Multi-Use Batch Chromatography Systems
PK/PKP platform are configurable automated systems with proven scalability, accompanied by extensive support pre and post-sales. PK/PKP Systems offer robust standard and customized 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 | ||
|---|---|---|
Scale of operation | Platform for clinical and commercial manufacturing | Platform for Pilot scale operation |
Automation | Common chromatography software | Increased flexibility as needed for pilot studies and scale; Analytical Tool |
Footprint | ≥990x1300mm | 600x600mm |
MU RCC is a liquid chromatography system intended for small scale production and process development in the purification of mAbs, ADC, vaccines, viral vectors, and recombinant proteins. This system provides a tailored design and configuration for the implementation of Rapid Cycling Chromatography (RCC) to overcome the limitations of processes based on resins.
PK Chromatography systems provide 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. PK 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 PK System 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 | PK10 | PK25 | PK50 | PK100 | PK300 |
| Flow Range (L/H) | 10 – 100 | 25 – 400 | 50 – 1000 | 300 – 4000 | |
Piping id | 4.6 mm (0.18 in.) | 12.5 mm (0.5 in.) | 15.7 mm (0.62 in.) | 34.8 mm (1.4 in.) | |
Pipe Connections | 6 mm (0.25 in.) Sanitary Clamp | 12.5 mm (0.5 in.) | 18 mm (0.75 in.) Sanitary Clamp | 38 mm (1.5 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
PKP systems are a platform for pilot and preclinical scale operations and process optimization. Their operations can be linearly scaled to the PK portfolio.
Key Features:
- Stainless steel construction
- cGMP compliance
- Smaller footprint for easier maneuverability
- Seamless scale up to larger PK systems
- Dedicated chromatography software
PKP chromatography systems are suitable for small production and process optimization for resin and membrane chromatography. The PKP systems has an identical flow path architecture as PK systems.
Each PKP System 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
System Option
System | PKP2 | PKP3 |
| Piping internal diameter | 1/4’’ | 3/8’’ |
Dimension WDH (mm) | 600 x 600 x1500 | 600 x 600 x 1500 |
Flow rate (L/h) | 1-100 ± 0.5% | 1-150 ± 0.5% |
Gradient/In-line dilution capability | 5-95% > 20L/h, 10-90% > 10L/h, 20-80% > 5L/h | |
Max. pressure | 6 barg | |
Working temperature | 2-60°C up to 80°C for CIP | |
Pumps | 2x Quattroflow 4-piston diaphragm pump | |
Inlets per pump | 8, extenstion up to 12 possible | |
Outlets per pump | 4, extention up to 12 possible | |
Column flow control | Forward, reverse, bypass | |
Bubble trap | By-pass, automated vent control, 3 Level Sensors | |
Filter | Pre-column with bypass valve block | |
Electrical Ratings | IP54/NEMA 13 | |
Electrical and Safety Approvals | CE and UL | |
Quality systems | ISO 9000 | |
Design standards | ASME BPE | |
CFR 21 Part 11 Compliance | Yes | |
Wetted Material
Item | Material |
Pipework | Stainless steel 316L (others on request) |
Pumps | Stainless steel 316L, EPDM, Santoprene, Polypropylene (PP) |
Valves | Stainless steel, EPDM |
Bubble trap | Acrylic, Stainless steel 316L; EPDM |
FiIter | Polyethersulfone, PVDF or as specified |
Instrumentation | Stainless steel 316L, Titanium, EPDM, PVDF, Quartz, Glass |
Elastomeric seals | EPDM or Silicone |
Instrumentation Option
Description | Type | Position | Specification |
Air sensor | Ultrasound | Pre-column | NA |
Flow meter | Magnetic induction/ Mass Coriolis | Post-column | Flow range ± 0.5 % |
Pressure sensor | Piezoresistive transducer | Pre- and post-column | 1-9 barg ± 1 % |
Conductivity sensor | Conductive | Pre- and post-column | 0-200 mS ± 2% |
UV sensor | Adsorption | Post-column | 0-2 AU with 2 Wavelengths, ± 2 % (± 1% typically) |
Temperature sensor | Resistance Thermometer Pt1000 | Pre- and post-column | 0-100 °C ± 0.5 °C |
pH sensor | Potentimetric | Pre- and post-column | 0-14 ± 0.14 |