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
Process columns for optimized, contained, and scalable operation
- High resolution flow path provides optimum efficiency, capacity, and peak symmetry.
- Central nozzle valve provides all column functions required for packing, unpacking, and running the column within a closed system.
- Scalable, reproducible packing methods reduce validation efforts as processes scale up.
- Common design from 280 to 1200 mm diameter (and up to 2000 mm on request).
- Designed to minimize packing events and buffer usage to optimize process economics.
- Options for manual or remote controlled nozzle valves.
Designed for Durability, Reliability, Versatility and Ease of Use
Resolute columns are available in diameters from 280 mm to 1200 mm, with 200 mm bed height adjustment and choice of bed heights up to 600 mm. Alternative bed height adjustment and diameters up to 2000 mm are available on request. Resolute manual columns feature:
- Manually operated nozzle valves. (See column options for pneumatically-actuated nozzle valves.)
- Choice of bed supports in polyethylene or 316L stainless steel.
- Acrylic column tube provides visibility of the packed bed.
- Simple, constant compression, adjuster seal, and precision bore eliminate need for additional mechanical or pneumatic activation of adjuster seals.
- Stainless steel support frame equipped with lockable castors (available up to 1000 mm column).
Sanitary Design
Sanitary design features ensure the longevity, consistency, and reliability of your process:
- Fully flushed flow path and adjuster seal facilitate clean-in-place (CIP).
- Minimum dead space fixed cell seal arrangement.
- Non-metallic mobile phase flow path is ideal for high salt, low pH conditions, and eliminates the risk of corrosion within the nozzle valve.
- Phthalate-free acrylic tube and peroxide-cured EPDM seals.
- Low-profile central nozzle retaining ring on the bottom bed support reduces media hold-up during unpacking.
Column Options
- Remote controlled pneumatic nozzle valve: a pneumatic actuator positions the nozzle to pre-set positions (Run, Pack, Unpack) with pneumatic controller and position feedback for increased process security. (Not available on 280 mm column.)
- Bed supports are available in stainless steel (10/20/50 μm) and polyethylene (10/20/60 μm), which offers a lower-cost alternative when frequent bed support changes are required.
- Robust stainless steel column tube with increased chemical compatibility. (Not available on 280 mm column.)
- Fixed bed capacity with no bed height adjustment available for media-specific or process requirements.
- Extended adjuster range (300 mm) adds packing flexibility.
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 |
|
| Operating Temperature | 2 – 30 ºC |
| Bed Support Type and Rating |
|
| Stainless Steel Surface Finish |
|
| 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 |
|
| Mobile Phase Termination |
|
| Slurry Nozzle Tip | PEEK |
| Slurry Inlet Port |
|
| 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 |
|
| 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 | ||
| Request a Quote |
* 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 |
| Request a Quote |
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.
