FDA Statement on Media Failures

GMP News No. 463

GMP News
13 September 2004
 

FDA Statement on Media Failures

 
In our GMP News of 6 August we have drawn your attention to FDA's new Q&A page. This page is the successor of the Human Drugs cGMP Notes.

In the 'Production and Process Controls' section, among others the following case can be found: In a company, several media fill failures occurred. As usual, the employed TSB (tryptic soy broth) had been sterilised by means of a 0.2 µm filter. The subsequent investigation could not uncover any plausible reason for this result. The contaminating organism could be neither isolated nor recovered by means of conventional tests. What had happened?

With the help of an RNA analysis, the cause could be clarified. The organism was identified as Acholeplasma laidlawii and also detected in the TSB media source. It belongs to an order of mycoplasma and can penetrate a 0.2 µm filter due to its characteristics (no cell wall). Thus, it had not been removed from the medium through the sterile filtration. 
As a consequence, the company now uses a 0.1 µm filter, which retains this organism. (This is just to solve the problem - the FDA does not require these filters in general.) The firm will change to sterile, irradiated TSB as soon as it becomes available. In addition, they have started monitoring for mycoplasma and revalidated their cleaning procedure in order to verify its removal.
  

Monitoring, Cleaning and Media Fills are just some of the topics discussed within the framework of the ECA Education Course "Microbiological Facility Control" to be held in Berlin from 5-7 October. Please click here for the complete event programme.

 
Author:
Dr Ulrich Herber
CONCEPT HEIDELBERG
  

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