Bacterial Endotoxin (LAL) Testing
Limulus Amebocyte Lysate (LAL) testing, also commonly known as pyrogen or bacterial endotoxin testing, tests for the presence of a membrane component of gram negative bacteria that remains after a product has gone through the sterilization process. These components are responsible for producing fever, lowering blood pressure, and activation of inflammation and coagulation in patients that have been exposed to them. Medical device and pharmaceutical manufacturers, as well as certain sectors of the biotech industry, are responsible for limiting product exposure to these endotoxins, from raw material receipt through the end of the manufacturing process, and prove the product meets global regulatory requirements surrounding the endotoxin levels in finished products contacting either the cardiovascular system, or cerebral spinal fluid. Standard industry practice is to demonstrate this compliance through LAL testing as a product release test. GTI offers the three most common methods of LAL detection – gel-clot, kinetic turbidimetric, and kinetic chromogenic, all described below. Our experienced micro staff can also help you to choose which method is best suited for your individual needs.
The Gel-Clot method is the qualitative (Pass/Fail) LAL test. This method is best suited for customers who submit a very limited number or samples, perform incoming quality control of raw materials, or where a quantitative endotoxin result is not necessary.
Kinetic Turbidimetric and Kinetic Chromogenic
The kinetic turbidimetric and kinetic chromogenic methods are a quantitative LAL tests which can precisely measure endotoxin concentrations of samples, and have a sensitivity as low as 0.005 EU/mL and 0.001 EU/mL, respectively. These tests are suited for clients who require a quantitative measurement. The maximum valid dilution (MVD) or minimum valid concentration (MVC) required to achieve a passing result, as the absence or presence of certain substances which may interfere with the nature of the specific assay will determine which of the two methods best suit your needs.
Our senior microbiologist brings years of experience performing all methods of endotoxin testing on raw materials and finished products for the pharmaceutical and medical device industry. GTI is committed to offering quality and cost-effective LAL testing which adheres to all applicable standards. Request a quote to get started with us today!
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