SMART FILL allows to perform 3 simulations of Media Fill (3 validation runs) of the procedure and administration of the radiopharmaceutical through automatic fractioning and doses infusion systems for radiopharmaceuticals. SMART FILL allows to validate the aseptic process with regard to the operator’s manual and the working procedures adopted as required in Chapter 11 of the “Rules of Good Preparation for Nuclear Medicine.”

The procedure for Media Fill is closely connected to each department’s internal operation rules and cannot therefore be generalized. The leaflet suggests a possible sequence of operations that must be approved by the person in charge of the Department of Nuclear Medicine.

All the material is packaged inside an appropriate transport packaging.

At the end of the three simulations all samples collected can be shipped to ITEL Telecomunicazioni, radiopharmaceutical division ITELPHARMA, for the verification of sterility by incubation at a temperature of 22.5 °C / 32.5 °C for a total period of 14 days. In case of compliance, sterile samples are then tested for fertility, performed to check the conformity of the medium.

Upon completion of testing, the quality control department shall issue the certificate of analysis with the results of analytical tests performed on the kit.