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 |
Resolute® Flowdrive MU
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.
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 Technology | Reduces dead-legs to a minimum Compacts flow path |
| 316L Stainless Steel Wetted Flow Path | Robust, chemically-resistant flow path In-line valve fabrication minimizes clamp connections |
| Two-pump Gradient and In-line Dilution | Precise in-line mixing Fast accurate step and gradient formation |
| Designed for CIP | Turbulent Flow velocities achievable in pipe work Extended temperatures possible |
| Flow through Instrumentation | Instrumentation flow cell in-line, eliminating dead-legs and minimizing hold-up volume |
| Industry Standard Instrumentation | Reliable 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 Drain | Post-pump system fully drainable for storage |
| Diaphragm Pump (4-piston) | Pump head design gives virtually pulsation-free flow |
| No Manual Pump-stroke Adjustment | Fully automated control – repeatable setting with reduced operator intervention |
| System Validation | Testing 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 Temperature | 2 - 60 oC |
| Surface Finish | Internal: 0.4 µm (16 µ-in.) Ra + Electro-polish |
| Operating Environment | Temperature and Humidity: 30 oC maximum, 95% humidity |
| Electrical Ratings | IP54/NEMA 13 |
| Electrical and Safety Approvals | CE and UL |
| Quality Systems | ISO 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.) | 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
| Item | Material |
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
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.