BEP III System - Home - English - Siemens Global...

Protection notice / © 2008 Siemens Healthcare Diagnostics Inc.

BEP 2000 AdvanceWhere convenience begins

BEP III SystemConfidence in Reliability

Quadriga BeFree System Enjoy the Freedom


Siemens Healthcare Diagnostics Belux

General aspects

BEP 2000 Advance

BEP III System

Quadriga BeFree System

AgendaAgenda



� Easy adaptation to specific needs

� Basically all ELISA MTP’s can be adapted (round & flat bottom)

� Total traceability of all operations

� Use of barcode system

� Barcode identification of reagents & samples

� Dispensing of all ELISA reagents

� Incubation at 37°C and room temperature

� Photometric reading (340 - 690 nm)

� Automatic evaluation of results

Automated instruments for ELISA testing

Leadership in open systemsLeadership in open systems



Auto

mation

Low volume labs Mid volume labs High volume Labs

BEP®2000 / BEP 2000 Advance®

BEP®III

BeFree 1: 2 2 x BeFree 1: 2BeFree 1: 1

BEP & Quadriga BeFree System



� More than 2500 BEP Systems installed worldwide

� More than 630 BEP 2000 instruments in 56 countries

� More than 1850 BEP III Systems in 56 countries

� More than 30 Quadriga BeFree Systems

since launch in August 2006

Source: European Datawarehouse

Instruments worldwideInstruments worldwide


BEP 2000 Advance

Where convenience begins

BEP®2000 / BEP 2000 Advance®



� Fully automated microtitre plate analyzer

� Sample pre-dilution and sample distribution from primary tubes

� Disposable conductive tips � No carryover & clot detection

� Up to 120 primary tubes on board � reload possibility during run

� Barcode identification of primary tubes and reagents

� Dispensing of all required reagents

� Processing of round and flat bottom plates

� Incubation at 37°C and room temperature (Built-in Shaker)

� Photometric reading & Evaluation of results

� Qual. & Quant. incl. Alpha method, Standard curves and User defined

� Inprocesscontrol of all steps

� Archiving of results by patient or worklist

� Broad Enzygnost® & Novagnost® test menu

BEP 2000 BEP 2000 AdvanceAdvance -- General FeaturesGeneral Features



Pipettor

Tray for tip racks

and pre-dilution plates

Sample and

reagent unit

Plate entry

Tip eject station

Pipettor wash position

Status-LED`s

Drawer with

wash unit and

photometer

BEP 2000 Advance BEP 2000 Advance -- OverviewOverview



Pre-dilution

area for

up to 4 plates Storage

area for

tip racks

Area for reagents

and primary tubes

Plate processing

area for up

to 4 MTP`s

37°C incubator

RT incubator

Tip eject station

Pipettor wash

station

Guide rail for pipettor (X,Y movement)

Barcode scanner




Wash unit

Wash buffer

Waste bottles

Photometer

Plate transport

RT incubator

Distilled water

Drawer




A

1

A

1

Dilution plate Tip rack (300,1100µl)

Positioning : A1 is on rear left

BEP 2000 Advance BEP 2000 Advance -- AccessoriesAccessories



T

T

J

R

5

T Patient sample rack (20 pos.)

R Control rack (18 pos.)

J Reagent rack (e.g. conjugate, 9 pos.)

5 Reagent rack (5 pos KuFla100, 8 pos. GW10)

LED Contact tappet 3-track-rack

12 11 10 9 8 7 6 5 4 3 2 1 TRACK

5JRTT TTT

Sample and reagent racks:

Order of rack positioning

BEP 2000 Advance BEP 2000 Advance -- AccessoriesAccessories

U Patient sample rack (20 pos.)

(Pediatric, CSF) – coming soon



� User friendly Software

� Multitasking: Multiple SW functions available during the run

� Combination of up to 6 tests / plate frame (same assay procedure)

� Schedule for optimising loading time.

� Bi-directional interface to a LIS (in compliance with ASTM

specification).

� Archive of results by individual patients and worklist

BEP 2000 Advance SoftwareBEP 2000 Advance Software



� All Enzygnost & Novagnost tests are validated

� Incl. Ortho Anti-HCV

� Use of Dade Behring bottles

� No refilling of reagents into instrument specific bottles necessary

� Automatic barcode identification �� Lot - management

� Volume management with level detection of reagents

� Alarm, if reagent volume is not sufficient according to joblist

� Assays of other vendors are easy to adapt

BEP 2000 Advance BEP 2000 Advance -- ReagentsReagents



22

33

11Enter worklist & load

Samples/Reagents.

Start Batch

Print / Send results to LIS

From Sample to Result in three simple steps :

Load, Start �� Result

From Sample to Result in three simple steps : From Sample to Result in three simple steps :

Load, Start Load, Start �� ResultResult

Simple RoutineSimple Routine

BEP 2000 Advance BEP 2000 Advance -- RoutineRoutine


BEP III System

Confidence in Reliability

BEP®III



Incubator for

room temperature Heating block

Incubator for 37°C

Transport carriage

Washing and

Aspirating unit

Reagent wheel

Input carriage

BEP III BEP III -- General OverviewGeneral Overview



� Automated System for ELISA testing

� Incubation, dispensing, washing, reading & evaluation

� Easy adaptation to specific needs

� Basically all ELISA MTP’s can be adapted (round & flat bottom)


� Use of barcode system

� Barcode identification of reagents & samples

� Incubation at 37°C and room temperature

� Photometric reading (340 - 690 nm)


BEP III System BEP III System –– General FeaturesGeneral Features



� Incubation unit

� 10 Incubators (37°C)

� 10 Incubators (RT)

� Reagent dispenser

� 1 reagent rotor (up to 20 positions each)

� Pipetting of reagents from original bottles

� Positive reagent identification

� Monitoring of reagent volumes

� Wash unit

� 1 washing station

� Integrated Barcode reader for strip identification

� Identification of assay & Reagent Lot No.

� Photometer unit

� 1 Photometer (340 – 650 nm)


BEP III System BEP III System –– General FeaturesGeneral Features



� Improves Lab Efficiency

� High throughput; more than 900 results (10 microplates) /run

� Fully automated ELISA processor

� Reduced manual steps or operator intervention

� Continuous loading

� Accurate and reliable results


� Disposable tips eliminate carryover

� GMP compliant

� Full process control and documentation of individual processing steps

� Automated validation procedure to check all critical functions

� Easy to use

� Graphical intuitive user-interface

Only a complete system of specially matched components

can ensure maximum safety

BEP III BEP III -- TheThe QualityQuality Management SystemManagement System



� Clear

documentation

� Report of results

� Positive process reports

� Validation records

� Service and maintenance

log

� Documentation of

validation

� Trouble shooting guide

� In-process control

� Initialization self check

� Assay processing

� Liquid handling

� Incubation

� Washing procedure

� Transport function

� Monitoring of positive

and neg. controls

� Level detection

� Sample handling

- identification,

- pipetting

- plate/sample flags

� Reagent and microtitre

plate identification

� Validation of all critical

operational procedures

� Dispense volumes, optical

functions, wash steps and

incubation temperature

� External validation tools

� Standardized and automated

validation method

� Daily / Weekly maintenance

� Pass / fail status

BEP III BEP III -- TheThe QualityQuality Management SystemManagement System



� Lot specific data handling

� Data can be entered via a barcode pen

� Automatic barcode identification of reagents

� Sample buffer

� Conjugates

� Chromogen

� Stop solution

� Automatic barcode identification of plates

� Plate frame

� Strips

BEP III BEP III -- SafetySafety firstfirst



� Automated validation procedure

� GMP/GLP requirements

� External validation tools

� Validation of all critical operation steps

� Dispense volumes, optical functions, wash steps and temperature

� Pass / fail status

Validation of operational proceduresValidation of operational procedures



� High throughput with up to 10 ELISA plates in parallel

� Continuous loading of plates

� Combination of different tests on one plate

� High safety standard

� Barcode system and process monitoring

� On board capacity for up to 20 reagents


� Monitoring & Liquid level detection

� Flexible and clear presentation of the results for the

laboratory, hospital ward or physician.

� Open system

� High Walk away time for up to 10 ELISA plates

BEP III BEP III -- SummarySummary


Quadriga BeFree System

The next Generation

in ELISA Automation



� Fully Automated and flexible MTP analyzer

� Medium and high throughput blood banks

� Validated Dade Behring screening assays

� Limited selection of validated non Dade Behring assays

� Sampler

� Freedom EVO-2

� Integrated Robotic Plate transport arm

� Integrated plate hotel

� ELISA Processor

� BEP III System

� User-friendly Quadriga BeFree system software

� Special designed instrument cabinets

What is Quadriga BeFree System?What is Quadriga BeFree System?



� Worktable with 50 positions� Up to 30 sample racks Initial load capacity for up to 450 primary tubes

� Carriers for 13 and 16 mm tubes (inner diameter)

� Other carrier available upon request

� Customized Diluent and Control racks

� Pipetting of reagents and controls from original bottles

� No necessity to pour reagents/controls

� Positive Identification of samples, diluents, controls and plates

� Fixed steel (Teflon coated) tips

� Pipetting precision ≤ 3.5% (10µl) / ≤ 0.75% (100µl)

� Integrated Robotic arm to move plates

� Integrated plate hotel for up to 21 plates

� Integrated photometer for SURE step

� Loading Interface (Grid Control)� Monitoring of system status

� Continuous loading of samples and reagents

Quadriga BeFree System Quadriga BeFree System -- SamplerSampler



� Two independent working BEP III

� Incubation unit� 10 Incubators each (37°C)

� 10 Incubators each (RT)

� Reagent dispenser� 1 reagent rotor each (up to 20 positions each)

� Pipetting of reagents from original bottles


� Monitoring of reagent volumes

� Wash unit� 1 wash station each

� Integrated Barcode reader for strip identification (Enzygnost Assays)

� Identification of assay & Reagent Lot No.

� Photometer unit� 1 Photometer each (340 – 650 nm)


Quadriga BeFree System Quadriga BeFree System -- ELISA ProzessorELISA Prozessor



� Fully automated System

� From sample to result

� Continuous loading of samples in batch mode process

� Open System

� Basically all ELISA MTP’s can be adapted (depends on ELISA design)


� High Quality

� Meeting GMP/GLP requirements

� Providing IQ (Installation Qualification), OQ (Operational Qualification)

� Seamless connection of BEP III with Freedom EVO-2

� Upscaling flexibility (flexible module configuration)

� BEP III and Freedom EVO-2 scalable (1+1 & 1+2 configuration)

Quadriga BeFree System - The Main features



� High flexibility

� All units are separately usable

� Integration of different workplaces into one workplace � Total automation

� Batch- and Optimized Sample oriented (selective) pipetting

� Safety aspects

� Security against mix-up of samples

� Identical barcodes are not accepted

� Throughput

� Up to 1320 results within 5 hours

� 264 samples with e.g. Anti-HIV 1/2 Plus or HIV Integral II, HBsAg 5.0, Anti-HBc monoclonal, Syphilis & ORTHO HCV.

� 440 samples with e.g. Anti-HIV 1/2 Plus or HIV Integral II, HBsAg 5.0 & ORTHO HCV.

� Low personnel involvement

Quadriga BeFree System - The Main Features



� Workplace consolidation

� CMV, Syphilis etc. can be implemented

� Low labour involvement

� Substantial savings (time and labour)

� Smart system software

� Truly walk away with little or no interruption

� Ease of use (few clicks to run)

� Open and flexible connectivity

� Capability to interface to any LIS vendor

� Less Space / Smaller Footprint

� ~ 2 x 2,50 m footprint

Quadriga BeFree System - Features & Benefits Features & Benefits



� Full quality management

� SURE feature (Sample Uniformity Recognition)

� Barcode system (positive identification of all reagents)

� Extended user management

� In-process control

� Validation of all critical operational procedures

� Flexible, clear documentation

Quadriga BeFree System - Features & BenefitsFeatures & Benefits



� Comprehensive line of mandatory assays

to cover the needs of blood banks

� Enzygnost® Anti-HIV 1/2 Plus

� Enzygnost® HIV Integral II

� Enzygnost® HBsAg 5.0

� Enzygnost® Anti-HBc monoclonal

� Enzygnost® Syphilis or alternatively INNO-TPHA sample distribution

� Enzygnost® Anti-CMV/IgG+IgM

� Enzygnost® Anti-HBs II

� ORTHO HCV 3.0 SAVe (short incubation)

� BioRad MONOLISA Anti-HCV Plus Version 2

� IBL Neopterin ELISA

� INNO TPHA processing (sample distribution only)

Quadriga BeFree System Quadriga BeFree System -- AssaysAssays



Quadriga BeFree System –

Versatile System configurationsVersatile System configurations



Quadriga BeFree System – Special Special ReagentReagent RacksRacks



Quadriga BeFree System – Software



... a continuous loading option permits the exchange of sample racks and

carriers while the cover shields are closed and operation is in progress.

Simultaneously the associated loading interface monitors user access to

the instrument. The continuous loading of samples is possible in batch

mode only, while a reload of reagents is possible at any time and indicated

by the software.

Quadriga BeFree System - Safety is not an option ...



� Open System

� No stop of routine

� Easy and flexible test adaptation (new test, change of regulations)

� Consolidation of Workstations

� Low labour involvement

� Personnel freed up for other duties

� Substantial savings in cost, time and labour

� High throughput

� Up to 1320 results per run (using 1:2 configuration)

� Optional independent operation of individual units

� Full traceability of all operations

� Full quality management

Quadriga BeFree System - Features & Benefits Features & Benefits

SummarySummary



Backup



Intensive internal & external validation

� System usability and acceptance

� Reliability in routine conditions

� Software

� User friendliness

� Clearness

� Endurance tests (extreme conditions)

� Validation of blood bank assays

� Test performance in comparison to standard method

� Carryover

System validation & acceptance



Enzygnost HIV Integral IIEnzygnost HBsAg 5.0

Results safety & carryover

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