|Detail of step
|Submit 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 accordingly
|Irradiation Inquiry Form
|Submit the duly signed client registration form (ARPF/OFR/02)
|Client Registration Form
|Submit 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
|Submit 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.
|Send the product lot to be irradiated with order registration form (ARPF/OFR/04)
|Order Registration Form
|The irradiated product will be dispatched with product irradiation certificate (ARPF/OFR/10)
|Product Irradiation Certificate