Plateforme de test des endotoxines bactériennes (BET) Sievers Eclipse

Galerie et schémas techniques

Description

Caractéristiques

• Offre une procédure de test de 21 échantillons en seulement 9 minutes.
• Répond à l’ensemble des exigences d’harmonisation des pharmacopées : USP 85, PE 2.6.14 et JP 4.01
• Sensibilité jusqu’à 0,005 UE/ml
• Solution logicielle d’entreprise conforme à la norme 21 CFR Part 11 et aux directives sur l’intégrité des données
• Utilisations commerciales possibles, amibocytes de limule (LAL) enregistrées auprès de la FDA
• Contrôle de la température de réaction allant de 37 +/- 1 °C en utilisant un analyseur d’absorbance d’incubation

Spécifications techniques

D

50.3 cm (19.8 in)

W

35.1 cm (13.8 in);

Fuses

T 8 A 250 VAC Fuse, size 5 x 20 mm.

Gamme

0,005-50 EU / mL

Range

0.005–50 EU/mL

9 MIN.

1mL 27

Weight

10 kg (22.1 lbs)

6O MIN.

10mL 242

Display

OLED

Outputs

Digital via USB

Accuracy

50–200% of actual

Capacity

Up to 21 samples in duplicate with positive product controls

Fusibles

Fusible T 8 A 250 VAC, taille 5 x 20 mm. UNIQUEMENT Littlfuse 218008 ou Cooper

Affichage

OLED

Precision

≤ 15% CV onset time

little as

requirements

BET Method

Kinetic chromogenic

Dimensions

H: 17,5 cm (6,9 po); L: 35,1 cm (13,8 pouces); D: 50,3 cm (19,8 pouces)

MICROPLATE

21 CFR Part 11

Précision

50-200% du réel

must meet.

operator-to-operator variability,

Calibration

Jusqu’à 12 mois

Sample Type

Aqueous, injected by pipette

Dimensions H

17.5 cm (6.9 in);

Light Source

LED emitter

Méthode BET

Chromogénique cinétique

assays in as

regulatory

Analysis Time

Up to 2 hours

Read Interval

5 seconds

stress injury

guidelines

85% and set up

Meet global

Detection Mode

Absorbance

UL 61010-2-010

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

UL 61010-2-020

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

ASSAY PREP TIME

REAGENT USE OPERATOR STEPS

Maximum Altitude

3,000 m (9,800 ft)

Optical Accuracy

≤ 5% deviation from expected value

Pollution Degree

2

Reduce pipetting

compliance

and decrease the

Part 11 and

use by up to 90%

sample throughput

Optical Linearity

R-Value ≥ 0.980

Power Requirement

100–240 Volts AC @50/60 Hz

Temps d’analyse

Jusqu’à 2 heures

Mode de détection

absorbance

Reduce LAL reagent

Increase daily

Sample Temperature

37 ± 1 °C

risk of repetitive

Data Integrity

steps by up to 89%

with 21 CFR

Ambient Temperature

17–30 °C

Temperature Control

37 ± 0.5 °C

CSA C22.2#61010-1-12

2012Ed.3+U1;U2 IEC 61010-1:2010 Ed.3+C1;C2

CSA C22.2#61010-2-010

2015Ed.3

Type d’échantillon

aqueux, injecté par pipette

Exigence d’alimentation

100-240 volts CA à 40/60 Hz

Fluidic Failure Detection

1450 nm emitter

Maximum Relative Humidity

85%, non-condensing

Optical Wavelength Filter

405 nm

and regulatory requirements

Eclipse platform significantly

drug and device manufacturers

decreases pipetting steps, reduces

endotoxin standards and PPCs.

features.

natural resources while still

and JP compendial requirements.

The Sievers Eclipse* Bacterial

HSC population can sustain.

empowers users to be conscious

decreases setup time by up to

Safety Certifications UL 61010-1

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

Endotoxins Testing (BET) Platform

The Sievers Eclipse BET platform

on the planet. It delivers a fully

sacrificing accuracy or

Precise liquid handling device that

and ALCOA+

compliant BET assay that the global

regulatory compliance.

natural endotoxin detection reagent

sample throughput without

complying with the strict analytical

Through innovative design, the

microfluidic technology with embedded

compliance

achieves automation through innovative

Data Integrity

of today’s needs to protect valuable

85% while meeting all USP, EP,

gradients to meet in the optical well in an exact 1

1 ratio for mixing.

This technology delivers automation through embedded

85%

saves time with deposited Reference Standard Endotoxin

of repetitive stress injury.

increasing the number of assays manufacturers can perform

90%

THE MICROPLATE ROTATES to automatically distribute LAL and

AS LITTLE AS

endotoxin standards and PPCs in conjunction with consistent

reduction in labor.

and sample uses the proprietary motion and technology of the

UP TO

The Eclipse platform dramatically streamlines assay setup and

steps and a decreased risk

Applications

• Dispositif médical
• Contrôle production pharmaceutique
• Contrôle des matières premières

Conformités et normes