CultiBag RM. Disposable CultiBags

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Aubrey Horn
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1 ultiag R isposable ultiags Sensors Precise and reliable single-use sensors for p and O come pre-installed and sterilized with the bag. The sensors are pre-calibrated and the calibration data is supplied together with the bag. fter entering the data in the controller, the sensors are ready for use. alibration is fast and convenient. n optical fibre connects to the sensor patch, which is located at end of a sleeve in the bag. s there is no physical contact of the optical fiber to the inside of the bag, sterility is maintained at all times. The optical fibre transmits light of specific wavelengths to the sensor patch and returns the luminescence response from the sensor back to the measuring amplifier. escription The ultiag R is a single use bioreactor bag available in multiple sizes and configurations depending on customer requirements. The inner layer of the disposable bioreactor bag is made of ethyl vinyl acetate (V), which shows an excellent biocompatibility. pplications Our IOSTT R bioreactors use rocking motion mixing technology which is ideal for cell cultivation with low shear stress. asy to use, it is hassle free and applicable to all cell types, including mammalian cells, stem cells, plant cells, insect cells and microbial cells. ost Reduction and Risk inimization isposable ags and single-use systems in general used in biopharmaceutical manu - facturing improve process safety and reduce costs at the same time. Time and capacity consuming IP & SIP operations are minimized. lexibility and onfigurations The ultiag R is available in 1 L, 2 L, 10 L, 20 L, 50 L, 100 L, 200 L and 600 L bag sizes. ags are available as basic, optical and perfusion pro configurations. asic bags are designed for use in seed train and production applications without p and O control. asic bags up to 20 L size are also available with screw caps (38 mm diameter). The screw cap can be used for the insertion removal of larger objects inside a laminar flow cabinet. Optical bags feature single use optochemical p and O sensors, which are already installed in everybag and calibrated. Used together with the IOSTT R control tower, they allow high end cultivation with full process automation. Perfusion bags feature an integrated 1.2 μm perfusion membrane (PS). The membrane is fixed at the bottom of the bag, forming a compartment for removal of cell free media. The wave created by the agition moves over the surface of the membrane, thereby flushing the membrane with every rocking motion. This innovative and patented design ensures low fouling and long cultivation times. asy Implementation, lexible ombinations ultiag R ags are supplied sterilized and ready to use. Setup times are kept to a minimum. The ultiag R is mounted on the bagholder of the rocker easily and secured on both sides through fixation clamps. edia is filled into the bag up to the required volume. seed culture is added to the bag and cultivation is started under optimized conditions of aeration, temperature and mixing. Sterile connection and disconnection devices like the iowelder or the iosealer, which are also provided by Sartorius Stedim iotech, can be used to make safe connections between the -lex 374 thermoplastic tubings which are used on all ultiag R bags. septic, needle-free sampling ports allow easy and convenient sampling without the risk of cross contamination. Operating Volumes ag Size in [l] ax [l] Total [l] 1 L L 0.2* L 1.0* L 2.0* L 5.0* L 10* L 20* L 60* * ags with sensors might require higher min. working volumes По вопросам продаж и поддержки обращайтесь: Астана+7(7172) , Волгоград(844) , Воронеж(473) , Екатеринбург(343) , Казань(843) , Краснодар(861) , Красноярск(391) , Москва(495) , Нижний Новгород(831) , Новосибирск(383) , Ростов-на-Дону(863) , Самара(846) , Санкт-Петербург(812) , Саратов(845) , Уфа(347) sst@nt-rt.ru sartorius.nt-rt.ru

2 Validation and xtractables Testing ultiag R ags have been qualified applying the most complex and innovative test regimes. iological, chemical and physical tests combined with extractable testing proove lowest extractables and leechables levels and excellent compatibilty to the relevant pharmacopoeias and guidelines. or more information, please refer to our Validation uide and xtractables uide. leachables testing service is also available. Please contact your local Sartorius Stedim iotech representative for further information. Quality ssurance ll relevant materials are selected following applicable regulations and standards such as, R s, cps and inhouse guidelines. This includes the terms of delivery and acceptance of our purchasing department. inished ultiag R bags undergo final product quality control which is certified with the Quality ssurance certificate included with every bag. Quality anagement Systems Sartorius Stedim iotech has implemented a certified Quality anagement System according to well established standards. The complete Quality Systems ertificates are continuosly updated and can be downloaded on our website: anufacturing Site ultiag R bags are produced in our factory in Tagelswangen Switzerland in ISO class 7 and class 8 clean rooms. Security of supply We ensure short lead times for all standard ultiag R ags. ultiple warehouse locations ensure a fast delivery all over the world. ag ultiag R basic: ultiag R basic screw cap: ultiag R optical: ultiag R perfusion pro: ir Inlet ir Outlet filter Sample port ill drain and spare ports emale luer, male luer, female P or male P connectors with dip tubes Tubing material: -lex 374; Silicone ir Inlet ir Outlet filter Sample port ill drain and spare ports emale luer, male luer, female P or male P connectors with dip tubes Tubing material: -lex 374; Silicone 38 mm screw cap ir Inlet ir Outlet filter Sample port ill drain and spare ports emale luer, male luer, female P or male P connectors with dip tubes Optical chemical O sensor Optical chemical Tubing material: -lex 374; Silicone ir Inlet ir Outlet filter Sample port ill drain and spare ports emale luer, male luer, female P or male P connectors with dip tubes Optical chemical O sensor Optical chemical eed harvest ports cid base ports Tubing material: -lex 374; Silicone; Phared

3 Ordering Information 002 L isposable ags Package Type = asic O = Optical P = Perfusion = ustomized Volume 001 = = = = = = = = 600 Units L = Liter ag Version = 1.2 μm pore size (perfusion pro bag) or standard (basic and optical bag) 2 = ag design fits Rocker 2 Vent ilter Type embrane S = Sartorius Stedim iotech perfusion pro membrane esign number esign variation S = bag with 38 mm screw cap Order ode escription asic ags 020L ultiag R 20 L basic xample: for Rocker L2 ultiag R 2 L basic for Rocker 2 Optical ags O020L ultiag R 20 L optical or xample: Perfusion Pro ags P020L--S ultiag R 20 L perfusion pro; xample: 1.2 μm pore size ustomized ags ustomer own bag design ultiag R 2 L customized version or xample: 002L----01xx

4 ag onfigurations ultiag R 1 L basic ultiag R 1L basic (for Rocker 2) 001L 001L2 ip Tube Silicone, -lex 374 tubing 1/8" + 1/4" (1000 mm), -Luer Silicone tubing 3/16" + 5/16" (50 mm), -Luer ultiag R 2L basic ultiag R 2L basic (for Rocker 2) 002L 002L2 ip Tube Silicone, -lex 374 tubing 1/8" + 1/4" (1000 mm), -Luer ; Silicone tubing 3/16" + 5/16" (50 mm), -Luer ultiag R 10L basic ultiag R 10L basic (for Rocker 2) 010L 010L2* ip Tube Silicone, -lex 374 tubing 1/4" + 7/16" (1000 mm), -P -lex 374 tubing 1/8" + 1/4" (1000 mm), -luer Silicone tubing 3/16" + 5/16" (50 mm), -Luer ultiag R 20 L basic 020L ip Tube Silicone, -lex 374 tubing 1/4" + 7/16" (1000 mm), -P -lex 374 tubing 1/8" + 1/4" (1000 mm), -luer ; Silicone tubing 3/16" + 5/16" (50 mm), -Luer * or bags that fit on the Rocker 2 the ports and are mounted vice versa.

5 ultiag R 50L basic 050L ip Tube Silicone, -lex 374 tubing 1/4" + 7/16" (1000 mm), -P -lex 374 tubing 1/8" + 1/4" (1000 mm), -Luer ; Silicone tubing 3/16" + 5/16" (50 mm), -Luer -lex 374 tubing 1/4" + 7/16" (1000 mm), -P J I ultiag R 100 L basic 100L ; Silicone tubing 3/16" + 5/16" (50 mm) -lex 374 tubing 3/8" + 5/8" (1000 mm), -P ; -lex 374 tubing 1/8" + 1/4" (1000 mm), -Luer as Outlet ilter, -Luer ;I as Inlet ilter 3/16" ose barb Port J ip Tube Silicone, -lex 374 tubing 3/8" + 5/8" (1000 mm), -P J I ultiag R 200 L basic 200L ; Silicone tubing 3/16" + 5/16" (50 mm) -lex 374 tubing 3/8" + 5/8" (1000 mm), -P ; -lex 374 tubing 1/8" + 1/4" (1000 mm), -Luer as Outlet ilter, -Luer ;I as Inlet ilter 3/16" ose barb Port J ip Tube Silicone, -lex 374 tubing 3/8" + 5/8" (1000 mm), -P

6 ultiag R 2L basic Screw ap 002L----01S ip Tube Silicone, -lex 374 tubing 1/4" + 7/16" (1000 mm), -P ; Silicone tubing 3/16" + 5/16" (50 mm), -Luerr Screw ap 38 mm ultiag R 10L basic Screw ap 010L----01S ip Tube Silicone, -lex 374 tubing 1/4" + 7/16" (1000 mm), -P -lex 374 tubing 1/8" + 1/4" (1000 mm), -Luer Silicone tubing 3/16" + 5/16" (50 mm), -Luer Screw ap 38 mm ultiag R 20L basic Screw ap 020L----01S ip Tube Silicone, -lex 374 tubing 1/4" + 7/16" (1000 mm), -P ; -lex 374 tubing 1/8" + 1/4" (1000 mm), -Luer Silicone tubing 3/16" + 5/16" (50 mm), -Luer Screw ap 38 mm

7 ultiag R 2L optical O002L ip Tube Silicone, -lex 374 tubing 1/8" + 1/4" (1000 mm), -Luer ; Silicone tubing 3/16" + 5/16" (50 mm), -Luer O sensor ultiag R 10L optical O010L ip Tube Silicone, -lex 374 tubing 1/4" + 7/16" (1000 mm), -P -lex 374 tubing 1/8" + 1/4" (1000 mm), -Luer Silicone tubing 3/16" + 5/16" (50 mm), -Luer O sensor ultiag R 20L optical O020L ip Tube Silicone, -lex 374 tubing 1/4" + 7/16" (1000 mm), -P -lex 374 tubing 1/8" + 1/4" (1000 mm), -Luer O sensor Silicone tubing 3/16" + 5/16" (50 mm), -Luer

8 ultiag R 50L optical I O050L ip Tube Silicone, -lex 374 tubing 1/4" + 7/16" (1000 mm), -P -lex 374 tubing 1/8"+ 1/4" (1000 mm), -Luer O sensor Silicone tubing 3/16" + 5/16" (50 mm), -Luer -lex 374 tubing 1/4" + 7/16" (1000 mm), -P Port I K I J ultiag R 100L optical O100L -lex 374 tubing 3/8" + 5/8" (1000 mm), -P Silicone tubing 3/16" + 5/16" (50 mm), -Luer ; -lex 374 tubing 1/8" + 1/4" (1000 mm), -Luer O sensor as Outlet ilter, -Luer Port I; J Port K ip Tube Silicone, -lex 374 tubing 3/8" + 5/8" (1000 mm), -P K I J ultiag R 200L optical O200L -lex 374 tubing 3/8" + 5/8" (1000 mm), -P Silicone tubing 3/16" + 5/16" (50 mm), -Luer ; -lex 374 tubing 1/8" + 1/4" (1000 mm), -Luer O sensor as Outlet ilter, -Luer Port I; J Port K ip Tube Silicone, -lex 374 tubing 3/8" + 5/8" (1000 mm), -P

9 ultiag R 600L optical ; Port I Port J Port K; L; Port N; O Port P Port Q ip Tube Silicone, -lex 374 tubing 3/8" x 5/8" (2000 mm), Phared tubing 3/8" + 5/8" (600 mm), -P O sensor ip Tube Silicone, -lex 374 tubing 3/8" x 5/8" (1000 mm), -P Silicone tubing 3/16" + 5/16" (50 mm), -Luer -lex 374 tubing 1/8" + 1/4" (1000 mm), -Luer -lex 374 tubing 1/4" + 7/16" (1000 mm), -P ip Tube Silicone, -lex 374 tubing 3/8" + 5/8" (2000 mm), -P as Outlet ilter, -Luer ip Tube Silicone, -lex 374 tubing 3/8" + 5/8" (2500 mm), -P ip Tube Silicone, -lex 374 tubing 3/8" + 5/8" (2500 mm), -P P Q L Product Label O N K I J Label O Label p

10 I I ultiag R 2L perfusion pro P002L--S Port I ip Tube Silicone, -lex 374 tubing 1/8" + 1/4" (1000 mm), Phared 1/16" + 3/16" (300 mm), -Luer (Perfusion eed) -lex 374 tubing 1/8" + 1/4" (1000 mm), -Luer -lex 374 tubing 1/8" + 1/4" (1000 mm), Phared 1/16" + 3/16" (300 mm), -Luer (Perfusion arvest) O sensor ultiag R 10L perfusion pro P010L--S Port I Silicone tubing 3/16" + 5/16" (50 mm), -Luer Perfusion membrane, PS 1.2 μm, fixed at the bottom of the bag -lex 374 tubing 1/8" + 1/4" (1000 mm), -Luer -lex 374 tubing 1/8" + 1/4" (1000 mm), Phared 1/16" x 3/16" (300 mm), -Luer (Perfusion eed) -lex 374 tubing 1/8" + 1/4" (1000 mm), Phared 1/16" + 3/16" (300 mm), -Luer (Perfusion arvest) O sensor ultiag R 20L perfusion pro ip tube Silicone, -lex 374 tubing 1/4" + 7/16" (1000 mm), -P Perfusion membrane, PS 1.2 μm, fixed at the bottom of the bag I P020L--S ip Tube Silicone, -lex 374 tubing 1/4" + 7/16" (1000 mm), -P -lex 374 tubing 1/8" + 1/4" (1000 mm), -luer -lex 374 tubing 1/8" + 1/4" (1000 mm), Phared 1/8" + 1/4" (300 mm), -Luer (Perfusion eed) O sensor -lex 374 tubing 1/8" + 1/4" (1000 mm), Phared 1/8" + 1/4" (300 mm), -Luer (Perfusion arvest) Port I Perfusion membrane, PS 1.2 μm, fixed at the bottom of the bag

11 ultiag R 50L perfusion pro I J P050L--S ip Tube Silicone; -lex 374 tubing 1/4" + 7/16" (1000 mm), -P -lex 374 tubing 1/8" + 1/4" (1000 mm), -Luer -lex 374 tubing 1/8" + 1/4" (1000 mm), Phared 1/8"+ 1/4" (300 mm), -Luer (Perfusion eed) O sensor -lex 374 tubing 1/8" + 1/4" (1000 mm), Phared 1/8" + 1/4" (300 mm), -Luer (Perfusion arvest) -lex 374 tubing 1/4" + 7/16" (1000 mm), -P Port I Port J Perfusion membrane, PS 1.2 μm, fixed at the bottom of the bag

12 ag ccessories Order ode S S S-----R S-----R2 S-----R2P S200L-R S V escription Light onductor able for ultiag R optical and perfusion pro (1 piece) lamp for Light onductor able fixation (1 piece) ilter eater for outlet filter of ultiag R 1 L 50 L ilter eater for outlet filter of ultiag R 1 L 50 L, connectable to IOSTT R II (second generation). lso works for 600 L bag. xternal Power Supply for S-----R2 ilter eater for outlet filter of ultiag R 100 L 200 L heck Valves for outlet filter of ultiag R (50 pcs) По вопросам продаж и поддержки обращайтесь: Астана+7(7172) , Волгоград(844) , Воронеж(473) , Екатеринбург(343) , Казань(843) , Краснодар(861) , Красноярск(391) , Москва(495) , Нижний Новгород(831) , Новосибирск(383) , Ростов-на-Дону(863) , Самара(846) , Санкт-Петербург(812) , Саратов(845) , Уфа(347) sst@nt-rt.ru sartorius.nt-rt.ru

CultiBag RM. Disposable CultiBags

CultiBag RM. Disposable CultiBags ultiag RM Sensors Single-use sensors for p and O come preinstalled and pre-sterilized with the bag. This avoids risky insertion of traditional sensors. isposable ultiags n optical fibre connects to the