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

PK System

PKP System

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 

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PK Chromatography System

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. 

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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

 3/8“(9.525 mm)

1/4“(6.35 mm) 

Flow rate (L/h) 

1 - 150  

1 - 100  

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 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

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.)
Sanitary Clamp

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

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

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 Chromatography System

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. 

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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

  1. Conductivity meter
  2. Flow meter
  3. Bubble trap [option]
  4. Display panels of conductivity, temperature, and pH measurement
  5. Reset button
  6. Emergency stop button
  7. Display panel of the UV measuring instrument
  8. Pump
  9. Pressure sensor (post column) [option]
  10. "pH" meter
  11. UV instrument
  12. 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.​

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