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Introduction:

RRCAT has developed indigenous 10 MeV, 10 kW electron linac (linear accelerator) for bulk electron beam radiation sterilization of medical devices and other industrial products. The sterilization dose required for electron beam and gamma radiation is identical (typically 25 kGy) as both have identical effect on microbial deactivation. Moreover, electron beam technology is eco-friendly, safe and is rising fast as it does not involve use of radioisotope (Cobalt-60) and radiation can be switched ON /OFF as per requirements. The dose rate in electron beam facility is very high due to which product hold time in irradiation zone (i.e., exposure time) is very less as compared to isotope-based facility. The general specification of the developed linac is summarized as Table-1 Table 1: General specification of linac Parameters Value Nominal Beam Energy : 10MeV Average beam power : 10kW Scanned beam size on beam window : 25 mm x 420 mm Overall System Size : 1 m x 1 m x 5 m

The linac has been endurance tested in lab in standalone configuration for non-stop operation of 32 hours at rated beam power and has been qualified for sterilization of medical devices through volumetric dosimetry on a few product boxes. As a precursor to the above, another linac with rated capacity 10 MeV, 6 kW is already being operated by RRCAT in the field on commercial basis. For more details, please visit: link to ARPF service on Incubation Web Page.

Invitation of incubation proposal:

In line with the Department of Atomic Energy (DAE)’s societal commitment, a successful effort has been made at the laboratory scale towards indigenous development of 10 MeV, 10 kW electron linac. Now, it is being planned to offer the above system under incubation for process operation in Indian industrial environment to meet the following objectives:

• Long term process operations (minimum 6,000 hours, likely to be completed within 2 years after commissioning) in the industry for e-beam sterilization of medical devices with linac in vertical configuration.
• Value addition to the developed technology with a product recipe based integrated facility operation control system with a single interface control of linac and process conveyor, and
• Value addition towards ruggedization by updating fail-prone subsystems identified during the incubation.

The participating industry will operate the system and upgrade the system as incubatee jointly with RRCAT under technology incubation provisions of DAE. The developed technology, generated experience, and knowhow will be exclusive property of DAE, however, the successful incubatee will be licensed to use the developed system as per agreement. This incubation effort is targeted towards developing a commercially viable and reliable linac on fast-track mode. The successful incubatee is expected to participate in the following activities to meet the above-defined objectives:

• The incubatee will participate in the above endeavour by providing requisite infrastructure, facilities and man-power.
• Incubatee will participate in the development and upgradation of the system as indicated as objectives (b) and (c).
• All regulatory approvals will be arranged by the incubatee. However, RRCAT will extend support for providing all necessary documentation for the above.

At the end of incubation, the incubatee will have option to purchase the linac at the derived equipment and incubation cost subject to DAE approval.  
The above development of industrial linac with Indian sources for supply, spares and service will be a big support to the Indian radiation processing industry. This will help in enhanced quality of life, healthcare, food security, and international trade in agricultural produce. The electron accelerator technology has potential for the installation of several facilities in India in near future.

Selection Criteria for Incubatee Entity:

Incubation Centre-RRCAT invites the expression of interest from industries meeting the following criteria:

1. Experience of radiation sterilisation of medical devices (e-beam or Co–60) with FDA license (India) for Risk Classes A/B/C/D in box sizes compatible with the penetration depth for 10 MeV electron beam.
2. Experience of radiation sterilisation of medical devices (e-beam or Co–60) with FDA license (foreign countries) for Risk Classes A/B/C/D medical devices in box sizes compatible with the penetration depth for 10 MeV electron beam.
3. Experience of having ISO: 13485 certifications.
4. Qualified personnel having operating experience of radiation processing facility and approved /recognized by AERB.
5. Radiological shielded vault having adequacy to meet AERB regulatory requirements for installation of the 10 MeV, 10 kW Linac.
6. Required infrastructure including electrical power, UPS, low conductivity water cooling system and air handling system.
7. Availability of dosimetry equipment and consumables suitable for Installation Qualification, Operation Qualification, and Performance Qualifications for electron beam dosimetry
8. Availability of dosimetry equipment and consumables for routine dosimetry of process suitable for electron beam dosimetry
9. Adequate financial, administrative, managerial and technical capability to run the radiation processing plant.
10. Technically sound incubatee participation and full cycle business plan.

All the above points of selection criteria carry equal weightage.

Incubation Centre-RRCAT invites industrial partner, with good engineering capabilities, infrastructure and domain knowledge to participate in this joint developmental effort as incubatee. Potential industrial partners may write to us (incubation@rrcat.gov.in) expressing interest for participation with the filled Know Your Potential Incubatee (KYPI) form at the earliest, not later than July 29, 2022. (Closed)

After the receipt of KYPI, the industrial partner will be invited to RRCAT along with the necessary documents indicating the preparedness to selection criteria for working out a detailed incubation proposal along with visit to RRCAT lab.