The FILL SAFE PET Kit consists of one 100 ml vial of TSB culture medium, one 10 ml vial of TSB culture medium, 10 sterile, non-pyrogenic, vacuum packed vials, identification labels, instructions leaflet and an analysis certificate guaranteeing product quality. All contents are packed in a polystyrene shell designed to maintain a stable temperature and prevent accidental breakage.
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.
The Kit will be shipped free of charge to the Nuclear Medicine Department and picked up at the end of the tests.
ITEL/Linearbeam will exhibit at the Annual Meeting of the American Society for Radiation Oncology (ASTRO 2019) to be held in Chicago, IL (USA) from Sep. 15th to 18th, 2019. Come and visit us in booth n° 843 to learn more about our activities in protontherapy!
ITEL will exhibit at the Annual Congress of the European Association of Nuclear Medicine (EANM'19) to be held in Barcelona (Spain) from 12th to 16th October 2019. Please come and visit us at our booth #44!
ITEL will exhibit at the “Arab Health 2020” to be held in Dubai from 27th to 30th January 2020. Please come and visit us at our booth J50 in pavillion S1!