E-beam Radiation
Facility for Sterilization of Medical Devices
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V C Petwal
Radiation Processing In-charge, ARPF & Head,
Radiation Processing Lab
Department of Atomic Energy, Govt. of India
Raja Ramanna Centre for Advanced Technology, Indore,
Madhya Pradesh - 452 012
vikash@rrcat.gov.in |
Sterilization is a process of
eliminating, killing or deactivating the microorganism
like fungi, bacteria, viruses and bacterial spores.
Different methods such as heat, chemicals and ionizing
radiation are used for sterilization of medical devices.
The sterilization method selected for a particular
product depends on many factors including availability.
The medical device industry mostly uses Ethylene Oxide (EtO)
gas and Gamma radiation to sterilize large volumes of
medical devices. ETO is facing significant pressure from
Environmental Protection Agencies. Gamma sources have
concerns of security, handling and safe storage
requirements lasting 100s years. Electron beam (E-beam)
radiation processing is a modern sterilization
technology which is both environmentally friendly and
inherently secure. Due to the many advantages associated
with it, the technology is rapidly growing across the
globe.
The electron beam radiation processing
for sterilization of medical devices is now available in
India with FDA and AERB licenses. Medical device
manufacturers interested in availing the ebeam
sterilization services or simply qualifying their
products for e-beam processing to begin with are being
welcomed by the facility. The indigenous technology
offers tremendous scope in the country and supports
AtmaNirbhar Bharat in high technology field.
1.0 Indigenous Ebeam facility
development
Raja Ramanna Centre for Advanced
Technology (RRCAT), a constituent unit of the Department
of Atomic Energy, Government of India has set-up an
electron beam facility for sterilization of medical
devices at Indore (named ARPF). The facility is based on
two indigenously developed 10 MeV, 6 kW electron linear
accelerators (Linacs).
Biological shielding (to provide
radiation protection to working personals and others)
Electron linac (radiation source
operating on electricity which can be switched ON / OFF)
Conveyor system
Automated process control and safety
system (to ensure process integrity)
Product storage areas for un-irradiated
and irradiated products
Dosimetry laboratory traceable to
National Standardization
Dosimetry Laboratory (equipped with
radiochromic film and Alanine EPR dosimetry system for
process development, validation and routine process
quality monitoring)
Microbiology and QC laboratory (for
microbial sterility test and QC measures for incoming,
outgoing and in process products) Layout of the facility
is shown in Figure-1 and the Linacs installed in the
irradiation vault are shown in Figure-2.
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