Multi-Use Batch Chromatography Systems
Companies may want to maximize utilization of their facility and existing assets while non-value-added activities are being eliminated. Risks in operations and failure in supply must be prevented. Fully automated system platforms with proven scalability, accompanied by extensive service pre and post-sales, can reduce process costs for large scale manufacturing facilities. PK Systems offer reliable standard and customized stainless-steel based solutions, drainable flow path, with or without steaming in place. High precision sensors allow for wide operational flow rates and in-line dilution options.
Find the Right Solution for Your Chromatography Process
PKP and PK systems have identical performance yet differ in flexibility.
Attributes | ||
|---|---|---|
Scale of operation | Platform for commercial manufacturing | Platform for Pilot scale operation, scale up/down studies |
Automation | Focus on robust operation; Includes Uninterruptable Power Supply (UPS) | Increased flexibility as needed for pilot studies and scale; Analytical Tool |
Mobility | ≥990x1300mm; 250kg | 600x600mm; 80kg on a mobile cart |
PK Chromatography Skid
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 are much better equipped than SU-Systems to run gradients, dilute product in-line and make buffers. PK Systems comprise bubble trap, pre-column air detection, and up and downflow operation for column operation and can also be optimized for membrane chromatography.
Key Features:
- Stainless steel construction offering robust production at clinical or small scale
- Automation and data analysis ensure cGMP compliance
- Smaller footprint for easier maneuverability
- Seamless scale up to larger PK systems
The PK systems are available in 2 configurations based on your chromatography requirements.
System | PKP2 | PKP3 |
Diameter | 1/4“(6.35 mm) | 3/8“(9.525 mm) |
Flow rate (L/h) | 1 - 100 | 1 - 150 |
Process Connection | Inlets 4 (12 max) / Outlets 4 (14 max) | |
Column Connection | 1 (down-flow/up-flow/ by-pass) | |
PK Chromatography Systems for the Biopharmaceutical Industry
PK chromatography systems cover a full range of applications with the highest standards in design principles and operating protocols.
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
- Reduction in time spent in process development and manufacturing applications
- Optimum flexibility for changing process demands
- Run-to-run reproducibility
- Wide performance operating range
- Efficiency of installation and ease of use
Features of PK Chromatography Systems
Process Performance
- Precision gradient with two pumps
- Broad system flow range for ion exchange, affinity, hydrophobic interaction and gel permeation applications
- Consistent system layout allows true linear process scale-up
- Forward/reverse and column by-pass control
- Low system hold up volumes
High Quality Material and Components
- Stainless steel (316L) pipework and internal surface finish to 0.4 µm (16µ-inch) + electropolish ensures system cleanability
- In-line sanitary grade system
- Full material certification package
GAMP Compliance
- Design in accordance with GAMP guidelines, to ensure that process and regulatory requirements are met
- Documentation and protocols include DQ, IQ/OQ and FAT to verify compliance to requirements
- Designed for full CFR21 Part 11 compliance
Flexible and Proven, User-friendly Software
- Operations by selection of pre-configured protocols
- Automation using convenient and flexible recipes
- Password controls to set different user levels
- Override of automated functions where required
- Simple but comprehensive intuitive screen display with touch screen and keyboard operation
Real-time Data Viewing, Data Storage and Analysis
- High quality instrumentation and signal generation
- Clear visual display of process conditions, set point and alarms
- Data point acquisition and recording
Simple System Intergration
- Industry standard platform running on Microsoft Windows OS
- Optional interfaces to allow master control or data acquisition
- Segmented system control and operator interface hardware
Safety and Ease of Operation
- Orientation friendly layout with easy component access and industry standard terminations
- IP/NEMA rated
- Easily-tranportable systems with locking adjustable castors
- Complete pre-column air detection
- Hard-wired back-up features
- Internal UPS included for safe shut-down and restore automation
Application Options for PK Chromatography Systems
- Single feed pump
- Buffer in-line dilution
- Pressure control
- Integration with single-use technology
- Segregated bubble trap and filtration
- Increase number of inlets and outlets
- Integration with column technology
- Gradient accuracy to +/- 1 %
- Steam-in-place design
- Integration with Mustang® technology
- Temperature control
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 |
Gradient Capability
The turn down ratio (maximum flow divided by minimum flow) of the pump determines system gradient and in-line dilution capabilities.
The diagram shows the coverage for the PK50 system within the flow range of the system pumps. Due to large turn down, the pumps are capable of 5 – 95 % mixing over a wide flow range.
The gradient is feedback controlled using the pre-column conductivity transmitter.
PKP Skid
PKP systems are a platform for small scale operation and process optimization. While keeping design and certification principles equivalent to the PK portfolio, programming flexibility and data analysis are enhanced. PKP operations can be linearly scaled to the PK portfolio.
Key Features:
- Reliable monitoring and control of process conditions through standardized instrumentation
- Minimizes dead-legs and hold-up volume through sanitary multi-port valve technology and flow through instrumentation
- Two-pump gradient and in-line dilution for precise in-line mixing and step/ gradient formation
- Consistent scale and easy maintenance
The PKP systems are available in multiple configurations based on your flowrate requirements.
System | PK10 | PK25 | PK50 | PK300 | PK500 |
Diameter | ¼’’ | ½ ’’ | ¾’’ | 1’’ | 1 ½’’ |
Flowrate (L/h) | 10 - 100 | 25 - 400 | 50-1200 | 100 - 2800 | 300 - 5000 |
Delivering Process-Scale Performance and Enabling True Linear Scale-Up at Pilot Scale
The ability to transition from pilot-scale chromatographic processes to final process-scale without loss in separation performance is the foundation of PKP chromatography systems. The easy-to-use software and flexible component combinations, along with the precision instrumentation, enable systems that encompass a flow range of 3 to 150 L/h for optimum gradient performance and true linear scale-up in a compact footprint.
Features
- Modular system design
- Scalable automation and design
- Stainless steel construction is cGMP compliant
- Minimized hold-up volume
- Full system drainability (manual)
- Dual 4-piston diaphragm pumps
- Optimized clean-in-place (CIP) design
PKP chromatography products, a family of standard modular automated systems, are designed to perform all types of low pressure column biochromatography (e.g., ion exchange, affinity, mixed mode, hydrophobic interaction, size exclusion and hydroxyapatite) and membrane chromatography. These systems are suitable for small-scale production or process optimization, in addition to manufacturing biotherapeutic molecules according to GAMP guidelines.
Base Unit System Overview
- Conductivity meter
- Flow meter
- Bubble trap [option]
- Display panels of conductivity, temperature, and pH measurement
- Reset button
- Emergency stop button
- Display panel of the UV measuring instrument
- Pump
- Pressure sensor (post column) [option]
- "pH" meter
- UV instrument
- Fraction outlets
PKP System Automation Software Controls
- Intuitive recipe creation enables smoother scale-up
- Batch or semi-automated mode allows users greater flexibility during operation
- Rapid instrument response provides clear visual display of process conditions, set points, and alarms
- Analytical Tool enables calculation of HETP, peak asymmetry, transition analysis, etc.
- Comparison of different batches to monitor process reproducibility
- Selection individual instrument curves enables greater flexibility in batch data reporting for regulatory submissions
- 21 CFR part 11 compliance
- High flexibility and ease of use in recipe creation
- "Smooth transition" / gapless recipe execution
- Recipe export/import fuctionality
- Standalone recipe editor available
- Batch schedule functionality
- Configurable batch report
Pall Analytic Tool
Pall 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.
PKP Chromatography System Overview
PKP2 | PKP3 | |
| Diameter, ID mm (in.) | 4.57 (0.18) | 7.75 (0.3) |
| Pump Flow Rate (L/h) | 3-100 | 3-150 |
| Maximum Pipe Velocity (m/s)* | 1.7 | 1.0 |
| Gradient/In-line Dilution | 5 - 95% > 60 L/h 10 - 90% > 30 L/h 20 - 80% > 15 L/h** |
| Process Connection | Inlets 4# (12 max) / Outlets 4 (14 max) #Per pump |
| Column Flow Control | forward, reverse, by-pass |
| Uncrated Weight | 80 Kg (176 lb) |
| Maximum Operating Pressure | 6 barg (87 psi) |
| Maximum Temperature | 2 - 60 ºC (36 - 140 ºF) for production; up to 80 ºC (176 ºF) for CIP |
| Pumps | 2 x four-piston diaphragm |
| Dimensions WDH, mm (in.) | 600 x 600 x 1500 (23.6" x 23.6 x 59) |
**Maximum limited by pipe velocity (< 2 m/s)
#Limited by minimum pump flow rate (50 mL/hr)
PKP System Standard Options
- Bubble trap including by-pass valve block, vent valve and level switches
- Additional inlets and outlets
- In-line filter, including by-pass valve block
- Air sensor at inlet
- Pre-column conductivity
- Post-column pressure sensor
- Second wavelength
- Mobile stainless steel trolley
- Drip trays for inlets and outlets
Instrument Specifications
Type | Measuring Range/Accuracy | |
Flow Measurement | Magnetic-Inductive | System range ± 0.5% MR |
| Air Sensor | Ultrasound | N/A |
| Pressure Sensor | Piezoresistive Transducer | -1 - 9 bar ± 0.5% MR |
| Temperature Sensor | Resistance Thermometer Pt1000 | 0 - 100 ºC (32 - 212 ºF) ± 0.5 ºC (32.9 ºF) |
| Conductivity Measurement | Conductive | 0 - 200 mS ± 5% MR |
| pH Measurement | Potentiometric | 0 - 14 ± 0.14 pH unit |
| UV Measurement | Absorption Measure | 0 - 3 AU ± 1% Reproducible 0 - 2 AU with 2 Wavelengths Optical path length 2 mm |
Table of Wetted Components
Process Wetted Parts | Materials |
| Bubble Trap End Plates, Pump Pistons, Pressure, pH/Cond/UV Flow Cell, Pipework, Valve Bodies, Conductivity Probe Electrodes | 316 L stainless steel (Ra ≤ 0.8 μm, electropolished) |
| Tri-clamp Gaskets, Valve Diaphragms, Bubble Trap Seals, Pump Seals/Check Valves, Instrument Seals, and Filter Seals | FDA conforming EPDM |
Air Sensors | 316 L stainless steel |
Bubble Trap Tube | Borosilicate glass (HALAR* coated for shatter protection) |
pH Probe | Glass |
Flowmeter | 316 L/PFA liner |
Pump Diaphragms | Santoprene |
UV-Windows | Sapphire |
Conductivity Body | PEEK |
PKP chromatography systems are supplied with a comprehensive documentation package. To support validation efforts and efficient commissioning, IQ and OQ protocols are available as an option. In addition, support for execution of the protocols.
PKP system documentation includes:
- User manual
- Materials data sheets
- Certificate of conformity
- Comprehensive parts list and certification
- Mechanical and electrical diagrams
- Spare parts recommendation
- Maintenance recommendation
PKP chromatography systems can help you optimize your process requirements. For additional information, or to order a PKP chromatography system, please contact you local Sartorius representative.