Protection notice / © 2008 Siemens Healthcare Diagnostics Inc.
BEP 2000 AdvanceWhere convenience begins
BEP III SystemConfidence in Reliability
Quadriga BeFree System Enjoy the Freedom
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General aspects
BEP 2000 Advance
BEP III System
Quadriga BeFree System
AgendaAgenda
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� 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
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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
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� 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
Protection notice / © 2008 Siemens Healthcare Diagnostics Inc.
BEP 2000 Advance
Where convenience begins
BEP®2000 / BEP 2000 Advance®
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� 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
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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
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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
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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
BEP 2000 Advance BEP 2000 Advance -- OverviewOverview
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Wash unit
Wash buffer
Waste bottles
Photometer
Plate transport
RT incubator
Distilled water
Drawer
BEP 2000 Advance BEP 2000 Advance -- OverviewOverview
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A
1
A
1
Dilution plate Tip rack (300,1100µl)
Positioning : A1 is on rear left
BEP 2000 Advance BEP 2000 Advance -- AccessoriesAccessories
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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
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� 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
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� 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
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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
Protection notice / © 2008 Siemens Healthcare Diagnostics Inc.
BEP III System
Confidence in Reliability
BEP®III
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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
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� 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)
� Total traceability of all operations
� Use of barcode system
� Barcode identification of reagents & samples
� Incubation at 37°C and room temperature
� Photometric reading (340 - 690 nm)
� Automatic evaluation of results
BEP III System BEP III System –– General FeaturesGeneral Features
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� 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)
� Automatic evaluation of results
BEP III System BEP III System –– General FeaturesGeneral Features
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� 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
� Positive reagent identification
� 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
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� 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
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� 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
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� 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
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� 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
� Positive reagent identification
� 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
Protection notice / © 2008 Siemens Healthcare Diagnostics Inc.
Quadriga BeFree System
The next Generation
in ELISA Automation
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� 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?
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� 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
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� 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
� Positive reagent identification
� 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)
� Automatic evaluation of results
Quadriga BeFree System Quadriga BeFree System -- ELISA ProzessorELISA Prozessor
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� 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)
� Total traceability of all operations
� 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
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� 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
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� 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
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� 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
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� 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
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Quadriga BeFree System –
Versatile System configurationsVersatile System configurations
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Quadriga BeFree System – Special Special ReagentReagent RacksRacks
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Quadriga BeFree System – Software
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... 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 ...
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� 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
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Backup
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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