flexible, reliable bioreactor and control systems for...

Benchtop bioprocessing solutionsFlexible, reliable bioreactor and control systems for laboratory applications

Robust bioprocessing solutions for small-scale applicationsThermo Scientific™ HyPerforma™ bioprocess control systems are designed to optimize your process, from the laboratory bench to full cGMP manufacturing. Our innovative control platform combines a flexible operating system with scalable, modular hardware, and state-of-the-art bioreactors for strategic and streamlined bioprocess control.

HyPerforma benchtop solutions offer robust management of both cell culture and fermentation processes. The open architecture provides process flexibility, and dedicated hardware control allows for expansion. Thermo Scientific™ TruBio™ software is designed to support easy process control and scaling.

Standard system components for benchtop solutions• Thermo Scientific™ HyPerforma™ G3Lab™ Controller tower

• Thermo Scientific™ TruFlow™ gas mass flow controller

• Thermo Scientific™ TruBio™ Bioprocess Control Software solutions powered by the Emerson™ DeltaV™ Distributed Control Platform

• PC workstations

• Autoclavable benchtop bioreactors, single-use benchtop bioreactors, and rockers

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HyPerforma G3Lab ControllerReliable process control

The HyPerforma G3Lab Controller can control most brands of single-use or autoclavable bioreactors or fermentors that are 50 L or less in volume, including stirred-tank and rocking models. The controller operates using TruBio software, which provides easy process scale-up or scale-down and the confi gurability to modify your control strategy along with your process. The enclosure contains state-of-the-art transmitters along with power supplies, pumps, and the hardware required to connect to the control network, providing maximum control capability.

HyPerforma G3Lab Controller key features• A common control platform throughout a product’s

life cycle

• Custom-confi guration options available to meet your specifi c process needs

• Open-architecture capabilities to integrate with vessels from other suppliers

• Compatible with our TruBio Bioprocess Control Software portfolio

– For non-GMP research and process development applications: Thermo Scientifi c™ TruBio™ Discovery Bioprocess Control Software powered by the Emerson™ DeltaV™ Discovery platform

– For GMP and typical scale-up to manufacturing applications: TruBio software powered by the conventional DeltaV platform

• Nonproprietary, industry-standard distributed control system (DCS) that provides networked multiple-vessel control capability

• Built-in calibration

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Watson-Marlow series 114 peristaltic pump specifications

Power supply 24 V DC

Max current (@25°C) 0.25 A

Average current (@25°C) 0.2 A

Operating temperature 5°C to 50°C (41°F to 122°F)

Storage temperature –10°C to 70°C (14°F to 158°F)

Humidity 10% to 90% (noncondensing)

Speed 5 to 160 rpm

Accuracy ±2 rpm or ±2% of setpoint

Certifications CE: EN-60101 and EN-61326

Tubing (thickness, ID) 0.8 mm, 4.8 mm

Watson-Marlow series 114 peristaltic pump speeds

Speed (rpm) Minimum/maximum flow rate (mL/min)

1 0.16/3

10 0.3/6

50 1.7/30

100 3.4/57.5

160 5.5/104

250 NA

300 NA

HyPerforma G3Lab Controller specifications

Cover description

Top cover material Stainless steel

Physical

Utility tower dimensions (H x W x D) 438.4 x 240 x 482.6 mm (17 1/4 x 9 3/8 x 19 in.)

Weight/shipping weight 16.4 kg/21.4 kg (36.5 lb/47 lb)

Enclosure rating Standard: NEMA 2

Operating conditions


Storage temperature 5°C to 40°C (41°F to 104°F)

Relative humidity 5% to 95% (noncondensing)

Utility Connection

Liquid controlWatson-Marlow™ series 114 peristaltic pumps

Tubing ID: 0.8 mm (wall thickness 1.6 mm) Tubing ID: 4.8 mm (wall thickness 1.6 mm)

Flow range 0.16 mL/min to 5.5 mL/min 3 mL/min to 104 mL/min

Gas control (TruFlow controller) Up to four mass flow controllers with output connectors (please see mass flow controller (MFC) page for details)

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Watson-Marlow series 114 peristaltic pump speeds

Speed (rpm) Minimum/maximum fl ow rate (mL/min)

1 0.16/3

10 0.3/6

50 1.7/30

100 3.4/57.5

160 5.5/104

250 NA

300 NA

The Thermo Scientifi c™ TruFlow™ Gas MFC is designed to work with all HyPerforma control systems. Its compact assembly provides standard mass fl ow controllers and associated solenoid valves. When connected, the TruFlow Gas MFC is instantly recognized by TruBio software to provide precise control of gas fl ow, without requiring any confi guration, even at extremely low fl ow rates.

TruFlow Gas MFC key features• Variety of fl ow rate options*

• Flow range confi gurability

• Plug-and-play connectivity

TruFlow Gas Mass Flow Controller (MFC)Strategic gas management

TruFlow gas MFC specifi cations

Enclosure dimensions (H x W x D)

Six mass fl ow controllers: 9.1 x 7.4 x 6.2 in.

Rating NEMA 5, IP 51 (liquid wipedown)

Maximum gas fl ow rate Confi gurable up to 30 L/min*

Weight/shipping weight 5.8 kg/9.1 kg (12.8 lb/20 lb)

Operating temperature 5ºC to 40ºC (41ºF to 104ºF)

Storage temperature –25ºC to 70ºC (–15ºF to 158ºF)

Relative humidity 5% to 95% (noncondensing)

Certifi cations CE: EN-61326 and EN-61010

Inlet pressure 1.6 to 2.3 bar/25 to 35 psig

Outlet pressure 0 to 1.38 bar/0 to 20 psig

Accuracy±0.8% of fl ow rate and ±0.3% full scale (Burkert)

Repeatability ±0.1% full scale (Burkert)

Cable assembly 2 m (6 ft) standard

TruFlow gas MFC fl ow rate (L/min)

Glass Rocker

Volume 1 L 3 L 7 L 15 L 10 L 20 L 50 L

Air-sparge 0.25 0.5 2 5 NA NA NA

Air-overlay 0.5 2 5 10 20

O2 0.25 0.5 2 5 NA NA NA

CO2 0.1 0.25 0.5 2 10

N2-optical 0.1 0.25 0.5 2 NA NA NA

MFCs with fl ow rates higher than 50 L/min are mounted as individual units and are not part of the main MFC block.* May require additional confi guration for specifi c fl ow rate. Please consult with your local Thermo Fisher sales representative for more information.

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TruBio Bioprocess Control SoftwareAutomation software and control solutions

TruBio Discovery softwareThis software solution combines power of TruBio software in defi ning process control strategies along with DeltaV automation for non-GMP laboratory applications. It provides a simplifi ed solution to help meet the needs of discovery research and process development labs while providing the benefi t of transferring to processes requiring a higher level of qualifi cation and control. It utilizes a single workstation-based controller to execute process control strategies, which is typically assigned to a physical controller such as the Thermo Scientifi c™ TruLogic™ controller, thereby reducing footprint.

TruBio Software with the conventional DeltaV platformTruBio Bioprocess Control Software with the conventional DeltaV platform and the TruLogic controller is preconfi gured with algorithms for controlling bioprocess parameters and feed strategy. With multiple sensor loops as well as gas and liquid addition capability, this software can be used with both Thermo Scientifi c™ HyPerforma™ Single-Use Bioreactors (S.U.B.s) as well as other third-party bioreactors to provide process control from research through commercial manufacturing.

TruChrom and TruPur softwareBased on the same robust, validated platform as TruBio software, TruChrom and TruPur customizable software platforms are designed specifi cally to control common third-party chromatography and purifi cation skids. This allows for integration and control of downstream processes to help ensure transferability of data throughout the workfl ow.

Thermo Scientifi c™ TruBio™, TruChrom™, and TruPur™

automation software powered by the Emerson DeltaV Distributed Control Platform facilitate easy integration of multiple vessels to help streamline process control and data management from research to production-scale applications—combining robust data transferability, ease of scale-up processes, and intuitive technology. Partner these with Thermo Scientifi c controllers to create a complete system to aggregate process data via a singular, robust DeltaV historian.

This standard control platform and software interface can help to minimize the engineering eff ort and time spent when navigating through the process stages of vaccine production and biomanufacturing—when speed to market is often what diff erentiates leaders from the competition within the industry. These highly confi gurable software solutions provide a unifi ed and seamless data aggregation and control user experience throughout upstream and downstream workfl ow processes.

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TruBio software capabilities

Basic operations Control and settings Calibration

• Key parameter display on configuration page

• Analyzer data entry pages

• Vessel settings

• Backup and restore procedure

• User access configuration

• Online parameter update

• 21 CFR Part 11 compliance*

• pH control

• Dissolved oxygen (DO) control

• Weight control

• Auxiliary input control

• Agitator speed control

• Gas flow control

• Pump control

• Foam and level control

• Vent heat control

• pH sensor: one-point, two-point (applicable only to electrochemical sensors, not for single-use sensors)

• DO sensor: one-point, two-point

• Temperature sensor: one-point, two-point

• Pressure sensor: one-point

• Pump

• Agitator speed: one-point, two-point

• Vessel weight: zero, tare

• Auxiliary input

Alarm management Process data control Miscellaneous

• Alarm configuration

• Alarm priorities

• Continuous historian

• Audit trail*

• Alarm and events

• Interlock configuration

Software comparison specifications

TruBio Discovery Software TruBio Software with Conventional DeltaV Platform

Communication limits (number of vessels per workstation)

4 units (vessels) per workstation • DeltaV™ MQ control module: up to 4 units

• DeltaV™ MX control module: up to 8 units

Footprint 178 x 127 x 152 mm (7 x 5 x 6 in.)

610 x 203 x 610 mm (24 x 8 x 24 in.)

Supported vessel size ≤50 L No set vessel size limit

Applications • Cell culture

• Process development scale cell expansion

• Early drug lifecycle phase

• Cell expansion

• Clinical

• Pilot launch

• Commercial manufacturing (applicable for both GMP and non-GMP environments)

Communication protocol Supports multiple communication protocols, which further enables open architecture

Modbus™, DeviceNET™, Profibus™ DP, traditional I/O module

Scan times 2x faster than TruBio Discovery software controller architecture

Architecture Workstation model: uses vEIOC card gateway box

Uses physical TruLogic controller that hosts a DeltaV MQ or MX controller

NOTE: TruBio Discovery software and TruBio software with the conventional DeltaV Platform employ different licensing from Emerson and hence cannot mixed or put on the same network.

* Not available for TruBio Discovery software.

Restrictions and limitations:• DeltaV Discovery software and the conventional DeltaV platform cannot coexist on the same network due to licensing limitation from Emerson.

• Life science laboratory applications must be non-production, non-GMP, with no products made for human consumption.

• No audit trail configuration or controller redundancy.

TruChrom and TruPur software are fully customized to meet your specific chromatography and purification needs. Please contact your Thermo Fisher sales representative for more information.

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Thermo Scientifi c™ HyPerforma™ Glass Bioreactors are available in 1 L, 3 L, 7 L, and 15 L sizes. They off er easy operation and rapid assembly and are manufactured with the highest standards for materials and surface fi nish. Developed using a computational fl uid dynamics (CFD) simulator, the HyPerforma Glass Bioreactor impellers provide maximum mixing with minimum shear force, resulting in a higher average kLa. The cold fi nger has been replaced by a cooling loop to increase the thermal surface area. Laboratory performance tests have demonstrated a cooling rate two times better than a sample of products from other suppliers. Control can be bidirectional, which allows a single-wall vessel to be used for mammalian applications and fermentation processes* (needs two kits).

HyPerforma Glass Bioreactor key features• The motor adapter uses coupling windows and an

alignment marker for easy assembly

• Ergonomic head plate design provides easy assembly and disassembly of components for rapid reconfi guration

HyPerforma Glass Bioreactors

Accessories• Kits to help enable the end user to confi gure the vessel

according to the intended use

• Heating blanket: designed for rapid thermal transfer; a bimetallic temperature-limiting switch embedded in the blanket helps protect against overheating or fi res

• Common accessories kit: includes blind stoppers for vessel reconfi guration

* Requires additional components. Please consult with your Thermo Fisher sales representative for more information.

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HyPerforma Glass Bioreactor specifi cations

Size 1 L 3 L 7 L 15 L

Vessel height 206.5 mm (8.1 in.) 256.5 mm (10.1 in.) 390.5 mm (15.4 in.) 463.5 mm (18.3 in.)

Vessel stand + motor height 281.5 mm (11.1 in.) 330 mm (12.9 in.) 465 mm (18.3 in.) 580 mm (22.8 in.)

Vessel diameter 160 mm (6.3 in.) 190 mm (7.5 in.) 220 mm (8.7 in.) 320 mm (12.6 in.)

Vessel stand diameter 160 mm (6.3 in.) 190 mm (7.5 in.) 240 mm (9.5 in.) 340 mm (13.4 in.)

Total volume 1.5 L 3.2 L 7.4 L 17.5 L

Working volume 1 L 2 L 5 L 10 L

Minimal working volume ~0.3 L ~1.2 L ~2.8 L ~6.0 L

Weight 8.6 lb 11.6 lb 17.4 lb 51.4 lb

Voltage 120 V/240 V

Material Borosilicate glass, 316L stainless steel, silicone

Drilled pipe sparger 5 holes (0.8 mm) 7 holes (0.8 mm) 13 holes (0.8 mm) 23 holes (0.8 mm)

Ring sparger NA18 holes (0.85 mm)

42 holes (0.85 mm)

90 holes(0.85 mm)

Frit pore spargerPore size: 12–15 µm Length: 7 mmDiameter: 7.9 mm

Pore size: 12–15 µm Length: 7 mmDiameter: 7.9 mm

Pore size: 12–15 µm Length: 18 mmDiameter: 7.9 mm

Pore size: 12–15 µm Length: 25.4 mmDiameter: 12.7 mm

Heat only Heating blanket (110 W)

Heat and cool1.32 kW heat + 0.18 kW (at 20ºC) water bath cool

1.32 kW heat + 0.3 kW (at 20ºC) water bath cool

Cooling loop solenoid valve cable assembly: 1 m (3 ft)

Optional scaleAnalog™ Benchtop, Combics™ Series, 15 kg x 0.5 g (16 bit) or 15 kg x 8 g (12 bit), 254 x 254 mm, CAPS1U-20CC-LU

Analog™ Benchtop, Combics™ Series, 30 kg x 1 g (16 bit) or x 15 g (12 bit), 457 x 457 mm, CAPS1U-50EE-LU

Indicator with optional scale Midrics 2, IP65, display, MIS2UR-V2

Resistance temperature detector (RTD)

Temperature sensor assembly, RTD to 5 pin, 3 ft (G3Lab Controller, glass)

Foam sensor cable assembly 1 m (3 ft)

Cable assembly with optional scale Analog output: 6 m (19.6 ft), 1 cable per scale indicator

Agitator kitTriple-stack motor (adapter included)

Agitator assembly: Teknic™ NEMA 23 Single to HyPerforma Glass BioreactorCable assembly: 2 m (6 ft)

Agitator speed 1,250 rpm (set as default); can be confi gured to lower values via TruBio software

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The Thermo Scientifi c™ HyPerforma™ Rocker Bioreactor brings control and measurement to rocking bioreactor applications. The rocker is controlled by a HyPerforma G3Lab Controller and TruBio software, providing a complete solution for research, process development, or seed train production applications. The rocker uses a Thermo Scientifi c™ Rocker BioProcess Container (BPC), which provides up to 25 L of working volume and integrates a novel Thermo Scientifi c™ TruFluor™ pH+dO2

sensor for combined pH, DO, and temperature monitoring.

Key features• Compatible with most cell culture applications

• Rocking motion is confi gurable—from a smooth waveform that minimizes shear forces for sensitive cell lines, through four intermediate steps, to an aggressive motion that maximizes oxygen transfer for robust cells with high oxygen demands

• Quick, simple setup with G3Lab Controller and TruBio software

• Optional tray adapter allows the use of 10 L and 20 L BPCs

HyPerforma Rocker Bioreactor

• Each BPC is available in 10 L, 20 L, and 50 L sizes,and is delivered with all relevant certifi cates, gamma-irradiated (25 to 40 kGy) and conforming to USP Class 6 specifi cations

• Standard service packages

• cGMP-compliant capabilities

• Load cell for weight control

• TruFluor pH+dO2 sensor provides measurement and control of critical process parameters: pH, DO, and temperature

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HyPerforma Rocker Bioreactor and BPC specifi cations

Rocker Bioreactor BPC sizes 10 L 20 L 50 L

Rocker BPC dimensions549.4 x 330.2 mm(21.6 x 13.0 in.)

549.4 x 660.1 mm(21.6 x 26.0 in.)

711.2 x 723.9 mm(28.0 x 28.5 in.)

Working volume 5 L 10 L 25 L

HyPerforma RockerRocker bioreactor assembly, load cell, GMP, stainless steel (includes rocker base, tray base, 50 L tray)

Bag adapter 10 L/20 L BPC mounting adapter for 50 L rocker tray

Heat only BPC fi lter heater (quantity: 2)

Dimensions (H x W x D)264 x 782 x 701 mm (10.4 x 30.8 x 27.6 in.); 490 x 835 x 712 mm (19.3 x 32.9 x 28.0 in.) with cover

Weight (base + tray) 38.5 kg (85 lb)

Rocking angle 2° to 12° per side

Rocking rate 2 to 40 cycles per minute

Electrical power 110–120 V, 220–240 V, 50/60 Hz, powered by the G3Lab Controller


Storage temperature –40°C to 70°C (–40°F to 158°F)

Humidity 5% to 95%, noncondensing

Acoustic noise level <70 dBA

pH sensor range pH 5.5 to 8.5

pH sensor relative accuracy±0.1 pH units over calibration range after a 2-point calibration having 0.3 to 0.8 pH units of separation

DO sensor range (percent saturation) 0% to 250%

DO sensor limit of detection 0.03% O2

DO accuracy At 25°C: ±1.1% at 20.95% O2

Temperature 10°C to 45°C (50°F to 113°F)

Temperature accuracy ±0.15°C at 15°C to 40°C (±0.25°F at 59°F to 104°F)

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We provide reusable sensors with high reliability and superior performance for cell culture and fermentation process monitoring. Thermo Scientifi c™ TruDO™ and TrupH™

sensors have been specifi cally designed to minimize drift in bioprocess environments, undergo sterilization cycles, and help ensure measurement consistency from batch to batch. We also provide material certifi cates and lot traceability for cGMP applications.

TruDO and TrupH sterilizable sensors

Sensor specifi cations

TrupH K8 TrupH VP6 TruDO Optical TruDO (12 mm, 25 mm)

Measurement Electrochemical Electrochemical Optical phase shift Polarographic

Range pH 0–14 pH 0–144 ppb to 300% saturation

10 ppb to 200% saturation

Max precision range pH 2–12 pH 2–12 – –

Temperature0°C to 135°C(32°F to 275°F)

0°C to 135°C(32°F to 275°F)

0°C to 130°C(32°F to 266°F)

0°C to 135°C(32°F to 275°F)

Pressure 6 bar (87 psi) max 6 bar (87 psi) max 12 bar (174 psi) max 4 bar (58 psi) max

Connection PG 13.5 PG 13.5 PG 13.5 PG 13.5

Connector type K8 VP6 VP8 D4, VP6

Sensor cable length (vessel size: 1 L)

120 mm (4.7 in.) 120 mm (4.7 in.) 120 mm (4.7 in.) 120 mm (4.7 in.)







Wetted material Glass Glass316L stainless steelUSP Class VI silicone

316L stainless steel

Temperature compensation NA NA 22 Kohm thermistor 22 Kohm thermistor

Surface fi nish NA NA Electropolish RA12 Electropolish RA12

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The TruFluor pH+dO2 sensor contains single-use sensors for dissolved oxygen, pH, and temperature, in a compact assembly that is welded securely into a single-use benchtop bioreactor.

• Compliant with USP Class 6, free of animal-derived components

• Leverages TruFluor™ pH and DO sensor technology in a compact precalibrated assembly

• Incorporates TruFluor 316L stainless steel thermal window for highly accurate readings

TruFluor pH+dO2 Single-Use Sensor and Reader

pH+dO2 sensor specifi cations

pH DO


Operating pressure (typical) 1 bar (14.7 psig)

Storage temperature 0°C to 60°C (32°F to 140°F)

Storage relative humidity 10% to 90% (noncondensing)

Altitude 12,192 m (40,000 ft)

Materials USP Class 6 and 316L electropolished stainless steel

Sample rate settings 1 sec to 30 min

Measuring range pH 5.5 to 8.5 0 to 52.5% O2 ; 0 to 250% air saturation

Limit of detection (O2 only) NA 0.03% O2

Relative accuracy (pH only)±0.1 pH units over calibration range after 2-point calibration using 0.3 to 0.8 pH units of separation

NA

Accuracy NA At 25°C: ±1.1% at 20.95% O2

Response time (T90 agitated) <60 sec <40 sec

Drift (21 days)<0.05 pH units for a standard process (5 sec sampling rate)

NA

CalibrationPrecalibrated (chip) 2-point calibration required prior to operation, 1-point standardization available

Precalibrated (chip) 1-point standardization, or 2-point calibration optional

Gamma irradiation 26 to 38 kGy is the standard range

Cross-sensitivity Isopropyl alcohol plus waterOrganic solvents (e.g., toluene, acetone, benzene, methylene chloride), sulfur dioxide, and chlorine gases

Temperature accuracy ±0.25°C between 4°C and 45°C; ±0.15°C between 15°C and 40°C

Temperature precision ±0.1°C

Find out more at thermofi sher.com/automationsoftware

For Research Use or Further Manufacturing. Not for diagnostic use or direct administration into humans or animals. © 2019 Thermo Fisher Scientifi c Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientifi c and its subsidiaries unless otherwise specifi ed. Combics is a trademark of Sartorius AG. DeviceNET is a trademark of ODVA, Inc. Emerson and DeltaV are trademarks of Emerson Process Management. Modbus is a trademark of Microsoft Corporation. Profi bus is a trademark of Profi bus. Teknic is a trademark of Teknic Incorporated. Watson-Marlow is a trademark of Watson-Marlow Fluid Technology Group. COL23660 0919

Consistent, accurate data management should play an important role for organizations and individuals in bioprocessing process development and scale-up. Dedicated data management platforms and automation solutions are a vital component of data governance, and We off er fl exible TruBio software solutions powered by the Emerson DeltaV Distributed Control Platforms—to help manage your mammalian cell culture and microbial fermentation processes.

Consistent, accurate data management

Robust data management helps to mitigate risks during all stages in biopharmaceutical scale-up. Effi cient, process-specifi c measuring of critical parameters as well as the aggregation of this data enables you to get your fi nal product to market quickly. We help you focus on your process optimization and scale-up, rather than worry about the software tools needed to get you there.

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