The Endotoxin indicator vials are ready-to-use vials composed of E. coli O55:B5 (>1000 EU/vial) for performing depyrogenation validation studies to ensure that a process is effectively inactivating and/or destroying endotoxin. These vials may be tested using reagents from our PYROSTAR™ ES-F series.
Traditionally, water or saline solution has been used to extract endotoxin in tests involving medical devices and equipment; however, the efficacy of this extraction method is debated. In order to provide our customers with a more reliable method, FUJIFILM Wako has developed a solution containing human serum albumin (HSA) that
The ES Buffer is an endotoxin-specific buffer that is ideal for untreated LAL. Though all LAL reagents produced by FUJIFILM Wako are endotoxin-specific, other commercially available LAL reagents are not. Without this buffer, tests can activate (1,3)-ß-D-glucan when trying to determine the endotoxin concentration in the sample.
The Toxinometer® ET-7000 is a computer-operated kinetic incubating tube reader, designed to be exceptionally user-friendly. State-of-the-art expansion modules can be connected to allow for endotoxin testing in a wide range of fields and sample quantities. The Toxinometer® ET-7000 can perform all LAL testing methodologies (gel clot, kinetic turbidimetric,
The Toximaster® QC8 software supports data processing based on the protocols complying with three types of pharmacopeia (USP/EP/JP) for bacterial endotoxin testing. This software is compliant with FDA 21 CFR Part 11 ERES (electronic records/electronic signature), which requires the proper information from all parties involved in the testing
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