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TAKEONE ® Aseptic Sampling System
TAKEONE® Aseptic Sampling System
■ Break BottlenecksThe patented TAKEONE® aseptic sampling system is the only system of its kind. TAKEONE® is delivered fully assembled and ready-to-use. Bypass parts washing, equipment prep and assembly with the TAKEONE® and break the bottlenecks to your process.
■ Single-UseThe TAKEONE® was conceived to embrace the benefits of single-use technology. TAKEONE® is not a hybrid of single-use and multi-use components. Dispose of the TAKEONE® aseptic sampling system at the conclusion of the batch and find time pre-viously lost to disassembly.
■ How much time can you find?
Hybrid Single | Multi-Use Systems TAKEONE® Aseptic Sampling System
Parts Washing 6 minutes 0 minutes
Equipment Prep 4 minutes 0 minutes
Assembly 3 minutes 0 minutes
Disassembly 3 minutes 0 minutes
Devices Per Year 1500 1500
Man Hours Used 400 hours 0 hours
Man Weeks Used 10 weeks 0 weeks
Contact your Sartorius Stedim sales person today for your customized time study analysis
What would you do if…
...you had more time?
...you could make a wish?
...you knew you wouldn’t fail?
■ Strategic DesignNot all samples are created equal — and we don’t treat them that way. Whether it’s sterility, bioburden or endotoxin testing or routine process monitoring, your TAKEONE® device is designed for your process demands. You don’t have to wish for a better sampling device; TAKEONE® is your better sampling device.
■ Erase WasteSamples collected from a process are valuable product that cannot be replaced. Sartorius offers collection vessels and procedures that reduce product loss from over-sampling, saving our customers millions of dollars.
■ 100% Leak TestingEvery sampling line of every TAKEONE® device is leak tested after assembly. Only a factory assembled aseptic sampling device can make this claim and it gives you assur-ance that your TAKEONE® is built right and can be relied upon.
■ QUICKSEAL® Aseptic DisconnectThe ingeniously intuitive QUICKSEAL® aseptic disconnect has no match for its performance in the field. Use QUICKSEAL®
to remove the collection vessel and remove any fear of failed aseptic disconnections or tube seals.
What would you do if…
Product Life Cycle
No aseptic sampling system matches the simplicity or efficiency of the TAKEONE® aseptic sampling system. The TAKEONE® device is assembled in an ISO 7 certified cleanroom in accordance with applicable cGMP guidelines
Receive
Install
Sample
■ Sampling VesselsTailored to your needs: – Choose from bags, bottles,
syringes – Needleless or septum sites
DisconnectRemoval
Disposal
Performance & Materials
– 2”: 9 sampling lines– 1.5”: 5 sampling lines
■ Spring-Loaded Actuator– Never touch a needle – Enhances operator safety
■ 2 mm CannulaElectropolished 316 L stainless steel
■ Silicone Septa– Platinum-cured – Self-sealing
■ MountElectropolished 316 L stainless steel
■ QUICKSEAL®
Aseptic tube separation Platinum-cured Silicone, C-Flex® & other tubing
■ Glass Reinforced Polyester BodyHermetically sealed cannula diaphragm
Technical Specifications
■ MechanicsSampling Mechanism 2mm needle pierces platinum-cured
silicone septaAseptic Disconnect QUICKSEAL® aseptic disconnectConnection to Tank 1.5” or 2” Sanitary Fitting
■ Materials of Construction2mm Needle 316L Stainless Steel, electropolished
Sanitary Fitting 316L Stainless Steel, electropolished
Septa Platinum-cured silicone
TAKEONE® body High Temperature Glass Reinforced Polyester
■ Performance Specifications (independent of collection vessel)SIP (30 psig, 30 mins) Up to 10 cycles (including after actuation)
Multiple Actuations Up to 40 actuations per sampling line
Sampling Pressure 7.5 psi (0.5 bar) @40°C
■ Validation & Material Tests (independent of collection vessel)USP <88> Class VI Pass
USP <85> Pass, routine testing
USP <788> Pass, routine testing
Gamma Irradiation Validated to SAL 10-6 per ISO11137-2
Leak Testing Pass, 100% testing
Recommended Configurations
AseptiQuik is ideal for supple-mental or unplanned samples and for autoclave applications.
BENCHMARK™ includes a check valve to prevent unintentional contamination.
Centrifuge tubes provide best fluid volume control. Select polystyrene (PS) for improved endotoxin sampling.
Bottles from Nalgene feature accurate molded-in gradua-tions for fluid volume control.
Flexboy® bags include graduations to assist with fluid volume control and support fully aseptic samples.
Materials of Construction EVA (S71)/PE (CX5-14), silicone or C-Flex® tube, PP, PC, Platinum-cured silicone
Sample Volume 50, 150, 500, 1000mL (EVA), 50, 100, 250, 500, 1000mL (PE)
Maximum Pressure 7.5 psi (0.5 bar)
Temperature -70 to 40 Celsius (EVA), -80 to 60 Celsius (PE)
Outlet 2-option; female luer & luer activated access site
USP VI Yes Phthalate Yes
TSE/BSE Free Yes BPA Free Yes
Latex Free Yes Melamine Free Yes
Materials of Construction PETG/PC, silicone or C-Flex® tube, platinum-cured silicone, PE, PP
Sample Volume 30, 60, 125, 250, 500, 1000 mL
Maximum Pressure 7.5 psi (0.5 bar)
Temperature -40° to 40° Celsius (PETG), -135° to 135° Celsius (PC)
Outlet Puncture Site (>125 mL bottles), PE Vent Filter
USP VI Yes Phthalate Yes
TSE/BSE Free Compliant* BPA Free Yes
Latex Free Yes Melamine Free Yes
Materials of Construction PP/PS, silicone or C-Flex® tube, platinum-cured silicone, PE, PP
Sample Volume 15, 50 mL
Maximum Pressure 7.5 psi (0.5 bar)
Temperature -40° to 40° Celsius
Outlet PE Vent Filter
USP VI Yes Phthalate Yes
TSE/BSE Free Compliant* BPA Free Yes
Latex Free Yes Melamine Free Yes
Materials of Construction PC, platinum-cured silicone, SAN, silicone or C-Flex® tube
Maximum Pressure 7.5 psi (0.5 bar)
Temperature -40° to 40° Celsius
USP VI Yes Phthalate Yes
TSE/BSE Free Compliant* BPA Free Yes
Latex Free Yes Melamine Free Yes
Materials of Construction PC, PE, PE, silicone or C-Flex® tube
Maximum Pressure 7.5 psi (0.5 bar)
Temperature -40° to 130° Celsius
USP VI Yes Phthalate Yes
TSE/BSE Free Compliant* BPA Free Yes
Latex Free Yes Melamine Free Yes
* The raw materials used to make components used in construction of these assemblies are treated high tempera-tures and undergo chemical reactions which exceed by far the stringent requirements laid down in the documents CPMP/BWP/1230/98 and WHO/CPS/VPH/95.145 and | or EMEA/410/01. These processing conditions are considered sufficient to inactive TSE & BSE transmitters.
Sales and Service ContactsFor further contacts, visit www.sartorius.com
EuropeGermanySartorius Stedim Biotech GmbHAugust-Spindler-Strasse 1137079 Goettingen
Phone +49.551.308.0Fax +49.551.308.3289
Sartorius Stedim Systems GmbHRobert-Bosch-Strasse 5 – 7 34302 Guxhagen
Phone +49.5665.407.0Fax +49.5665.407.2200
FranceSartorius Stedim FMT S.A.S.ZI des PaludsAvenue de Jouques – CS 9105113781 Aubagne Cedex
Phone +33.442.845600Fax +33.442.845619
Sartorius Stedim France SASZI des PaludsAvenue de Jouques – CS 7105813781 Aubagne Cedex
Phone +33.442.845600Fax +33.442.846545
AustriaSartorius Stedim Austria GmbHFranzosengraben 121030 Vienna
Phone +43.1.7965763.18Fax +43.1.796576344
BelgiumSartorius Stedim Belgium N.V.Leuvensesteenweg, 248/B1800 Vilvoorde
Phone +32.2.756.06.80Fax +32.2.756.06.81
HungarySartorius Stedim Hungária Kft.Kagyló u. 52092 Budakeszi
Phone +36.23.457.227Fax +36.23.457.147
ItalySartorius Stedim Italy S.p.A.Via dell’Antella, 76/A50012 Antella-Bagno a Ripoli (FI)
Phone +39.055.63.40.41Fax +39.055.63.40.526
NetherlandsSartorius Netherlands B.V.
Phone +31.30.60.53.001 Fax +31.30.60.52.917
PolandSartorius Stedim Poland Sp. z o.o.ul. Wrzesinska 7062-025 Kostrzyn
Phone +48.61.647.38.40Fax +48.61.879.25.04
Russian FederationLLC “Sartorius ICR”Uralskaya str. 4, Lit. B199155, Saint-Petersburg
Phone +7.812.327.5.327Fax +7.812.327.5.323
SpainSartorius Stedim Spain, S.A.U.Avda. de la Industria, 32Edificio PAYMA28108 Alcobendas (Madrid)
Phone +34.902.110.935Fax +34.91.358.96.23
SwitzerlandSartorius Stedim Switzerland AGRingstrasse 24 a8317 Tagelswangen
Phone +41.52.354.36.36Fax +41.52.354.36.46
U.K.Sartorius Stedim UK Ltd.Longmead Business CentreBlenheim Road, EpsomSurrey KT19 9 QQ
Phone +44.1372.737159Fax +44.1372.726171
AmericaUSASartorius Stedim North America Inc.5 Orville Drive, Suite 200Bohemia, NY 11716
Toll-Free +1.800.368.7178Fax +1.631.254.4253
ArgentinaSartorius Argentina S.A. Int. A. Ávalos 4251 B1605ECS Munro Buenos Aires
Phone +54.11.4721.0505 Fax +54.11.4762.2333
BrazilSartorius do Brasil Ltda Avenida Senador Vergueiro 2962 São Bernardo do Campo CEP 09600-000 - SP- Brasil
Phone +55.11.4362.8900Fax + 55.11.4362.8901
MexicoSartorius de México S.A. de C.V.Circuito Circunvalación Poniente No. 149Ciudad Satélite53100, Estado de MéxicoMéxico
Phone +52.5555.62.1102Fax +52.5555.62.2942
Asia|PacificAustraliaSartorius Stedim Australia Pty. Ltd.Unit 5, 7-11 Rodeo DriveDandenong South Vic 3175
Phone +61.3.8762.1800Fax +61.3.8762.1828
ChinaSartorius Stedim Biotech (Beijing) Co. Ltd.No. 33 Yu’an RoadAirport Industrial Park Zone BShunyi District, Beijing 101300
Phone +86.10.80426516Fax +86.10.80426580
Sartorius Stedim Biotech (Beijing) Co. Ltd.Shanghai Branch Office3rd Floor, North Wing, Tower 1No. 4560 Jin Ke RoadPudong District, Shanghai 201210
Phone +86.21.68782300Fax +86.21.68782332 | 68782882
Sartorius Stedim Biotech (Beijing) Co. Ltd.Guangzhou Representative OfficeUnit K, Building 23Huihua Commerce & Trade BuildingNo. 80 Xianlie Middle RoadGuangzhou 510070
Phone +86.20.37618687 | 37618651Fax +86.20.37619051
IndiaSartorius Stedim India Pvt. Ltd.#69/2-69/3, NH 48, JakkasandraNelamangala Tq562 123 Bangalore, India
Phone +91.80.4350.5250Fax +91.80.4350.5253
JapanSartorius Stedim Japan K.K.4th Fl., Daiwa Shinagawa North Bldg.8-11, Kita-Shinagawa 1-chomeShinagawa-ku, Tokyo, 140-0001 Japan
Phone +81.3.4331.4300Fax +81.3.4331.4301
MalaysiaSartorius Stedim Malaysia Sdn. Bhd.Lot L3-E-3B, Enterprise 4Technology Park MalaysiaBukit Jalil57000 Kuala Lumpur, Malaysia
Phone +60.3.8996.0622Fax +60.3.8996.0755
SingaporeSartorius Stedim Singapore Pte. Ltd.1 Science Park Road, The Capricorn, #05-08A,Singapore Science Park IISingapore 117528
Phone +65.6872.3966Fax +65.6778.2494
South KoreaSartorius Korea Biotech Co., Ltd.8th Floor, Solid Space B/D, PanGyoYeok-Ro 220, BunDang-GuSeongNam-Si, GyeongGi-Do, 463-400
Phone +82.31.622.5700Fax +82.31.622.5799
www.sartorius.com
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