Manual Chromatography Columns

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 300 to 1000 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^® ManuPak are available in diameters from 300 mm to 1000 mm, with 100 mm bed height adjustment and choice of bed heights up to 400 mm. Alternative bed height adjustment and diameters up to 2000 mm are available on request. Resolute^® ManuPak 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 μm/20 μm) and polyethylene (10 μm/20 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.

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

Principle of Slurry Transfer

Resolute^® ManuPak 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^® ManuPak 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.

^{Note: Bed support pore size = 10 or 20 μm | Bed height = 100 – 400 mm. Nozzle valve = manual | Max. operating pressure = 4.2 bar}

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

Port Sizes and Resolute^® Pressure Flow Kit (PFK)

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

Note that the standard Resolute^® pressure flow kits does not include sight glasses.

* (ASME BPE standard)

Chemical Compatibility

+ 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^® ManuPak 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

Optimized for Efficiency and Scale Up

Resolute^® ManuPak 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^® ManuPak columns maintain identical design parameters throughout both the standard column range (from 300 mm to 1000 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^® ManuPak 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^® ManuPak 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^® ManuPak 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^® ManuPak column.

Request a Quote   Learn More

Resolute^® ManuPak

Resolute^® ManuPak 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.

^{* PE = Polyethylene, SS 1.4404 = Stainless steel 1.4404}

Resolute^® Pressure Flow Kit (PFK)

Resolute^® Pressure Flow Kits (PFK) are available to complement the standard columns. All connections are sanitary Tri-Clamp™ connections with EPDM gaskets.

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.