routine lal assay

Routine LAL Assay

Routine LAL testing involves the testing of each lot of product following an LAL Validation. For this test, a  product extract is made, then the product is exposed to and incubated with the horseshoe crab lysate (LAL). The product extract is incubated along with a standard series of the Control Standard Endotoxin (CSE) as the positive control and the unexposed extract fluid as a negative control. After the incubation period, the tubes containing the controls and the extract are observed for the presence of the gel clot. A clot indicates the presence of endotoxins. No clot indicates absence of endotoxins (i.e. < 0.06 EU/ml).

The Routine LAL assay is a qualitative test utilizing the LAL Gel Clot method to test the endotoxin levels of the product to be either greater than or less than the sensitivity of the test, which is 0.06 EU/ml. This type of test can be performed on solid and liquid products.

Once the certification assay is completed, the customer is contacted with the preliminary results if indicated and a report containing a Data and Results sheet and a Certificate of Analysis is mailed to the customer.

Non-Pyrogenic certification testing consists of device extraction or liquid, controls and inhibition/enhancement using the LAL gel clot method. Additional fees apply for quantitative testing.