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Endotoxins

A Time-Saving Recombinant Factor C (rFC) Endotoxin Test

A Time-Saving Recombinant Factor C (rFC) Endotoxin Test Including a Novel Microplate Pre-Coated with Control Standard Endotoxin (CSE) Concentrations and Positive Product Controls.

 

PDA Annual Meeting • ORLANDO, FL •  2018

The vast majority of endotoxin tests for pharmaceuticals and medical devices as well as their in-process intermediates and raw materials are microplate-based. They require tedious reconstitution and dilution steps for preparation of Control Standard Endotoxin (CSE) dilutions and Positive Product Controls (PPCs). These time-consuming manual handling steps can result in substantial variability and a significant rate of invalid results that demand repeat testing. 

 

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