Production of ¹³¹I capsules: Quality control of the different stages from the physician's order to patient's administration

Abstract

The Radiochemistry Department of Rotem Industries produces ¹³¹I hard gelatin capsules for the treatment and diagnosis of different thyroid disorders. Each capsule is designated for a specified patient according to the physician's decision that is based on the patient's morbid status. GMP (Good Manufacturing Practices) requirements have been implemented throughout the production process resulting in the accreditation by the Israeli Ministry of Health. A computerized system has been developed and is used as a QC tool throughout the process of ¹³¹I capsule production. The request by the physician for capsules of various activities are introduced into the system and the process from production through packaging and external radiation monitoring is computer-controlled. The system prevents the possibility of double orders, out of specification production and enables documentation of data regardless of production date.