Pyrogen Testing

Pyrogens are foreign bodies or materials in the body that induce various biological reactions when even a small amount enters the bloodstream, examples are endotoxin, peptidoglycan (PG) and (1->3)-β-D-glucan. 

They are fever-inducing substances usually derived from microorganisms.

Products contaminated with pyrogens can cause severe consequences as they elicit a strong immune response that can escalate rapidly. Pyrogen testing is essential for the manufacturing of pharmaceutical products, biologicals for injection, medical devices, and media for tissue cultures.

Recombinant Protein Synthetic LAL Assay

PYROSTAR™ Neo+ is a genetically engineered alternative for endotoxin detection for pharmaceutical and medical equipment manufacturing.

LAL Kinetic Colorimetric Assay

KCA is a quantitative test that uses synthetic chromogenic substrate cleavage to detect the activation of the LAL reagent induced by endotoxin.

LAL Gel Clot/Kinetic Turbidimetric Assay

GCA is a qualitative test to detect endotoxin by the presence of gel formation. KTA is a quantitative test that uses the change in gel turbidity to detect the activation of the LAL reagent induced by endotoxin.

LAL Kinetic Turbidimetric Assay

KTA is a quantitative test that uses the change in gel turbidity to detect the activation of the LAL reagent induced by endotoxin.

SLP Pyrogen Assay

Quantitative determination of peptidoglycan (PG) and (1->3)-β-D-glucan in parental solutions and active pharmaceutical.

Pyrogen Accessories

Accessories for use with any of the available Pyrogen Testing kits, including pyrogen and endotoxin free test tubes, pipette tips and microplates.

Pyrogen Reagents

Reagents for use with any of the available Pyrogen Testing kits, including the ES buffer for specific endotoxin testing, endotoxin free reagent water, endotoxin indicators, endotoxin extracting solution and curdlan.

Instruments and Software

The Toxinometer® ET-7000 is an endotoxin analysis system which can perform all LAL testing methodologies (GCA, KTA and KCA).  Software and PC available individually and in sets.