ENDOTOXIN ANALYSIS SYSTEMS
Toxinometer® ET-7000 + 21 CFR PART 11 (ERES) COMPLIANT SET
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 chromogenic assays). The instrument has 16 wells for single-test configuration in order to easily detect erroneous readings or contamination associated with each well. The kinetic incubating tube reader has uniformity temperature settings of 30°C and 37°C.
Toxinometer® ET-7000 Analysis Modules
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 chromogenic assays). The instrument has 16 wells for single-test configuration in order to easily detect erroneous readings or contamination associated with each well. The kinetic incubating tube reader has uniformity temperature settings of 30°C and 37°C
BIOTEK ELx808 Microplate Reader
The BioTek ELx808 microplate reader provides the flexibility to manipulate and analyze data. This multi-channel reader continues BioTek’s tradition of offering the strictest specifications of any microplate reader that insure both accurate and repeatable results. The ELx808 offers a superior 4-zone™ incubator, providing excellent stability for temperature-sensitive assays such as endotoxin analysis and long-term bacterial studies. FUJIFILM Wako now offers this highly reliable instrument with a convenient laptop and software package specifically dedicated to LAL testing.
KEY FEATURES
- 96 well configuration, Ideal for high throughput of samples
- Superior 4-Zone™ incubation
- Fast kinetics, endpoint and linear well scanning
- Optical design eliminates crosstalk
- Extensive endotoxin analysis with Toximaster® QC8 software
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, standard deviations, and has robust data processing functions. The data processing functions can be performed by defining sample types such as standards, controls and test samples.
KEY FEATURES
- FDA 21 Part 11 ERES compliant
- Endotoxin determination in compliance with pharmacopoeias (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 reagent
TOXINOMETER® ET-7000 — 21 CFR PART 11 (ERES) COMPLIANT SOFTWARE
Catalog No. | Model | Contents |
| 297-35981 | Part 11 software PC set | Toximaster® QC8 Software, 1 Personal Computer |
| 293-35961 | Part 11 software only | Toximaster® QC8 Software |
BIOTEK ELX808IU MICROPLATE READER — 21 CFR PART 11 (ERES) COMPLIANT SOFTWARE
Catalog No. | Model | Contents |
292-35931 | Part 11 software PC set | Toximaster® QC8 Software, 1 Personal Computer |
| 290-35971 | Part 11 software only | Toximaster® QC8 Software |
