Standards Development
This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in health care products, components or raw materials using bacterial endotoxins test (BET) methods, using recombinant animal-free reagents.
This document is not applicable to the evaluation of pyrogens other than bacterial endotoxins. Other endotoxin detection methodologies described in ISO 11737-3:2023 are not included.
This document does not address setting specific endotoxin limit specifications.
The European and US Pharmacopeias recently updated or added chapters on Bacterial Endotoxin Testing to allow the use of recombinant animal-free reagents as an acceptable alternative to the classic limulus amoebocyte lysate (LAL)-based methods for the quantification of endotoxins from gramnegative bacteria. ISO 11737-3:2023 does not include such alternative. The objective is to create a Technical Specification to supplement the bacterial endotoxin testing methods described in the ISO 11737-3:2023.
There are several vendors with different LAL, recombinant factor (rFC) and Cascade Reagents (rCR) solutions on the market, there is no monopolistic ownership of any of the technology, giving the opportunity to the health care products manufacturers the flexibility to choose and implement one or the other method.
The rFC and rCR methods have been shown in numerous validation studies to be substantially equivalent to the LAL assay in certain applications. References will be added to the bibliography section (more than 10 publications) of this technical specification.
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