The MEDIAFILL-PE KIT Kit consists of one 100 ml vial of TSB culture medium, one 10 ml vial of TSB culture medium, one 10 ml empty bottle for needle setting 10 sterile, non-pyrogenic, vacuum packed vials, identification labels, instructions leaflet and an analysis certificate guaranteeing product quality.
The kit packaging is made of insulating material. This reduces thermal shock risk thus minimizing culture medium fertility damage and ensuring adequate microbial contaminants recovery.
The MEDIAFILL-PE Kit allows to simulate 1 complete fractionation process of a radiopharmaceutical multidose vial (3 simulations are required in case of initial validation of the operator) 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.
At the end of the three simulations all the specimens collected may be shipped to Eurofins 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.
1MP 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.