Radioisotope handling facilities and automation of radioisotope production

If a survey is made of the advances in radioisotope handling facilities, as well as the technical conditions and equipment used for radioisotope production, it can be observed that no fundamental changes in the design principles and technical conditions of conventional manufacture have happened over the last several years. Recent developments are mainly based on previous experience aimed at providing safer and more reliable operations, more sophisticated maintenance technology and radioactive waste disposal. In addition to the above observation, significant improvements have been made in the production conditions of radioisotopes intended for medical use, by establishing aseptic conditions with clean areas and isolators, as well as by introducing quality assurance as governing principle in the production of pharmaceutical grade radioactive products. Requirements of the good manufacturing practice (GMP) are increasingly complied with by improving the technical and organizational conditions, as well as data registration and documentation. Technical conditions required for the aseptic production of pharmaceuticals and those required for radioactive materials conflicting in some aspects are because of the contrasting contamination mechanisms and due consideration of the radiation safety. These can be resolved by combining protection methods developed for pharmaceuticals and radioactive materials, with the necessary compromise in some cases. Automation serves to decrease the radiation dose to the operator and environment as well as to ensure more reliable and precise radiochemical processing. Automation has mainly been introduced in the production of sealed sources and PET radiopharmaceuticals. PC controlled technologies ensure high reliability for the production and product quality, whilst providing automatic data acquisition and registration required by quality assurance. PC control is also useful in the operation of measuring instruments and in devices used for packaging, identification and labeling. This TECDOC summarizes major advances in the conditions of radioisotope handling facilities ensued with relation to the reliability, quality assurance, aseptic processing and automation. Examples of the major radioisotope production technologies are given together with several pictures of the devices discussed. Also included are a few papers submitted by the experts who attended the consultants meeting