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

PK System

PKP System

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

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New Membrane Chromatography System – MU RCC

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.

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PK Chromatography System

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.

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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 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 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

  • 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 Chromatography System

PKP systems are a platform for pilot and preclinical scale operations and process optimization. Their operations can be linearly scaled to the PK portfolio. 

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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

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