The Pyrogenicity Manufacturing Challenge


Pyrogens constitute a heterogeneous group of fever causing substances which comprise both microbial and non-microbial substances. The most potent and most widely known are the endotoxins or lipopolysaccharides (LPS), which are cell wall components of gram-negative bacteria. Gram-positive bacteria are also sources of pyrogens, in particular lipoteichoic acid (LTA), as are particles from yeasts and viruses. Non-microbial pyrogens often emanate from production environments. Small particles of packaging materials are a typical example.

Pyrogen Testing

Because pyrogen contaminations in pharmaceutical products, biotherapeutics, cosmetics and on medial devices can induce life threatening fever, it is mandatory for manufacturers to ensure that the pyrogen concentrations do not exceed certain limits. Sterility tests cannot address this requirement appropriately as many of the pyrogenic structures persist after elimination of living pathogens.

The pyrogenicity hazzard was discovered more than a century ago, and tests to determine whether a parenteral or medical device is safe for human use have been in place for 70 years. Currently, there are three test methods available: the rabbit pyrogen test (RPT), the Limulus Amoebocyte Lysate (LAL) assay (a bacterial endotoxin test), and a method based on human whole blood or human monocytes called Monocyte Activation Test (MAT).

 
 
PyroDetect System

Brochure:
PyroDetect System

Download here
PyroDetect Analysis Tool

Datasheet:
PyroDetect Analysis Tool

Download here
 

Events

Apr 21
04/21/15 - 04/23/15
Interphex
Javits Center
New York, NY, USA
Small Molecule Pharmaceuticals,Biopharmaceutical Manufacturing,Industrial Biomonitoring North America 20150421
Mar 31
03/31/15 - 04/02/15
ContaminExpo
Porte de Versailles - Pavillon 6
Paris, France
,Small Molecule Pharmaceuticals,Reagents Chemicals and Labware,Life Science Research,Industrial Biomonitoring,IVD/OEM Materials and Reagents,Biopharmaceutical Manufacturing,Analytics and Sample Preparation Europe 20150331
Mar 19
03/19/15 - 03/20/15
Laborama
Brussels Kart Expo
Brussels, Belgium
,Small Molecule Pharmaceuticals,Reagents Chemicals and Labware,Life Science Research,Industrial Biomonitoring,IVD/OEM Materials and Reagents,Biopharmaceutical Manufacturing,Analytics and Sample Preparation Europe 20150319
Mar 18
03/18/15 - 03/19/15
ChemBio
Expo & Convention Centre Helsinki
Helsinki, Finland
,Small Molecule Pharmaceuticals,Reagents Chemicals and Labware,Life Science Research,Industrial Biomonitoring,IVD/OEM Materials and Reagents,Biopharmaceutical Manufacturing,Analytics and Sample Preparation Europe 20150318
Mar 08
03/08/15 - 03/12/15
Pittcon Conference and Expo
Ernest N. Morial Convention Center
New Orleans, LA, USA
,Industrial Biomonitoring North America 20150308
Feb 24
02/24/15 - 02/27/15
ENOMAQ
Feria de Zaragoza
Zaragoza, Spain
Industrial Biomonitoring,Biopharmaceutical Manufacturing Europe 20150224