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GMP News No. 463
13 September 2004
FDA Statement on MediaFailures
In our GMP Newsof 6 August we have drawn your attention to FDA's new Q&A page.This page is the successor of the Human DrugscGMP Notes.
In the 'Production and Process Controls' section, amongothers the following case can be found: In a company, several media fillfailures occurred. As usual, the employed TSB (tryptic soy broth) had beensterilised by means of a 0.2 µm filter. The subsequent investigationcould not uncover any plausible reason for this result. The contaminatingorganism could be neither isolated nor recovered by means of conventionaltests. What had happened?
With the help of an RNA analysis, the cause could be clarified. Theorganism was identified as Acholeplasma laidlawii and alsodetected in the TSB media source. It belongs to an order of mycoplasma andcan penetrate a 0.2 µm filter due to its characteristics (no cell wall).Thus, it had not been removed from the medium through the sterilefiltration.