FDA Statement on Media Failures

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. 
As a consequence, the company now uses a 0.1 µm filter, which retainsthis organism. (This is just to solve the problem - the FDA does notrequire these filters in general.) The firm will change to sterile, irradiated TSB as soon asit becomes available. In addition, they have started monitoring for mycoplasma and revalidated their cleaning procedurein order to verify its removal.

Dr Ulrich Herber

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