PK Chromatography Systems product photo Primary L

PK Chromatography Systems

PK Chromatography Systems for the Biopharmaceutical Industry

Pall’s 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 Pall 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 Pall's 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

PK Chromatography Systems

 


 


 

PK Chromatography System

View additional chromatography systems.



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Description

PK Chromatography Systems for the Biopharmaceutical Industry

Pall’s 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 Pall 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 Pall's 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

PK Chromatography Systems

 


 


 

PK Chromatography System

View additional chromatography systems.

Applications

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
Specifications

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 o
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.)
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

 
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
 



Performance

Gradient Capability


PK Chromatography Systems: Gradient CapabilityThe 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. 

 

 

 

 

 

Ordering Information
Please contact your Pall Representative for ordering information.
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