The MEDIAFILL-PMC Kit consists of two 100 ml vials of Tryptic Soy Broth (TSB) culture medium, eight 10 ml vials of Tryptic Soy Broth (TSB) culture medium ,10 sterile, non-pyrogenic, vacuum packed vials, polypropylene labels, instructions leaflet and a conformity 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 kit allows to carry out the simulation of a radiopharmaceutical preparation (require three simulations in case of operator initial validation) performed by labelling patient autologous tissue, and to validate the aseptic process in terms of operator handling and production procedures 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 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.