When this test applies
Any device labelled non-pyrogenic, and any device contacting blood, cerebrospinal fluid, or the cardiovascular or lymphatic system, is expected to meet an endotoxin limit — 20 EU per device for most devices, 2.15 EU per device for those contacting cerebrospinal fluid. Bacterial endotoxin and material-mediated pyrogenicity are different questions: this test detects endotoxin left by manufacturing, not a pyrogenic leachable from the material itself.
When to run it
On the sterilised, finished device in its final packaging, because endotoxin is a property of the manufacturing environment rather than the material. It is quick — five days — so it fits at the end of a build or as a routine release test. Run it alongside material-mediated pyrogenicity (GRK-4004-01) where the biological evaluation opens that endpoint too.
What a pass tells you
That the endotoxin level in the device eluate, reported in EU per device or per mL, was below the limit for the device's route and contact, with the positive product control recovering within 50 to 200% — which confirms the device did not interfere with the assay.
What it does not tell you
Nothing about material-mediated pyrogens, which the LAL reagent cannot see, and nothing about sterility or bioburden — endotoxin can be present on a sterile device. It also reflects the lots tested; a change in the manufacturing environment changes the result.
Method
Testing per USP <85> by the kinetic turbidimetric method. The device is eluted in LAL reagent water, the eluate is incubated with Limulus amebocyte lysate and the onset time of turbidity is read kinetically against a standard curve, with a positive product control to demonstrate the absence of inhibition or enhancement. At least three devices are required.
Where it runs
This method is domestically sourced (US). The laboratory is ISO/IEC 17025 accredited and GLP certified, and the report is issued under Groenakker’s ISO 13485:2016 certified quality system, in Groenakker’s report template or in your document template on request at no extra cost.
Usually ordered alongside
Material-mediated pyrogenicity (GRK-4004-01), which is the companion pyrogen test rather than an alternative; the pooling fee (GRK-7003-03) where several devices are pooled into one result; and cytotoxicity as the baseline biological screen.
