Manufacturing

E-beam Radiation Facility for Sterilization of Medical Devices

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.