E-beam Sterilization : A Unique Opportunity For Indian Medical Device Industry

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

Mr V C Petwal , Head , Radiation Processing Lab, Raja Ramanna Centre For Advanced Technology (RRCAT ),Department Of Atomic Energy , Government Of India located in Indore. RRCAT is working in non-nuclear frontline research in the area of accelerator and laser technologies. The facility is designed, developed, commissioned and operated by RRCAT under the “AtmaNirbhar Bharat Abhiyan” of government India and providing radiation services for medical devices sterilization ( e-beam sterilization ) . The facility is licensed by Atomic Energy Regulatory Board (AERB), Food and Drugs Administration (FDA) MP state and has ISO 9001:2015 and ISO 13485:2016 certification for providing electron beam processing service for sterilization of medical devices as per the requirements of ISO 11137. In a free-wheeling interview to “Medical Plastics Data Service", apart from introducing the first e-beam sterilization facility in the country , the process of sterilization, Medical Devices that can be sterilized by this technique, its comparative advantages as well as how the Indian Medical Device Industry can take benefit from this facility. Raja Ramanna Centre For Advanced Technology (RRCAT) has set-up an electron beam sterilization facility at Indore. Can you please briefly share over view on this facility?

Raja Ramanna Centre for Advanced Technology (RRCAT) is a Premier R&D Institute of Department of Atomic Energy, Government of India. RRCAT is working in non-nuclear frontline research in the area of accelerator and laser technologies. RRCAT has setup an in-house developed 10 MeV electron linear accelerator (Linac) technology based radiation processing facility at Indore, Madhya Pradesh. The facility is designed, developed, commissioned and operated by RRCAT under the “AtmaNirbhar Bharat Abhiyan” of government India and providing radiation services for medical devices sterilization. The facility is licensed by Atomic Energy Regulatory Board (AERB), Food and Drugs Administration (FDA) MP state and has ISO 9001:2015 and ISO 13485:2016 certification for providing electron beam processing service for sterilization of medical devices as per the requirements of ISO 11137. With these credential and approvals, this is the first e-beam facility in the country providing commercial radiation sterilization service to the regulated medical devices.

RRCAT Linac based e-beam sterilization facility at Indore

Different medical devices sterilized with e-beam

Apart from commercial sterilization of medical devices, the e-beam facility is being used by many institutes, universities and industries across the country for variety of research applications such as sterilization of pharmaceutical API, irradiation of seeds for developing new crop varieties, modification of semiconductor device properties, colour modification of gem stones etc.

We understand you have already started offering this facility to the Industry. Can you please explain how is this facility being offered to Indian Medical Device Industry?

Yes,

Being the first e-beam facility in the country, various protocols/ process/ procedures are designed & developed to fulfil the requirement of Schedule IV & V of MDR-2017 and ISO 13485. The facility is critically audited by AERB, FDA, CDSCO notified bodies and after taking regulatory approvals & ISO certifications, RRCAT started offering radiation sterilization services to Risk Class-A and Risk Class-B medical devices on commercial basis.

As the Government of India is celebrating the “Azadi ka Amrit Mahotsav”, to commemorate 75 years of progressive India and it’s achievements, DAE has decided to celebrate it by providing the e-beam sterilization service with indigenous Linac technology, at concessional rates. Medical device manufacturers from all around the country are welcome to take the advantage of the novel e-beam technology to sterilize their devices. Detail information on the procedure to be followed for availing sterilization service is provided on the link: https://www.rrcat.gov.in/organization/cat/incubation/ebrpf.html.

In short, the facility have all the technical capabilities and control on process to provide e-beam sterilization services to Medical Device Industry, in conformance with international standard.

Layout of electron beam radiation processing facility

Currently the Indian Industry is using either ETO Sterilization or Gamma Ray Sterilization process. Can please explain advantages of using e-beam sterilization.

Sterilization by EtO requires long exposure time (typically 5-6 days), leaves chemical residue on devices and requires expensive breathable packaging for medical devices. Ionizing radiation is an attractive method for terminal sterilization of medical devices. Electron beam sterilization is equivalent to sterilization performed with Co-60 Gamma radiation. For example Gamma irradiation, e-beam doesn’t leave any residue and requires no post processing quarantine time. The processing time in electron beam is faster and based on ON/OFF technology. Electron beam is eco-friendly, and inherently safe and secure technology, due to which its application is increasing at a rapid rate. The medical devices are sterilized in their final packaging using the penetrating power of electron beams (without the need for opening packing).

Are there any limitation of using e-beam sterilization particularly with respect to penetration or any other output?

Typical scenario of radiation processing using electron beam