In order to measure the dose absorbed by a product, the first control is the cycle time setting, utilising an electric timer. Its accuracy is checked and calibrated on a periodic basis.

Radiochromic Dye Dosimetry System is used to measure and determine the dose absorbed by any given product. The radiochromic dosimeters are calibrated by the National Atomic Energy Agency of Indonesia (BATAN). The dosimeters are placed at the maximum and minimum dose area during each production run. A Milton Roy Spectrophotometer is employed for reading the dosimeters, and like the dosimeters, is calibrated by BATAN.

Documentation

Rel-ion will provide a Certification of Irradiation following the processing of all products to its customers. A copy will be maintained by Rel-ion for 5 years. During processing, several documents are generated and will be retained in Rel-ion file, together with the copy of the Certification of Irradiation.

These documents are :

icon tick The Incoming Material Control Sheet records the count and surface inspection for each incoming shipment.
icon tick The Work Order provides all instructions to the shift supervisors for processing and handling the individual run.
icon tick The Run Data Sheet lists all Dosimetry readings and calculations.
icon tick The Material Handling Control Sheet contains accountability for count and conditions of products when:
  • loaded onto totes

  • unloaded from totes

  • loaded for shipment to customer.

The Pallet Configuration Sheet describes how the customerís product is be re-palletised.

The Dosage Distribution Map and Density Data Work Sheet are developed from dose distribution reports performed at the time of product validation.

The Notice of Deviation is used in the event of any circumstances deviating from customer specification.

A Radiation Services Agreement insures conformance with subsections 201.150 and 801.150 of Title 21 (US-FDA), if applicable.

 

Quality Assurance

All activities of the facility and all the above records are continuously reviewed by the Quality Assurance Department. Once a year the facility will be audited by the Corporate Quality Assurance Department to insure consistency with the Quality Assurance Manual.

The Quality Assurance Department consists of:

icon tick Product Quality Assurance.
icon tick Technical Quality Assurance.
 

The Product Quality Assurance person is responsible for proper processing of the products, while the Technical Quality Assurance person is responsible for the equipment and all machinery used during processing.







 

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