Novel Endotoxin and β-glucan Testing In-House
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Endotoxin testing is a vital, regulatory mandated assay for all injectable or implantable products. PYROSTAR®, now available in the UK from Alpha Laboratories Ltd., enables in-house endotoxin testing, providing full control over one of the most important aspects of quality control and offering many benefits over outsourcing. With samples tested in-house results are available as soon as the assay finishes. The flexible system offers assays in different formats and pack sizes, at a range of sensitivities, allowing you to tailor your testing and workflow to your needs.
The FUJIFILM Wako PYROSTAR® range provides 3 highly sensitive assays; Gel Clot Assay (GCA), Kinetic Turbidimetric Assay (KTA) and Kinetic Colorimetric Assay (KCA), for use with the ET-7000 toxinometer. These are all based on the long established and trusted Limulus Amebocyte Lysate (LAL) method, testing for the presence of bacterial endotoxins and β-glucans and ensuring that your products are safe and pyrogen free. The GCA and KTA assays have been approved by the FDA when used with the Part 11 software, PC and testing module set.
Alpha laboratories can supply all the reagents, accessories, consumables, equipment and support necessary for this testing, providing you a one stop shop for all your endotoxin testing needs.