Media-Fill test is used to validate the production process of a radiopharmaceutical product aseptically, using appropriate culture media in replacement of the product, in order to prove the absence of microbial contaminants.
For the execution of the Media-Fill tests, ITEL’s microbiological quality control laboratory offers the supply of all the consumable requested by the customer to the execution of the Media-Fill tests (eg sterile culture medium, sterile and pyrogen free vials). On request, ITELPHARMA, radiopharmaceutical division of ITEL, 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.
At the end of the execution of Media-Fill tests, all of the samples collected may be shipped to ITEL which offers an incubation, reading and fertility service of the samples. The samples are incubated 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 results of the analysis are delivered to the customer by way of a suitable analysis certificate.