Reliability and compliance for modern endotoxin testing

The Sievers Eclipse BET Platform is a breakthrough solution for simplifying Bacterial Endotoxin Testing (BET), allowing labs to achieve reliable, and confident results the first time. Designed for pharmaceutical, medical device, and biotechnology laboratories, Eclipse drastically reduces manual pipetting and operator variability while ensuring full compliance with harmonised pharmacopeias: USP <85>, EP 2.6.14, JP 4.01, and ChP 1143.

With its innovative microfluidic liquid handling and embedded endotoxin standards, the Eclipse platform automates kinetic chromogenic assays, delivering reliable, reproducible results without the complexity of robotics or traditional LAL testing workflows.

Key benefits:

✅ Up to 85% less assay setup time

✅ Up to 90% reduction in LAL reagent use

✅ Reduced operator-to-operator variability

✅ Automation without robotics

✅ Full 21 CFR Part 11 and ALCOA

Data integrity compliance

Gain reliable results the first time, reduce retest rates, and minimize LAL reagent use!

 

Sievers Eclipse_open with microplate_pres

Key resources to discover

  • 1-Nov-05-2025-09-49-46-9232-AM
    📘Download your BET efficiency guide
  • Carrousel Eclipse Hubpage (1)
    🎓 Join our endotoxin testing Masterclass
  • Carrousel Eclipse Hubpage
    📄 Download the Sievers Eclipse brochure

Customer testimonials

“The Sievers Eclipse platform was chosen and has been an indispensable tool in our laboratory. Its easy-to-use design and reliability have significantly enhanced the efficiency and accuracy of our large-scale water validation projects. The instrument's software interface is intuitive, and Sievers’ technical support has been exemplary. The Sievers Eclipse has been a game changer in our laboratory.”
Dr Cheryl Andreoli, Lab Director, Technical Safety Services LLC

“A standout feature of the Sievers Eclipse BET Platform is the intuitive software. The step-by-step interface is remarkably straightforward, allowing our team to focus more on interpreting results than navigating complex software. Integration with our LIMS system was seamless, enabling a fully paperless endotoxin testing process from sampling to review.”
Lindsay Matern, QC Microbiology Lab Manager, Selkirk Pharma

Video demonstration

See how the Eclipse platform simplifies endotoxin testing - from 60 minutes to just 9.

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FAQ for Bacterial Endotoxins Testing with Eclipse 

 

What is bacterial endotoxin testing?
Bacterial endotoxin testing (BET) is a critical quality control process that detects endotoxins, toxic components from Gram-negative bacteria, in pharmaceuticals, medical devices, and water systems. It helps ensure patient safety and product quality in regulated industries.

Why test for endotoxins in pharmaceutical water and products?
Endotoxins can trigger severe immune responses if present in injectable drugs or medical devices that contact the bloodstream. Regular BET is required under global pharmacopoeias (USP <85>, EP 2.6.14, JP 4.01) to verify water-for-injection (WFI) systems and parenteral products meet strict safety limits.

How does endotoxin testing work?
Most BET assays use Limulus Amoebocyte Lysate (LAL), which reacts with endotoxins to produce measurable colour or turbidity changes. Methods include gel-clot (qualitative), turbidimetric, and chromogenic (quantitative). Eclipse automates the kinetic chromogenic assay using precise microfluidics and preloaded endotoxin standards.

How much LAL reagent does Eclipse use?
Just 1 mL of LAL reagent runs up to 21 samples on Eclipse, reducing horseshoe crab lysate use by up to 90%. This promotes sustainability while maintaining full regulatory compliance.

Is the Sievers Eclipse platform compliant?
Yes. Eclipse meets all harmonised pharmacopeial requirements (USP <85>, EP 2.6.14, JP 4.01) and supports 21 CFR Part 11 data integrity. It uses FDA-licensed LAL, includes built-in standard curves and PPCs, and automates compliant assay setup.

How does Eclipse automate BET setup?
With preloaded endotoxin standards and PPCs, Eclipse automatically constructs standard curves and negative controls. Users simply load samples and water, setup takes about 9 minutes, compared to 60 minutes with traditional methods.