Mr. Roland Biset

2Check ’Display drawing

WHOLE BLOOD PROCESSING BY AUTOMATION

ROLAND BISETTERUMO BCTNOVEMBER 19TH, 2016 – BHOPAL, INDIA

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Commonly seen whole blood process lay-out in blood banks of India

& Pooling & Filtration

Optional: Sterileconnection of PC’s,

pool and LR in case of pre-storage filtration, else bedside filtration

LD TherapeuticPlatelet

Pool

PC

2nd Step: PRP centrifugation & separation Hard Spin

PRP

Plasma

1st Step: WB centrifugation & separation stepSoft Spin (ancillary step filtration of RCs)

Non FilteredRed Cells

LD RCC

PRP

WB

Crowded, plenty of equipment and back and forward displacementsthat are affecting the component quality

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Unmet needs for the manual and semi-automated methods

• On simplification of the process- Reduction of the operator-dependent factors- Technical proficiency demands long-term practice - Overcome the complexity of multi-equipment environment- Reduce the traffic in the blood component processing area

• On lean processing - Limit the list of complex SOP and GLP- Reduce non-conformities and discards- Improved quality and reduced risks for errors- Reduction of wastage/discards

• On standardization• Demand for meeting new techniques guard bands (re.PRT)• Increasing pressure for consistency

5 CONFIDENTIAL

IS AUTOMATION THE SOLUTION?

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Automation is already established and growing!AUTOMATION was introduced in the DIAGNOSTIC DEPARTMENT to increase productivity and efficiency, and reduce errors

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Elytra Blood TypeAnalyzer - Grifols

ABBOTT PRISMImmunoassayanalyzer

ORTHO VISION TManalyzer

Galileo ECHO Blood Bank AnalyzerIMMUCOR Inc.

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Automation is already present since long! AUTOMATION was introduced for a long time in the COLLECTION DEPARTMENT to improve quality, reduce errors and increase safety

Manual plasmaphaeresis Cobe BCT

Aphaeresis devicesFirst generation

TRIMA Terumo BCTLatest generation ofAphaeresis devicesWith SW capabilities

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Automation is getting more sophisticated!At the LABELING & PACKAGING DEPARTMENT – AUTOMATION gets introduced to increase productivity and efficiency, and reduce errors

Component bag centering Component labeling Component packaging

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Centrifuges

Manualpresses

Blood ComponentSeparators

Automation of Pooled Buffy-CoatPlatelet Production

FullAutomation

Automation has developed and is evolving!Manual operations in the processing area are gradually shifting towards Semi- AUTOMATION and now FULL AUTOMATION

T-ACE II+

TACSI PL

Deg

ree

of A

utom

atio

n

Degree of Lean Manufacturing Compliance

REVEOS

Gradually increasing Software capabilities

10 CONFIDENTIAL

WHAT ARE THE BENEFITS OF AUTOMATION

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Automation platforms did develop to

•Optimize staff and increase efficiencies

•Assure critical manual steps are eliminated

• Increase standardization and safety

•Secure a controlled process for optimal quality

•Facilitate traceability and easily correct deviations

•Enhance compliance to GMP/GLP

•Provide lean processes and increase productivity

•Reduce wastage / discards•

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Current Multiple Equipments Are replaced by only one

For TBCT it became Reveos

Reveos 3C/2C kit Reveos Interim Platelet Unit (IPU)Pooling kit

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“Split buffy-coat” extraction into IPU + Leuko Pack

While spinning continues, the plasma will be sent to the plasma bag and the IPU layer (residual plasma, platelets and some Leukocytes) will be sent to the IPU bag. The reamining BC (WBC’s

and residual Red Cells) will then be sent to the LP bag!. The RC will be filtered after mixing with SAGM

Extractionwith

g-force

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Buffy-Coat

IPULP

In a manual process blood will be transported to a separator

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Reveos patented system operates in a single centrifugation step

4 Whole Blood Units 450 mL ± 10%

2C Protocol: 22 Minutes (*)

4 RBC Units 4 Plasma Units 4 Residual

Leukocyte Units

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3C Protocol: 24 Minutes(*)

4 RBC Units 4 Plasma Units 4 Interim Platelet Units 4 Leuko Pack (LP) or

Residual WBC’s

(*) Protocol times = “occupation time” of the device - it includes loading, processing and unloading times of the kit

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Centrifugation& Separation

Plasma

Non FilteredRed Cells

WB

Only one centrifugation & separation step

Whole blood method using Reveos

IPU

LeukoPack

Sterile Connection of IPU,

with or W/O PASwith IPU pooling kit

LeukodepletedPlatelet

Pool

IPU pooling, connecting and filtration step

IPU Poolfiltration

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Comparison of process steps using semi-automated method vs Reveos

Semi-Automated BC 1.Receive2.Assess3.Fold4.Balance5.Centrifuge6.Extract7.Filter/Segment8.Label9.Dock10.Pool11.Fold 12.Balance13.Centrifuge14.Extract15.Label

Reveos with IPU1.Receive2.Assess3.Centrifuge4.Filter/Segment5.Label6.Dock7.Pool8.Label

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ComponentsComponent

recoveryCellular

contamination

Residual plasma Storage

Transfusion reaction risks

increment

Leukoreduction performance

Flexibility

Operator dependenc

y

PR

P

Tri

ple

B

ag m

eth

od RCC

100% WBC , PLT 30 to 50mlAggregates,

Haemolysis,... TRALI, TACO, Aggregates Challenged

PlasmaVery low NA NA

More frequent transfusions?

PLT CONC50 to 80% RC, WBC 50 to 70ml Aggregates, pH drop,...

Alloimmunization, ABO comp bedside!

SBC

me

tho

d

T&B

bag

s RCC70 to 85% Low (F and ON) <10ml

More frequent transfusions?

PlasmaLow(*) NA NA

PLT CONC50 to 70% Low (*) 50 to 70mL Aggregates, pH drop,...

Alloimmunization, ABO comp

Challenged (bedside)

PB

C m

eth

od

in

TAB

wit

h P

AS

RCC70 to 85% Low (F and ON) <10ml More frequent transfusions?

PlasmaLow (*) NA NA (*)

PLT CONC55 to 70% Low(*) Further improved

REV

EOS

3C

FIL

set

RCC> 85% <20ml (F)

Plasma by use of 2C/3CNA NA

PLT CONC POOL in PAS

60 to 80%By use of PYI

(*) operator dependent steps

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Common variation in quality of PC’s

PC’s derived from whole blood too often depend on the skills of operators

Why to accept such variations when you can have it always like this?

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Mean ± SD (n) Reveos Control pWhole blood

Collect volume (ml) 457±8 (361) 452±9(356) <0.001

Hb content in WB (g/dl) 14.5±1.2 (264) 14.6±1.3(285) NS

Platelets count WB (10e9/l)

221±48 (264)

(124-378)

226±51 (285)

(100-430)

NS

LR-RBCs concentratesVolume (mL) 296±21 (360) 251±19 (345) <0.001

RBC: Hb content (g/unit) 59.9±6.2 (323) 49.2±7.8( 324) <0.001

Units with < 40 g Hb 0 41 units (12.7%)

Hb recovery (%) 90±7(226) 75±8(265) <0.001

RBC: Hematocrit (%) 59.5±2.7 (322) 56.1±6.3(327) <0.001

RBC: WBCs>1x106(%) 0 %(30) 0%(30) ns

Plasma unitsPLASMA: volume (ml) 249±23 (360) routine268 280±17( 346) <0.001

PLASMA: platelets (10e9/l) 19±13 (303) 9±7 (346) <0.001

Erythrocytes >0.1x109/L1 unit (303)

0.3%

18 unit (346)

5.2%

<0.0001

WBCs> 0.1x 109/L 0 0 ns

Platelets concentratesIPU: volume (ml) 30.8±3.9 (63) NA NA

Pool volume (mL) 350±20 312±11 <0.001

Platelet yield (10e9/pool of 5) 361±61 (35) 386±84 (53) NS

Symposium of Terumo BCT17th of November. Bali

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Platelet component yields using ReveosTypical yields in platelet pools obtained after Leuko-reduction

# IPU per pool

Yield of PLTsx 109 / pool

Belgium 5 422

Thailand 4 336

Indonesia4 (F) 322

4 (S) 430

Spain 5 (F) & 5 (S) 361

Obtained through Reveos 3C process of 450mL whole blood collections

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Platelet “intelligence” with PYI

PYIPlatelet Yield Index

An estimation of the platelet yield in the IPU

The Reveos System

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The T-IPU select program

The Reveos System

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The T-IPU select program

• Set target number of IPU’s per

• Set target Yield

• Tool will help you identify what IPU’s to pool together

The Reveos System

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Australia

Solomon Islands

Fiji

Vanuatu

New Caledonia

Tasmania New Zealand

Galapagos

Brazil

Bolivia

Peru

Ecuador

Colombia

VenezuelaGuyana

SurinameFrench Guiana

Paraguay

Falkland Islands

South Georgia

ArgentinaChile

Uruguay

Guam

Alaska

Canada

USA

Mexico

Hawaiian Islands

Guatemala

Belize

El Salvador

Honduras

Nicaragua

PanamaCosta Rica

Cuba

The Bahamas

Martinique

Dominican Republic

Jamaica

Greenland

Iceland

Faroe Islands

Ireland UK

Svalbard

Portugal

France

Spain

Norway

SwedenFinland

Malta

GermanyPoland Lithuania

Latvia

Estonia

Italy

Romania

Ukraine

Denmark

Greece

Canary IslandsMadeira Island

Azores

Kazakhstan Mongolia

China

Russia

Kashmir

Uzbekistan

Turkmenistan

India

TurkeySyria

SaudiArabia

IranIraq

Yemen

Oman

Pakistan

Afghanistan

Indonesia

Malaysia

PhilippinesThailand Vietnam

MyanmarLaos

Papua New Guinea

North Korea

South Korea Japan

NepalEgypt

Sudan

LibyaAlgeria

Morocco

Western Sahara

Ethiopia

Mali NigerChad

SomaliaUgandaKenya

CentralAfricanRepublic

Democratic Republic of the Congo

Nigeria

Mauritania

CongoGabon

Burkina Faso

Cape Verde Senegal

Cameroon

Angola

TanzaniaSeychelles

Zambia

NamibiaZimbabwe

South Africa

Mozambique

BotswanaMadagascar

Kerguelen Island

Heard Island

MauritiusReunion

Guinea

Sierra LeoneLiberia

Cote d’Ivoire

Ghana

Mexico: 4Mexico City: 1Guadalajara: 3

Canada: 4Montreal

Paraguay: 1Asunción: 1

Libya: 3Benghazi : 2Tripoli: 1

Greece: 2Nikaia: 1, Athens: 1

Lithuania: 2Vilnius: 2

Norway: 5Lørenskog: 2, Bergen: 3

▇ Routine: EMEA 82, LATAM 7, APAC 3 Total: 92 (devices)▇ Scheduled/Won Tender: EMEA : 6, NA 4 Total: 20▇ Trial: EMEA 2, APAC 2 Total: 4

Turkey: 5Bursa: 2, Izmir: 2, Kocaeli: 1

Thailand: 7NBC/TRC, Bangkok: 5

Portugal: 4São João: 2Lisbon, 2

Algeria: 1Constantine: 1

Luxembourg: 2Luxembourg: 2

Sweden: 12Gӧteborg: 4 , Borås: 1, Lund: 3, Helsingborg: 2, Kristianstad: 2

Spain: 23 Barcelona: 14Galdakao, 6Zaragoza, 3

Indonesia: 1Jakarta

UAE: 2Dubai Qatar: 2

Doha

Saudi Arabia: 14 + 13Aramco , DammamPSMC, Riyadh

Belgium: 3Charleroi: 3

REVEOS

Philippines: 1Manila

Brunei: 1Bandar Seri Begawan

Uruguay: 1Montevideo: 1

Costa Rica: 1 San Jose: 1

Albania: 1Tirana

Iraq: 1Baghdad: 1

Germany: 1Jena: 1

Poland: 1Military Blood bank: 1

Italy:3L’aquilla: 3

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In conclusion

• Blood banks• Lean process that will lead to savings (optimization of staff, reduction of

wastage/discards) and facilitate compliance• Highly standardized quality products (yields, recoveries, leukoreduction, purity) will

lead to better storage and inventory management• Increased productivity (more products available, more quickly)

• Hospitals – based on existing literature we could expect• Highly standardized quality products will increase efficiencies and maximize

patient treatments• Potential cost reduction by use of more random donor platelets• Potentially less exposure to claims

• Patients – based on existing literature we could expect• Potentially reduce transfusion reactions• Potentially high yield products may possibly lead to less transfusions• Potentially reduce hospital stay

• MOH and other governmental authorities• Potentially better patient outcomes• Potentially less costly treatments to be expected thanks to less complications•

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Automation of the whole blood processing can potentially benefit all key stakeholders of the transfusions service

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QuestionsAutomation should be much appreciated here!

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Key features of the Reveos system

• 4 unit processing

• Only 1 centrifugation step for 3 leukodepleted products

• High productivity per machine (~72/8hours/device)

• Highest productivity per operator (1 person / 4 devices)

• Components• High Hb recovery

• Leukodepleted plasma by centrifugation

• Consistent high platelet recovery or greater standardizarion of yields by use of “Platelet intelligence” with PYI and T-Select SW

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Assure a LEAN process to

Before After