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Media fill failure

Als u een media fill failure heeft dan wilt u dat dit zo snel mogelijk wordt onderzocht. Krijg snel de controle terug en laat u door PCS adviseren en helpen dit probleem op te lossen. Door gebruik te maken van onze 32 jaar steriele productie-ervaring, voorkomt u toekomstige storingen in uw steriele proces.

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Waarom zou u PCS bellen na een media fill failure?

Our specialists have years of experience performing a media fill failure investigation
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We have experts with more than 39 years of experience in sterile manufacturing and vaccines

De media fill test failure

Wanneer de steriliteit van farmaceutische producten niet kan worden gegarandeerd, is het verplicht om dit defect te onderzoeken. Dit is om de oorzaak van de failure te achterhalen en te voorkomen dat dit in de toekomst opnieuw gebeurt. De mediavultest controleert de steriliteit van het steriele productieproces. Wanneer de test mislukt, toont het de verontreiniging in het systeem.

Julian Koster, Business Development

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Componenten van de mislukte media fill

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.

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