cultibag rm - sartogosm.spb.rusartogosm.spb.ru/pdf/data_biostatcultibagrm_sbt2002-e.pdf · cultibag...

SensorsSingle-use sensors for pH and DO come pre-installed and pre-sterilized with the bag. Thisavoids risky insertion of traditional sensors.

An optical fibre connects to the sensor patchthrough a sterile barrier at the end of a sleevein the bag. Sterility is maintained at all times.The optical fibre transmits light of specificwavelength to the sensor patch and returnsthe luminescence response from the sensorback to the measuring amplifier. Calibration isfast and easy.

Operating Volumes

Bag Size Min [l] Max [l] Total [l]

1 L 0.1 0.5 1

2 L 0.2* 1 2

10 L 1.0* 5 10

20 L 2.0* 10 20

50 L 5.0* 25 50

100 L 10* 50 100

200 L 20* 100 200

600 L 60* 300 600

* Bags with sensors might require higher min. working volumes

CultiBag RM

DescriptionThe CultiBag RM is a disposable bag optimisedfor cell cultivation. Bags are available in multiple sizes and configurations dependingon customer requirements. The inner layer of the disposable bioreactor bag is made of ethyl vinyl acetate (EVA), which shows anexcellent biocompatibility.

ApplicationsOur systems use rocking motion mixing technology which is ideal for cell cultivationwith low shear stress. Easy to use, it is hasslefree and applicable to all cell types, includingmammalian cells, stem cells, plant cells, insectcells and microbial cells.

Cost Reduction and Risk MinimizationDisposable Bags and single-use systems ingeneral used in biopharmaceutical manu -facturing improve process safety and reducecosts at the same time. Time and capacityconsuming CIP & SIP operations are mini-mized.

FlexibilityThe CultiBag RM is available in 1 L, 2 L, 10 L,20 L, 50 L, 100 L, 200 L and 600 L bag sizes.Bags are available as basic, optical (withpH/DO sensors) and perfusion pro (withpH/DO sensors and internal perfusionmembrane). Additionally, basic bags withscrew caps are also available.

Easy Implementation, Flexible CombinationsCultiBag RM Bags are supplied sterilized andready to use. Setup times are kept to a minimum. The CultiBag RM can be mountedon the bagholder of the rocker easily and issecured on both sides through fixationclamps. Your process can be started rightaway. Media can be filled into the bag up tothe required volume. A seed culture is addedto the bag and cultivation is started underoptimized conditions of aeration, tempera-ture and mixing. Combining your basic rockerwith our BIOSTAT® RM Control Tower willoptimize your process for real culturing convenience.

Sterile connection and disconnection devices like the BioWelder® or the BioSealer®,which are also provided by Sartorius StedimBiotech, can be used to make safe connec-tions between the C-Flex® 374 thermoplastictubings which are used on all CultiBag RMbags. Needle-free sampling ports allow easyand convenient sampling without the risk of cross contamination.

Disp

osab

le C

ulti

Bags

Validation and Extractables TestingCultiBag RM Bags have been qualifiedapplying the most complex and innovativetest regimes. Biological, chemical and physicaltests combined with extractable testingproove lowest extractables and leechableslevels and excellent compatibilty to the rele-vant pharmacopoeias and guidelines. Formore information, please refer to our Valida-tion Guide and Extractables Guide. A leach-ables testing service is also available. Pleasecontact your local Sartorius Stedim Biotechrepresentative for further information.

Quality AssuranceAll relevant materials are selected followingapplicable regulations and standards such asFDA, CFR’s, cGMPs and inhouse guidelines.This includes the terms of delivery andacceptance of our purchasing department.Finished CultiBag RM bags undergo finalproduct quality control which is certified withthe Quality Assurance certificate includedwith every bag.

Quality Management SystemsSartorius Stedim Biotech has implemented a certified Quality Management Systemaccording to well established standards. The complete Quality Systems Certificates are continuosly updated and can be downloaded on our website: www.sartorius-stedim.com/qm-certificates.

Rapid SupplyAll standard CultiBag RM Bags are availablefrom stock. Multiple warehouse locationsensure a fast delivery all over the world.

Bag PortsCultiBag RM basic: Air Inlet | Air Outlet filter

Sample portFill | drain and spare portsFemale luer, male luer, female MPC or male MPC connectorsPorts with dip tubesTubing material: C-Flex® 374; Silicone

CultiBag RM basic screw cap: Air Inlet | Air Outlet filterSample portFill | drain and spare portsFemale luer, male luer, female MPC or maleMPC connectorsPorts with dip tubesTubing material: C-Flex® 374; Silicone38 mm screw cap

CultiBag RM optical: Air Inlet | Air Outlet filterSample portFill | drain and spare portsFemale luer, male luer, female MPC or male MPC connectors Ports with dip tubesOptical chemical DO sensorOptical chemical pH sensorTubing material: C-Flex® 374; Silicone

CultiBag RM perfusion pro: Air Inlet | Air Outlet filterSample portFill | drain and spare ports Female luer, male luer, female MPC or male MPC connectorsPorts with dip tubesOptical chemical DO sensorOptical chemical pH sensorFeed | harvest portsAcid | base portsTubing material: C-Flex® 374; Silicone; PharMed®

Order Code Description

Basic BagsExample: DBB020L CultiBag RM 20 L basic

for Rocker 20 | 50DBB002L2 CultiBag RM 2 L basic

for Rocker 2

Optical BagsFor Example: DBO020L CultiBag RM 20 L optical

Perfusion Pro BagsExample: DBP020L--SM CultiBag RM 20 L perfusion pro;

1.2 μm pore sizeDBP020L5-SM CultiBag RM 20 L perfusion pro;

5 μm pore size

Customized Bags Customer own bag designFor Example: DBC002L----01xx CultiBag RM 2 L customized

customer version

Ordering Information

DB B 002 L – – – – – – – –

Disposable Bags

Package TypeB = BasicO = OpticalP = PerfusionC = Customized

Volume001 = 1002 = 2010 = 10020 = 20050 = 50100 = 100200 = 200600 = 600

Units L = Liter

Bag Version– = 1.2 μm pore size (perfusion pro bag)

or standard (basic and optical bag)

2 = Bag design fits Rocker 2 5 = 5 μm pore size (perfusion pro bag)

Vent Filter Type

MembraneSM = Sartorius Stedim Biotech

perfusion pro membrane

Design number

Design variation

Bag Configurations

CultiBag RM 1 L basic | CultiBag RM 1L Basic (for Rocker 2)

DBB001L |DBB001L2 Ports

Port A Dip Tube Silicone, C-Flex® 374 tubing 1/8" + 1/4" (1000 mm), FM-Luer

Port B Septum for needle-free sampling, FM-Luer

Port C Silicone tubing 3/16" + 5/16" (50 mm), FM-Luer

Port D Gas Outlet Filter with Check Valve, M-Luer

Port E Gas Inlet Filter 1/4" Hose barb

CultiBag RM 2L Basic | CultiBag RM 2L Basic (for Rocker 2)

DBB002L | DBB002L2 Ports



Port C;D Silicone tubing 3/16" + 5/16" (50 mm), FM-Luer

Port E Gas Outlet Filter with Check Valve, M-Luer

Port F Gas Inlet Filter 1/4" Hose barb

CultiBag RM 10L Basic | CultiBag RM 10L Basic (for Rocker 2)

DBB010L | DBB010L2* Ports

Port A Dip Tube Silicone, C-Flex® 374 tubing 1/4" + 7/16" (1000 mm), FM-MPC

Port B C-Flex® 374 tubing 1/8" + 1/4" (1000 mm), FM-luer

Port C Septum for needle-free sampling, FM-Luer

Port D Silicone tubing 3/16" + 5/16" (50 mm), FM-Luer



CultiBag RM 20 L basic

DBB020L Ports

Port A Dip Tube Silicone, C-Flex® 374 tubing 1/4" + 7/16" (1000 mm),FM-MPC



Port D;G Silicone tubing 3/16" + 5/16" (50 mm), FM-Luer



* For bags that fit on the Rocker 2 the ports C and D are mounted vice versa.

B CA

D E

DCB

FE

A

DCB

FE

A

E F G

B C DA

CultiBag RM 50L basic

DBB050L Ports


Port B C-Flex® 374 tubing 1/8" + 1/4" (1000 mm), FM-Luer


Port D; H Silicone tubing 3/16" + 5/16" (50 mm), FM-Luer

Port E C-Flex® 374 tubing 1/4" + 7/16" (1000 mm), M-MPC

Port F Gas Outlet Filter with Check Valve, M-Luer

Port G Gas Inlet Filter 1/4" Hose barb


DBB100L Ports

Port A;C Silicone tubing 3/16" + 5/16" (50 mm)

Port B C-Flex® 374 tubing 3/8" + 5/8" (1000 mm), M-MPC

Port D;E Septum for needle-free sampling, FM-Luer

Port F C-Flex® 374 tubing 1/8" + 1/4" (1000 mm), FM-Luer

Port G Gas Outlet Filter, M-Luer

Port H;I Gas Inlet Filter 3/16" Hose barb

Port J Dip Tube Silicone, C-Flex® 374 tubing 3/8" + 5/8" (1000 mm), M-MPC


DBB200L Ports

Port A;C Silicone tubing 3/16" + 5/16" (50 mm)

Port B C-Flex® 374 tubing 3/8" + 5/8" (1000 mm), M-MPC

Port D;E Septum for needle-free sampling, FM-Luer

Port F C-Flex® 374 tubing 1/8" + 1/4" (1000 mm), FM-Luer

Port G Gas Outlet Filter, M-Luer

Port H;I Gas Inlet Filter 3/16" Hose barb


B C D E

HGF

A

A B C D E F

G H I

J

A B C D E F

G H I

J

CultiBag RM 2L Basic Screw Cap

DBB002L----01SC Ports



Port C; D Silicone tubing 3/16" + 5/16" (50 mm), FM-Luerr



Port G Screw Cap 38 mm









Port G Screw Cap 38 mm






Port D; G Silicone tubing 3/16" + 5/16" (50 mm), FM-Luer



Port H Screw Cap 38 mm

DCB

FE

A

G

DCB

FE

A

G

E F G

B C DA H

CultiBag RM 2L Optical

DBO002L Ports



Port C;D Silicone tubing 3/16" + 5/16" (50 mm), FM-Luer

Port E DO sensor



Port H pH sensor


DBO010L Ports





Port E DO sensor



Port H pH sensor


DBO020L PortsPort A Dip Tube Silicone, C-Flex® 374 tubing 1/4" + 7/16" (1000 mm), FM-MPC



Port D DO sensor

Port E pH sensor

Port F Silicone tubing 3/16" + 5/16" (50 mm), FM-Luer

Port G Gas Outlet Filter with Check Valve, M-Luer

Port H Gas Inlet Filter 1/4" Hose barb

DCBA

HGFE

DCBA

HGFE

D E FCBA

HG


DBO050L Ports


Port B C-Flex® 374 tubing 1/8"+ 1/4" (1000 mm), FM-Luer


Port D DO sensor

Port E pH sensor

Port F Silicone tubing 3/16" + 5/16" (50 mm), FM-Luer

Port G C-Flex® 374 tubing 1/4" + 7/16" (1000 mm), M-MPC

Port H Gas Outlet Filter with Check Valve, M-Luer

Port I Gas Inlet Filter 1/4" Hose barb


DBO100L Ports

Port A C-Flex® 374 tubing 3/8" + 5/8" (1000 mm), M-MPC

Port B Silicone tubing 3/16" + 5/16" (50 mm), FM-Luer

Port C;D Septum for needle-free sampling, FM-Luer

Port E C-Flex® 374 tubing 1/8" + 1/4" (1000 mm), FM-Luer

Port F DO sensor

Port G pH sensor

Port H Gas Outlet Filter, M-Luer

Port I; J Gas Inlet Filter 1/4" Hose barb

Port K Dip Tube Silicone, C-Flex® 374 tubing 3/8" + 5/8" (1000 mm), M-MPC


DBO200L Ports

Port A C-Flex® 374 tubing 3/8" + 5/8" (1000 mm), M-MPC

Port B Silicone tubing 3/16" + 5/16" (50 mm), FM-Luer

Port C;D Septum for needle-free sampling, FM-Luer

Port E C-Flex® 374 tubing 1/8" + 1/4" (1000 mm), FM-Luer

Port F DO sensor

Port G pH sensor

Port H Gas Outlet Filter, M-Luer

Port I; J Gas Inlet Filter 1/4" Hose barb

Port K Dip Tube Silicone, C-Flex® 374 tubing 3/8" + 5/8" (1000 mm), M-MPC

D E F GCBA

IH

A B C D E

F G

H I J

K

A B C D E

F G

H I J

K

P Q

A J

O

N

M

K

L

FG H I

B C EDLabelDO

LabelpH

ProductLabel


Ports

Port A Dip Tube Silicone, C-Flex® 374 tubing 3/8" x 5/8" (2000 mm), PharMed® tubing 3/8" + 5/8" (600 mm), FM-MPC

Port B; C Septum for needle-free sampling, FM-Luer

Port D DO sensor

Port E pH sensor

Port F Dip Tube Silicone, C-Flex® 374 tubing 3/8" x 5/8" (1000 mm), M-MPC

Port G Silicone tubing 3/16" + 5/16" (50 mm), FM-Luer

Port H C-Flex® 374 tubing 1/8" + 1/4" (1000 mm), FM-Luer

Port I C-Flex® 374 tubing 1/4" + 7/16" (1000 mm), M-MPC


Port K; L; M Gas Outlet Filter, M-Luer

Port N; O Gas Inlet Filter 1/4" Hose barb

Port P Dip Tube Silicone, C-Flex® 374 tubing 3/8" + 5/8" (2500 mm), M-MPC

Port Q Dip Tube Silicone, C-Flex® 374 tubing 3/8" + 5/8" (2500 mm), FM-MPC

CultiBag RM 2L Perfusion Pro

DBP002L--SM | DBP002L5-SM Ports

Port A Dip Tube Silicone, C-Flex® 374 tubing 1/8" + 1/4" (1000 mm),PharMed® 1/16" + 3/16" (300 mm), FM-Luer (Perfusion Feed)


Port C C-Flex® 374 tubing 1/8" + 1/4" (1000 mm), FM-Luer

Port D C-Flex® 374 tubing 1/8" + 1/4" (1000 mm), PharMed® 1/16" + 3/16" (300 mm), FM-Luer (Perfusion Harvest)

Port E DO sensor



Port H pH sensor

Port I Silicone tubing 3/16" + 5/16" (50 mm), FM-Luer



Port A C-Flex® 374 tubing 1/8" + 1/4" (1000 mm), FM-Luer

Port B C-Flex® 374 tubing 1/8" + 1/4" (1000 mm), PharMed®1/16" x 3/16" (300 mm), FM-Luer (Perfusion Feed)


Port D C-Flex® 374 tubing 1/8" + 1/4" (1000 mm), PharMed®1/16" + 3/16" (300 mm), FM-Luer (Perfusion Harvest)

Port E DO sensor



Port H pH sensor

Port I Dip tube Silicone, C-Flex® 374 tubing 1/4" + 7/16" (1000 mm), FM-MPC





Port C C-Flex® 374 tubing 1/8" + 1/4" (1000 mm), PharMed® 1/8" + 1/4" (300 mm), FM-Luer (Perfusion Feed)

Port D Septum for needle-free sampling, FM-Luer

Port E DO sensor

Port F pH sensor

Port G C-Flex® 374 tubing 1/8" + 1/4" (1000 mm), PharMed® 1/8" + 1/4" (300 mm), FM-Luer (Perfusion Harvest)

Port H Gas Outlet Filter with Check Valve, M-Luer

Port I Gas Inlet Filter 1/4" Hose barb

HE F G

C DBA

I

HE F G

C DBA

I

E F

H I

C DB GA



Port A Dip Tube Silicone; C-Flex® 374 tubing 1/4" + 7/16" (1000 mm), FM-MPC


Port C C-Flex® 374 tubing 1/8" + 1/4" (1000 mm), PharMed® 1/8"+ 1/4" (300 mm), FM-Luer (Perfusion Feed)

Port D Septum for needle-free sampling, FM-Luer

Port E DO sensor

Port F pH sensor

Port G C-Flex® 374 tubing 1/8" + 1/4" (1000 mm),PharMed® 1/8" + 1/4" (300 mm), FM-Luer (Perfusion Harvest)

Port H C-Flex® 374 tubing 1/4" + 7/16" (1000 mm), M-MPC

Port I Gas Outlet Filter with Check Valve, M-Luer

Port J Gas Inlet Filter 1/4" Hose barb




Port B C-Flex® 374 tubing 1/4" + 7/16" (1000 mm), PharMed® 3/16" x 5/16" (300 mm), FM-Luer (Perfusion Feed)

Port C C-Flex® 374 tubing 3/8" + 5/8" (1000 mm), M-MPC

Port D; E Septum for needle-free sampling, FM-Luer

Port F C-Flex® 374 tubing 1/4" + 7/16" (1000 mm), PharMed® 3/16" x 5/16" (300 mm), FM-Luer (Perfusion Harvest)

Port G DO sensor

Port H pH sensor

Port I Gas Outlet Filter, M-Luer

Port J; K Gas Inlet Filter 1/4" Hose barb

Port L Dip Tube Silicone, C-Flex® 374 tubing 3/8" + 5/8" (1000 mm), M-MPC




Port B C-Flex® 374 tubing 1/4" + 7/16" (1000 mm), PharMed® 3/16" x 5/16" (300 mm), FM-Luer (Perfusion Feed)

Port C C-Flex® 374 tubing 3/8" + 5/8" (1000 mm), M-MPC

Port D; E Septum for needle-free sampling, FM-Luer

Port F C-Flex® 374 tubing 1/4" + 7/16" (1000 mm), PharMed® 3/16" x 5/16" (300 mm), FM-Luer (Perfusion Harvest)

Port G DO sensor

Port H pH sensor

Port I Gas Outlet Filter, M-Luer

Port J;K Gas Inlet Filter 1/4" Hose barb

Port L Dip Tube Silicone, C-Flex 374 tubing 3/8" + 5/8" (1000 mm), M-MPC

E F

I J

C DB G HA

E FC D

J KI

BA

L

G H

E FC D

J KI

BA

L

G H

Bag Accessories

Order Code Description

DS-------GF Light Conductor Cables for CultiBag RM optical and perfusion pro (2 pcs)

DS-------CGF Clamps for Light Conductor Cable fixation (2 pcs)

DS-----RMFH Filter Heater for outlet filter of CultiBag RM 1 L–50 L

DS200L-RMFH Filter Heater for outlet filter of CultiBag RM 100 L–200 L

DS-------CV Check Valves for outlet filter of CultiBag RM (50 pcs)

FBP101950 MPC 3/8“ PC Female Body (40 pcs)

FBP101955 MPC 1/4“ PC Female Body (40 pcs)

FBP101956 MPC 3/8“ PC/Silicone Male Insert (40 pcs)

FBP101957 MPC 1/4“ PC/Silicone Male Insert (40 pcs)

FBP101947 MPC PC/Silicone Male Sealing Plug (40 pcs)

FBP101949 MPC PC Female Sealing Cap (40 pcs)

Luer conncetors are available on request

Sartorius Stedim Biotech GmbHAugust-Spindler-Strasse 1137079 Goettingen, GermanyPhone +49.551.308.0Fax +49.551.308.3289www.sartorius-stedim.com

USA Toll-Free +1.800.368.7178UK +44.1372.737159France +33.442.845600Italy +39.055.63.40.41Spain +34.90.2110935Japan +81.3.3740.5407

Specifications subject to change without notice. Printed and copyrighted by Sartorius Stedim Biotech GmbHW · GPublication No.: SBT2002-e10079Order No.: 85030-532-47Ver. 07 | 2010

cultibag rm - sartogosm.spb.rusartogosm.spb.ru/pdf/data_biostatcultibagrm_sbt2002-e.pdf · cultibag...

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