Due to the need for endotoxin automation that is simple to utilize without compromising compliance, Veolia Water Technologies & Solutions presents the Sievers Eclipse Bacterial Endotoxins Testing (BET) Platform.
Image credit: Veolia Water Technologies & Solutions
The Sievers Eclipse BET Platform combines ease-of-use and groundbreaking technology to automate endotoxin assay setup without altering reaction biochemistry or compliance. What it does alter is the speed and simplicity with which the assay can be started, the demand on Limulus Amoebocyte Lysate (LAL) reagent, and the necessary training time for analysts.
The platform is comprised of a microplate, analyzer and software developed to considerably streamline kinetic chromogenic assays for identifying bacterial endotoxins. At the Eclipse’s core is the microplate, a microfluidic liquid handling device that has been precision-crafted to facilitate precise and rapid dispersion of reagents and samples without complicated robotics, while drastically reducing the use of LAL.
Regulatory compliance
The Eclipse platform makes use of commercially available, FDA licensed LAL that is compliant with all provisions of the harmonized global pharmacopoeia, USP <85>, EP 2.6.14 and JP 4.01. In relation to data management and integrity, Eclipse software was developed with ALCOA+ principles at the forefront to offer an exceptional enterprise solution with 21 CFR Part 11 and data integrity compliance features.
- Compliance with 21 CFR Part 11 and data integrity guidelines
- FDA licensed LAL
- Analyst and lysate lot qualification in triplicate
- Minimum 3-point standard curve in duplicate using standardized endotoxin
- Negative controls in duplicate
- Samples and positive product controls (PPCs) in duplicate
Increased efficiency and simplicity
With precision and automation that is technology-driven, the Eclipse platform significantly decreases assay setup time and expands the number of assays manufacturers can conduct in a single day.
- Reduces pipetting steps up to 89% with decreased risk of repetitive stress injury
- Reduces labor by up to 85% with setup in 9 minutes
- Reduces operator-to-operator variability
- Streamlines training and reduces the risk of error and contamination
- Increases daily throughput
Sustainability
By reducing the demand for horseshoe crab (HSC) lysate use by up to 90%, the Eclipse platform reduces the demand on the most sensitive and unparalleled natural endotoxin detection reagent on the planet. It delivers a fully compliant BET assay that the global HSC population can sustain.
- Empowers users to be conscious of today’s needs to protect valuable natural resources
- Up to 90% reduction in LAL use in comparison to traditional assays
- Uses commercially available FDA licensed LAL
Analytical performance
The patented Sievers Eclipse microplate provides users with powerful analytical performance and precision microfluidic technology. In combination with the analyzer and software, the Eclipse platform delivers accurate and consistent BET results.
- Consistent liquid handling
- Embedded endotoxin standards and PPCs
- Incubating spectrophotometer ensures reactions takes place at 37 ±1 °C
By sustaining full compliance and introducing a straightforward assay setup, making a move to using an Eclipse delivers a streamlined optimized endotoxin platform.
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