Industrial Accelerators Division
Activities of Industrial Accelerators Division

Industrial Accelerators Division

Electron Accelerator Based Radiation Processing Facility
  1. Introduction
  2. Accelerators
  3. Testing Facilities
  4. E-beam Processing
  5. Facility Qualification, Licenses and Accreditation
  6. Quality Assurance Program at ARPF
  7. Recent Product Performance Qualifications Carried out at ARPF
  8. How to Avail the e-beam Processing Services at ARPF and Service Charges
  9. Electron Beam Irradiation Services for Research Samples
  10. Facility Address and Contact Detail
  1. Introduction:

    The electron beam radiation processing facility (named ARPF) is operating at Devi Ahilya Bai Holkar Fruit and Vegetable Mandi Complex, Indore. The facility is based on in-house developed 10 MeV, 6kW electron linear accelerators (linacs). This facility provides electron beam irradiation services for terminal sterilization of medical devices as well as irradiation of research samples for development of new crop varieties, color modification of gem stones, development of novel materials, modification of semiconductor properties etc. Controlled doses in the range of few Gray (Gy) to several Mega Gray (MGy) can be delivered as per the requirements.

    Use of electron beam irradiation technology is growing rapidly across the globe due to its eco-friendly and safe nature. It does not involve use of any radioisotope such as Cobalt-60 or Cesium-137 continuous source of gamma radiation. The radiation from the electron accelerator can be switched ON /OFF as per user requirements. Also, 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 product batch size can be customized to meet user requirements.

    Electron Accelerator based Radiation Processing Facility (ARPF)
    Electron Accelerator based Radiation Processing Facility (ARPF)

  2. Accelerators

    Two in-house developed 10 MeV, 6 kW linacs are used as powerful radiation sources at the facility. Both the linacs have been endurance tested for hundreds of hours at RRCAT prior to installation. The Linacs deliver a pencil electron beam in horizontal direction which is scanned in vertical direction to get a wide radiation field in vertical plane. The products to be radiation processed are transported in front of scanned beam in horizontal plane with a roller conveyor. The speed of conveyor and number of passes are controlled to deliver the required dose to the products.

    10 MeV, 6 kW Electron LINAC installed at ARPF
    10 MeV, 6 kW Electron LINAC installed at ARPF

  3. Testing Facilities:

    The following facilities are available for irradiation process development, validation and routine irradiation service:-

    a) 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).

    b) Microbiology and QC laboratory (for microbial sterility test and QC measures for incoming, outgoing & in process products).

    Dosimetry laboratory at ARPF
    QC and Microbiology laboratory at ARPF
    Dosimetry laboratory at ARPF
    QC and Microbiology laboratory at ARPF

    Sterility validation using Biological Indicator

    Sterility testing of e-beam irradiated product
    Sterility validation using Biological Indicator
    Sterility testing of e-beam irradiated product
  4. E-beam Processing:

    The following e-beam processing capacity is available:

    Parameter DescriptionValue
    Throughput6 kGy.ton/hour
    Minimum dose100 Gy
    Maximum dose50 MGy
    Typical box size for medical devices (density 0.14 g/cc)Note-1 (Length x Width x Height)60 cm x 45 cm x 35 cm
    Throughput of medical device at 25 kGy dose250 kg/hr
    Note-1: The box dimensions can be adjusted according to product density. User’s box size and internal device packing arrangement need to be discussed with process experts at ARPF. (jishnu(at)rrcat.gov.in or vikash(at)rrcat.gov.in)
  5. Facility Qualification, Licenses and Accreditation:

    The facility is designed, developed, licensed and is being operated in conformance with regulatory requirements of Atomic Energy Regulatory Board (AERB), CDSCO (Central Drugs Standard Control Organization) and State Food and Drugs Administration (FDA).

    The facility has been validated for sterilization of medical devices in accordance with ISO 51649:2015 standard. IQ (Installation Qualification), OQ (Operation Qualification and PQ (Performance Qualification) have been performed through detailed dosimetric measurements to qualify the facility. The quality management system complying with the requirements of Medical Device Rules (MDR)-2017 has been implemented at the facility. The facility has license for radiation processing of Risk Class-A medical devices from Food and Drugs Administration (FDA, Madhya Pradesh). The facility has 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.

    FDA Risk Class-A medical devices license
    ISO 9001:2015 certificate
    ISO 13485:2016 certificate

    ARPF is the first 10 MeV electron beam facility in the country having all licenses and accreditations to provide sterilization service for medical devices.

    ISO Certificates
    ISO Certificates
  6. Quality Assurance Program at ARPF:

    The facility operates under stringent quality assurance program including the following elements to deliver quality irradiation services to the customer products-

    a) Calibrated dosimetry system is used to ensure correct irradiation dose measurements.
    b) Process monitoring dosimetry is done for each batch being irradiated.
    c) Monitoring and logging of process critical parameters.
    d) Implementation of process parameter control window to ensure that machine operates within the specified limits of parameters.
    e) An electronic tracking system for product traceability throughout the process cycle, i.e. receiving, storage, handling, irradiation, QC checks and release from facility.
    f) Periodic maintenance, servicing and calibration of the subsystems
    g) Electronic storage of dosimetry and process parameter and QC related data of each batch traceable using a bar code system.
  7. Recent Product Performance Qualifications Carried out at ARPF:

    ARPF provides technical support solution though a team of dedicated experts at every stage of E-beam sterilization process from process development, validation to routine bulk processing. Sterilization process development and validation for different products as listed below have been carried out successfully by conducting 3-dimensional volumetric dosimetry and subsequently performing sterility test at NABL certified laboratories.

    a) Self-standing VTM tubes used for COVID-19 testing
    b) Petri-dishes used for microbiological testing
    c) Blood vacutainers used for blood sample collection
    d) Cotton Gauze pieces used for surgical purpose
    e) Latex surgical gloves sued for surgical examination
    f) Collagen Sheet (Skin Temp®)- used in burn healing

    Bulk irradiation of a medical devices for several products has been carried out. Sterility test conducted on these products carried out by NABL certified and CDSCO approved testing laboratories routinely confirm sterilization of the medical devices.

    Self-standing VTM tubes
    Petri-dishes
    Self-standing VTM tubes
    Petri-dishes


    Blood vacutainers


    Cotton Gauze pieces
    Blood vacutainers
    Cotton Gauze pieces


    Latex surgical gloves


    Latex surgical gloves
    Latex surgical gloves


    Latex surgical gloves
    Collagen Sheets (Skin Temp®)


    Bulk sterilization of medical devices with electron beam at ARPF
    Bulk sterilization of medical devices with electron beam at ARPF
  8. How to Avail the e-beam Sterilization Services at ARPF and Service Charges

    ARPF is now available to provide e-beam sterilization service for medical devices at industrial scale. The customer shall send a request to jishnu@rrcat.gov.in or vikash@rrcat.gov.in for radiation processing of their products.

    ARPF Electron Beam Use Procedure for medical devices radiation processing

    StepDetail of stepForm Link
    Step-1Submit the information about the product in the irradiation inquiry form (ARPF/OFR/01). Our team will evaluate its suitability for irradiation at our plant and intimate accordinglyIrradiation Inquiry Form
    Step-2Submit the duly signed client registration form (ARPF/OFR/02)Client Registration Form
    Step-3Submit the product registration form (ARPF/OFR/03) and send 6 boxes duly packed for pre-irradiation dosimetry & process optimization and generation of Product Dose Mapping (PDM number) and process specifications. The boxes are non-returnable.Product Registration Form
    Step-4Submit the copy of loan licence issued by FDA (Madhya Pradesh State) in form MD-6 (as prescribed by CDSCO, Medical Device Rules 2017) to ARPF

    Note: Only for notified medical devices as per MDR-2017

    In case irradiation service is required for non-notified products, the customer may submit a declaration by the manufacturer that e-beam sterilization services are required and the product does not need loan license.
    Declaration
    Step-5Send the product lot to be irradiated with order registration form (ARPF/OFR/04)Order Registration Form
    Step-6The irradiated product will be dispatched with product irradiation certificate (ARPF/OFR/10)Product Irradiation Certificate

    Note: ARPF, RRCAT reserves the right to display the customer’s logo /company name /irradiated products name/photographs on the website/ public bulletin for the awareness purposes. Customers may communicate their preferences to (vikash(at)rrcat.gov.in) if they have any limitations in line with their business requirements.

    Service charges

    The e-beam irradiation services are being offered on “no processing charge basis” # for a limited period to encourage the medical device manufacturers to use the e-beam facility.

    # 18% GST on the notional charges through Reverse Charge Mechanism (RCM) basis and logistics charges including loading & unloading charges to be borne by the customer/client.

  9. Electron beam irradiation services for Research samples:

    ARPF provides electron beam and X-ray irradiation/processing services for R&D samples also.

    ARPF Electron Beam Use Procedure for R&D samples
    StepDetail of stepForm Link
    Step-1Submit the duly signed client registration form (ARPF/OFR/02)Client Registration Form
    Step-2Submit the Research sample irradiation & undertaking form. Our team will evaluate its suitability for irradiation at our plant and intimate accordingly.Request form for irradiation using 10 MeV electron linear accelerator at ARPF


    To avail the irradiation service, fill-in the Request for sample irradiation and undertaking form & Client registration form for research users and send to jishnu(at)rrcat.gov.in / vikash(at)rrcat.gov.in.

    Recent Example of Electron Beam Irradiation of Research Sample

    ARPF is committed to expand the use of electron beam in different areas of science and technology through active collaboration with institutions, universities and private industries. Variety of new applications have been successfully developed and demonstrated with electron beam at ARPF which includes, new crop variety development through mutation breeding, phytosanitary treatment of agricultural products, exotic color development in ornamental flowers, radiation damage studies for space applications, modification of properties of semiconductor components, development of novel materials, color modification of gem stones (Topaz) etc.


    Electron beam produced mutant variety of TG-68 ground nut and novel mutants of black grams under study
    Electron beam produced mutant variety of TG-68 ground nut and novel mutants of black grams under study


    Electron beam produced mutant of Rice
    Electron beam produced mutant of Rice


    Electron beam induced variation in ornamental flowers (Chrysanthemum varieties)
    Electron beam induced variation in ornamental flowers (Chrysanthemum varieties)


    X-ray irradiation of mango for phytosanitary and shelf-life extension research


    Irradiation of components for space applications
    X-ray irradiation of mango for phytosanitary and shelf-life extension research
    Irradiation of components for space applications


    Before Irradiation


    After E-beam Irradiation
    Before Irradiation
    After E-beam Irradiation


    Thyristors and Power Electronics Devices
    Thyristors and Power Electronics Devices
  10. Facility Address and Contact Detail:

    Facility Address:Electron Beam Radiation Processing Facility (ARPF),
    Adjacent to Phool Mandi, Devi Ahilyabai Hokar Fruit and Vegetable Mandi,
    Nirbhay Singh Patel Marg, Indore- 4502001 (Madhya Pradesh)

    Contact Detail: • Jishnu Dwivedi, Facility In-charge (jishnu(at)rrcat.gov.in)
    • V.C. Petwal, Radiation Processing In-charge (vikash(at)rrcat.gov.in)
    • Phone no.- 0731-2332001, 0731-2488587, 0731-2488564
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