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radiotherapy
Land-Based High Intensity Radiation Processing Facilities
(other than Gamma Irradiation Chambers)
Gamma Radiation Processing Facility (GRAPF) Links to Forms

General

Gamma irradiation facilities are in use for preservation of food products, sterilization of health care products, polymerisation of wood, vulcanisation of rubber and such purposes for which high intensity irradiation is required. The high intensity gamma radiation processing facility considered here is of land-based stationary installation type. Land-based gamma radiation processing facilities are either dry source storage or wet source storage using several GBq of suitably encapsulated radioactive material (60Co or 137Cs) for radiation processing of the target material.
AERB carries out multi-tier review at all the stages of consenting process involved for installation and operation of GRPF. The various stages involved and related regulatory procedures in brief during installation and operation of GRPF are as follows;

Site Assessment and Approval

The first stage of Consenting process is assessing the suitability of the site in accordance with the AERB Safety Standard on Land-based Stationary Gamma Irradiators [AERB/RF-IRRAD/SS-6 (Rev.1), 2008]. For this purpose the applicant has to submit an application (Form ID: AERB/RSD/GRAPF/SA) along with detailed site characteristics/ assessment report as per APPENDIX 1. The applicant should also submit the authenticated documents issued by relevant Government agency showing the status of ownership/lease of the premises.

Layout and Construction Approval

The design of land-based gamma radiation processing facility should meet the requirements specified by AERB in the Safety Standard on Land-based Stationary Gamma Irradiators [AERB/RF-IRRAD/SS-6, (Rev-1)].

The general requirements for a GRAPF should cover: Layout of the facility; Integral source units (ISU); Source-frame and Source-drive mechanism; Water-pool and DM Plant; Ventilation system; Biological shielding; Access control; Safety systems; Emergency systems; Product-movement system and operating controls; and Material handling facilities.

A preliminary safety analysis report (PSAR), as per APPENDIX 2, covering the above aspects along with the application for obtaining Consent for construction/layout approval (Form ID. AERB/RSD/GRAPF/L&CA), shall be submitted to AERB for review. PSAR should also contain information regarding provisions/commitment of applicant for safe disposal of spent/ disused sources. The facility should maintain and keep available the reports on Quality Assurance (QA) during construction of the facility as given in APPENDIX 3.

Commissioning

When all the systems are in place, performance of each system should be verified independently and also in an integrated manner. Acceptance Test Reports (ATR) containing the results of the tests and Radiation Protection Manual (RPM) should be prepared and submitted to the AERB as per APPENDIX 4 and APPENDIX 5 respectively. The applicant has to also submit the application for obtaining the authorisation for procurement of Co-60 source (Form ID.:AERB/RSD/GRAPP/Co-60). The safety personnel such as Radiological Safety Officer (RSO); Certified operators and Trained servicing and maintenance personnel shall be available prior to the initial source loading. The application form for obtaining approval to act as Radiological Safety Officer is given in Form ID: AERB/RSD/RSO/APP.

Operation

The applicant should submit the Final Safety Analysis Report (FSAR) along with Quality Assurance Manual (QAM) of the design and systems installed in the facility, to the AERB for review. These should be in the formats given in APPENDIX 6 AND APPENDIX 3. Based on the review of information provided in the ATR, FSAR, and obtained from inspections by the AERB, and the trouble free performance of facility and radiation levels and dosimetry results within the acceptable limits, the regulatory consent in the form of Licence is issued by AERB. The application format for obtaining the Licence for Commissioning and Operation is given in Form ID: AERB/RSD/GRAPF/LCO.

If the irradiation facility is used for radiation processing of food products, additional review of dosimetry will be carried out to ensure that the food items receive radiation dose as stipulated in the Atomic Energy (Control of Irradiation of Food) Rules, 1996. The application format for obtaining the Certificate of Approval is given in Form ID:AERB/CA-FORM-III. The appointment of a quality control officer (QCO) is mandatory to look after the microbiological quality of food is mandatory. The AERB grants Certificate of Approval in accordance with these Rules. Based on the Certificate of Approval and the application for Licence, the Licence for food irradiation is issued by the Department of Atomic Energy, Government of India.

At each stage of replenishment/ addition to the source strength of the radiation facility, the Licensee is required to obtain authorisation for procurement of additional Co-60 source (Form ID.:AERB/RSD/GRAPP/Co-60RPL). After each source loading Licensee shall obtain a Consent for resumption of routine operation.

The Licensee is required to submit to the AERB, periodic status reports (Form ID: AERB/RSD/QSSR/GRPF). Unusual occurrences should be promptly reported within 24 hours and this should be followed by a detailed report within the prescribed period. The Licensee should operate the facility as per the requirements stipulated in the AERB Safety Code on Operation and Maintenance of Land-Based Gamma Irradiators, AERB/SC/IRRAD,1993.

Decommissioning /Disposal

When the radiation processing facility is no longer to be used, the facility should be decommissioned by returning the the radioactive sources to the original supplier after obtaining prior approval from AERB. The application format for obtaining the said Authorisation for safe disposal of radioactive waste is given in Form ID: AERB/RSD/TR/TRF. The Consentee is required to submit a report to the AERB on completion of decommissioning, safe disposal of sources and personnel doses received during decommissioning operations.

  1. Application form for Obtaining Consent for Site Approval
    AERB/RSD/GRAPF/SA

  2. Site characteristics/assessment report - APPENDIX 1

  3. Preliminary Safety Analysis Report (PSAR) - APPENDIX 2

  4. Application form for obtaining Consent for construction/layout approval
    AERB/RSD/GRAPF/L&CA)

  5. Quality Assurance (QA) guidelines during Construction - APPENDIX 3

  6. Acceptance Test Report (ATR) - APPENDIX 4

  7. Radiation Protection Manual (RPM) - APPENDIX 5

  8. Application form obtaining authorisation for procurement of Co-60 source.
    AERB/RSD/GRAPP/Co-60

  9. Application form for obtaining approval as Radiological Safety Officer

  10. Final Safety Analysis Report (FSAR) - APPENDIX 6

  11. Quality Assurance Manual (QAM) - APPENDIX 3

  12. Application form for obtaining the Licence for Commissioning and Operation
    AERB/RSD/GRAPF/LCO

  13. Application form for obtaining the Certificate of Approval is given in AERB/CA-FORM-III.

  14. Format of Periodic Safety Status Reports
    AERB/RSD/QSSR/GRPF

  15. Application form obtaining authorisation for procurement of additional Co-60 source.
    AERB/RSD/GRAPP/Co-60RPL

  16. Format for Reporting Unusual Incidence

  17. Application form for obtaining the Authorisation for safe disposal of radioactive waste
    AERB/RSD/TR/TRF

  18. Flow Chart for Installation of New Gamma Radiation Processing Facility