Supplier of Veolia Sievers Eclipse bacterial endotoxin testing platform

NegotiableUpdate on 01/18

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Nature of the Manufacturer: Producers

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Overview

The Sievers Eclipse bacterial endotoxin testing (BET) platform is a breakthrough endotoxin testing technology that enables automation and compliance innovation. The Sievers Eclipse automated endotoxin testing platform can shorten laboratory preparation time by up to 85%, reduce the use of Limulus Amebocyte Lysate (LAL) by 90%, and meet all requirements of various pharmacopoeias: USP<; 85、 European Pharmacopoeia EP 2.6.14, Chinese Pharmacopoeia ChP, Japanese Pharmacopoeia JP 4

Product Details

Sievers Eclipse Bacterial endotoxin testing (BET) platform

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

The Eclipse endotoxin detection system can achieve automation and high accuracy in endotoxin detection without affecting compliance, biochemical reactions, or increasing laboratory footprint. By using embedded endotoxin standards and positive product controls (PPC) with less than 30 pipetting steps, the Sievers Eclipse microplate obtained can achieve automated processes without the complexity or cost of robotic endotoxin testing equipment. In addition to automated endotoxin testing, Sievers analyzers also provide customer service to ensure the success of laboratory testing.

Only 9 minutes are needed to achieve compliant testing settings for 21 samples
Reduce the usage of horseshoe crab reagent by 90%
Meets all requirements of the pharmacopoeia: USP<85>, EP 2.6.14, JP 4.01, and ChP
Embedded endotoxin standard curve and positive product control (PPC)
Provide segmented standard curves, samples, and positive product controls (PPC)
Sensitivity as low as 0.005 EU/mL
Control the reaction temperature at 37+/-1 C using a cultivation absorbance analyzer
Reduce the need for extensive operator training and the risk of repetitive stress injuries
Increase daily sample completion volume
Use FDA approved commercially available horseshoe crab reagents provided by major horseshoe crab reagent manufacturers
Enterprise software complies with 21 CFR PART 11 and data reliability guidelines

System Specifications
Bacterial endotoxin detection method	Dynamic color rendering
Detection Mode	absorbance
Range, ppm	0.005–50 EU/mL
accuracy	≤ 15% CV onset time
accuracy	50-200% of the true value
Sample Type	Water solution, injected with a pipette
calibration	Up to 12 months
analysis time	Up to 2 hours
Sample temperature	37 ± 1 °C
ambient temperature	17–30 °C
capacity	Standard configuration: single sample flow; Optional: Dual Sample Flow
temperature control	37 ± 0.5 °C
light source	LED emitter
Fluid fault detection	1450 nm emitter
Optical accuracy	≤ 5% deviation from expected value
Optical linearity	R ≥ 0.980
Optical wavelength filter	405 nm
read interval	5 seconds
Analyzer specifications
output	USB data output
display	OLED
Power requirements	100–240 Volts AC @50/60 Hz
fuse	T8 A 250 VAC fuse, size 5 x20 millimeters. Littlfuse218008 or Cooper Bussmann S 506-8-R.
size	Height: 17.5 cm (6.9 in), Width: 35.1 cm (13.8 in), Depth: 50.3 cm (19.8 in)
weight	10 kg (22.1 lbs)
Safety Certification	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
relative humidity	85%, no condensation
altitude	3,000 m（9,800 ft）
pollution level	2

Sievers Eclipse Bacterial endotoxin testing (BET) platform

Supplier of Veolia Sievers Eclipse bacterial endotoxin testing platform

Overview

Product Details

System Specifications

Analyzer specifications