TERUMO AUTOMATED CENTRIFUGE AND SEPARATOR INTEGRATION
(TACSI)FOR THE BUFFY COAT METHOD OF WHOLE BLOOD PROCESSING
Unlocking the Potential of Blood
tacsi wb is not yet available for sale in all world areas.
1
PUT AUTOMATION TO WORK FOR YOU
THE TACSI WHOLE BLOOD (WB) SYSTEM IMPROVES LABORATORY EFFICIENCY, BLOOD COMPONENT QUALITY AND PROCESS CONTROL
2
Traditional, manual methods of whole blood processing introduce many challenges, making it harder to contend with:
■ Regulatory requirements ■ Process and product control ■ Staffing issues ■ Recording and tracking data
THE TACSI WB SYSTEM SOLVES PROBLEMS
The TACSI WB system is a full, stand-alone technology that automates and integrates the manual steps in the Buffy Coat (BC) method of WB processing, six units at a time. It offers a single, modular platform for processing both WB and pooled BCs.
This new TACSI device is a natural evolution of the TACSI Platelet (PL) system, already used by many component laboratories to create more consistent platelet concentrates from pooled BCs.
The TACSI WB device can do everything the TACSI PL device does, plus it can process WB into red blood cell (RBC) concentrates, plasma and BCs. Now, from start to finish, your products can be consistent and high quality, and your lab even more efficient. You may more easily meet the challenges every component lab faces.
THE IMPORTANCE OF AUTOMATION
3
SMART LABS SEEK SMARTER SOLUTIONS
2002Technology that integrates automated centrifugation and separation not yet available
AUTOMATION IS WIDESPREAD
4
While the prospect of automation may seem daunting, we have helped more than 100 customers around the world successfully upgrade their laboratories. And that number is growing rapidly. These blood centers are already experiencing the rewards of automation; you could, too.
Put our knowledge and expertise to work to improve your whole blood process.
A CLEAR PATH TO AUTOMATED BLOOD PROCESSING
2012Blood centers in 32 countries have adopted Terumo BCT’s integrated automation technologies
5
THE TACSI WB SYSTEM:SIX UNITS AT A TIME
6
The TACSI WB system is straightforward and intuitive to operate. It automates and consolidates manual processing steps, including:
■ Balancing
■ Centrifugation
■ Transportation
■ Separation and leukoreduction
■ Volume determination
■ Recording procedure and process data
ONE DEVICE, TWO PROCEDURESThe TACSI WB system is designed to process blood from start to finish, using two separate procedures.
■ TACSI Concentrated Red Cell (CRC) Procedure processes WB: 6 WB units –► 6 plasma units + 6 RBC units + 6 BC units
■ TACSI PL Procedure processes pooled BCs: 6 pooled BC units –► 6 platelet concentrate units
7
1 2
3
465
TRADITIONAL BC PROCESS
COMPARE YOUR PROCESS TO THE TACSI WB PROCESS
THE TACSI WB PROCESS
1 2
5
67
1011
4
9
13
3
8
12
1 Pack and position in cups
2 Balance
3 Centrifuge
4 Transport units
5 Separate units
6 Seal and separate plasma, packed RBC and BC units
7 Leukoreduction of RBCs
8 Separate RBC units from filter and seal
9 Leukoreduced RBC units ready for storage
10 Enter data for traceability; store or additionally process products
11 Plasma units
12 Enter data for traceability; store or additionally process products
13 Manually pool and rinse BC units
14 Pack and position in cups
15 Balance
16 Centrifuge
17 Transport units
18 Separate and leukoreduce
19 Therapeutic platelet dose
20 Enter data for traceability; store or additionally process products
8
7
10
12
13
14
11
17
1 Load WB kit
2 TACSI WB process
3 Plasma units
4 Enter data; store or additionally process products
5 Pool and rinse BC units
6 Load PL kit into PL insert
7 TACSI PL process
8 Leukoreduced platelet concentrates
9 Enter data; store or additionally process products
10 Leukoreduction of RBC units
11 Separate RBC from filter
12 Leukoreduced RBC units
13 Enter data; store or additionally process products
PROCESS SIX UNITS AT ONE TIME
9
8
16 18
19
20
15
9
THE BUFFY COAT PLATELET PROCESS, SIMPLIFIED
TACSI WB PRODUCTS ARE HIGH QUALITY AND REMARKABLY CONSISTENT
10
Traditional methods of processing whole blood into platelet concentrates are very time-consuming. They require many manual steps, errors are easily made and waste is common.
The TACSI WB system automates and standardizes the process, creating more consistent products, reducing errors, reducing product losses, and improving product quality and yields.
IMPROVED PRODUCT QUALITY AND YIELDS*
■ More than 90% platelet recovery ■ Clear plasma with a total recovery of >90% with BC ■ RBC concentrate with <10% plasma and >85% RBC recovery ■ Platelet yield increases up to 25% ■ More plasma volume ■ Low white blood cell (WBC) count in final platelet product, <1.0 x 105
■ Ability to process WB and BCs, up to 24 units per hour per device
THE TACSI WB SYSTEM IS ABLE TO REACH A MEAN OF:* ■ >300 x 109/unit in additive/plasma media using four BCs per pooling bag ■ >460 x 109/unit using five BCs per pooling bag ■ >500 x 109/unit using six BCs per pooling bag
*Data on file at Terumo BCT.
11
DESIGNED FOR SPEED AND ACCURACY
INSERTS HELP IMPROVE YOUR PROCESS
12
Each procedure has a dedicated insert created to hold the bag compartments securely in place during processing. The TACSI CRC insert works with a TACSI CRC kit; the TACSI PL insert works with the TACSI PL kit. The inserts are designed to be removed from the device, so loading and unloading the kits takes place outside of the device. This helps save time; you can pre-mount the next batch while TACSI WB is processing the previous one.
TACSI CRC INSERT TACSI PL INSERT
Processes WB Processes pooled BCs
Includes an insert and insert cover Includes an insert and insert cover
Holds TACSI CRC kit Holds TACSI PL kit
Can be removed from device for mounting Can be removed from device for mounting
Saves time: pre-mount another batch of inserts while TACSI WB processes the previous batch
Saves time: pre-mount another batch of inserts while TACSI WB processes the previous batch
Incorporates holder for leukoreduction filter Incorporates holder for leukoreduction filter
Assures correct loading with tubing guide Assures correct loading with tubing guide
Protects the collection and satellite containers Protects the pooling and storage containers
Detects plasma/BC interface with integrated sensor Detects platelet/RBC interface with integrated sensor
PROCESSING KITS
The processing kits for the TACSI CRC and TACSI PL procedures include PVC blood bags, clamps, a filter and tubing, all assembled in an integrated cassette. The cassette makes mounting the kit fast and easy. Platelets can be stored with platelet additive solution (PAS) or plasma for up to seven days.
IN-PROCESS LEUKOREDUCTION
High-quality filters help create high-quality products.
TACSI CRC KIT TACSI PL KIT
Soft housing leukoreduction filter for RBCs Hard housing leukoreduction filter for platelets
Made from highly biocompatible polyurethane Made from highly biocompatible polyurethane
Provides stable and rapid filtration with improved efficiency
Mechanically traps the majority of leukocytes in small pores or dimples
Supports an easy and convenient centrifugation procedure
Produces higher quality blood products
■ Very limited cell material interaction ■ Absence of cellular or protein activation
Limits handling and decreases risk of breaking during processing
Produces a stable, fully leukoreduced product with a high recovery of RBCs
13
RBCs Plasma Platelets
Higher Hb content Produces higher volume of plasma Higher platelet content
Higher Hct % More pure product with fewer RBCs and WBCs
More pure product with fewer RBCs and WBCs
PRODUCE HIGHER QUALITY PRODUCTS*
The TACSI WB system delivers precision that improves both product output and product quality.
INCREASE PRODUCT CONSISTENCY*
Automation eliminates the variances caused by manual operations. The TACSI WB system offers a level of consistency that cannot be attained with traditional manual processing methods.
THE ADVANTAGES OF THE TACSI WB SYSTEM
LOOK AT WHAT THE TACSI WB SYSTEM CAN DO
As compared to manual processing
PLT
per p
ool x
10E
9
320 338 400 420 460 493 500
600
500
400
300
200
100
0
Centre 1–Spain(4 BC)
Centre 2–Spain(4 BC)
Centre 3–Spain(5 BC)
Centre 4–Belgium(5 BC)
Centre 5–France(5 BC)
Centre 6–France(5 BC)
Centre 7–Belgium(6 BC)
TACSI IN DAILY USE
IMPROVE THROUGHPUT*
Each TACSI WB system can process WB and pooled BCs, six units at a time, up to 24 units per hour per device. Each technician can operate two devices at once. To ensure continuous operation, you can pre-mount six new inserts while the device processes the previous batch. The stability of the design eliminates the need to balance the cups prior to centrifugation, saving even more time.
OBTAIN HIGHER YIELDS*
The TACSI platform can help you improve your yields in several ways, by:
■ Increasing production by 20%: pools may be made from five BCs instead of six, with the same production target (>400 x 109)
■ Providing extremely stable platelet recovery of 80% to 85% from initial pool
■ Reducing product losses
*Data on file at Terumo BCT.
14
OPTIMIZE WORKFLOW
The TACSI WB device merges centrifugation, separation and leukoreduction into one automated process, greatly reducing the number of steps required to process WB and pooled BCs. You can also reduce the number of standard operating procedures, the amount of equipment and the hands-on time required. Staff training is also simplified.
REINFORCE GOOD MANUFACTURING PRACTICES (GMPs)
A high degree of process control and comprehensive collection of run data reinforces GMPs and compliance.
■ Minimal handling of blood bags reduces the risk of errors
■ Built in cassette facilitates standardized mounting of TACSI kits, ensuring positioning of the bags to reduce the risk of breakage
■ Program parameters are set by our experts and require no further adaptations after installation
■ Lower centrifugation speed reduces stress on components and safety risks
■ TOMEs data management system captures all recorded procedure data and allows for electronic transfer to your system
FACILITATE ADOPTION OF OTHER NEW TECHNOLOGIES
The TACSI WB platform allows processing staff to devote more time to other processes. (Above statements are made when compared to manual whole blood processing)
SAVE SPACE
The TACSI WB device can be installed in the main lab area, close to other equipment used in the procedure. No separate centrifugation room is required.
■ Limited space needed for processing ■ Quiet operation ■ More room for new technologies ■ Integrated, internal cooling system
CRC insert prep
Wei
ghin
g an
d se
alin
g
Pooling PL insert prepWeighing and sealing
Cooling and WB storage
CRC insert prep
POSSIBLE CONFIGURATIONSPOSSIBLE CONFIGURATIONS
In clusters In line
INTEGRATION CLUSTERS
15
MANAGE INFORMATION WITH EASE
TOMEs TAKES YOUR SYSTEM FURTHER
16
TOMEs is a simple solution designed to link multiple Terumo devices. TOMEs can help improve:
■ Data management with electronic documentation, reporting, traceability and data exchange
■ Workflow management with real-time device activity monitoring and centralized device configuration
■ GMPs by assisting with donor verification, process standardization and error reduction
■ Infrastructure as a dedicated hardware and software solution that includes built-in failsafe, backup and security
TOMES FOR TACSI
CURRENT CHALLENGES TOMEs CAPABILITIES
Enabling flexibility and scalability of operations
Provides centralized process control and defines the workflow for your TACSI systems
Achieving regulatory compliance Captures and stores procedure data automatically
Managing the human factorCaptures detailed information about each procedure, enabling traceability of equipment, materials, blood units and operators
Producing consistent, high-quality products
Generates a variety of data-rich reports that can be used to troubleshoot issues and identify areas for improvement of operator performance
WORKING SMARTER
17
We believe that each investment you make in automated whole blood solutions should pay for itself over time. Working together, we can quantify the benefits of the TACSI WB system based on your lab and processes. We are here to help you make an informed decision about how to best produce consistent, high-quality products; streamline your business processes; and create value for you and your stakeholders.
A RETURN ON YOUR INVESTMENT
Like any capital investment, the TACSI WB system can help you reduce costs and increase revenue; it brings automation and streamlined operations to your blood center.
Capital investments usually impact the cash flow statement negatively in the first year of implementation. In subsequent years, cash flow increases through an improvement in operating margin.
Most organizations depreciate assets over time. Doing so may buffer the impact of your investment on your income statement over five to 10 years. Many organizations may experience improved profitability immediately.
TECHNOLOGY THAT COULD PAY FOR ITSELF
POSSIBLE TANGIBLE BENEFITS POSSIBLE FINANCIAL RETURN
Decreased RBC and plasma discard rates
Net present value: >0
IRR: >10% to 20%
Payback: ~ 2 to 5 years
Decreased platelet and BC discard rates
Improved labor productivity
Better yields for platelets, plasma and RBCs
Improvements on overhead
Shortened training period
Significant reduction in space requirements
QUANTIFYING THE TACSI WB SYSTEM BENEFITS
18
SYSTEM SPECIFICATIONSDEVICE AND OPERATING ENVIRONMENT SPECIFICATIONS
SPECIFICATION TYPE VALUE
ManufacturerAndreas Hettich GmbH & Co. KG D-78532 Tuttlingen, Germany*
Model TACSI FM
Reference ME+TACSIFM
Size (W x H x D)813 mm x 973 mm x 1,035 mm (32 in x 38.3 in x 40.74 in)
Weight <330 kg (727 lbs) 460 kg (1,014 lbs) including accessories
Mains voltage (± 10%) 400 V 3~ + N + PE
Mains frequency 50–60 Hz
Connected load 2,300 VA
Cooling medium R 404A
Maximum capacity 6 x 600 mL
Allowed density 1.2 kg/dm3
Speed Max. 2,500 rpm
Force (RCF) Max. 1,677 g
Kinetic energy Max. 130,000 Nm
Obligatory inspection (BRG 500) Yes
Ambient Conditions (EN/IEC 61010-1)
Environment Indoor use only
Altitude Up to 2,000 m (6,561 ft) above sea level
Ambient temperature 5 °C–40 °C (41 °F–104 °F)
Humidity
Maximum relative humidity 80% for temperatures up to 31 °C (87.8 °F) linearly decreasing to 50% relative humidity at 40 °C (104 °F)
Excess voltage category (IEC-60364-4-443)
II
Pollution degree 2
Device protection class I
Not suitable for use in explosion-endangered areas
EMC–Emitted interference, Interference immunity
EN/IEC 61326-1, Class B
Noise level (dependent on rotor) ≤60 dB (A)
CALCULATE WHAT THE TACSI WB SYSTEM COULD DO FOR YOU. CONTACT YOUR TERUMO BCT REPRESENTATIVE TODAY.
*tacsi pl and tacsi wb were developed in collaboration with hettich gmbh & co. kg, d-78532 tuttlingen, germany
UNLOCKING THE POTENTIAL OF BLOOD | TERUMOBCT.COM
Terumo BCT, Inc. USA
10811 West Collins Ave.Lakewood, Colorado 80215-4440USA
USA Phone: 1.877.339.4228Phone: +1.303.231.4357Fax: +1.303.542.5215
Terumo BCT Europe N.V.
Europe, Middle East and AfricaIkaroslaan 411930 ZaventemBelgium
Phone: +32.2.715.05.90 Fax: +32.2.721.07.70
Terumo BCT (Asia Pacific) Ltd.
Room 3903-3903A, 39/F ACE Tower, Windsor House 311 Gloucester Road Causeway Bay, Hong Kong
Phone: +852.2283.0700 Fax: +852.2576.1311
Terumo BCT Latin America
La Pampa 1517–12th Floor C1428D2E Buenos AiresArgentina
Phone: +54.11.5530.5200 Fax: +54.11.5530.5201
©2012 Terumo BCT, Inc. / PN 306720472
Terumo BCT Japan, Inc.
Ebisu South One Bldg. 9F 1-7-8, Ebisu-minami, Shibuya-ku Tokyo 150-0022Japan
Phone: +81.3.6743.7890Fax: +81.3.6743.9800
