The Limulus Amebocyte Lysate (LAL) test is the most sensitive and most specifically effective method for the detection of endotoxins. Customers of Labor LS can rely on a broad range of LAL test methods. For instance, we offer our customers a selection of four well-established test methods for product testing: the gel-clot method (method A and B), the kinetic turbidimetric method (method C) and the kinetic chromogenic method (method D). On request, we perform a product-specific matrix validation of the LAL tests for each of the test methods.
Our services in the LAL test include both testing of in-process controls and release tests of pharmaceuticals and medical devices (control unit ANSI/AAMI ST72:2011). The quantitative endotoxin determination by means of our kinetic test methods (methods C and D) gives our customers the most detailed and informative result evaluation.
Furthermore, our “hard spike” analysis offers customers the possibility of testing their products (in particular final products, but also active ingredients as well as raw and packaging materials) for possible product-related endotoxin masking effects. The “hard spike” analysis involves the artificial contamination of an initial test substance or a specimen with endotoxins. Based on the endotoxin value, which is determined from the known contamination value, this method allows to detect product-related endotoxin masking effects. In this way, we can offer our customers the highest level of security in product testing and enable them to rule out potentially false-negative results.
Taking into account a defined product life and storage conditions, the “hard spike” analysis also enables our customers to conduct “hold time” studies, i.e. product life validations, at Labor LS. These studies on the topic of “Low Endotoxin Recovery (LER)” address product safety and define the available analytical time-frame for performing endotoxin tests.
Labor LS looks back on many years of experience also in terms of the qualification of dry heat sterilisers and depyrogenation tunnels. We offer this knowledge as part of our commercially-available test specimens (so-called “challenge vials”) as well as in our customers' individual test specimens contaminated with endotoxins.
New at L+S AG: with the EndoLISA™ test system, Labor LS offers a new possibility for testing for bacteria endotoxins. This ELISA-based test method provides an alternative to the pharmacopoeia methods of the LAL test. Both for product matrices strongly interfering with the LAL test as well as for pharmaceutical formulations, the EndoLISA™ test system offers new possibilities of sample processing. Particularly for the phenomenon of Low Endotoxin Recovery (LER), the EndoLISA™ test design provides new solutions for the product-related masking of endotoxins and for test conditions that enable to rule out potentially false negative results in the context of release analysis. A detailed article on this new test method can be found in our current edition of UpDate (starting on page 5).