Media Fill per sistemi automatici
di frazionamento e infusione

SMART FILL allows to perform 3 simulations of Media Fill (3 validation runs) of the procedure and administration of the radiopharmaceutical through automatic fractioning and doses infusion systems for radiopharmaceuticals. SMART FILL allows to validate the aseptic process with regard to the operator’s manual and the working procedures adopted as required in Chapter 11 of the “Rules of Good Preparation for Nuclear Medicine.”

The procedure for Media Fill is closely connected to each department’s internal operation rules and cannot therefore be generalized. The leaflet suggests a possible sequence of operations that must be approved by the person in charge of the Department of Nuclear Medicine.

All the material is packaged inside an appropriate transport packaging.

At the end of the three simulations all samples collected can be shipped to ITEL Telecomunicazioni, radiopharmaceutical division ITELPHARMA, for the verification of sterility by incubation at a temperature of 22.5 °C / 32.5 °C for a total period of 14 days. In case of compliance, sterile samples are then tested for fertility, performed to check the conformity of the medium.

Upon completion of testing, the quality control department shall issue the certificate of analysis with the results of analytical tests performed on the kit.

The SMART FILL kit is constituted by:

  • 3 bottles containing 500 ml of culture medium Tryptic Soy Broth (TSB)

  • 3 vials containing 20 ml of TSB

  • 3 vials containing 10 ml of TSB (to be used alternatively 20 ml)

  • 21 vials under vacuum of 50 ml, sterile and non-pyrogenic

  • 24 needles 21G

  • 3 ventilation filters

  • Identifying labels

  • Instructions for use leaflet

  • CD-ROM containing a standard format for Protocol and Validation Reports

  • Analytical Certification for the quality assurance of the product

Contact Itelpharma

We will be happy to assist you.