The risk analysis used to manufacture ⁹⁹Mo/^99mTc generators

In this work the steps to be followed for the risk analysis in the process of production of ⁹⁹Mo / ^99mTc generators in CENTIS, using the methodology of analysis of modes and effects of failures are collected. The analysis of the type and probability of occurrence of the failures in the process, as well as the impact on the quality of the same and the probability of detection of such failures, were used for the use of techniques used in quality assurance such as: storm Ideas and cause-effect diagram. Scales were established for the determination of severity, probability of occurrence, probability of detection and calculation of the number of risk probabilities. The guidelines were laid down for the future application of this technique, which will establish a decision-making process regarding the risks associated with the production process of ⁹⁹Mo / ^99mTc generators. (author)