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Related Manuals for Astrea Evolve AB070505
Summary of Contents for Astrea Evolve AB070505
- Page 1 Technical User Guide Evolve ™ Process Columns (70, 100 & 140mm diameter columns)
- Page 2 PC: Evolve Columns Operating Manual v2...
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Page 3: Table Of Contents
Contents Table of Figures ..................4 1. Column Hardware ..................5 Mechanical Description: ................5 Design features: ..................5 Technical data ..................6 Weights and Dimensions ................6 Pressure Drop ..................7 Material Conformity .................. 9 Materials of Construction – Process-Wetted Parts ..........9 Materials of Construction –... - Page 4 Fixed Assembly ..................24 Adjuster Assembly ................25 6. Troubleshooting ..................28 Leakage from Adjuster Seal ................ 28 Leakage from Fixed Bed Support Seal ............28 Leakage from Inlet or Outlet ..............28 Excessive Column Back Pressure ..............28 Media Leakage ..................29 7.
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Page 5: Table Of Figures
Table of Figures Figure 1 Pressure Drop Evolve™ 70 mm Process Column Figure 2 Pressure Drop Evolve™ 100 mm Process Column Figure 3 Pressure Drop Evolve™ 140 mm Process Column Figure 4 Diagram showing the location of the fixed bed support Figure 5 Photograph showing the installation of the fixed bed support Figure 6... -
Page 6: Column Hardware
1. Column Hardware Mechanical Description: Evolve™ Process Columns are designed specifically for use in biopharmaceutical applications and can be used in both pilot and production scale chromatographic processes. A pressure rating of 4 bar, operating temperature range of 2-30°C and adjustable bed height makes this column suitable for a wide range of chromatography media types and chromatographic techniques. -
Page 7: Technical Data
Technical data Column: Product Code AB070505 AB100505 AB140505 Tube i.d. (mm) Cross sectional area (cm 38.5 78.5 Maximum bed height (cm) Minimum bed height (cm) Max. column volume (L) Adjustable capacity (L) Pressure rating (bar/psi) 4/ 58 4/ 58 4/ 58 Operating temperature 2 to 30°C 8µm... -
Page 8: Pressure Drop
Pressure Drop The pipework and column contribute to the pressure drop of the chromatographic system. Measuring the pressure drop from the column inlet to the column outlet shows the contribution made by the column hardware. The tests were performed at ambient temperature 15-20°C using RO water. -
Page 9: Figure 3 Pressure Drop Evolve™ 140 Mm Process Column
Figure 3 Pressure Drop Evolve™ 140 mm Process Column PC: Evolve Columns Operating Manual v2... -
Page 10: Material Conformity
Material Conformity All materials in contact with the process stream have been selected for their suitability for use in equipment utilised in biopharmaceutical applications and so either conform to relevant sections of FDA code of Federal Regulations vol. 21 170-199 and/or have passed USP class VI test for in vivo toxicity. -
Page 11: Chemical Compatibility
Chemical Compatibility Acrylic columns are ideally suited for aqueous-based applications. See the table below for detailed compatibility information. Key: Resistant; suitable for continuous use Not resistant; not recommended Resistance Limited resistance No information available All solvents are at 100% concentration unless noted otherwise Notes General Concentrations: % refer to w/w... - Page 12 Non Wetted Wetted Chemical Stainless Steel 316L Guanidine hydrochloride 6.0 M Hydrochloric acid 10% Hydrofluoric acid Hydrogen peroxide Industrial methylated spirit (IMS) Methanol 20% Methanol 50% Methyl chloride (Chloromethane) ...
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Page 13: Safety Guidelines
2. Safety Guidelines Safety considerations • Please read through this user guide prior to use to ensure safe and careful handling of the product • Please follow all local laws and regulations for safe disposal for laboratory and manufacturing production use only and is not for administration into humans •... -
Page 14: Column Installation And Operation
3. Column Installation and Operation Column Installation The column is shipped pre-assembled. On receipt, it is recommended to check for damage or loosening of components during transit. Complete instructions for disassembly and reassembly can be found in the ‘Maintenance’ section of this operating manual. The following column preparation and installation procedures should be followed prior to operation: Install of bed supports and flow path checks Leveling the column... -
Page 15: Levelling The Evolve™ Process Columns
Figure 5 Photograph showing the installation of the fixed bed support 3. Locate fixed flow cell into the tube unit and fix in place. (3) Levelling the Evolve™ Process Columns After installation of the fixed flow cell and before installation of the adjuster unit, it is recommended to level the column. -
Page 16: Setting The Bed Height
Work around the circumference of the flow cell ensuring that seal is correctly fitted. See Figure 7. Figure 7 Photograph showing the location of the adjuster bed support (5) Setting the Bed Height Reinstate the adjuster unit in the acrylic tube, using the location pins and ensure the adjuster seal is de-energized. -
Page 17: Column Operation
4. Column Operation This section provides general guidance on operating the Evolve™ range of columns. It includes a hydrostatic leak test to establish that the column is installed correctly and advice for the preparation of the chromatography media. Further advice specific to each chromatography media should be attained directly from the media manufacturers guide;... -
Page 18: Column Packing (Constant Flow Rate Method)
Column Packing (Constant Flow Rate Method) 1. To identify the column components, see the schematics in this subsection. 2. Attach a valve to the fixed end pipe spool. 3. Remove the adjuster assembly. 4. Fill the fixed cell with buffer until approximately 20 mm depth of buffer is seen in the acrylic column tube. - Page 19 19. If the media is compressible, the packed bed may expand while the adjuster is being lowered, and it may prove necessary to repeat steps 16 to 18 above. 20. When the final bed height has been reached, turn the seal actuation knob to apply maximum seal compression.
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Page 20: Figure 8 Schematic Of The Column With Part Identification
Figure 8 Schematic of the column with part identification PC: Evolve Columns Operating Manual v2... -
Page 21: Unpacking
Unpacking The column may be unpacked conventionally, that is, the adjuster can be removed, the bed re- slurried and the media poured or pumped out of the acrylic column tube. Cleaning The extensive solvent and chemical resistance of the column components allows the use of a wide range of Cleaning and sanitization solutions, including: •... -
Page 22: Maintenance
5. Maintenance Routine Maintenance Procedures and General Guidelines To disassemble and reassemble the Evolve™ Process Columns follow the instructions below. Note: after reassembling the Evolve™ Process Column ensure that the column does not leak by performing a hydrostatic leakage test. When assembling/dissembling attention should be paid to: CAUTION! Column units are heavy and can roll 1. -
Page 23: Disassembly Of Evolve™ Process Columns
Disassembly of Evolve™ Process Columns Adjuster Assembly 1. Detach any pipework from the top sanitary clamp adapter. 2. Remove flange fixing bolts from the underside of the top tube flange. 3. Check that adjuster seal is released by turning the seal actuation nut counterclockwise. 4. -
Page 24: Fixed Assembly
Fixed Assembly 1. Disconnect the pipework elbow from the bottom of the column. 2. Using the fixed end fixing tool and torque wrench, loosen each of the fixing screws, supporting the flow cell with your hand. Remove the flow cell and place it on a clean work surface. 3. -
Page 25: Reassembly Of Evolve™ Process Columns
Reassembly of Evolve™ Process Columns Note: Reassembly of the column is the reverse of disassembly. Fixed Assembly 1. Install the process flow tube into the back of the flow cell. Ensure the flow tube seal is located. Tighten process flow tube using correct tools. 2. -
Page 26: Adjuster Assembly
4. Support the flow cell with your hand and locate fixing bolts. Initially, hand tighten the bolts, working diametrically opposite to ensure equal loading on the seal. Then using the fixed end fixing tool and torque wrench, tighten the bolts to the torque settings shown in the table below. Column Model Torque Setting Torque Setting Ft lbf... -
Page 27: Figure 14 Diagram Showing The Location Of The Adjuster Bed Support
Figure 14 Diagram showing the location of the adjuster bed support 2. Push the adjuster seal onto the seal setting ring. Ensure that the seal is correctly located by checking it is located in the groove in the setting ring. 3. -
Page 28: Figure 16 Photograph Showing The Alignment Of Markings On Flow Tube And
Figure 16 Photograph showing the alignment of markings on flow tube and sanitary clamp adapter to ensure component is correctly tightened. Lift the adjuster unit into the acrylic column tube. Note: alignment pins are located in the top flange to assist orientation. CAUTION - Adjuster units are heavy 10.Locate the flange fixing bolts in the underside of the column tube flange and tighten. -
Page 29: Troubleshooting
6. Troubleshooting Note: Refer to the ‘Maintenance’ section before undertaking any procedure advised below. Leakage from Adjuster Seal • Ensure that the adjuster seal is not damaged or twisted. If the seal is damaged, replace. • Ensure no media or other foreign material is trapped between the seal and sealing faces on the acrylic column tube, flow cell and seal setting ring. -
Page 30: Media Leakage
• Unpack and empty the column. Run a pressure drop test over a range of flow rates and compare results to pressure/flow curves in this manual. • Ensure all connections to/from the column are correctly connected and correct size pipework and ladish seals have been used. •... -
Page 31: Ready To Use
7. Ready to Use Kits supplied with Column The following 3 x kits are supplied with the Evolve™ Process Column. Note: to purchase any replacement parts please see our ‘Spare Parts, Kits & Accessories’ section (p32 onwards). Tool kit PRODUCT NUMBER DESCRIPTION Allen key set Allen key adaptor 10 mm... -
Page 32: Spares Kit
Spares Kit PRODUCT NUMBER DESCRIPTION Bed support assembly, 70 Fixed, Bed support assembly, 70 Adjuster, Bed support assembly, 100 Fixed, Bed support assembly, 100 Adjuster, Bed support assembly, 140 Fixed, Bed support assembly, 140 Adjuster, Adjuster seal, Evolve™ 70 mm Adjuster seal, Evolve™... -
Page 33: Spare Parts, Kits & Accessories
8. Spare Parts, Kits & Accessories Please do not hesitate to contact us via sales@astrea-bio.com if you would like to re-order any of the components described in this section. Column Refresh Kit PRODUCT NUMBER DESCRIPTION Sanitary Clamp Adapter 3 mm Bore... - Page 34 PRODUCT NUMBER DESCRIPTION Fixed Cell 100 mm Fixed Cell 140 mm Acrylic Tube, 70 X 530 mm Acrylic Tube, 100 X 530 mm Acrylic Tube, 140 X 530 mm Buffer Ring, 70 mm Buffer Ring, 100 mm Buffer Ring, 140 mm Scale Label, 70 mm Scale Label, 100 mm Scale Label, 140 mm...
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Page 35: Wetted Flow Path Kit
Wetted Flow path Kit PRODUCT NUMBER DESCRIPTION Sanitary Clamp Adapter 3 mm Bore Sanitary Clamp Adapter 6 mm Bore Adjuster Flow Tube 3 mm Bore Adjuster Flow Tube 6 mm Bore Bottom Flow Tube 3 mm Bore Bottom Flow Tube 6 mm Bore Flow Tube Seal 4.8 mm Bore Flow Tube Seal 7.0 mm Bore Adjuster Seal 70 mm Column... -
Page 36: Elastomer Seal Kit
Elastomer Seal Kit PRODUCT NUMBER DESCRIPTION Adjuster Seal, 70 mm Column Adjuster Seal, 100 mm Column Adjuster Seal, 140 mm Column Flow Tube Seal, Ladish 3.83 mm Bore Flow Tube Seal, Ladish 7.0 mm Bore Flow Tube Seal, 4.8 mm Bore Flow Tube Seal, 7.0 mm Bore Adjuster Cell Kit PRODUCT NUMBER... -
Page 37: Fixed Cell Kit
Fixed Cell Kit PRODUCT NUMBER DESCRIPTION Fixed Cell 70 mm Fixed Cell 100 mm Fixed Cell 140 mm Anti-jet Fluid Connection Kit (70- & 100 mm diameter columns) DESCRIPTION Product Number 2 Way Sanitary Pinch Valve Flexible Hose 3 mm Diameter x 1.0 m 3 mm Tee AAFCK1 Click Clamp, 3/4"... -
Page 38: Flexible Hose (140, 200 & 250 Mm Diameter Columns)
Flexible Hose (140, 200 & 250 mm diameter columns) DESCRIPTION Product Number Flexible Hose 6 mm Diameter x 2.0 m AAFHK2 Flow Tube Seal, Ladish 7.0 mm Bore Click Clamp, 3/4" Ladish Torque Wrench Kit (70, 100 & 140 mm diameter columns) DESCRIPTION Product Number Torque Wrench... -
Page 39: Chromatography Performance
9. Chromatography Performance To determine chromatographic efficiency of a packed chromatography column it is usual practice to inject a small analytical sample onto the column and monitor the response at the outlet. Typical solutions used are acetone in RO water or a 1.0 M NaCl solution. If acetone solution is used, then the UV absorbance is measured and plotted. - Page 40 Two further calculations can be performed to describe column efficiency. Reduced plate height - takes into account the particle size of the media and enables comparison between different media types. A low value of RPH denotes good column efficiency; a RPH of less than 6 is expected.
- Page 41 All other trademarks, trade names, trade dress, product names and logos appearing on this document are the property of Astrea Bioseparations Ltd. Copyright © 2020 Astrea Bioseparations Ltd.
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