Multi-Use Batch Chromatography Systems

Multi-Use Batch Chromatography Systems

The Sartorius Resolute® multi-use chromatography systems are configurable automated systems with proven scalability, accompanied by extensive support pre and post-sales. Resolute® multi-use systems offer robust configurable stainless-steel-based solutions. High precision industry-standard sensors allow for wide operational flow rates and in-line dilution options.

Find the Right Solution for Your Chromatography Process

Attributes

Resolute® Flowdrive MU

Resolute® Flowdrive ATEX

Scale of operation 


Pilot, Clinical and Commercial manufacturing

Pilot, clinical and commercial manufacturing

Automation 

Common chromatography software

Footprint

≥990x1300mm

Application

Isocratic and gradient batch chromatography

Isocratic and gradient batch chromatography in explosive environments

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Resolute® Flowdrive MU

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Resolute® Flowdrive MU provides an established portfolio of standard and customized products from clinical development to commercial manufacturing. The systems cover a full range of applications with the highest standards in design and operation. Besides isocratic separations, they can run precision gradients and perform in-line dilution. Resolute® Flowdrive MU systems are capable to process both columns and membrane chromatography.

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Key Features: 

  • Industry standard instrumentation

  • High quality manufacturing standards

  • Operator focused software and imbedded specific analytical tool are optimized for clinical and commercial manufacturing to GMP

  • Process focused engineering design to meet customer needs (backed up by rigorous project management from process engineers)


We provide process solutions with both standardized and fully customized products, and offer comprehensive local support wherever the location.

Each Resolute® Flowdrive MU is designed to provide:

  • Conformance to critical industry standards
  • GAMP compliant Software enable high flexibility
  • Run-to-run reproducibility
  • Wide performance operating range


High Quality Material and Construction

  • Stainless steel 316L (other grades on request) pipework and internal surface finish to 0.4 µm (16µ inch) + electropolish ensures system cleanability
  • Full documentation package to ensure GMP standards


Flexible and Proven, User-friendly Software

  • Designed for full Data Integrity (CFR21 Part 11)
  • Automation using convenient and flexible recipes
  • Override of automated functions where required
  • Simple but comprehensive intuitive screen display with touch screen and keyboard operation
  • Analytic tool enables calculation of column evaluation parameters such as: HETP, peak asymmetry, and transition analysis.
  • Configurable to meet user requirements for batch data reporting and comparison.
  • Availability to demonstrate systems at our facilities

  • Dedicated chromatography support through our process specialists

  • Pre-sale consulting from experiences engineers

Hardware Features and Benefits

Sanitary Multi-port Valve TechnologyReduces dead-legs to a minimum
Compacts flow path
316L Stainless Steel Wetted Flow PathRobust, chemically-resistant flow path
In-line valve fabrication minimizes clamp connections
Two-pump Gradient and In-line DilutionPrecise in-line mixing
Fast accurate step and gradient formation
Designed for CIPTurbulent Flow velocities achievable in pipe work
Extended temperatures possible
Flow through InstrumentationInstrumentation flow cell in-line, eliminating dead-legs and minimizing hold-up volume  
Industry Standard InstrumentationReliable monitoring and control of process conditions 
Conformance to ASME, BPE

Major components designed for conformance to BPE for inherent sanitary design

FDA Conforming Non Metallic Parts

Validation and compatibility with pharmaceutical manufacturing requirements

System DrainPost-pump system fully drainable for storage 
Diaphragm Pump (4-piston)

Pump head design gives virtually pulsation-free flow

No Manual Pump-stroke AdjustmentFully automated control – repeatable setting with reduced operator intervention 
System ValidationTesting protocols, including DQ, IQ/OQ and FAT support, for fast track validation and system start-up 
Documentation

Comprehensive support documentation in accordance with GAMP guidelines

Easily Accessible Parts

Easy maintenance and replacement

Standard Skid Range uses Consistent Layout Philosophy and Components

Consistent scale-up



System Ratings (Applicable to All)

Working Pressure

6 barg (87 psig)

Working Temperature2 - 60 o
Surface FinishInternal: 0.4 µm (16 µ-in.) Ra + Electro-polish
Operating EnvironmentTemperature and Humidity:
30 oC maximum, 95% humidity 
Electrical RatingsIP54/NEMA 13 
Electrical and Safety ApprovalsCE and UL 
Quality SystemsISO 9000 
Design Standards ASME BPE, GAMP 
CFR 21 Part 11 Compliance

Yes


System Sizes

System

Resolute® Flowdrive MU
Flow Range (L/H) 

2– 150

20 – 500

30 – 1200 

Piping id

4.6 mm (0.18 in.)

12.5 mm (0.5 in.) 

15.7 mm (0.62 in.)

Pipe Connections

6 mm (0.25 in.)
Sanitary Clamp

12.5 mm (0.5 in.)
Sanitary Clamp

18 mm (0.75 in.)
Sanitary Clamp

Dimensions

900 mm x 1300 mm x 1400mm
(35 in. x 51 in. x 55 in.) 
950 mm x 1300 mm x 1400mm
(37 in. x 51 in. x 55 in.) 
950 mm x 1300 mm x 1400mm
(37 in. x 51 in. x 55 in.)  

Uncrated Weight

250 kg (550 lbs)

275 kg (606 lbs)

300 kg (660 lbs)



General Specification

Description

Specification

Pumps

Two x Four -piston diaphragm pump

Gradient/In-line dilution capability

5 to 95 % typical (see diagram)

Inlets including product sample

8

Outlets including waste

4

Column flow control

Forward, reverse, by-pass

Bubble trap

Automated vent control, with by-pass

Filter

Pre-column, 0.2 µm Pall standard, with by-pass

Air sensor

Sample feed, pre-column


Instrumentation

Item

Position

Range

Accuracy

Flow meter

Post-column

0 - 1,500 L/H

± 1 % (of reading)

Pressure transmitter

Pre and post-column

0 - 6 bar (0 - 87 psi)

± 0.5 %

Conductivity

Pre and post-column

0 - 200 mS

± 2 %

Temperature

Pre-column with post-column option

0 - 100 °C

± 0.5 %

pH

Pre-column with post-column option

0 - 14 pH

± 1 %

UV

Post-column

0 - 5 AU, 280 nm

± 2 % (± 1% typical)



Wetted Material List

ItemMaterial

Pipework

Stainless steel 316L

Pumps

Stainless steel 316L, EPDM, Santoprene, Polypropylene

Valves

Stainless Steel, EPDM

Bubble trap

Acrylic, Stainless steel 316L, EPDM

Filter

Polyethersulfone, PVDF or as specified

Instrumentation

Stainless steel 316L, Titanium, EPDM, PVDF, Quartz, Glass

Elastomeric seals

EPDM or silicone

  • Wide and robust gradient or dilution capability
  • Broad system flow range for ion exchange, affinity, hydrophobic interaction and gel permeation applications
  • Consistent system layout across the platform make process scale-up easy
  • Forward/reverse and column by-pass control
  • Minimized system hold up volumes

Resolute® Flowdrive ATEX System

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The Resolute Flowdrive Atex product family provides a solution for customers requiring systems for use in an Explosive environment. Rated to ATEX Zone or Class 1 Div 2  these systems are fully configurable and come in a range of sizes to suit a wide range of clinical and commercial applications.

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