PKP Chromatography Systems product photo Primary L

PKP Chromatography Systems

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 Pall’s 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


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Description

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 Pall’s 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
Applications

Pall’s 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.

Specifications

Base Unit System Overview

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
  • Pall analytic 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 
 
Ordering Information

Pall’s 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, Pall also can provide 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

Pall can help you optimize your process requirements. For additional information, or to order a PKP chromatography system, please contact your local Pall Life Sciences representative.

Application
Systems