Bacterial endotoxin testing is not known for being simple or fast. Add in compendial compliance and instrument validation, and it can become even more cumbersome. Or, at least, that’s how it’s always been — until now.
This webinar will highlight microfluidic technology that not only simplifies bacterial endotoxin testing while fully adhering to global regulations, but also provides an automated and sustainable solution.
The use of centripetal microfluidics for endotoxin testing allows for the desired characteristics of assay automation to be achieved — easy liquid handling, reduced reagent consumption, cost-effective testing, and increased throughput — without compromises in accuracy or compliance. A microfluidic system enables users to carry out the same biochemistry with a 1:1 sample to lysate ratio that is performed in traditional 96-well plate assays, but with minimal manual effort, greater consistency, and reduced reagent consumption.
By combining microfluidic liquid handling with embedded Reference Standard Endotoxin (RSE), automation of fully compliant bacterial endotoxin testing assays is achieved without the need for robotics and using up to 90% less Limulus Amebocyte Lysate (LAL). Users can set up an assay in 9 minutes —with up to a 5-point standard curve in triplicate, negative controls, and up to 21 samples in duplicate with positive product controls (PPCs).
As far as implementation and validation go, a full Installation/Operational/Performance Qualification (IOPQ) document is available to support a complete system validation, including 21 CFR Part 11 and data integrity test cases during the operational qualification. Software features are also built in to streamline sample validation.
The Sievers Eclipse Bacterial Endotoxins Testing Platform was developed with years of customer input on the challenges faced during bacterial endotoxins testing and the desire to simplify this cumbersome assay.
Register for this webinar to understand how microfluidic technology can drastically simplify endotoxin testing, automate setup and increase throughput, all while maintaining full compliance with USP<85>, EP 2.6.14, and data integrity guidelines.
Dave Wadsworth, Global Product Manager, Bio-Detection, SUEZ
In his role as the Global Product Manager, Bio-Detection at Sievers Analytical Instruments by SUEZ, Dave focuses on next-generation endotoxin detection and the Sievers Eclipse Bacterial Endotoxins Testing (BET) platform. He has a Bachelor of Science degree in Biology from Wheaton College Massachusetts and has over 14 years of experience in the endotoxin industry. His first introduction to endotoxin detection was as a seasonal employee responsible for collecting and processing amebocytes for a LAL manufacturer, and he’s been enthusiastic about bacterial endotoxins testing ever since.Message Presenter
Who Should Attend?
- QC Analyst (all levels)
- QC Manager
- QC Supervisor
- Director of Quality
- Quality Assurance
- Analytical Services
- QC Scientist (all levels)
- Microbiologist (QC/EM)
- Environmental Monitor (all levels)
- Contract Testing Services
- Regulatory Affairs
What You Will Learn
- How microfluidic technology greatly simplifies bacterial endotoxin testing assay setup without robotics and with drastically reduced use of LAL
- Why the Eclipse platform was developed
- How the Eclipse platform aligns with USP <85>, EP 2.6.14, JP 4.01, and data integrity guidelines
- What validation tools are available to customers and how the platform can be validated in a QC lab
Sievers Analytical Instruments offers deep expertise in ultrapure water quality monitoring, cleaning validation, and other life science applications. As experts in Total Organic Carbon (TOC), Conductivity, and Bacterial Endotoxins Testing (BET), we help optimize environmental monitoring and cleaning programs with accuracy and efficiency. Our standards are consistently produced, controlled, and audited, ensuring compliance. Learn more at www.sieversinstruments.com.