Pyrogen Testing
Pyrogens are fever-inducing substances usually derived from microorganisms or chemicals that cause severe biological reactions. Examples include bacterial endotoxin, peptidoglycan (PG) and (1->3)-β-D-glucan (BDG).
Products contaminated with pyrogens can cause severe consequences as they activate a strong inflammatory immune response, even when a small amount enters the bloodstream.
Pyrogen testing is essential for the detection of pyrogenic contamination in the research and manufacturing of pharmaceutical, injectables, medical devices, vaccines, media for tissue cultures, dialysis /infusion related products and validation of depyrogenation processes.
Applications
Testing for bacterial endotoxin contamination is vital for quality control practices for manufacturing of pharmaceuticals and medical devices, to ensure the products are endotoxin free.
The Bacterial Endotoxin/LAL Test is used for the high sensitivity and specificity detection of endotoxin, which are complex lipopolysaccharide (LPS) found in the cell wall of gram-negative bacteria. They are a highly heat resistant toxin that exhibits various biological activities such as pyrogenicity (fever).
Endotoxin can be detected in three ways using the Limulus Amoebocyte Lysate (LAL) Clotting principle:
Gel Clot Assay (GCA) - Presence of gel formation
Kinetic Turbidimetric Assay (KTA) - Measurement of time for change in turbidity
Kinetic Colorimetric Assay (KCA) - Measurement of time for colour change
GCA
Easy to use
Low equipment cost
Reference method USP
KTA
Real time measurement
Readings are automated
Less dilution than GCA
Over-coming interference
Fast and more sensitive
Can be used for Coloured samples
KCA
Real time measurement
Readings are automated
Less dilution than GCA
Over-coming interference
Fastest and most sensitive
Can be used for Turbid samples
Product Selection Flow Chart
Benefits
Our Pyrogen Testing range is perfect for those looking to take control of their pyrogen testing by moving it in-house. The advanced features of our large product range provide many advantages over outsourcing:
High Sensitivity and Specificity – Improve your current methodology for specific bacterial endotoxin detection.
Selection of Methodologies – GCA, KTA and KCA all available to meet your specific endotoxin/LAL test requirements for different applications.
Testing that Fits Around You – All assays are available in different formats and pack sizes at a range of specificities allowing you to tailor your testing and workflow to your needs.
GCA/KTA Assay – PYROSTAR™ ES-F is available for both methods giving you a qualitative and a quantitative option for endotoxin detection.
KCA Assay – Limulus Color KY is the most sensitive at detecting the presence of endotoxins, providing swift and accurate results.
Synthetic LAL Alternative – PYROSTAR™ Neo is a recombinant Factor C (rFC) reagent which is a non-animal derived LAL substitute with the same high sensitivity as PYROSTAR™ ES-F.
SLP Assay – SLP-HS Single Reagent Set II is a highly sensitive test to detect the pyrogens; peptidoglycan (PG) found in all bacterial cell walls and (1->3)-β-D-glucan (BDG) in most fungi.
Greater Control – Control every aspect of your testing process allowing you to ensure that it is carried out to your standards.
Quicker Results – In-house testing, results are available as soon as the assay finishes, no more waiting for external laboratories.
Improved Troubleshooting – Fix issues with testing and products as soon as they occur, don’t rely on other laboratories to alert you to or fix problems. Track product results over time to identify potential problems before they affect quality.
FDA Approved – GCA/KTA endotoxin testing methods have been approved for use by the FDA when used with the Part 11 software, PC and testing module set.
Testing that Grows with You – With the modular nature of the Toxinometer® ET-7000 your testing capabilities can grow as you need them. Each testing module can process 16 per run with up to 11 modules connected to a single PC. This allows you to test up to 176 samples per run for each PC.
Featured Products
Colorimetric Kits
PYROSTAR ® Color KY Series endotoxin testing kits use the Kinetic Colorimetric Assay (KCA) method.
GCA/KTA Kits
PYROSTAR ® ES-F Series endotoxin testing kits use the Kinetic Turbidimetric Assay (KTA) and Gel Clot Assay (GCA) methods.
Pyrosep Kits and Accessories
PYROSTAR® kits and accessories using the Pyrosep™ method reduce sample interference and allow testing of previously unusable samples.
