Development, validation and routine control of a radiation process

Today, radiation is used in industrial processing for variety of applications; from low doses for blood irradiation to very high doses for materials modification and even higher for gemstone colour enhancement. At present, radiation is mainly provided by either radionuclides or machine sources; cobalt-60 is the most predominant radionuclide in use. Currently, there are several hundred irradiation facilities worldwide. Similar to other industries, quality management systems can assist radiation processing facilities in enhancing customer satisfaction and maintaining and improving product quality. To help fulfill quality management requirements, several national and international organizations have developed various standards related to radiation processing. They all have requirements and guidelines for development, validation and routine control of the radiation process. For radiation processing, these three phases involve the following activities. Development phase includes selecting the type of radiation source, irradiation facility and the dose required for the process. Validation phase includes conducting activities that give assurance that the process will be successful. Routine control then involves activities that provide evidence that the process has been successfully realized. These standards require documentary evidence that process validation and process control have been followed. Dosimetry information gathered during these processes provides this evidence. (authors)