60
Source (A key component of the Gamma Irradiators) has been
a prime motivating factor for metamorphosing the
conventional sterilisation practices in to ubiquitous
radiation sterilisation practices particularly for the
single use disposable medical devices. It is strongly
believed that ensuing years certainly hold enthralling
promises for the entire radiation sterilisation industry.
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