Resolute Manual Chromatography Columns

Process development and manufacturing may have to deal with a variety of resins ranging from small to large particles, from narrow to wide distribution of particle size and from soft to rigid, perhaps even brittle particles. ​Manual Columns can provide a flexible and economic toolbox for column packing and the capacity to develop and optimize column packing as required for individual processes and flexibility. ​

Resolute columns are ideally suited for process purification in the biopharmaceutical industry. The nozzle valve provides all column functions required for packing, unpacking and running of the column in a closed system. The packing process is controlled by a slurry packing system which, combined with a Resolute column, offers a complete solution for process chromatography from development to manufacturing scale.​

Resolute columns enable monitoring of actual column pressure resulting from media bed properties by eliminating non-linear interference from column design. Pressure versus bed height relationship for a specific media, packed at the same compression, remains constant up to at least 1000 cm/h linear flow in any diameter of Resolute column.

Resolute Manual Columns

Resolute columns enable monitoring of actual column pressure resulting from media bed properties  

By eliminating non-linear interference from column design. Pressure versus bed height relationship for a specific media, packed at the same compression, remains constant up to at least 1000 cm/h linear flow in any diameter of Resolute column. 

Description

Applications

Resolute columns have proven performance with a wide range of chromatography sorbents and chromatographic modes including ion exchange, mixed-mode, affinity, size exclusion, hydrophobic interaction, and hydroxyapatite.

Principle of Slurry Transfer

Resolute columns can be packed and unpacked with the column fully assembled. At the center of the operation is a nozzle valve in both the top and bottom of the column. Process liquids can enter and exit the column via either nozzle valves depending on which packing method is employed. Top and bottom nozzle valves are identical, making the flow profile the same in either direction. The ability to pack media with the top end cell in place contributes to process hygiene by reducing exposure to the external environment.
 

Effective Column Packing

Contained Operation
All column operations are performed in a closed system; therefore, there is less risk of the operator coming into contact with hazardous materials or the process being exposed to contamination. This results in improved safety and hygienic operation of the column process.

Reproducibility
By eliminating labor intensive column handling operations, the packing parameters can be set and applied within a standard operating procedure. This improves the reproducibility of the packed column performance.

Scalability
All design elements within the column mobile phase flow path are maintained throughout the range (up to 2000 mm diameter). Unlike conventional columns that are based on different seal and distributor cell designs as size increases, the Resolute column sealing arrangement and flow path follow a single design principle that delivers proven and consistent column performance.

Reduced Process Validation
Resolute columns and packing systems maintain identical linear velocities and pressure profiles during the packing process, whether in a 400 mm pilot-scale column or a 2000 mm process-scale column. Using the same packing methods reduces the effort required during preparation of SOP’s for large-scale manufacturing packing methods.

Specification

Maximum Allowable Pressure
  • 280 mm Ø Column: 5.0 barg (72.5 psig)
  • 400 – 1200 mm Ø Column: 4.2 barg (60.9 psig)
Operating Temperature 2 – 30 ºC
Bed Support Type and Rating
  • Stainless Steel Mesh: 10, 20, 50 μm
  • Polyethylene Sinter: 10, 20, 60 μm
Stainless Steel Surface Finish
  • < 0.6 μm Ra, electropolished
  • Exterior Components: < 0.9 μm Ra, electropolished
  • Pressure Retaining Plates: < 1.5 μm Ra, 240 (UK) grit sateen
  • Column Frame: Bright polished
Adjuster Seal Precision bore with compression seals
Media Transfer Nozzle Manual or pneumatic remote controlled

Design

The basis of design for Resolute columns is PD5500. Columns, where applicable, are CE marked in accordance with the European Pressure Equipment Directive 97/23/EC.

Materials of Construction

Process Wetted Components Material
Column Tube Acrylic
Distribution Cell Polypropylene
Nozzle Body
  • 280 – 1000 mm Ø Column: PVDF
  • 1200 mm Ø Column: Polypropylene
Mobile Phase Termination
  • 280 – 1000 mm Ø Column: PEEK
  • > 1200 mm Ø Column: Stainless steel 316L
Slurry Nozzle Tip PEEK
Slurry Inlet Port
  • 280 mm Ø Column: PEEK
  • 400 – 1200 mm Ø Column: Stainless steel 316L
Bed Support Polyethylene sinter or stainless steel mesh
Main Seals EPDM (peroxide cured)
Nozzle Tip Seals FEP encapsulated silicone
Wiper Ring PTFE
External Components Material
Stand Stainless steel 316L
Castor Stainless steel 304L
Wheel
  • 280 – 600 mm Ø Column: Polyurethane
  • 800 – 1000 mm Ø Column: Nylon
Foot 1200 mm Ø Column: Stainless steel 316L

 

Port Sizes and Pressure Flow Kit (PFK)

Below are the termination sizes for the column and PFK, and a schematic showing the scope of the column PFK kit. All connections are sanitary Tri-Clamp™ connections with EPDM gaskets. PFK kits are available to complement the standard columns, also available within 8 weeks lead time.

Note that the standard PFK does not include sight glasses.

Pressure Gauge Burst Disk Block Valve Termination Size* Flexible
Hose Size*
Column Ø
mm
Nozzle Valve Termination Size* Wika:
233.50
BS&B:
GCR-S
GEMU 3-Way Manual Diaphragm Valve
673 / 671 Bonnet
Pharmaline
NV1 NV2 NV3 NV4 NV5 NV6 G1 BD1 TC1 TC2 TC3 TC4 H1
300 0.5 in. 0.5 in. 0.5 in. 0.5 in. 0.5 in. 0.5 in. 1.0 in. 1.0 in. 0.5 in. 0.5 in. 0.5 in. 0.5 in. 0.5 in.
400–450 0.75 in. 0.75 in. 0.75 in. 0.75 in. 0.75 in. 0.75 in. 1.0 in. 1.0 in. 0.75 in. 0.75 in. 0.75 in. 0.75 in. 0.75 in.
600–630 1.0 in. 1.0 in. 1.0 in. 1.0 in. 1.0 in. 1.0 in. 1.0 in. 1.0 in. 1.0 in. 1.0 in. 1.0 in. 1.0 in. 1.0 in.
800–1000 1.5 in. 1.5 in. 1.5 in. 1.5 in. 1.5 in. 1.5 in. 1.0 in. 1.5 in. 1.5 in. 1.5 in. 1.5 in. 1.5 in. 1.5 in.

* (ASME BPE standard)

Chemical Compatibility

Substance/Concentration Acrylic SS PVDF PP EPDM/FEP PE PEEK PTFE
Acetic acid < 1M + + + + + + + +
Ethanol < 40% (v/v) + + + + + + +
Benzyl alcohol < 2% (v/v) + + + + + + +
Isopropyl alcohol < 30% (v/v) + + + + + + + +
Hydrochloric acid 0.1M + + + + + + +
Nitric acid 0.1M + + + + + + +
Phosphoric acid 25% + + + + + +
Sodium chloride < 2M + + + + + + +
Sodium hydroxide < 2M + + + + + + + +
Triton X-100 + + + + + + + +
Guanidine HCl < 6M + + + + + + +
Urea < 8M + + + + + + + +

+ Compatible
• Conditional compatibility; contact Sartorius for details

Abbreviations: EPDM = Ethylene propylene di-monomer, FEP = Fluoroethylene polymer, PE = Polyethylene, PEEK = Polyether ether ketone, PP = Polypropylene, PTFE = Polytetrafluoroethylene, PVDF = Polyvinylidene fluoride, SS = Stainless steel

Installation and Validation Documentation

Resolute columns are supplied with a comprehensive validation and support package including an operator’s manual. The validation support package contains comprehensive protocols and provides the required documentation and procedures to support FAT, IQ, and OQ. To support validation efforts and efficient commissioning, the documentation includes records of the pre-shipment test results.

Column manual documentation includes:

  • Operating guide
  • Materials and compatibility data
  • Comprehensive parts list
  • Spare parts recommendation
  • Maintenance recommendation

Additional Column and Equipment Needs

  • Column maximum allowable pressure up to 10 barg (145 psig)
  • Pressure vessel certification to ASME
  • Alternative column diameters may be specified (440 and 700 mm) up to 2000 mm
  • Hydraulic actuation of adjustable end cell (not available on 280 mm column)
  • Integrated column maintenance assist system (not available on 280 mm column)
  • Automated column packing systems

Performance

Optimized for Efficiency and Scale Up

Resolute columns are equipped with high resolution mobile phase flow path which consists of a mobile phase flow path within the nozzle valve body, distribution end cells, and a fully flushed piston seal arrangement. The performance of these important column components is essential for optimal process efficiency, capacity, and peak symmetry.

Resolute columns maintain identical design parameters throughout both the standard column range (from 280 mm to 1200 mm diameter) and the larger capacity columns (up to 2000 mm diameter). Operation at high linear velocities is free from non-linear column effects and assures true linear scalability of column performance, enabling users to scale up simply without method redevelopment or impact on the reproducibility of the packing process.

Key flow path features:

  • Nozzle valve mobile phase path delivers consistent low pressure drop across column for true linear scale up.
  • Distribution with coned end cell channels provides near plug flow conditions.
  • Secondary cone on support ribs provides unimpeded route via top central nozzle for simple and effective removal of entrapped air as well as effective recovery of slurry via bottom central nozzle when unpacking.
  • Nozzle tip retracts flush with bed support with no protrusion into packed bed.

Consistent Chromatography Performance

Resolute columns’ high resolution mobile phase flow path enables operation at high linear velocities up to 1000 cm/hr. The flow distribution cells and mobile phase flow path support near plug flow conditions irrespective of column diameter. Resolute columns exhibit identical pressure flow curves, linear up to 1000 cm/hr, at which the pressure drop is 0.1 barg (1.5 psig). Alternative column designs exhibit high, exponential pressure flow curves. During normal operations, actual pressure drop will be the sum of the value shown below and the additional value from the packed bed.

Resolute columns support true linear scale up of both the purification performance and column packing methods:

  • Elimination of non-linear interference from column design enables monitoring of actual column pressure resulting from media bed properties.
  • Pressure versus bed height relationship for a specific media, packed at the same compression, remains constant up to at least 1000 cm/hr linear flow in any diameter of Resolute column.

Ordering Information

Columns Available Within 8 Weeks Lead Time

The following standard columns are available within 8 weeks from the point of receipt of purchase order.

Ordering Information

All columns are acrylic tubed, with manual nozzles and a stroke length of 100–400 mm. Different diameter and bed height ranges are available on request.

Part Number Resolute
Column Ø (mm)
Mesh Material Mesh Pore Size (μm)
M-DM0301040AP10 300 PE* 10
M-DM0301040AP20 20
M-DM0301040AM10 300 SS 1.4404* 10
M-DM0301040AM20 20
M-DM0401040AP10 400 PE 10
M-DM0401040AP20 20
M-DM0401040AM10 400 SS 1.4404 10
M-DM0401040AM20 20
M-DM0451040AP10 450 PE 10
M-DM0451040AP20 20
M-DM0451040AM10 450 SS 1.4404 10
M-DM0451040AM20 20
M-DM0601040AP10 600 PE 10
M-DM0601040AP20 20
M-DM0601040AM10 600 SS 1.4404 10
M-DM0601040AM20 20
M-DM0631040AP10 630 PE 10
M-DM0631040AP20 20
M-DM0631040AM10 630 SS 1.4404 10
M-DM0631040AM20 20
M-DM0801040AP10 800 PE 10
M-DM0801040AP20 20
M-DM0801040AM10 800 SS 1.4404 10
M-DM0801040AM20 20
M-DM1001040AP10 1000 PE 10
M-DM1001040AP20 20
M-DM1001040AM10 1000 SS 1.4404 10
M-DM1001040AM20       20
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* PE = Polyethylene; SS 1.4404 = Stainless steel 1.4404

Pressure Flow Kit (PFK)

Part Number Applicable Column Diameter (mm)
M-PFK-030 300
M-PFK-040 400
M-PFK-045 450
M-PFK-060 600
M-PFK-063 630
M-PFK-080 800
M-PFK-100 1000
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Triton is a trademark of The Dow Chemical Company. Tri-Clamp is a trademark of Alfa Laval. WIKA is a trademark of WIKA Alexander Wiegand GmbH. GCR-S is a trademark of BS&B Safety Systems, LLC. GEMU is a trademark of Gebruder Muller Apparatebau GmbH. Pharmaline is a trademark of Aflex Hose Ltd.