Which process ensures that a radiopharmaceutical is free of contaminants?

The process that ensures a radiopharmaceutical is free of contaminants is primarily through quality assurance processes, including sterility testing. This is because sterility testing is a specific procedure designed to determine whether a product is free from viable microorganisms, which is crucial for safety and efficacy in medical applications. Contaminated radiopharmaceuticals can lead to serious adverse health effects, making sterility a critical focus in their preparation and quality assurance.

Quality assurance encompasses a wide range of activities aimed at maintaining high-quality standards throughout the manufacturing process. Sterility testing, as part of this assurance, ensures compliance with regulatory standards and helps to verify that the manufacturing environment and processes have effectively eliminated the risk of contamination.

While quality control processes, routine maintenance of equipment, and calibration of instruments are important practices in the overall quality management system, they serve different purposes. Quality control focuses on monitoring and measuring products during the manufacturing process, maintenance ensures equipment operates correctly, and calibration ensures radiation detection instruments provide accurate readings. However, these processes do not specifically address the contamination aspect as directly as sterility testing does.