The FILL SAFE PET Kit allows to simulate 1 complete fractionation process of a radiopharmaceutical multidose vial into a number of patient single doses ranging from 1 to 10, and to validate the aseptic process in terms of production procedures and operator handling as required by Chapter 11 of “Good Preparation Procedures in Nuclear Medicine”.

Media Fill procedures are closely linked to the operating procedures of each individual Nuclear Medicine Department and cannot be generalized. The leaflet suggests a possible operating sequence that must be approved by the persons in charge of the Nuclear Medicine Department.

Incubation/reading/fertility service and issuing of analysis certificate

At the end of the three simulations all the specimens collected may be shipped to ITELPHARMA for incubation at temperatures of 22.5°C and 32.5°C for a total of 14 days. The sterile specimens undergo a fertility test carried out to verify the conformity of the culture medium.

Upon completion of the tests, the Quality Control Department issues a certificate of analysis with the results of the analytical tests performed on the specimens.

Validation protocol and final report

ITELPHARMA provides technical support for laying out the validation protocol by supplying a document template to be adapted by the Nuclear Medicine Department according to its own requirements. This document is essential to demonstrate to the inspection authorities the conformity to standards of the procedures followed.

Shipment

The Kit will be shipped free of charge to the Nuclear Medicine Department and picked up at the end of the tests.