Veolia Water Technologies & Solutions

Sievers Eclipse Bacterial Endotoxins Testing (BET) Platform

Breakthrough BET technology that delivers automation and compliance

The innovative Sievers Eclipse automated endotoxin detection platform decreases assay setup time by up to 85% and reduces Limulus Amebocyte Lysate (LAL) reagent use by up to 90% while meeting all requirements of the harmonized pharmacopeia: USP <85>, EP 2.6.14 and JP 4.01. Through groundbreaking technology, the Eclipse endotoxin testing solution significantly decreases pipetting steps, reduces operator-to-operator variability, and simplifies BET test setup. The Eclipse platform leverages precise microfluidic liquid handling and embedded endotoxin to automate kinetic chromogenic assays. Throughput of 21 samples per plate is maintained without the complexity of robotics or the time and technique demands of a traditional LAL test.

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Compliant, consistent, and conscious bacterial endotoxin testing equipment and services

The Eclipse endotoxin testing system achieves automation and precision in BET tests without sacrificing compliance, reaction biochemistry, or footprint in the lab. Using embedded endotoxin standards and positive product controls (PPCs) with only <30 pipetting steps, the patented Sievers Eclipse microplate delivers automation without the complexity or expense of robotic endotoxin testing equipment. In addition to BET automation, Sievers instruments provide unmatched customer service to ensure success in the lab. 

Features & Benefits

  • Enables fully compliant, 21-sample assay setup in as little as 9 minutes

  • Reduces LAL reagent use by up to 90%

  • Meets all requirements of the harmonized pharmacopoeia: USP <85>, EP 2.6.14 and JP 4.01

  • Embedded endotoxin standard curve and positive product controls (PPCs) 

  • Provides segments for standards curves, samples, and positive product controls (PPCs)

  • Sensitivity down to 0.005 EU/mL 

  • Controls reaction temperature within 37 +/- 1 C using incubating absorbance analyzer

  • Decreases the need for extensive operator training and the risk of repetitive stress injury

  • Increases daily sample throughput

  • Uses commercially available, FDA licensed Limulus Amoebocyte Lysate (LAL) from the major LAL manufacturers 

  • Enterprise software solution that complies with 21 CFR Part 11 and Data Integrity guidelines

System Specifications

System Specifications

BET Method

Kinetic chromogenic

Detection Mode



0.005–50 EU/mL


≤ 15% CV onset time


50–200% of actual

Sample Type

Aqueous, injected by pipette


Up to 12 months

Analysis Time

Up to 2 hours

Sample Temperature

37 ± 1 °C

Ambient Temperature

17–30 °C


Up to 21 samples in duplicate with positive product controls

Temperature Control

37 ± 0.5 °C

Light Source

LED emitter

Fluidic Failure Detection

1450 nm emitter

Optical Accuracy

≤ 5% deviation from expected value

Optical Linearity

R-Value ≥ 0.980

Optical Wavelength Filter

405 nm

Read Interval

5 Seconds

Analyzer Specifications


Digital via USB



Power Requirement

100–240 Volts AC @50/60 Hz


T 8 A 250 VAC Fuse, size 5 x 20 mm. ONLY Littelfuse 218008 or Cooper Bussmann S506-8-R.


H: 17.5 cm (6.9 in); W: 35.1 cm (13.8 in); D: 50.3 cm (19.8 in)


10 kg (22.1 lbs)

Safety Certifications

UL 61010-1:2012Ed.3+R:20Apr2016             CSA C22.2#61010-2-020

CSA C22.2#61010-1-12:2012Ed.3+U1;U2    IEC 61010-1:2010 Ed.3+C1;C2

UL 61010-2-010:2015Ed.3                             IEC 61010-2-010:2003Ed.2

UL 61010-2-020:2016Ed.3                             IEC 61010-2-020:2016Ed.3

CSA C22.2#61010-2-010:2015Ed.3

Maximum Relative Humidity

85% non-condensing

Maximum Altitude

3,000 m (9,800 ft)

Pollution Degree


Options & Accessories

  • Analyzer: Absorbance analyzer with consistent incubation control at 37 °C, centrifugal technology, and secure data transmission.

  • Microplate: Precise liquid handling device that achieves automation through innovative microfluidic technology with embedded endotoxin standards and PPCs.

  • Software: Highly customizable enterprise solution with 21 CFR Part 11 and ALCOA+ Data Integrity compliance features.

The Eclipse microplate, in conjunction with the Eclipse analyzer and software, uses centrifugal force and pneumatic chambers to measure and evenly distribute precise amounts of LAL reagent water, samples, and LAL across 104 optical wells. The optical wells comprise segments for standards curves, samples, and positive product controls (PPCs). The reaction is controlled at 37 +/-1 C, and a high definition view of each well is obtained through a reading at 405 nm every five seconds.


What are bacterial endotoxins?

Bacterial endotoxins are found in the outer membrane of the cell wall of Gram-negative bacteria. The endotoxic effect from Gram-negative bacteria is primarily due to the Lipid A component of lipopolysaccharides (LPS), which can exert pyrogenic (fever-inducing) responses that can be dangerous and even fatal when found in the bloodstream and other body fluids above certain concentrations. Because certain pharmaceuticals and medical devices enter the bloodstream, endotoxin testing is required in those industries. Due to its potent toxicity and effect on patient safety, endotoxin is globally regulated by the US FDA and international pharmacopoeia for any life sciences product that will come in contact with human and/or animal blood.

Why would you test for bacterial endotoxins in water or final products?

Within the pharmaceutical, medical device, and other life science industries, testing for endotoxins is critical for patient safety and quality control. Endotoxin tests are performed on pharmaceutical grade water systems, including water for injection (WFI) that is used as ingredient water, and finished products such as drug, animal drug, biological, and medical device products. Pharmaceutical and medical products tested include parenteral drug products (administered through injection, such as intravenous, subcutaneous, intramuscular, and intradermal) and medical devices that have direct or indirect contact with the blood, cardiovascular system, lymphatic system, or cerebrospinal fluid. Global pharmacopoeia (USP <85>, EP 2.6.14 and JP 4.01) describe requirements for Bacterial Endotoxins Testing (BET) and endotoxin limits. FDA guidance provides recommendations for biological product, drug, and device manufacturers on current thinking concerning testing recommendations and acceptance criteria covered in compendial procedures.

How does the bacterial endotoxin test method work?

For almost 40 years, the US FDA has accepted the Limulus amoebocyte lysate (LAL) test as a finished product test for endotoxins. This is in lieu of rabbit pyrogen testing and is an in vitro assay that can detect presence and concentration of bacterial endotoxins. In LAL tests, the lysate from the blood of horseshoe crabs (Limulus Polyphemus) reacts with bacterial endotoxins to indicate the presence of endotoxins in a sample. There are three bacterial endotoxin test principle methodologies for LAL testing: gel-clot, turbidimetric, and chromogenic. In the gel-clot method, LAL and sample are mixed, followed by the operator screening for gel formation in the reaction tube. The results are from a subjective interpretation of the clot formation, and thus the gel-clot method is a qualitative test. In turbidimetric and chromogenic methodologies, samples are mixed with LAL reagent, and the color change or turbidity are measured over time. Chromogenic and turbidimetric LAL assays are quantitative and demonstrate the amount of endotoxin present. Results are calculated from a standard curve. Endotoxin limits and requirements for conducting BET are described in global pharmacopoeia, USP <85>, EP 2.6.14 and JP 4.01. A new general chapter in the European Pharmacopoeia describes a method for BET using recombinant factor C (rFC) instead of the classic LAL-based method.

How much LAL reagent is used with the Sievers Eclipse BET Platform?

With just 1 mL LAL reagent, 21 samples can be run on the Eclipse platform. By decreasing horseshoe crab (HSC) lysate use by up to 90%, the Eclipse reduces the demand on this valuable natural resource and delivers a fully compliant BET assay that the global HSC population can sustain.

Is the Sievers Eclipse BET Platform compliant?

Yes. The Eclipse platform uses commercially available, FDA licensed LAL and meets all requirements of the harmonized global pharmacopoeia, USP <85>, EP 2.6.14 and JP 4.01. Bacterial endotoxin testing with the Eclipse platform includes: minimum three-point standard curve in duplicate using standardized endotoxin; samples and PPCs in duplicate; negative controls in duplicate; analyst and lysate lot qualification in triplicate; use of FDA licensed LAL. It also complies with 21 CFR Part 11 and data integrity guidelines.

Are standard curves automated with the Sievers Eclipse?

Yes. Traditionally, for compliant endotoxin assays, the end user must construct at least a three-point standard curve in duplicate from a stock vial of standardized endotoxin; must have duplicate negative controls; and must run each sample in duplicate with a PPC, also in duplicate. With the Sievers Eclipse BET Platform, these steps are automated using preloaded endotoxin standards spanning up to a five-point standard curve and preloaded PPCs. Therefore, all the end user must do is load Water for BET and samples onto the plate with no additional prep work. The result is the ability to set up the assay in 9 minutes, compared to upwards of 60 minutes that other platforms require.