If sample is fail in Bacterial endotoxin test, does it mean it will be fail in sterility testing or vice versa?

 As a microbiologist question arise in mind that if a sample is fail in bacterial endotoxin test, does it fail in sterility test also?

The answer is big NO!

Bacterial endotoxin test is the test to detect the amount of endotoxin present in the sample. Endotoxin is release by the gram negative bacterial cells. Endotoxin is basically lipopolysaccharide (LPS) in nature and only release after the death of the bacterial cell. It means a dead gram negative bacterial cell only can release the endotoxin. 

               Gel clot formation in bacterial endotoxin test showing presence of endotoxin

Whereas in sterility testing, only viable (living) contamination is detected by checking the contamination of product in media (SCDM and FTM). If growth is observed in the media, it means viable (living) contamination is present in the sample. In sterility testing only viable contamination can be detected. 

Conclusion:

Based on the above discussion, it can be concluded that if any sample is failing in bacterial endotoxin test, it is not necessary that it will be fail in sterility test also and vice versa because bacterial endotoxin test only detect endotoxin released by dead bacterial and sterility only detects viable contamination. 

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