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Pyrogen and Endotoxin Testing of Parenterals and Implanted Medical Devices

Water for Injection (WFI)

Special Focus on Pyrogen and Endotoxin Testing

Showcasing Limulus Amebocyte Lysate (LAL) formats and non-animal Recombinant Horseshoe Crab Factor C (rFC) and Monocyte Activation Tests (MAT).

CORK CITY, CORK, IRELAND, March 8, 2019 / -- This special focus showcases commercially available products and services that manufacturers of parenteral drugs and implanted medical devices can use to test raw materials and finished products for pyrogens such as endotoxins.

Explore different formats based on the established Limulus Amebocyte Lysate (LAL) plus new approaches that use non-animal based methods such as Recombinant Horseshoe Crab Factor C (rFC) and the Monocyte Activation Test (MAT).

This feature includes:

- Overview of Bacterial Endotoxin Testing (BET), what are endotoxins and what methods are available for their detection?

- Three case studies outlining the risk that endotoxin poses to poorly maintained pharmaceutical water systems.

- Products for bacterial endotoxin testing designed to increase data integrity compliance, reduce retest rates, and streamline manufacturing processes.

- Non-animal based methods, find out about recombinant Factor C assays that don't use lysate from horseshoe crabs and have proven equivalency to LAL-based methods. Plus, a Monocyte Activation Test (MAT) that detects both endotoxin and non-endotoxin pyrogens in the one in vitro test.

- How to assure compliance by outsourcing your Bacterial Endotoxin Testing (BET).

Visit this special focus page on

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Catherine Ryan
Rapid Test Methods Ltd.
+353 23 883 1884
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