PKP Chromatography Systems (For Europe) product photo Primary L

PKP Chromatography Systems (For Europe)

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 1 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
  • 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 1 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
  • 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 Layout

PKP Chromatography System Layout

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

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.

Recipe Management

Batch Management

PKP System Automation P&ID

PKP Chromatography System Overview

 
  PKP1 PKP2 PKP3
Diameter, ID mm (in.)  3.2 (1/8)  6.3 (1/4)  9.5 (3/8) 
Pump Flow Rate (L/h)  1 - 20  1 - 100  1 - 150 
Maximum Pipe
Velocity (m/s)* 
1.7  1.7  1.0 
 
 
Gradient/In-line Dilution  5 - 95% > 20 L/h
10 - 90% > 10 L/h
20 - 80% > 5 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 (17 mL/min)


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 u Pre-column conductivity
  • Post-column pressure sensor u 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
 

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 ≤ 0.6 μm, electro polished)
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 
 
Additional Information

Chromatography Systems for Scale-Up

The PK solution platform and PKP chromatography system range incorporate proven component technology, delivering accurate precision gradients as well as in-line buffer dilution. Maintaining the performance necessary to make your chromatography process consistent from batch-to-batch and optimal at pilot and manufacturing scales. Covering a range from 1 - 4000 L/h, Pall’s PK and PKP systems ensure robust operation and flexibility for all biochromatography applications. These systems can be used with Resolute chromatography columns as well as Mustang® chromatography membrane capsules.

PKP System Range

 
System PK10 PK25 PK50 PK100 PK300
Flow Range (L/H) 10 - 100 25 - 400  50 - 1000  100 - 2000  300 - 4000 
 

Chromatography Columns for Production

Resolute® DM and DP columns are ideally suited for process purification in the biopharmaceutical industry. A patented nozzle valve provides all column functions required for packing, unpacking, and running of the column in a closed system. Standard column diameters range from 280 mm to 1200 mm – all with selectable bed heights from 100 mm up to 600 mm. Resolute FM columns are purpose-designed glass columns for the manufacturing of clinical batch material or small scale production. Column diameters are 100, 140 and 200 mm with a bed height span of 100 mm to 460 mm. Based on established and well-proven design, the Resolute column range provides improved column performance and true linear scalability combined with reproducible column packing methods for today’s high performance media.

Resolute FM Column Range with Corresponding PKP Systems

Membrane Chromatography

Mustang® Ion-exchange Membrane Chromatography Capsules deliver a flexible solution in bioprocessing, with scalable devices that can be used either as single- or multiple-use products. High volumetric flow rates lead to increased throughput, and the simple, easy-to-use compact design enables reduced buffer consumption in addition to overall process economic improvements. Mustang membrane products are ideal for efficient contaminant removal and capturing large target molecules (plasmid DNA, viral vectors, etc.).

Chromatography Sorbents

A large range of scalable, high productivity sorbents are available as ion exchangers (Q, and S HyperCel™, Q, CM, DEAE, and S Ceramic HyperD™) and mixed-mode sorbents (MEP, HEA, and PPA HyperCel). Please contact your local Pall Life Sciences representative for additional information.

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:
  • Users 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