SUEZ Water - Water Technologies & Water

Sievers Eclipse Bacterial Endotoxins Testing (BET) Platform

Breakthrough technology that delivers automation and compliance

The innovative Sievers Eclipse 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 pharmacopoeia: USP <85>, EP 2.6.14 and JP 4.01. Through groundbreaking technology, the Eclipse platform significantly decreases pipetting steps, reduces operator-to-operator variability, and simplifies assay 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 assay.

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Compliant, consistent, conscious bacterial endotoxins testing

The Eclipse platform achieves automation and precision in BET assays 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 robotics.

Features & Benefits

Eclipse Platform Lab Features & Benefits

  • Enables fully compliant, 21-sample assay setup in as little as 9 minutes
  • Reduces Limulus Amebocyte Lysate (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 for a standard curve and PPCs
  • Provides segments for standard curves, samples, and PPCs
  • Sensitivity down to 0.005 EU/mL
  • Enterprise software solution that complies with 21 CFR Part 11 and Data Integrity guidelines
  • Decreases the need for extensive operator training
  • Reduces the risk of repetitive stress injury
  • Increases daily sample throughput
  • Uses commercially available, FDA licensed LAL
  • Controls reaction temperature within 37 +/- 1 °C using incubating absorbance analyzer

Specifications

Eclipse Specifications

System Specifications

BET Method Kinetic chromogenic
Detection Mode Absorbance
Range 0.005-50 EU/mL
Precision ≤ 15% CV onset time
Accuracy 50-200% of actual
Sample Type Aqueous, injected by pipette
Calibration Up to 12 months
Analysis Time Up to 2 hours
Sample Temperature 37 ± 1 °C
Ambient Temperature 17- 30 °C
Capacity 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

Outputs Digital via USB
Display OLED
Power Requirement 100-240 Volts AC @40/60 Hz
Fuses

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

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

Environment

Maximum Relative Humidity 85%, non-condensing
Maximum Altitude 3,000 m (9.800 ft)
Pollution Degree 2

Components

Eclipse Platform Components

  • 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 positive product controls (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 PPCs. The reaction is controlled at 37 +/-1 °C, and a high definition view of each well is achieved by obtaining a reading at 405 nm every five seconds.

What is bacterial endotoxin?

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?

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 is endotoxin testing performed?

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 principal 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.