Endotoxin (LAL) Testing
Did you know that the FDA has revised its guidance “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile”? Implant manufacturers who are putting together a 510k submission for devices labelled as sterile must now routinely test their implants for endotoxins using the LAL method – this has not previously been compulsory unless the product was labelled as non-pyrogenic.
We routinely perform analysis of endotoxins using Kinetic Turbidimetric methodology. Limulus Amoebocyte Lysate (LAL) is used to detect and quantify bacterial endotoxins extracted from the products.
Endotoxin testing is important to ensure that sterile pharmaceuticals/devices/injectables are safe for human use. The new guidance from the FDA advises that all implants, labelled as sterile, must undergo endotoxin testing.
Bacterial endotoxins are known to cause fevers and disease if introduced into the bloodstream. Many therapeutics are made in bacteria, so testing is vital to ensure products are endotoxin free. The LAL method uses an enzyme to clot endotoxins, using quantitative turbidimetric assaysing.
At Lucideon we pride ourselves on providing a fast turnaround for our bacterial endotoxin testing services.
We provide regulatory submission support to medical device manufacturers, providing both quality data and technical support with full documentation.