Chapter 19: Qualification and Certification of Ionizing Radiation Facilities

Gamma, e-beam, and X-ray irradiators are equipment that delivers ionizing radiation, and their manufacture and operation are subjected to strict radiation safety regulations. This fact gives a good level of confidence on the reliance of the equipment. However, as for many other radiation processing applications, for food irradiation, it must be confirmed that the radiation processing consistently affords the expected results. This type of proof can be acquired by installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) certificates. Most radiation processing applications have specific standards, guidelines, or regulations (i.e., radiation sterilization for medical devices for pharmaceuticals) with more or less detailed requirements for qualification. The goal is to prove that the equipment complies with its design specifications (IQ), the equipment performs as intended throughout its normal operation range (OQ), and the output of the radiation processing is consistently (effectively and reproducibly) achieved. This chapter describes the actions required for the qualification of gamma, e-beam, and X-ray irradiators with application to food irradiation and the different types of certifications that allow worldwide operation and aid the acceptance of food irradiation.