ENDONEXT™ Automated Endotoxin Testing
UNLOCKING LAB EFFICIENCY
Aligning your laboratory with the future of QC testing programs requires optimization of business processes and ensuring high-quality results.
To support your strategic decision-making, we have paired our ENDONEXT® rFC-based endotoxin testing solutions with the Tecan Fluent® automation platform.
- ENDOLISA Endotoxin testing
- Overview
- Integration
- Quality
- Services
- Resources
In today’s rapidly evolving environment of biotechnology and pharmaceutical companies, achieving efficient, reliable, and sustainable endotoxin testing is crucial to ensure product safety and compliance with stringent regulatory requirements.
By prioritizing compliance, sustainability, and efficiency, our automation solution helps you optimize QC processes, reduce operational costs, and ensure environmental conservation by eliminating the need for horseshoe crab blood.
EFFICIENCY
- Reduce hands-on time: extensive automation by over 95%, allowing your team to focus on critical tasks.
- High throughput quality control: process up to 120 samples in about an hour, achieving results faster than ever with parallel processing.
- Increased ROI: flexible and open platform that can adapt to meet your laboratory's specific needs and run additional assays.
SUSTAINABILITY
- Regulatory compliance: our rFC-based methods are recognized in the European Pharmacopoeia and align with the new USP Chapter <86> draft and support 21 CFR Part 11 requirements.
- Sustainable practices: align with ethical and sustainable initiatives by eliminating horseshoe crab dependency, reducing waste, and plastic usage.
- Maintain data integrity: ensure traceability and sustain data integrity through sample tracking, LIMS integration, and electronic signatures.
Optimize your Lab Space
Our compact design offers a small footprint, with an optional HEPA Hood to provide a clean air environment without taking up lab space.
RELIABILITY
- Decreased retest rate: pre-coated plates ensure simple handling, reducing errors, retests, and out-of-specification results.
- Expertise: with over 15 years of experience, benefit from our proven track record in accuracy and reliability.
Seamless Integration
Your team’s time is precious and in the endotoxin testing lab, every minute counts. With bioMérieux and Tecan, you can automate your entire endotoxin testing process, meaning that your skilled professionals can focus on more critical tasks - resulting in overall improved efficiency.
Our ENDONEXT™ endotoxin testing solution deployed on the Fluent® automation platform offers seamless integration with your existing laboratory workflow, ensuring smooth testing from start to finish with reduced manual steps.
From sample preparation to data analysis, this platform simplifies every step of the testing process, allowing you to focus on what matters most: delivering accurate and reliable results. It is an investment in your laboratory’s future, achieving enhanced ROI and increasing your laboratory’s capabilities with our flexible and adaptable solution.
Quality & Compliance
At bioMérieux, we understand your need for consistent and reliable endotoxin testing. You can achieve faster, easier and environmentally friendly QC testing programs!
- Compliance: instrument includes hardware, software IQOQ, and method validation for high-quality standards.
- Enhanced accuracy: the platform is designed for precise sample handling and data integrity, reducing the risk of human error and retests.
- Facilitated training: comprehensive training programs to help your team efficiently operate the system and maintain high-quality results.
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Integration Services
Our validation services are tailored to meet the specific needs of pharmaceutical laboratories, assuring that our systems meet regulatory requirements and operate effectively.
- Comprehensive qualification: Our field application specialists offer Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) services.
- Regulatory compliance: Ensure compliance with industry standards.
- Risk mitigation: Identify and control risks associated with software and instrument integration.
- Documentation: Thorough documentation of qualification processes for audit readiness.
- Efficiency: Minimize downtime with efficient and timely services.
- Expert guidance: Experienced specialists guide you through the validation process.
Get the Most With Our ENDOXPERTS™ Services
ENDOXPERTS™ Endotoxin Services by bioMérieux provide routine testing and feasibility studies as well as specialized services for analytical issues such as LER.
Our work for leading pharmaceutical companies has resulted in validated methods for LER, fulfilling regulatory requirements. Applying true scientific soundness, we continue our contribution to the deepened knowledge of the LER phenomenon and complex nature of endotoxin.
Resources
Brochure - ENDONEXT™ using the Tecan platform
Download
- Filename
- PHARMA_ BROCHURE_ENDONEXT_TECAN_Pages.pdf
- Size
- 2 MB
- Format
- application/pdf
Brochure - ENDONEXT™
Download
- Filename
- PHARMA_BROCHURE_ENDONEXT_A4_05_23_9324113_Pages.pdf
- Size
- 488 KB
- Format
- application/pdf
Brochure - ENDONEXT™ Software
Download
- Filename
- BROCHURE_ENDONEXT_SOFTWARE_A4_05_23_9324112.pdf
- Size
- 277 KB
- Format
- application/pdf
Poster - PDA 2023 - Endotoxin Testing for Cell & Gene Therapy Products
Download
- Filename
- bioMerieux_Poster_PDA_2023_Endotoxins.pdf
- Size
- 740 KB
- Format
- application/pdf
Citation List - Recombinant Factor C (rFC) Assay
Download
- Filename
- BMX_rFC_Citation_List_2010_2022_Final.pdf
- Size
- 74 KB
- Format
- application/pdf
- The Hunt for the Missing Endotoxin
- The Hunt for the Missing Endotoxin
- Adoption of rFC for bacterial endotoxin testing
- Low Endotoxin Recovery case studies
- Waste in Endotoxin Detection Assays LAL vs rFC
