Sterility tests cannot address this requirement appropriately as many of the pyrogenic structures persist after elimination of living pathogens, or may be part of packaging and filling materials that need to undergo depyrogenation and/or passivation processes prior to final fill or packaging. There is extensive data (www.criver.com) to support comparability to USP<85> and PharmEur 2.6.14 Bacterial Endotoxin testing.
Endotoxins are pyrogens, which are life-threatening, fever-causing molecules. Endotoxin/Pyrogen testing is done using Endosafe®-PTS™, a rapid FDA-licensed closed system test containing assay and control reagents in disposable test cartridges. Data outcomes are analyzed with a handheld reader and stated as an Endotoxin Unit (EU). The PTS™ is used by the QC laboratory for product testing and raw materials release. When there is interference with the assay, dilutions and other test methods, such as gel clot or immunoassays may be done.