Microbiology / Endotoxins

Eclipse Analyzer for Endotoxin Assays

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Description

Specifications

Parameters

Standards

Accessories

The new Suez Eclipse Bacterial Endotoxin Test (BET) analyzer complies with all requirements of the harmonized pharmacopoeia: USP 85, EP 2.6.14 and JP 4.01.

The Eclipse analyzer achieves greater automation and precision in the assay while complying with standards, without biochemical reactions and without impacting the laboratory.

  • Up to 21 samples per duplicate, positive controls per duplicate, calibration line of up to 5 points per triplicate and negative controls per assay.
  • Reduces preparation and pipetting time by up to 89%.
  • We reduce LAL consumption by up to 90%.
  • Powerful software compliant with Data Integrity and CFR 21
  • Meets the requirements of EP, USP and JP pharmacopoeias.
System Specifications:
BET method: Chromogenic kinetic
Detection mode: Absorbance
Range: 0.005-50 EU/mL
Accuracy: ≤ 15% CV start time.
Accuracy: 50-200% of actual accuracy
Type of sample: Aqueous, injected through a test tube.
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
Fluid failure detection: 1450 nm emitter
Optical precision: ≤ 5% difference from the expected value.
Optical linearity: R-value ≥ 0.980
Wavelength optical filter: 405 nm
Reading interval: 5 seconds
 
Analyzer specifications:
Outputs: Digital via USB
Display: OLED
Dimensions (HxWxD): 17.5 cm x 35.1 cm x 50.3 cm
Weight: 10 kg
Power supply: 100-240 volts AC at 40/60 Hz
Fuses: Fuse T 8 A 250 VAC, size 5 x 20 mm SOLO Littlfuse 218008 or Cooper Bussmann S506-8-R.
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
Degree of contamination: 2

Bacterial Endotoxins

International Pharmacopoeia
USP <85>
EP 2.6.14
JP 4.01
CFR21 part 11
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