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BIOSTAT ® STR True Scalability in Single-Use

BIOSTAT® STR True Scalability in Single-Use

The BIOSTAT ® STR is a fully scalable single-use bioreactor with a conventional design. The system is comprised of a stainless steel bag holder, a single-use bioreactor chamber and a superior control system utilizing single-use or conventional electrochemical sensors. Its advanced control platform offers an excellent solution for every budget and every need.

BIOSTAT ® STR is ideal for

– Suspension and microcarrier applications

– High cell density cultivation of all cell types including mammalian and insect cells

– Process development

– Process scale-up

– Pilot scale production

– Seed cultivation for large scale bioreactors

– Production scale

Single-use systems have many advantages over reusables in terms of reduced maintenance, reduced overhead expenses and reducing or eliminating the need for:

– Sterilization in Place (SIP)

– Cleaning in Place (CIP)

– Water for Injection (WFI)

– User time and effort

– Validation requirements

– Risk of cross contamination

The scalable single-use cultivation vessel, CultiBag STR, has a classical stirred tank design, making the transition from traditional stainless steel to single-use as easy as possible. Set-up is simple and hassle free. The CultiBag STR is installed in a compact stainless steel housing, reducing the footprint and saving laboratory space. The Sartocheck® 4 plus Bag Tester enables the user to check the STR bag after installation directly prior to use. This eliminates the potential loss of a filled bioreactor volume.

The BIOSTAT ® STR Control Tower features best-in class control capabilities with feedback control. It is operated via an intuitive touch screen keeping staff training to a minimum.

The gas mixing strategy has been designed in coope ration with multiple world leading biopharma-ceutical companies enabling the use in a wide range of different appli-cations.

The BIOSTAT ® STR is available in both single and twin controller configuration*. The twin configuration increases flexibility and allows simul-taneous, independent control of two cultures.

* Twin available for 50 L and 200 L scale.

Features

– Single-use bio reactor in completely traditional design

– Aspect Ratio (H:D) 1.8:1

– Top driven stirrer with magnetic coupling

– Heating blankets for only heating* or jacketed vessel with cooling water for heating|cooling

– Flexible gassing system with Overlay & Sparger aeration with ring-, micro-, or combisparger for efficient oxygen transfer and CO2 stripping

– Choice between 6-blade disk, 3-blade segment impellers and combination of both

– Control of agitation speed, pH, DO, temperature, substrate addition, gasmix and gas flow via optional mass flow controllers (MFC)

– Single-use or conventional DO & pH sensors for measurement with pH & DO recalibration

– Overpressure safety protection

– Single-use exhaust cooler with condensate return

– Bags can be tested for potential leak at point-of-use

– User-friendly touch screen interface for easy operation

– Trend display with up to 6 process values

– Available as single and twin version*

– BioPAT ® MFCS/DA data logging software included

– Full GMP qualification support package

* for 50 L and 200 L

The First Single-Use Bioreactor with a Conventional Stirred Tank Design

Single-Use Cultivation Chamber

Skid

Bag Holder

SkidThe BIOSTAT ® STR consists of a Control Tower skid and a bag holder skid. The BIOSTAT ® STR Twin system consists of two bag holder skids which can be connected to one Control Tower.

During operation, the bag holder and Control Tower skid are easily and quickly connected to each other for a space saving system combination. After cultivation, the bag holder skid can be disconnected and transported for further production steps such as harvesting and purification. The BIOSTAT ® STR Control Tower is imme-diately ready to start a new cultiva-tion by connecting it to the next bag holder skid. This flexibility transforms the cultivation process into a con-tinuous process without delays due to harvesting, cleaning or purifica-tion steps.

Temperature ControlTwo different ways of controlling temperature are possible: heating only or heating|cooling.

– Heating OnlyPowerful heating blankets around the stainless steel hous-ing allow excellent temperature control. Temperature range from room temperature to 40°C is possible. Only available for 50 L and 200 L.

– Heating|CoolingA combination of an electrical heater with a jacketed vessel with cooling water recir-culation for fast heat up and cool down during your process. Temperature range from 8°C above cooling water to 40°C is possible.

AgitationA powerful high performance motor drive combines low-shear agitation with excellent mixing. The motor assures quiet operation and provides convenient handling. The stirrer is magnetically coupled to the motor drive ensuring safe and sterile con-nection.

Bag HolderFor additional convenience, the bag holder is installed on a separate skid. Installation of a single-use cultiva-tion chamber has never been so easy. The cylindrical holder is designed as 2 hemispheres which can be opened for convenient installation of the bag. The CultiBag STR fits per-fectly into its holder, avoiding any creases and crinkles.

Single-Use Exhaust Cooler Single-use exhaust cooler increases process safety and maintains stable process conditions. The SU exhaust cooler is installed between the CultiBag and the exhaust gas filter in the holder and thus within the sterile barrier. It reduces aerosol load in off gas and protects the exhaust filter from blocking. The condensate is returned into the bag.

BIOSTAT ® STR Control TowerThe Control Tower offers a wide range of options for easy configuration according to the application requirements. It is equipped with all necessary measurement and control hardware, including pumps and gassing systems.

Fully validated DCU controllerThe control system features an intuitive “easy-to-use” touch screen display for local operation and process control. It is validatable and developed according to good automation manufacturing practice guidelines (GAMP). Proven industrial control hardware ensures reliable system performance.

Gassing SystemThe highly flexible gassing module for mix-ing Air, O2, CO2 and N2 makes the BIOSTAT ® STR a powerful tool for all your application demands. It allows individual flow rates and gas mixing for each cultivation cham-ber. Flow rates are adjustable via precision flow meters. In addition to that integrated mass flow controllers ensure optimal pro-cess control. The gassing module is equipped with 3 outlets. Air and CO2 can be routed to the overlay. Air, N2, O2 and CO2 can be routed to the ring - or microsparger, which is the mainsparger outlet. The third gassing outlet is used to O2 to the microsparger-part of the combisparger, when used.

Dosing PumpsIndustrially proven, easy-to-use peristaltic pumps are integrated in the system. They can be used for addition of corrective agents, feeding purposes as well as control of the culture volume. Alternatively, exter-nal pumps can be easily connected for advanced feed or harvest.

Single-Use Cultivation Chamber

BIOSTAT ® STR Control Tower

Agitation

Fully validated DCU controller

Dosing pumps

Gassing System

CultiBag STR Single-Use Cultivation Chamber

Please note: Not all variations are possible for all ports.

Bag Geometry and RatiosThe CultiBag STR design is based on the gold standard of conventional stainless steel bioreactors. This allows for an easy transfer from stainless steel to single-use. The table on the following page shows all relevant details and demonstrates geometrical equivalence to classical bioreactors.

Single-Use Cultivation ChamberThe CultiBag STR is available in a working volume range of 12.5 to 1000 L, allowing for scalability from R&D over pilot to large-scale produc-tion. The systems feature a 1:4 turn-down ratio. The vertically positioned stirrer is pre-installed inside the bag and contains two impellers. Both 3-blade segment, 6-blade disk impellers as well as combination of both are available. Traditional 0.8 mm ring-, micro- and combisparger are available for integration inside the CultiBag STR.

The microrsparger features holes of defined diameter (150 µm) and is free of any particle shedding. Furthermore, we offer the innovative combisparger, which is a combination of the ring-

CultiBag STR Design VariationsThe CultiBag STR is a configurable product, which offers multiple options for tubings, connectors, spargers and agitation system to cover all application demands. Pre-configured standard bags are available from stock.

Tubing Size Choice between silicone and C-flex 374 tubing in various diameters.

Sparger Type Choice between ring-, micro- and combisparger. The combisparger is a combination of the ring- and microsparger.

Impeller Type Choice between 2 + 3-blade segment impel-ler, 2 + 6-blade disk impeller (Rushton) or combination of both.

Connections Choice between Luer, MPC, Opta sterile con-nectors and tube welding.

Sensors Choice between single-use and | or conventional probes.

and microsparger for efficient oxygen transfer and CO2 removal. A dip tube allows gentle feeding or harvesting without shear stress. Furthermore, various ports are available for feed, inoculation, harvest and sampling. For additional safety back-up filters can be connected.

SensorsState of the art single-use sensors for pH and DO come pre-installed and pre-sterilized with the bag. This avoids insertion of traditional, reus-able sensors. Calibration is fast and safe. A Pt100 reusable sensor for temperature is installed inside a sili-con sleeve for precise temperature control. If desired, additional conven-tional probes can be inserted via aseptic connections.

Easy Implementation, Flexible CombinationsCultiBag STR bags are supplied gamma- sterilized and ready to use. This allows easy process implementation and set-up times are kept to a minimum. Sterile connection and disconnection devices like the BioWelder® or the BioSealer®, also available from Sartori-us Stedim Biotech, can be used for safe transfer of your medium to the next process step. Needle-free sam-pling ports allow easy and convenient sampling without the risk of cross contamination.

Geometrical data

CultiBag STR 50 L 200 L 500 L 1000 L

Volume Total Volume [L]

68 280 700 1300

Minimum Working Volume [L] 12.5 50 125 250

Maximum Working Volume [L] 50 200 500 1000

Bag Diameter d1 [mm] 370 585 815 997

Bag Height h1 [mm] 666 1055 1467 1800

Ratio h1/d1 1.8 1.8 1.8 1.8

Liquid Height h2 [mm] 480 783 1005 1360

Ratio h2/d1 1.29 1.34 1.23 1.36

Impeller Diameter d2 [mm] 143 225 310 379

Ratio d2/d1 0.39 0.38 0.38 0.38

Distance between Impellers [mm] 186 300 403 493

Example of CultiBag STR 200 L Basic Configuration

Pos. Designation Tubing Size | Material Tubing Termination Remarks

A Overlay Aeration 1” + 3”, Si(Pt) Opta connector without spare port

B Substrate Line 1 a” + b” MPC Quick coupling

C Substrate Line 2 a” + b” MPC Quick coupling

D Sparger Aeration 1” + 3”, Si(Pt) Opta connector without spare port

E Substrate 3-4 4” + 7/16”, C-Flex;a” + b”, C-Flex

MPC Quick coupling 2 lines via Y, dip tube

F Base Addition 8” + 4”, C-Flex Clave connector

G Antifoam Addition

4” + a”, C-Flex Clave connector

H Gas Out (Exhaust)1” ID, Si(Pt) Opta connector 2 lines via Y

I Temperature Sensor

Si(Pt) N/A Reusable sensor (Pt100)

J | K DO/pH Sensor N/A N/A Optical sensor

L Small Volume Sampling

8” + 8”, Si(Pt) Clave connector

M Bottom Drain Harvest

1” + 3”, C-Flex MPC Quick coupling

The bag material is certified BSE | TSE free and is in compli-ance with the EMA’s guidance (EMA | 410 | 01 Rev. 3) and the Euro-pean Pharmacopoeia # 5.2.8. on minimizing the risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Product. Fur-thermore, it meets or exceeds the requirements of the USP Class VI – 70°C Plastic tests and is considered as non- cytotoxic and non-haemolytic. The bag material has been carefully selected based on thourough cell cultivation trials with a panel of dif-ferent cell lines and organisms. It provides an excellent environment for cell growth and productivity.

Bag MaterialThe CultiBag STR has a multilayer film structure to provide a robust structure with low gas permeability and high chemical resistance.

The contact layer is made of ultra-low density polyethylene (ULDPE). ULDPE is in compliance with respec-tive pharma copoeias and provides a clean, inert and highly chemical resistant contact layer.

Testing of CultiBag STRThe Sartocheck® 4 plus Bag tester is the ideal tool for eliminating the risk of filling a defective single-use bioreactor with high valuable cell culture media. The CultiBag STR is tested pre-use after installation into the STR bag holder. A unique pat-ented fleece avoids direct contact between the plastic film of the bag and the smooth stainless steel sur-face of the bag holder. Any kind of potential masking effect is therefore eliminated and environmental heat transfer is reduced giving unrivalled test accuracy.

Technical Specifications

Description Hardware BIOSTAT ® STR 50 L BIOSTAT ® STR 200 L BIOSTAT ® STR 500 L BIOSTAT ® STR 1000 L

VolumeTotal volume 68 L 280 L 700 L 1300 L

Minimum working volume 12.5 L 50 L 125 L 250 L

Maximum working volume 50 L 200 L 500 L 1000 L

Power Supply208 VAC • • • •

400 VAC • • • •

Bag HolderInstalled on skid • • • •

Electro-polished • • • •

Hemispherical doors 2 2 2 2

Holder for gas filters • • • •

Temperature control Only Heating or Heating|Cooling

Only Heating or Heating|Cooling

Heating|Cooling Heating|Cooling

Viewing window 2 2 2 2

Opening for sideports • • • •

Pt 100 probe 1 1 1 1

Pressure sensor • • • •

Sensor clamps • • • •

Filter heater 1 1 1 1

Single-use exhaust cooler (•) (•) (•) (•)

Top drive motor • • • •

Ladder – – (•) (•)

Control TowerSingle version • • • •

Twin version • • – –

Installed on skid • • • •

Temperature control, single wall RT –40°C RT –40°C n|a n|a

Temperature control, double wall 8°C above cooling water –40°C

8°C above cooling water –40°C



Stirrer speed 10 – 240 rpm 10 – 150 rpm* 10 – 110 rpm 10 – 90 rpm*

pH range 5.5 – 8.5 5.5 – 8.5 5.5 – 8.5 5.5 – 8.5

pH sensor in bag • • • •

DO range 0 – 100 % 0 – 100 % 0 – 100 % 0 – 100 %

DO sensor in bag • • • •

Amplifiers for:– Disposable DO sensor 1 1 1 1

– Disposable pH sensor 1 1 1 1

– Reusable DO sensor 1 1 1 1

– Reusable pH sensor 1 1 1 1

– Temperature 1 1 1 1

Multi-channel DO cascade control • • • •

Recalibration Function for:– Disposable DO sensor • • • •

– Disposable pH sensor • • • •

Description Hardware BIOSTAT ® STR 50 L BIOSTAT ® STR 200 L BIOSTAT ® STR 500 L BIOSTAT ® STR 1000 L

Interface:

– Ethernet • • • •

– RS232 2 2 4 4

– Analogue IN 2 2 4 4

– Analogue OUT 2 2 4 4

BioPAT ® MFCS/DA • • • •

Gassing Module Rotameter [L/min]:outlets 3 3 3 3

Sparger Line (ring or micro)– O2 0.7 – 5.5** 1.0 – 23** 5.0 – 55** 12 – 104**

– N2 0.7 – 5.5** 1.0 – 23** 5.0 – 55** 12 – 104**

– CO2 0.7 – 5.5** 1.0 – 23** 5.0 – 55** 12 – 104**

– Air 0.7 – 5.5** 1.0 – 23** 5.0 – 55*** 12 – 104**

Overlay Line– Air 0.7 – 5.5** 1.0 – 23** 5.0 – 55** 12 – 104**

– CO2 0.7 – 5.5** 1.0 – 23** 5.0 – 55** 12 – 104**

MFC for: Sparger Line (ring or micro)– O2 (0.1 – 5.0)** (0.4 – 20)** (1.0 – 50)** (2.0 – 100)**

– N2 (0.1 – 5.0)** (0.4 – 20)** (1.0 – 50)** (2.0 – 100)**

– CO2 (0.1 – 5.0)** (0.4 – 20)** (1.0 – 50)** (2.0 – 100)**

– Air (0.1 – 5.0)** (0.4 – 20)** (1.0 – 50)** (2.0 – 100)**

Overlay Line– Air (0.1 – 5.0)** (0.4 – 20)** (1.0 – 50)** (2.0 – 100)**

– CO2 (0.1 – 5.0)** (0.4 – 20)** (1.0 – 50)** (2.0 – 100)**

Soft Button to switch between ring- and microsparger:– Air (•) (•) (•) (•)

– O2 (•) (•) (•) (•)

Pumps & BalancesDigital pumps WM102 3 3 – –

Digital pumps WM313D – – 2 2

Analogue pumps (via Analogue OUT)

(up to 2) (up to 2) (up to 4) (up to 4)

Balances (via RS232) (up to 2) (up to 2) (up to 4) (up to 4)

Point-of-use bag test (•) (•) (•)*** (•)***

* Valid in case 2 + 3-blade impellers are used. In case of 1 + 3-blade + 1 + 6-blade impeller maximum stirrer speed may be reduced depending on the filling level. At maximum filling level stirrer speed at 200 L scale is limited to 110 rpm and 70 rpm at 1000 L scale.

** Alternative lower flow ranges are available on request*** available from Q3/2013( ) optional, needs to be ordered separately

BIOSTAT® STR Bioreactor System

System will be configured according to customer demands, please contact sales representative

CultiBag STR Single-Use Bioreactor Bag

Standard Design

Description Order No.

CultiBag STR 50 L FRB114043




Customer Specific Designs

Please contact sales representative

Bag Tester Fleece


For CultiBag STR 50 L DZ050L-SBSIT



For CultiBag STR 1000 L DZ001K-SBSIT

Accessories


Filter Line IN 50 | 200 L DS200L-SBFLI

Filter Line OUT 50 | 200 L DS200L-SBFLO

Filter Line IN 500 |1000 L DS001K-SBFLI

Filter Line OUT 500 |1000 L DS001K-SBFLO

Single-Use Exhaust Cooler


SU Exhaust Cooler CultiBag STR 50 | 200

DS200L---EC

SU Exhaust Cooler CultiBag STR 500 |1000

DS001K---EC

Ordering Information

Advanced Process Control for Ideal Culture Conditions

BioPAT ® MFCS SCADA (Super visory control and data acquisition) ensures total process safety, when used in combination with the advanced BIOSTAT ® STR Control Tower for local process control.

BioPAT ® MFCSBioPAT ® MFCS/DA is delivered with every BIOSTAT ® STR package. It is ideal for capturing, storing and visualizing process data as well as research & development settings. Batch-oriented bioprocessing is the key aspect in our data management software. Therefore, all batch- related data are stored under a unique batch name | ID.

The Sample Data Management module simplifies the inclusion of external, manu-ally-entered data (e.g. glucose analyzer, cell density, etc.) into your batch record.

Visualization of the batch data is realized by a powerful plotting function, allowing for multiple variables as well as the com-parison of multiple batches simultaneously. The export function may be used to export batch data to other data analysis programs.

Advanced functionality for supervisory process control and data acquisition is provided by BioPAT ® MFCS/win, a feature-rich GAMP category 4 software package. It is capable of supporting the most demanding research or production environments, including S88- and 21CFRp11-compliance as well as OPC connectivity. Multi-user network access to up to 16 process units and remote alarming are additional features. Please contact your local Sartorius Stedim Biotech representative for further details.

SYNCHRONIZED

PATSOLUTIONS

Features

– Up to 4 process units

– Batch oriented software package

– Sample Data Management

– Enhanced Plotting

– Export functions

– Easy to use programming interface

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Sales and Service ContactsFor further contacts, visit www.sartorius-stedim.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 Biotech S.A.ZI Les PaludsAvenue de Jouques – CS 9105113781 Aubagne Cedex

Phone +33.442.845600Fax +33.442.845619

Sartorius Stedim France SASZI Les 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 Stedim Netherlands B.V.Edisonbaan 243439 MN Nieuwegein

Phone +31.30.6025080Fax +31.30.6025099

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

ScandinaviaSartorius Stedim Nordic A/SHoerskaetten 6D, 1.2630 Taastrup, Denmark

Phone +45.7023.4400Fax +45.4630.4030

SpainSartorius Stedim Spain SAC/Isabel Colbrand 10, Oficina 70Polígono Industrial de Fuencarral28050 Madrid

Phone +34.90.2110935Fax +34.91.3589623

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 LtdaAv. Dom Pedro I, 241Bairro Vila Pires Santo André São PauloCep 09110-001

Phone +55.11.4451.6226Fax +55.11.4451.4369

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.Airport Industrial Zone BNo. 33 Yu’an RoadBeijing 101300, Shunyi District

Phone +86.10.80426516Fax +86.10.80426580

Sartorius Stedim Biotech (Beijing) Co. Ltd.Shanghai Branch officeRoom 618, Tower 1, German Centre,Shanghai, PRC., 201203

Phone +86.21.28986393Fax +86.21.28986392.11

Sartorius Stedim Biotech (Beijing) Co. Ltd.Guangzhou representative officeRoom 704, Broadway Plaza,No. 233–234 Dong Feng West RoadGuangzhou 510180

Phone +86.20.8351.7921Fax +86.20.8351.7931

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.Kiba Park Bldg5-11-13 KibaKoto-kuTokyo 135-0042

Phone +81.3.5639.9981Fax +81.3.5639.9983

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

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Disclaimer Product photos shown in this brochure represent product examples. The appearance of the product may be different and is subject to change.

biostat str true scalability in single-use · biostat® str true scalability in single-use the...

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