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26th July 2021 Content supplied by: FUJIFILM Wako Chemicals U.S.A. Corporation
Toxinometer® & QC8 - Advanced Technology for Bacterial Endotoxin Testing
Toxinometer® ET-7000 Endotoxin Measurement System
The Toxinometer® ET-7000 is a computer-operated kinetic incubating tube reader, designed to be exceptionally user-friendly. Our 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 and kinetic chromogenic assays). The instrument has 16 wells for single test configuration to easily detect erroneous readings or contamination associated with each well. The kinetic incubating tube reader has uniform temperature settings of 30°C and 37°C.
- Single assay module can simultaneously measure up to 16 samples
- Expansion modules are available (up to 8) to extend the number of samples in multiples of 16
- Single test configuration avoids the “hot wells” phenomenon associated with microplate readers by evenly distributing the temperature in all single wells
- Reduces the chance of contamination due to the single-well formats
- Ideal for users who are converting from gel clot method to kinetic turbidimetric assays
Toximaster® QC8 Software
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 of the sample. Toximaster® QC8 offers excellent audit trail capabilities, can provide statistical processing of means and standard deviations and has robust data processing functions. These data processing functions can be performed by defining sample types such as standards, controls, and test samples.
- FDA 21 CFR Part 11 ERES compliant
- Endotoxin determination in compliance with pharmacopeias (USP/EP/JP) for BET
- Capable of creating three types of curves: internal standard curve, manual input curve and a measured curve
- Product endotoxin limit and MVD generation
- Allows trending of product results over time and early detection of potential product failures
- Generates hard copy printouts with all pertinent information for routine audits through three unique audit trails
- Creation of a standard workflow to be reviewed, confirmed, and approved prior to operating
- Security functions to lock the application, disable an account and lock out the system
- Backup of the user management database and automatic backup of the system information database
- Improved precision and accuracy over the traditional gel clot method
- Ideal software for comparative testing and validating most LAL
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Date Published: 26th July 2021
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