Toxinometer ET-7000/E Part11 Set

PYROSTAR is Fujifilm Wako’s range of endotoxin testing instruments and reagents, based on the Limulus Amoebocyte Lysate (LAL) assay.

The PYROSTAR ET-7000 Toxinometer is a combined incubation and photometric measuring device, allowing, through the PYROSTAR range of reagents, the use of all 3 PYROSTAR Bacterial Endotoxin Test (BET) methods, the Gel Clot Assay (GCA), Kinetic Turbidimetric Assay (KTA) and Kinetic Colorimetric Assay (KCA), all on the same system.

The Toxinometer can operate as a heating block, providing reliable, uniform heat to each of the 16 tube slots at 30°C or 37°C. The photometric reader of the ET-7000 operates by passing a 430nm light, generated by an Ultrabright-Blue-LED, through the sample before impacting a silicon photocell, generating a current proportional to the amount of light impacting it. When used in conjunction with a computer and Toximaster® QC8 software, this current is recorded as the sample’s transmission ratio.

Negative controls have a transmission ratio of 100%, however if endotoxin is present, this causes the sample to coagulate and allow less light through, reducing the transmission rate. If the transmission rate drops below a threshold, endotoxin can be said to be present in the sample. Using the time taken to reach this threshold, reported as Gelation time (Tg) for the KTA method and activation time (Ta) for the KCA method, the ET-7000 and QC8 software can calculate the endotoxin level in the sample. Each tube is measured independently and simultaneously, allowing processing of 16 samples per run.

This ET-7000/E part 11 set includes the toxinometer module, 5 licenses of Toximaster QC8 software, a personal computer to remotely control the system and system validation documents allowing compliance with FDA 21 CFR Part 11. Additional ET-7000 expansion units (Purchased separately), up to a total of 8, can be connected and controlled by a single PC, allowing for simultaneous analysis of up to 128 samples per run in 1 system. This flexibility allows the system to scale with your needs as you perform your endotoxin analysis in-house.

The ET-7000 replaces the older ET-6000 toxinometer, retaining all of the functionality while also offering many improvements including:

•An improved temperature control mechanism and algorithm improves the reliability of results by reducing the effects of ambient temperature.
• Improvements in stability, including an improved test tube insertion mechanism reduce the effect of vibrations on the system thereby increasing result reliability even further.
•The tube detection sensor and algorithm have also been improved so that when used with the Toximaster QC8® software measurements can be started automatically when a tube is inserted, reducing waiting time.
•A single run of measurement data can now be stored in the Toxinometer, so when used with the Toximaster® QC8 software, results can be retrieved even if the PC malfunctions and disconnects in any way. This prevents data loss and reduces the need for retesting, speeding up your testing and increasing your maximum sample throughput.