FILL-SAFE Kit for Media-Fill testing

The FILL-SAFE Kit is composed by four 100 ml vials of TSB culture medium, 15 sterile, non-pyrogenic, vacuum packed vials, identification labels, instruction leaflet and an analysis certificate guaranteeing product quality. Everything is packaged inside a polystyrene shell that reduces the temperature fluctuations during shipping and prevents accidental breakage of the content.

FILL-SAFE allows three simulations of a conventional radiopharmaceutical preparation. FILL-SAFE enables aseptic process validation in terms of operator skills and of the manual procedures adopted according to Chapter 11 of “Good Preparation Procedures in Nuclear Medicine”.
Media-Fill procedure is closely linked to the operating procedures of each individual department and cannot be generalised. The leaflet suggests a possible operational sequence, that must be approved by the responsible personnel of the Nuclear Medicine Department.

Incubation/reading/fertility service and drafting of analysis reports

At the end of the three simulations, all of the samples collected may be shipped to ITELPHARMA for incubation at the temperature of 22.5°C/32.5°C for a total of 14 days. The sterile samples then undergo a fertility test performed to verify the compliance of the culture medium.
Upon completion of the tests, the quality control department issues an analysis certificate containing the results of the analytical tests performed on the samples.

Validation protocol and final report

ITELPHARMA, on request, will provide technical support for the definition and revision of the validation protocol and respective report. The latter constitutes indispensable documentation for demonstrating the performed work compliance to applicable standards