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E-beam Radiation Facility
for Sterilization of Medical Devices
2.0 Regulatory frame work for
radiation sterilization
Sterilization of medical devices by
ionizing radiation is globally approved and widely used
technology. Nearly 50% of the global sterilization
requirement is met by ionizing radiation and it is
considered the best technology for terminal The Indian
pharmacopoeia, Volume-1, 2018 already includes electron
beam from accelerator (machine source) as approved
method for sterilization of medical devices.
International standard ANSI/AAMI/ISO 11137:2006/(R) 2010
“Sterilization of health care products - Radiation”
specifies the requirements for development, validation
and routine control of a sterilization process for
medical devices. The standard is widely applied
worldwide for sterilization of medical devices using
radiation. Therefore, from scientific, technological and
regulatory purposes Gamma radiation from Cobalt-60,
electron beams up to energy of 10 MeV and X-ray beam up
to energy of 5 MeV are all equally permitted and are
useful for sterilization applications. The regulatory
limits on energy are such that “no radioactivity” is
induced in the sterilized medical devices. This point is
elaborated here to remove any misconceptions and to
highlight that there is no chance of medical devices
getting radioactive. ISO 13485 “Medical devices- Quality
management systems- Requirements for Regulatory
Purposes” specifies the requirements of quality
management system to be implemented for sterilization of
health care products. CDSCO and State FDA regulate the
manufacturing and licensing of the medical devices in
our country and have accorded approval for the e-beam
facility at ARPF. ARPF has been designed, developed,
licensed and is being operated in compliance to these
regulatory requirements.
3.0 Regulatory Licenses for
Sterilization of Medical Devices
Plant IQ (Installation Qualification),
OQ (Operation Qualification) and PQ (Performance
Qualification) tests and other safety related tests have
been carried out. The quality management system
complying the requirements of Medical Device Rules (MDR)-2017
has been implemented at the facility. The license for
radiation processing of Risk Class-A medical devices has
been obtained from Food and Drugs Administration (FDA,
Madhya Pradesh). The process for obtaining license for
medical devices of higher risk class is in process. The
facility has been granted ISO 9001:2015 and ISO
13485:2016 certifications for providing electron beam
processing services for sterilization of medical devices
complying the requirements of ISO 11137.
4.0 Advantages of e-Beam Processing
The e-beam process has the following
advantages -
• Does not leave any residues in the
processed products.
• Does not use toxic and carcinogenic chemicals
• Does not require device boxes to be opened, no chances
of recontamination.
• Can be switched ON or OFF as and when required,
inherently secure.
• Short exposure and processing time.
The use of electron beam technology is
rapidly increasing acrossthe globe due to the many
advantages associated to it.
5.0 How E-beam sterilization works
5.1 Scientific principle
The e-beam is able to penetrate medical
devices in their final shipping box. The e-beam deposits
energy to the microorganism either directly or
indirectly through interaction with other atoms or
molecules in the surrounding. This process of energy
deposition, generates a large number of free radicals.
These free radicals are highly reactive |
