recirculating mixer system single-use bioprocess rev3 · 2019-05-29 · plc (2 digital in/outputs,...

Features• Up to 3000-liter mixing volume

• Quick and simple bag installation

• Standard single-use mixing bags with 3-port design or a customized solution

• Magnetically driven, single-use centrifugal pump head integrated with the single-use mixing bag

• Integrated load cell for weighing of media (optional)

• Venturi port for fast and simple powder/liquid addition (optional)

• Mixing bags gamma stable up to 40 kGy

• Contract testing and development for end-user process

• Open or closed system mixing

Benefits• Faster than traditional single-use mixing

systems

• Simple operation provides ease of use

• Low cost of ownership, flexibility to use multiple carts with a single control unit

• Easy bag deployment simplifies the filling process

• Saint-Gobain standard validation packages available for all single-use component materials

Simple and Effective Mixing SolutionsThe Single-Use Bioprocess Recirculating Mixing System (SURM) from Saint-Gobain has been developed to create a simple and effective single-use mixing alternative for biopharmaceutical applications. The innovative design utilizes an externally mounted pump to recirculate and mix the fluid in a single-use bag system. The pump on the revolutionary mixing system has no bearings to wear out or seals to break. Utilizing magnetic levitation, the pump's impeller is levitated inside a sealed casing and driven by the magnetic field of the motor — resulting in zero particle generation.

The portable control unit allows for use on multiple carts, reducing capital investment while maximizing system flexibility. The fully validated, single-use mixing system ensures a robust system for either liquid/liquid or powder/liquid mixing needs.

The mixing system offers maximum flexibility and product security. Choose from a standard range of products or work with our team of engineers to develop a customized solution for your application.

Applications• Buffer and media preparation and storage• Cell culture and centrifuge transport• Harvest hold and clarification operations• Chromatography and concentration operations• Product pooling• Media distribution

Single-Use Bioprocess Recirculating Mixing System

(SURM)

Saint-Gobain Life Sciences – Bioprocess Solutions

FLS-5243J-0519-BPS ©2019 Saint-Gobain Life Sciences

Pump Drive Unit with Single-Use Pump Head


Cart Powder/Liquid Venturi Port (Optional)

Control Unit Single-Use Bag (Inside)Tote

(500L pictured)


SURM Frames/TanksMaterials of construction

Frame 304 stainless steel

Tank (internal body) 304L stainless steel

Tank (external body) 304 stainless steel

Casters Polyurethane 75D

Overall Dimensions H x L x W in (cm)

200L 50 (125) x 61 (153) x 34 (85)

500L 57 (143) x 61 (153) x 40 (100)

1,000L 74 (185) x 61 (153) x 47 (118)

2,000L 101 (254) x 64 (162) x 52 (130)

3,000L 133 (333) x 64 (162) x 52 (130)

Weight - empty (w/o jacket) lb (kg)

200L 610 (277)

500L 630 (286)

1,000L 820 (372)

2,000L 1160 (526)

3,000L 1480 (671)

Weight - empty (w/jacket) lb (kg)

200L 650 (295)

500L 900 (408)

1,000L 1240 (563)

2,000L 1560 (708)

3,000L 2070 (939)

Weight - working (w/o jacket) lb (kg)

200L 1050 (476)

500L 1740 (790)

1,000L 3020 (1370)

2,000L 5570 (2527)

3,000L 8090 (3670)

Weight - working (w/jacket) lb (kg)

200L 1090 (494)

500L 2000 (907)

1,000L 3440 (1560)

2,000L 5970 (2708)

3,000L 8680 (3937)

Jacket fluid volume (approximate) gal (L)

200L 1.6 (6)

500L 2.6 (10)

1,000L 5.3 (20)

2,000L 5.3 (20)

3,000L 10.8 (41)

Maximum working pressure 150 psi @ 150°F

ASME U-1 code stamped Included on jacketed units

Load cells (optional) Mettler Toledo SWB505 MultiMount™ Model #0745A

Ingress protection rating IP68

Load cell readout display(optional)

Mettler Toledo IND 331 part #: 33H100000A00A00

Console (for 200L, 500L, and 1000L SURM's)

Materials of construction

Enclosure Coated polyurethane

Seals Polyurethane, EPDM, silicone

Display Glass

Back panel Coated aluminum

A2/A4 screws Inox

Weight lb (kg) 29.3 (13.3)

Electrical

Supply voltage 100 – 240 VAC ±10%, 47-63 Hz

Current 6.1 – 2.5 A ±10%

Power 650W

Interfaces

Multi-touch screen, 7” 2 pressure sensors 1 flow sensor 1 temperature sensor PLC (2 digital in/outputs, 1 analog in/output) RS232 LAN USB

Power cable

Length ft (m) 9.8 (3)

Ingress protection rating IP66 rating of connector on console side


Cleaning agents Isopropanol or water

Washdown limit Up to 40 L/min

PLC

2 digital outputs 2 digital inputs 1 analog output (4-20 mA) 1 analog input (4-20mA) Note: All signals isolated

Wall mounting information

Number of threads 4

Thread diameter M5

Thread depth 9mm

Maximum torque 1.5Nm

Thread distance 290mm x 310mm

Weight - w/o cables lb (kg) 28.4 (12.9)

Console (for 200L, 500L, and 1000L SURM's) continuedRegulatory information

CE Marking

NRTL certified motor controller NRTL certified AC/DC power supplies European directive conformance: Machinery Directive 2006/42/EC Low Voltage Directive 2014/35/ ECEMC Directive 2014/30/EC

IECEE CB Safety Certification

Certified by Electrosuisse following the IECEE CB Scheme according to the following safety standards: IEC61010-1: Safety requirements for electrical equipment for measurement, control and laboratory use CB certification number: CH-8454

NRTL/ETL Safety Certification and Marking

Tested by the US Nationally Recognized Testing Laboratory (NRTL) Intertek according to the following safety standards: UL61010-1: Safety requirements for electrical equipment for measurement, control and laboratory (US Standard) CSA-C22.2 No. 61010-1-12: Safety requirements for electrical equipment for measurement, control and laboratory use (Canadian Standard) ETL control number for listing: 4010272

General environmental conditions

Usage Indoor (laboratory, industrial environments)

Altitude Up to 2000m

Operating ambient temperature 10 to 40 °C

Storage ambient temperature (transportation extremes) -20 to 70 °C

Operating humidity range (relative humidity) 15 – 95% (non-condensing)

Storage humidity range (relative humidity) (transportation extremes)

15 – 95% (non-condensing)

Normal storage conditionsAmbient temp.: 20 to 30 °C Relative humidity: 50% (non-condensing)

Mains supply fluctuations ± 10% of nominal voltage

Transient over-voltages typically present in mains supply

Surge immunity according to EN 61000-4-5

Pollution degree 2

Console (for 2000L and 3000L SURM's)


Enclosure Polypropylene

Seals Polyurethane

Display Glass

Back panel Coated aluminum

A2/A4 screws Inox

Weight lb (kg) 3.5 (1.6)

Electrical

Supply voltage 24 VDC

Power 30W or 160 W

Interfaces

Multi-touch screen 7” 2 pressure sensors 1 flow sensor 1 temperature sensor PLC (2 digital in/outputs, 1 analog in/output) RS232 LAN USB

IP Adaptor Cable Hybrid ft (m) IP40


PLC

2 digital outputs 2 digital inputs 1 analog output (4-20 mA) 1 analog input (4-20mA) Note: All signals isolated.


Number of threads 4

Thread diameter M4

Thread depth 8mm

Maximum torque 0.6nM

Thread distance 170mm x 114mm

Weight - w/o cables lb (kg) 3.5 (1.6)

Regulatory information

CE marking

European directive conformance: Machinery Directive 2006/42/EC Low Voltage Directive 2014/35/EC EMC Directive 2014/30/EC

General environmental conditions

Usage Indoor (laboratory, industrial environments)

Altitude Up to 2000m

Operating ambient temperature 10 to 40 °C

Storage ambient temperature (transportation extremes) -20 to 70 °C

Operating humidity range (relative humidity) 15 – 95% (non-condensing)

Storage humidity range (relative humidity) (transportation extremes)

15 – 95% (non-condensing)

Normal storage conditionsAmbient temp.: 20 to 30 °C Relative humidity: 50% (non-condensing)

Transient over-voltages typically present in mains supply

Surge immunity according to EN 61000-4-5

Pollution degree 2



Pump Motor


Motor body Epoxy (anti-corrosive) coated aluminum, waterproof

Pump head socket Anodized aluminum

Cables PVC jacket


Connectors 2x circular (M23)


ATEX / IECEx

Certification Category 3G and 3D (Zone 2 for Gas and Zone 22 for Dust)

Thermal classification T4 (< 110 ⁰C = 230 ⁰F) for maximum liquid temperature of 90 ⁰C / 194 ⁰F

Marking of motor with pump head CE Ex II 3G Ex c nAc IIC 110°C (T4) CE Ex II 3D Ex c tc IIIC T110°C IP67

Explosion groups

Group IIA: Propane (IPA), Methane, Acetone, Acetaldehyde Group IIB: Ethylene, Ethylenglycol Group IIC: Acetylene, Hydrogen (not carbon disulphide)

Corresponding UL classification Hazardous location Class 1 Division 2

Control Box (for 2000L and 3000L SURM's)


Enclosure Stainless steel (1.4404/316L)

Seals EPDM

Weight 34.8 (15.8)

Electrical

Supply Voltage 1 x 200 – 240 ± 10% or 3 x 200 – 240 ± 10%

Current 1 x 13.5 - 11.0 A ± 10% or 3 x 8.5 - 8.0 A ± 10%

Power 2100 W, 50/60 Hz

Interfaces RS232 to LCO-i100 (including 24VDC supply, fan cooling module

Power cable (open wire) 1-phase or 3-phase




Number of threads 6

Thread diameter M8

Thread depth 9mm

Thread distance 310 ± 1mm, 360 ± 1mm

Regulatory information

CE Marking NRTL certified motor controller NRTL certified circuit breakers and European directive conformance: Machinery Directive 2006/42/EC Low Voltage Directive 2014/35/EC EMC Directive 2014/30/EC

IECEE CB Safety Certification Certified by Electrosuisse following the IECEE CB Scheme according to the following safety standards: IEC61010-1: Safety requirements for

electrical equipment for measurement,

control and laboratory use CB certification number: CH-10393

NRTL/ETL Safety Certification and Marking

Tested by the US Nationally Recognized Testing Laboratory (NRTL) Intertek according to the following safety standards: UL61010-1: Safety requirements for

electrical equipment for measurement,

control and laboratory (US Standard)

CSA-C22.2 No. 61010-1-12: Safety

requirements for electrical equipment

for measurement, control and

laboratory use (Canadian Standard)

ETL control number for listing: 4010272

Flow Meter (for 200L, 500L, and 1000L SURM's)Flow range 0-80 lpm

Clamp shape 22 mm

Calibrated liquid Water @ 20°C / 37°C

Calibrated tubing Silicone / C-Flex®

Tube: ID x OD ID = 3/4” (19.05 mm) OD = 1” (25.4 mm)

Accuracy of reading ±3 %

Weight 327 g

Maximum Fluid Pressure (max. pressure of tube might limit this value)

4 bar

Pressure Drop Coefficient C ∆P = C x Q2 , (for water) Q = Flow [l/min], ∆P = Press. Drop [kPa = 10 mbar]

1.58*10-4 at 20°C and 1.47*10-4 at 37°C

Note: Pressure coefficient accounts only for the clamp length

Fluid Temperature 10–60 ⁰C (50–140 ⁰F)

Ambient Temp. 0– 40 ⁰C (32-104 ⁰F)

Standard Tube Material C-Flex® 1 (Types: 374, 072 and 082) and Silicone (Pharma 50, 65 and 80)

Kinematic Viscosity 0.7 – 10 mm2/s (0.7 – 10 cSt)

Sound Speed 1300 – 1700 m/s (others on request)

IP Classification IP-65 (for connected sensor)

Allowed Cleaning Wiping with IPA or water


Flow Meter (for 2000L and 3000L SURM's)Flow range 0-160 lpm

Clamp shape 29.5 mm

Calibrated liquid Water @ 20°C / 37°C

Calibrated tubing Silicone / C-Flex®

Tube: ID x OD ID = 1” (25.4 mm) OD = 13/8” (34.9 mm)

Accuracy of reading ±3 %

Weight 502 g

Maximum Fluid Pressure (max. pressure of tube might limit this value)

3 bar

Pressure Drop Coefficient C ∆P = C x Q2 , (for water) Q = Flow [l/min], ∆P = Press. Drop [kPa = 10 mbar]

3.9*10-5 at 20°C and 3.5*10-5 at 37°C

Note: Pressure coefficient accounts only for the clamp length

Fluid Temperature 10–60 ⁰C (50–140 ⁰F)

Ambient Temp. 0– 40 ⁰C (32-104 ⁰F)

Standard Tube Material C-Flex® 1 (Types: 374, 072 and 082) and Silicone (Pharma 50, 65 and 80)

Kinematic Viscosity 0.7 – 10 mm2/s (0.7 – 10 cSt)

Sound Speed 1300 – 1700 m/s (others on request)

IP Classification IP-65 (for connected sensor)

Allowed Cleaning Wiping with IPA or water

Cooling Fan (for 2000L and 3000L SURM's)

Materials of construction Polypropylene (+ 20% Talkum)

Electrical

Supply Voltage 24 VDC

Power 33.5 W

Power cable


Ingress protection rating IP65 (fan is IP68)

Single-Use Pump Head

Materials of constructionPolypropylene (FDA, USP Class VI, BSE/TSE/Animal free)

Wet volume 113 ml - 200, 500, 1000L SURM's 260 ml - 2000, 3000L SURM's

Wet surface 370 cm2 - 200, 500, 1000L SURM's 635 cm2 - 2000, 3000L SURM's

Connections 1" sanitary triclamp

Maximum flow rate L/min (gal/min)

75 (20) - 200, 500, 1000L SURM's 140 (37) - 2000, 3000L SURM's

Maximum pressure differential bar (psi)

3.1 (45) - 200, 500, 1000L SURM's 4.3 (62.4) - 2000, 3000L SURM's

Maximum viscosity 50 cP

Sterilization Gamma radiation up to 40 kGy

Biocompatibility/physicochemical suitability (wet materials)

FDA

According to a written statement of the raw material supplier the used polypropylene meets the FDA requirements outlined in the Code of Federal Regulations 21 CFR 177.1520(a)(3)(i) and (c)3.1a. Furthermore all other ingredients used in the formulation meet their respective FDA regulations and 21 CFR 177.1520(b). Specifically, this product meets the FDA criteria for food contact.

Animal Free and BSE/TSE

The supplier of the raw material made a written statement that it doesn’t use tallow or any other animal derived materials in the manufacture or formulation of the used polypropylene resin. Hence the resin can also be considered BSE/TSE free.

USP Class VI (USP <88>)

The supplier of the raw material confirmed with certification of a 3rd party test institute that the used polypropylene was tested in Vivo by a USP systemic toxicity study in mouse, USP intracutaneous toxicity study in rabbit and a USP muscle implantation study in rabbit. The results confirm that the test article extracts meet the requirements of a USP Plastics Class VI.

Cytotoxicity per ISO 10993-5

The supplier of the raw material confirmed with a test report of a 3rd party test institute that the used polypropylene was tested in Vitro according to the guidelines outlined in ISO 10993-5. The extracts from the test articles showed no evidence of causing cell lysis or toxicity.

Endotoxin per USP <85>

A test report per USP <85> has been received by the supplier showing that testing on resin pallets of the wet material resulted in an Endotoxin value < 0.05 EU/g.

Physicochemical per USP <661>

The supplier of the raw material confirmed with a test report that the used polypropylene was tested per USP <661> concerning nonvolatile residues, extractable heavy metals and buffering capacity. The results show that the extracts of the test article were below the limits stated in USP <661>.


FLS-5243K-0519-BPS ©2019 Saint-Gobain Life Sciences

Saint-Gobain Life Sciences 15301 Highway 55

Plymouth, MN 55447 Tel: (763) 398-1560 Fax: (763) 398-1589

www.biopharm.saint-gobain.com

IMPORTANT: It is the user’s responsibility to ensure the suitability and safety of Saint-Gobain Life Sicences products for all intended uses and that the materials to be used comply with all applicable regulatory requirements. Saint-Gobain Life Sciences assumes no responsibility for any product failures that occur due to misuse of the materials it provides arising out of the design, fabrication or application of the products into which the materials are incorporated.

WARRANTY: Except for products which have a specific written warranty, Saint-Gobain Life Sciences products are sold without and guaranty and/or warranty. The only obligation under any applicable product warranty will be to replace any portion proving defective, or at our option, to refund the purchase price thereof. SAINT-GOBAIN LIFE SCIENCES DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

Contact us today for:Consultations • Samples • Quotes • Orders

Ordering Information

Standard Jacket Load Cells Jacket + Load Cells

Mix

ing

Vo

lum

e

200

L

RXCARTR0200 RXCARTR0200J RXCARTR0200LC RXCARTR0200JLC

500

L


1,0

00

L


2,0

00

L


3,0

00

L


SURM Hardware

Description Part Number

Venturi funnel - SS RX-FBFUNNEL-SS

Venturi funnel - PP (gamma irradiated)

RX-FBFUNNEL-G

Venturi ball valve - PP (gamma irradiated)

RX-VENTURIBV-G

4" component addition funnel (gamma irradiated)

RX-FUNNEL4-G

Description Part Number

200L SURM Mixing Bag RX0200LR

200L SURM Mixing Bag w/Venturi tee RX0200LR-V





1000L SURM Mixing Bag w/2000 series pump head

RX1001LR

1000L SURM Mixing Bag w/Venturi tee and 2000 series pump head

RX1001LR-V



Standard Single-Use SURM Mixing Bags Optional SURM Accessories

recirculating mixer system single-use bioprocess rev3 · 2019-05-29 · plc (2 digital in/outputs,...

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