Resolute® FM Chromatography Columns
Contents
1. flexibility for all biochromatography applications These systems can be used with Resolute chromatography columns as well as Mustang chromatography membrane adsorber capsules PKP Chromatography System Pall LRC chromatography columns have been designed to meet the requirements of most laboratory applications ion exchange affinity size exclusion mixed mode chromatography Four internal diameters from 10 to 50 mm and four lengths provide a range of column volumes up to 900 mL and bed heights up to 750 mm Each column is supplied assembled and ready to use with tubing and fittings for connection to a standard system The column body is made of a borosilicate glass tube The columns are equipped with one adjustable and one fixed plunger and a screw lock system to allow a rapid adjustment of the piston LRC Glass Columns The Resolute DM columns are equipped with Pall s proprietary 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 essential column components is increasingly important for optimal process efficiency capacity and peak symmetry when scaling up to larger capacity columns Resolute DM 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 diamete2. 0D NOTES Column ships with 20 um nets fitted Spares Kits and Accessories Spare Kits Column Fixed amp Adjuster Fixed amp Adjuster Adjuster Net Fixed Net Wetted Non Wetted mm Net 10 pm Net 20 um Support Support Seals Seals 100 SFM100A150A99 SFM 100A160A99 SFM 100A350A99 SFM 1 00A360A99 SFM 1 00A300A99 SFM100A340A99 140 SFM140A150A99 SFM140A160A99 SFM140A350A99 SFM 1 40A360A99 SFM 1 40A300A99 SFM140A340A99 200 SFM200A150A99 SFM200A160A99 SFM200A350A99 SFM200A360A99 SFM200A300A99 SFM200A340A99 Accessories Accessories Tools Column Column Bottom Valve mm Valve Kit Mounting Kit Foot Kit Tubing Kit Deep Socket Stirring Paddle 100 SFM100A270A99 SFM 100A320A99 SFM100A310A99 SFM 100A420A99 SFM 100A330A99 SFM100A390A99 140 SFM140A270A99 SFM140A320A99 SFM100A310A99 SFM140A420A99 SFM140A330A99 SFM100A390A99 200 SFM140A270A99 SFM140A320A99 SFM100A310A99 SFM140A420A99 SFM140A330A99 SFM100A390A99 1 Net support 1 to fit between net and distributor 2 Adjuster seal 1 tube seal 2 inlet tube seal 1 3 Adjuster nut flange seal 1 inlet spool top seals 2 4 Two way valve 1 clamp 1 gasket 1 2 valve kits required per column for top and bottom 5 Bottom elbow 1 clamp and gasket 1 bracket 1 and bolts washers 2 6 Reinforced tubing 2 x 150 cm 1 x 200 cm with hose barbs 6 gaskets 6 and clamps 6 7 Required when dismantling tube assembly Installation and Validation Documentation Resolut
3. J J J X Nitric acid 20 J J J J J X Phosphoric acid 40 Not recommended J Minor effect VY J X sodium acetate All conc s J J J J J sodium bicarbonate All conc s J J J J J J sodium chloride 0 5M At pH lt 7 pitting occurs J J J J also on storage at any pH gt 30 days sodium chloride 2M At pH lt 7 pitting occurs also J J J J at storage at any pH gt 24 hrs sodium hydroxide 2M J J J Exposure gt 3 months can damage glass surface sodium hydroxide 0 02M J J J J J J sodium hypochlorite 20 some discoloration can Minor effect Minor effect VY X 200 ppm Cl occur if contact time is gt 1 hr sodium nitrate All conc s J J J J J J Sulphuric acid lt 10 some minor effect J J J J X Tri n buty lt 3 J J J J phosphate with 1 Tween Trifluoroacetic acid lt 0 1 Higher concentration s can J J J cause minor damage to steel Triton X 100 3 J J J J J Urea 8M J J J J J J Y Compatible Limited compatibility X Not compatible www pall com biopharm Ordering Information Resolute FM Chromatography Column Adjustable Capacity Columns Diameter CSA Adjustable Adjustable Pressure Resolute FM and Item Description mm cm Height mm Capacity Liters psi bar Resolute FM Documentation Pack FM 100 100 460 100 79 100 460 078 21 72 5 FMIO0A100A20 FMI00A100A20D FM 140 100 460 140 154 100 460 1 54 4 1 72 5 FM140A100A20 FM140A100A20D FM 200 100 460 200 314 100 460 3 14 8 4 69 46 FM200A100A20 FM200A100A2
4. Resolute FM columns are ideal for chromatographic purification from process development through to manufacturing scale with a wide range of commonly used media These glass columns for development and manufacturing applications are robust and incorporate new features to improve the outcome of column packing events The industry accepted constant compression seal design used in the successful Resolute DM range is also incorporated in the FM series The columns are ideal for use with Pall s PKP chromatographic systems providing an ideally suited platform for pilot scale and small volume manufacturing purification operations with a wide range of chromatographic media Accessory column valves and tubing kits are available to provide a complete solution for your next purification challenge USD 2776 Unique constant compression adjuster seal simplifies column operation Low friction adjuster mechanism enables packing compression to x1 2cf Easy air removal prior to packing for first time packing event Improved safety with an adjuster that enables packing without removal from column Low pressure drop flow path supports high linear velocity up to 700 cm hr for maximum productivity Simple maintenance of seals and nets with quick and easy removal of both distributor plates with out use of special tools Hygienic design suitable for effective sanitization Precision borosilicate glass tube and stainless steel flow path provides excel
5. VI tests for toxicity All Wetted Elastomers Plate Only Conform to USP VI or CFR 177 2600 Applicable Codes and Standards Design Standard PD5500 2009 BSEN1595 1997 Steel Components Glass Tube Materials of Construction Process Wetted Components Glass borosilicate 3 3 Stainless steel grade 316 L EN 1 4404 Mechanical Design PED 97 23 EC Nets 20 um Polypropylene 10 um Polyamide P E D Category SEP Net Support Polypropylene ose ee Seals EPDM black peroxide cured Stand Stainless steel grade 316 L EN 1 4404 Castors Stainless steel grade 304 Life Sciences Chemical Combatibility Column Overall Substance Concentration Stainless Steel Polypropylene EPDM Glass Status Nylon Acetic acid lt 25 J J J J J X Acetone 50 J J J J J J Acetonitrile 100 J softens after J J J 7 days constant contact effect is reversible Ammonium 2M Minor corrosion to 304 stainless s J J J sulphate steel Non corrosive to 316 Benzyl alcohol 2 J J J J J X Ethanol 100 J J J J J J Ethanol 40 J J J J J J Ethanol 20 J J J J J J Ethyl acetate 100 J J J J J J Ethylene glycol 50 J J J J J J Formaldehyde 40 J J J J J Formic acid 100 J J J J J X Guanidine 8M X J J J X hydrochloride Hydrochloric acid 20 X J J J X X Hydrogen peroxide 10 J J J J J X Isopropyl alcohol 100 J J J J J X IPA Propan 2 ol Nitric acid 5 J J
6. e FM columns can be ordered with an optional comprehensive validation and support package To support validation efforts and efficient commissioning this docu mentation includes all the pre shioment test results Documentation gt Each column is supplied with a user manual gt CD ROM with user manual and language versions gt Column documentation includes e Setup and test report e Materials and compatibility data e Comprehensive parts list Must be ordered with column at time of purchase Life Sciences Chromatography Process Solutions from Pall Pall offers a comprehensive versatile and environmentally friendly range of chromatography sorbents that greatly simplifies protein purification challenges from lab to process scale Pall chromatography sorbents can improve the downstream purification accuracy speed safety reliability and decrease purification cost Sorbent chemistries include ion exchange mixed mode hydroxyapatite affinity size exclusion solvent detergent removal and HIC The PK solution platform and PKP chromatography system range incorporate proven component technology delivering accurate precision gradients as well as in line buffer dilution This occurs while maintaining the perform ance 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
7. he adjuster during axial bed compression Unlike other column designs the adjuster is always main tained in a relative vertical plane to the column tube by the adjuster plate and does not need to be inserted by the operator at an angle into the tube to remove air while the seal is formed against the tube wall Resolute FM columns Life Sciences have a unique feature on the lower frame which allows the column assembly to be tilted from vertical while the adjuster is lowered This feature has simplified the packing prepara tion process and results in a reproducible outcome which can be defined in SOP s and avoids awkward handling of heavy column components and attached tubing This proce dure is ideal for concise SOP s and produces reproducible column priming outcomes due the security of the mechani cal steps involved in place of manual manipulation of sepa rate column parts Fast Packing and Unpacking The design of the central adjuster mechanism provides adequate clearance for entry of the slurry directly into the column tube With a measured volume of slurry in the column the liquid level is then topped up with buffer to a specific bed height marked on the tube unit The column is then set in the priming position and the adjuster lowered into the tube by rotating the centrally located handles As the seals enter the tube the air is displaced and once the seal is made the column is again set vertical before applying the req
8. lent chemical compatibility Scale up with 3 column sizes 100 140 and 200 mm diameter with capacities from 0 78 L to 8 4 L Applications The superior design of Pall s Resolute columns is optimized for purification in both process optimization and small scale manufacturing operations These columns have proven performance with a wide range of chromatography media and chromatographic modes including ion exchange mixed mode affinity size exclusion and hydrophobic interaction Column bed heights up to 27 cm may be prepared with a compression factor of 1 2 Modular Design Resolute FM columns can be packed and unpacked with the column adjuster remaining supported above the top of the tube The central adjuster mechanism enables the top distribution cell to travel within the tube and to be raised clear of the tube for packing and unpacking operations Thus eliminating the requirement to remove and lay down the adjuster and associated tubing This improves operator safety and reduces preparation time with connected hoses being left in place The adjuster seal positioned close to the edge of the distri bution plate is under constant compression within the tube There is no need to adjust and fine tune seal compression as a seal is assured every time without operator involvement This feature avoids problems associated with seals being either under or over compressed This avoids leakage of fluids past the seal during the lowering of t
9. r 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 Resolute Column www pall com biopharm Life Sciences Corporate Headquarters Port Washington NY USA 1 800 717 7255 toll free USA 1516 484 5400 phone biopharm pall com e mail European Headquarters Fribourg Switzerland 41 0 26 350 53 00 phone LifeSciences EU pall com e mail Asia Pacific Headquarters Singapore 65 6389 6500 phone sgcustomerservice pall com e mail Filtration Separation Solution sm Visit us on the Web at www pall com biopharm E mail us at biopharm pall com International Offices Pall Corporation has offices and plants throughout the world in locations such as Argentina Australia Austria Belgium Brazil Canada China France Germany India Indonesia Ireland Italy Japan Korea Malaysia Mexico the Netherlands New Zealand Norway Poland Puerto Rico Russia Singapore South Africa Spain Sweden Switzerland Taiwan Thailand the United Kingdom the United States and Venezuela Distributors in all major industrial areas of the world To locate the Pall office or distributor nearest you visit www pall com contact The information provided in this literature was reviewed for accuracy at the time of publication Product data may be
10. s 100 10 O D a A 14 00 14 10 14 20 14 30 10 21 2010 Time 10 21 2010 www pall com biopharm Specifications Adjustable Maximum Column Adjustable Capacity Allowable Height at Diameter Height Packed Pressure Net Weight Minimum Width Depth Height Product mm CSA cm Range mm Volume L barg psig Kg Ib Bed mm mm mm mm Resolute FM 100 79 100 460 0 78 2 1 9 0 72 9 30 66 1105 385 385 1625 Resolute FM 140 154 100 460 1 54 4 1 50 725 45 99 Lo 415 415 1655 Resolute FM 200 314 100 460 3 14 8 4 4 6 66 7 70 154 1135 455 455 1655 Based on 70 slurry and compression factor x 1 2 oo External Components i Column Tube Column Termination Sizes Glass borosilicate 3 3 Ti mm T2 mm Pressure Envelope Components Diameter mm 100 4 20 Stainless steel grade 316 L EN 1 4404 Diameter mm 140 6 20 Stand Diameter mm 200 6 25 Stainless steel grade 316 L EN 1 4404 Castors Component Weights Kg Ib Stainless steel grade 304 FIM100 FIM140 F200 Wheels Column 30 661 46014 2367 etal Adjuster Assembly 8 6 19 0 18 57 41 0 25 1 55 3 Materials used in the manufacture of the column product Complete contacting components either conform to relevant sections Adjuster Distribution 1 1 2 4 2 2 4 8 4 6 10 1 of the FDA Code of Federal Regulations Volume 21 parts Plate Only 170 to 199 or are non FDA recognized materials that pass Five DIMDLOH 4 0 8 8 67 148 _ 11 9 26 2 __ USP Class
11. subject to change without notice For current information consult your local Pall distributor or contact Pall directly 2011 Pall Corporation Pall ALD Mustang and Resolute are trademarks of Pall Corporation indicates a trademark registered in the USA Filtration Separation Solution is a service mark of Pall Corporation 9 11 PDF GN11 7232 USD2776
12. uired flow to pack the bed Once the bed is compressed to a target value the flow is stopped and the adjuster lowered to meet the packed bed This may be repeated several times dependant on media type Unpacking can be performed through the bottom or top of the tube Typically the adjuster is raised by rotating the centrally located handles until it is clear of the tube After rinsing the top distribution plate and net to recover residual media the column contents are gently agitated with buffer to form a slurry before being pumped to a container Performance Ease of Use Figure 1 Resolute FM columns are suitable for sanitization as an Acetone 2 w v injection volume 1 5 Column empty column or in a packed condition as well as having Volume bed height 20 cm easy access to all seals and supports for fast maintenance requirements With a minimal number of parts access for FM100 wipe down and the electropolished stainless steel surface finish minimizes entrapment of contaminants and reduces the risk of corrosion Validation of all column sizes demon strated that the columns can be effectively sanitized 30 Flow litres min w im 10 20 UV AUFS as 100 10 11 30 11 40 11 50 12 00 11 04 2010 Time 11 04 2010 50 40 Flow litres min UV AUFS as 100 30 13 10 13 15 13 20 13 25 13 30 13 35 13 40 13 45 01 18 2011 Time 01 18 2011 FM200 12 30 Flow litres min AI min 20 UV AUFS a
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