What it is
Sterility testing looks for viable organisms under defined conditions. Endotoxin testing measures bacterial components capable of causing pyrogenic reactions. Bioburden is another distinct test.
What the evidence tells us
The tests use different methods and acceptance criteria. Results need units, sample preparation, detection limits and evidence that the sample did not interfere with the method.
What remains uncertain
“Not detected” means below that method’s reporting limit. It does not mean zero. Neither a purity percentage nor a single negative microbial result certifies a product’s overall safety.
Check the population, product, route, comparator and outcome. A laboratory mechanism is not a proven health benefit, and a supplier’s certificate is not a clinical study.
Follow the evidence
Sources accessed 10 September 2026. Vendor claims and vendor-hosted reports are identified as such.