Reagent medium reagent kit FILL-SAFE

for microbial contamination

FILL-SAFE allows three simulations of a conventional radiopharmaceutical preparation. The kit 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 generalized. The leaflet suggests a possible operational sequence, that must be approved by the responsible personnel of the Nuclear Medicine Department. 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 using the kit. Il kit contiene: 4 100 ml vials of TSB culture medium 15 sterile, non-pyrogenic, vacuum packed vials Identification labels, Instruction leaflet CD-ROM containing a standard format for Protocol and Validation Reports Analysis certificate guaranteeing product quality