Media fill failure

1. Product and quality control

First of all, research is done at the laboratory level. When errors and mistakes are found in the laboratory this is also investigated. The sterility of the filling test is also examined in the laboratory. If nothing is found in phase A, the investigation proceeds to the next phase.

 

2. Risk assessment

This is where the identification of all microorganisms present in contaminated vials takes place, down to the species level. This helps to investigate the cause of contamination. All contaminated vials are checked for breaks and any cracks.

The possible source of contamination corresponding to the environmental isolates are ascertained. The history of the media that was last filled for the product is also checked for contamination. In addition, the batches that have been filled with the same filling line since the last test of the media filling are checked.

Now a list of all possible causes of failure can be made. But also a list of the batches that are held, that are suspicious and need to be analyzed again.

The area cleaning and hygiene report should also be checked for proper cleaning before the day of the media fill validation run. Area qualification and maintenance documents can be reviewed to get an idea of a possible root cause.

3. Quality assessment review

If the root cause of the failure is determined, the cause is considered as assignable and the media fill test is repeated with the corrective and preventive actions. But if the cause is not determined, the cause is considered a non-attributable cause and the fill process is considered a new production system. Three consecutive successful media fill runs are required to restart the manufacturing process.