Home
ReadyToProcess columns User Manual
Contents
1. Product Column size L erelo HNT RTP Phenyl Sepharose 6 FF low sub 2 5 25 28 9017 35 RTP Phenyl Sepharose 6 FF low sub 10 10 28 9017 36 RTP Phenyl Sepharose 6 FF low sub 20 20 28 9017 37 RTP Phenyl Sepharose 6 FF high sub 1 1 28 9511 97 RTP Phenyl Sepharose 6 FF high sub 2 5 2 5 28 9291 08 RTP Phenyl Sepharose 6 FF high sub 10 10 28 9291 09 RTP Phenyl Sepharose 6 FF high sub 20 20 28 9291 10 RTP CM Sepharose FF 2 5 25 28 9291 17 RTP CM Sepharose FF 10 10 28 9291 18 RTP CM Sepharose FF 20 20 28 9291 19 Empty lab scale columns Product Column size L erlo CANTO XK 16 40 column includes tube end 1 18 8774 01 piece and adapter XK 16 adapter 1 18 8778 01 Tricorn 10 50 column 10 mm i d 1 28 4064 14 Tricorn 10 200 column 10 mm i d 1 28 4064 17 1 To achieve a 20 cm bed height an extra XK16 adapter must be used This adapter is ordered separately 74 ReadyToProcess columns User Manual 28 9256 44 AE 11 Reference information 11 5 Ordering information Bulk resins Product Pack size ml L Code No Capto S 25 17 5441 10 100 17 5441 01 1 17 5441 03 5 17 5441 04 Capto Q 25 17 5316 10 100 17 5316 02 1 17 5316 03 5 17 5316 04 Capto SP ImpRes 25 17 5468 10 100 17 5468 02 1 17 5468 03 5 17 5468 04 Capto Q ImpRes 25 17 5470 10 100 17 5470 02 1 17 5470 03 5 17 5470 04 Capto S ImpAct 25 17 3717 0
2. adhere 2 5 contains 20 ethanol as preservative Max Operating Pressure 4 Bar Max Operating Temperature 30 C Warning Flammable liquid and vapour Keep away from heat sparks open flames hot surfaces No smoking Keep container tightly closed Wear protective gloves Store in a well ventilated place Keep cool Label text Description Article number Article number for the column Column size Column size which can be 1 2 5 10 or 20 L Lot Lot number Refers to a column produced at a specific time The lot number and ID number ensures that the ReadyToProcess column is fully traceable to the produc tion source Expiry Estimated expiry date Id No Identifies the individual column The lot number and ID number ensures that the ReadyToProcess column is fully traceable to the production source Bar code The bar code GS1 128 a total of 30 digits contains an application identifier1 90 the code number digits 3 to 10 a second application identifier 10 lot number digits 13 to 20 a third application identifier 21 and the ID number digits 23 to 30 14 ReadyToProcess columns User Manual 28 9256 44 AE 2 Safety instructions 2 3 Recycling information 2 3 Recycling information Introduction This section contains information about the decommissioning of ReadyToProcess columns Disposal of the column Make sure to always follow national and local
3. parts 18 ReadyToProcess columns and the chromatography resins are resistant to chemical agents used in protein recovery including agents commonly contained in crude broth buffer solutions for adsorption elution and washing and to solutions effective in cleaning and storage The chemical resistance of the outer surface of the column is listed in the table Chemical resistance external surfaces on page 66 and the resistance of the wetted parts is listed in the table Chemical resistance wetted parts on page 66 The concentrations and expo sure times listed are typical for the intended use of the ReadyToProcess columns Note Chemical resistance data has been collected from several published sources not from individual tests on column components It should be used only as a guide Note Chemical resistance external surfaces on page 66 and Chemical resistance wetted parts on page 66 list the chemical resistance of the column and not the chromatography resin For the chemical resistance of the chromatography resin see the data file for the specific resin The effects of a chemical will generally be more severe at higher temperatures Note also that the combined effects of agents have not been taken into account in this table In general the ReadyToProcess columns are not compatible with long time exposure to organic solvents The effects of a chemical will generally be more severe at higher tem peratures ReadyToProcess co
4. storage solution and equilibration of the column on page 55 ReadyToProcess columns User Manual 28 9256 44 AE Problem Efficiency test result is not the same as on the certifi cate Comment The test is performed on a different instrument than the one used in the pro duction The plate number can also vary between repetitive runs 10 Troubleshooting Action If the test result is within acceptance limits accord ing to the certificate the column is OK to use ReadyToProcess columns User Manual 28 9256 44 AE 63 11 Reference information 11 Reference information About this chapter This chapter provides reference information regarding specifications chemicals resis tance wetted parts flow conversions and ordering information In this chapter 64 This chapter contains the following sections Section See page 11 1 Specifications 65 11 2 Chemical resistance 66 11 3 Wetted parts 68 11 4 Flow conversion tables 69 11 5 Ordering information 71 ReadyToProcess columns User Manual 28 9256 44 AE 11 Reference information 11 1 Specifications 11 1 Specifications General specifications The table below shows general specifications of the ReadyToProcess columns LIE 2 5L 10L 20L Column volume L 1 0 2 5 9 9 20 2 Inner diameter mm 80 126 251 359 Inner cross section cm 50 124 495 1012 Packed bed height mm 200 200 200
5. 200 Mechanical compression factor 15 lt 15 lt 15 lt 15 1 Outer height mm 469 482 527 527 Outer diameter incl lid mm 155 210 450 598 Packed column total weight kg 3 6 25 55 Inlet TC25 connectors 6 3 mm 6 3 mm 9 5mm 12 7 mm tubing i d 0 19 0 19 0 375 0 5 Outlet TC25 connectors 6 3 mm 6 3 mm 9 5mm 12 7 mm tubing i d 0 19 0 19 0 375 0 5 Ambient temperature C 4 30 4 30 4 30 4 30 Liquid temperature C 4 40 4 40 4 40 4 40 Maximum liquid pressure Depends on packed resin See specifications for each column bar psi MPa 3 Estimated shelf life months 18 18 18 18 1 The mechanical compression factor does not include flow compression and varies depending on the resin and or the size of the column 2 The temperature difference between the fluid running through the column and the ambient temperature in the room should never be greater than 20 C 3 The maximum pressure for an empty ReadyToProcess column is 4 0 bar 58 psi 0 40 MPa For a packed column restrictions regarding maximum pressure drop depend on the chromatography resin The pressure drop between inlet and outlet of the ReadyToProcess column should never exceed the specified maximum pressure drop for the resin in the column ReadyToProcess columns User Manual 28 9256 44 AE 65 11 Reference information 11 2 Chemical resistance 11 2 Chemical resistance Chemical resistance external surfaces The table be
6. Sepharose HP 1 1 29 1017 11 RTP SP Sepharose HP 2 5 25 29 1017 12 ReadyToProcess columns User Manual 28 9256 44 AE 11 Reference information 11 5 Ordering information Product Column size L Code No RTP SP Sepharose HP 10 10 29 1017 13 RTP SP Sepharose HP 20 20 29 1017 14 RTP Capto adhere 1 1 28 9511 09 RTP Capto adhere 2 5 2 5 28 9017 14 RTP Capto adhere 10 10 28 9017 15 RTP Capto adhere 20 20 28 9017 16 RTP Capto MMC 1 1 28 9511 18 RTP Capto MMC 2 5 25 28 9291 20 RTP Capto MMC 10 10 28 9291 21 RTP Capto MMC 20 20 28 9291 22 RTP Capto adhere ImpRes 1 1 29 1017 03 RTP Capto adhere ImpRes 2 5 2 5 29 1017 04 RTP Capto adhere ImpRes 10 10 29 1017 05 RTP Capto adhere ImpRes 20 20 29 1017 06 RTP Capto MMC ImpRes 1 1 29 1017 07 RTP Capto MMC ImpRes 2 5 2 5 29 1017 08 RTP Capto MMC ImpRes 10 10 29 1017 09 RTP Capto MMC ImpRes 20 20 29 1017 10 RTP Capto Phenyl ImpRes 1 1 29 1016 97 RTP Capto Phenyl ImpRes 2 5 2 5 29 1016 98 RTP Capto Phenyl ImpRes 10 10 29 1017 00 RTP Capto Phenyl ImpRes 20 20 29 1017 02 RTP Phenyl Sepharose HP 1 1 29 1017 19 RTP Phenyl Sepharose HP 2 5 2 5 29 1017 20 RTP Phenyl Sepharose HP 10 10 29 1017 21 RTP Phenyl Sepharose HP 20 20 29 1017 22 RTP Phenyl Sepharose 6 FF low sub 1 1 28 9511 11 ReadyToProcess columns User Manual 28 9256 44 AE 73 11 Reference information 11 5 Ordering information
7. drop 39 Storage solution 24 55 7 TC connection 20 Troubleshooting 62 Typographical conventions 6 81 Page intentionally left blank Page intentionally left blank For local office contact information visit www gelifesciences com contact GE Healthcare Bio Sciences AB Bj rkgatan 30 751 84 Uppsala Sweden www gelifesciences com readytoprocess GE and GE monogram are trademarks of General Electric Company KTA AKTApilot AKTAprocess BioProcess Capto CPC MabSelect MabSelect SuRe ReadyToProcess Sepharose and Tricorn are trademarks of General Electric Company or one of its subsidiaries Triton is a trademark of Dow Chemical Comapny Tygon is a trademark of Saint Gobain Corporation All other third party trademarks are the property of their respective owner 2007 2014 General Electric Company All rights reserved First published Sep 2007 All goods and services are sold subject to the terms and conditions of sale of the company within GE Healthcare which supplies them A copy of these terms and conditions is available on request Contact your local GE Healthcare repre sentative for the most current information GE Healthcare Europe GmbH Munzinger Strasse 5 D 79111 Freiburg Germany GE Healthcare UK Limited Amersham Place Little Chalfont Buckinghamshire HP7 9NA UK GE Healthcare Bio Sciences Corp 800 Centennial Avenue P O Box 1327 Piscataway NJ 08855 1327 USA GE Healthcare Japan Co
8. from mass transfer resistance and molecular diffusion could be minimized These specific conditions depend on many factors including type of mobile phase and tracer chosen for the efficiency test temperature at which the test is performed and type of chromatography resin especially its particle size distribution Considering that GE chromatography resins are manufactured according to high quality standards and within a very tight technical specification it can be expected that the contribution from intraparticle mass transfer resistance to the overall dispersion in the column will be constant and in effect scalable for a given chromatography resin Similarly the contribution related to molecular diffusion of the tracer will be constant providing that specific test conditions such as temperature are constant Therefore the packing quality can be evaluated at conditions where mass transfer contribution is not optimized i e minimized Consequently performing efficiency tests at higher veloc ity than the normally recommended range will provide sufficient data to correctly assess column integrity if the other contributions to the overall dispersions are known 60 ReadyToProcess columns User Manual 28 9256 44 AE 9 Operation 9 5 Evaluation of the packed bed optional The figure below shows efficiency tests of a ReadyToProcess 20 L column at 30 and 100 cm h liquid velocity respectively where N m theoretical plates per meter packe
9. impressive resolution The ability to run at higher flow rates and higher bed heights also increases flexibility in process design Pressure drop The pressure drop over the packed bed depends on the liquid velocity applied as well as the viscosity and temperature of the liquid A maximum pressure drop of 3 0 bar over the column shall not be exceeded in order to ensure integrity of the packed bed Typically a liquid velocity of 200 cm h results in a pressure drop of less than 3 0 bar when using the 2 5L with aqueous solutions at room temperature Pressure flow curves for 1 L RTP Capto SP ImpRes and RTP Capto Q ImpRes are shown in the figure below for operation with water at room temperature 20 C 400 350 Capto SP ImpRes 1 L e Capto Q ImpRes 1 L 300 250 200 150 Velocity cm h 100 50 0 T T T T T T 1 0 0 5 1 1 5 2 2 5 3 3 5 Pressure bar ReadyToProcess columns User Manual 28 9256 44 AE 33 6 lon Exchange IEX chromatography resins 6 2 Capto SP ImpRes and Capto Q ImpRes Characteristics Some of the characteristics of Capto SP ImpRes and Capto Q ImpRes resins are summa rized in the table below Characteristic Capto SP ImpRes Capto Q ImpRes Matrix High flow agarose Average particle size dso 1 40 um Ligand Sulfonate group Quaternary amine strong cation exchanger strong anion exchanger pH working range 4to 12 2 to 12 Workin
10. of the characteristics of SP Sepharose HP and Q Sepharose HP are summarized in the table below Characteristic SP Sepharose HP Q Sepharose HP Matrix Cross linked 6 agarose Average particle size dso 1 34 um Ligand Sulphopropyl group Quaternary amine strong cation exchanger strong anion exchanger pH working range 4 to 13 2 to 12 Working temperature 4 C to 30 C Storage temperature 4 C to 30 C Maximum pressure drop over packed bed 2 4 Bar 35 psi 0 24 MPa Storage solution 20 ethanol 20 ethanol 0 2 M sodium acetate pH 5 5 1 dzo is the resin particle size of the cumulative volume distribution 40 ReadyToProcess columns User Manual 28 9256 44 AE 7 Multimodal chromatography resins 7 Multimodal chromatography resins About this chapter This chapter describes the multimodal chromatography resins that can be used with Related literature on page 78 columns In this chapter This chapter contains the following sections Section See page 7 1 Capto adhere and Capto MMC 42 7 2 Capto adhere ImpRes and Capto MMC ImpRes 45 Introduction The multimodal chromatography resins are IEX resins with multimodal functionality that gives a different selectivity compared to traditional ion exchangers Apart from ionic interactions also hydrogen bonding and hydrophobic interactions are involved For detailed information refer to the Data files or Instructions applicable for the
11. packed bed Typically a liquid velocity of 220 cm h results in a pressure drop of less than 2 0 bar when using the 2 5L column with aqueous solutions at room temperature Pressure flow curve for 1 L RTP Capto S ImpAct is shown in the figure below for operation with water at room temperature 20 C 350 300 Capto S ImpAct 1 L 250 200 150 Velocity cm h 100 50 0 T T T T T 1 0 0 5 1 1 5 2 2 5 3 Pressure bar ReadyToProcess columns User Manual 28 9256 44 AE 35 6 lon Exchange IEX chromatography resins 6 3 Capto S ImpAct Characteristics Some of the characteristics of Capto S ImpAct in the table below Characteristic Capto S ImpAct Matrix High flow agarose Average particle size dso 1 50 um Ligand Sulfonate group strong cation exchanger pH working range 4to 12 Working temperature 4 C to 30 C Storage temperature 4 C to 30 C Maximum pressure drop over packed bed 2 0 Bar 29 psi 0 2 MPa Storage solution 20 ethanol 0 2 M sodium acetate pH 5 5 1 dso is the resin particle size of the cumulative volume distribution 36 ReadyToProcess columns User Manual 28 9256 44 AE 6 lon Exchange IEX chromatography resins 6 4 Sepharose Fast Flow IEX resin 6 4 Sepharose Fast Flow IEX resin lon exchangers Sepharose Fast Flow based IEX resin available for ReadyToProcess columns are DEAE Sepharose FF SP Sepharose FF Q Sepharose FF
12. regulations for handling and disposal The columns are designed to be disposed intact as combustible material Decontamination The ReadyToProcess column must be decontaminated before decommissioning and all local regulations must be followed with regard to scrapping of the equipment ReadyToProcess columns User Manual 28 9256 44 AE 15 3 Column description 3 Column description About this chapter This chapter provides a description of the ReadyToProcess RTP column and an illustration of the main parts In this chapter This chapter contains the following sections Section See page 3 1 General description 17 3 2 Illustration 20 16 ReadyToProcess columns User Manual 28 9256 44 AE 3 Column description 3 1 General description 3 1 General description ReadyToProcess column platform ReadyToProcess columns are part of the ReadyToProcess platform from GE including chromatography and filtration products as well as other downstream solutions ReadyToProcess columns are supplied as complete units that can be connected directly to AKTA ready The columns can also be used with standard chromatography systems such as AKTAprocess The smaller columns 1 Land 2 5 L may also be used with AKTApilot systems within a limited liquid velocity range for the 2 5 L columns Note ReadyToProcess columns are recommended for upflow mode running condition but they can be run in downflow mode Prepacked resins Ready
13. resin listed in Related literature on page 78 ReadyToProcess columns User Manual 28 9256 44 AE 41 7 Multimodal chromatography resins 7 1 Capto adhere and Capto MMC el Capto adhere and Capto MMC lon exchangers 42 Capto adhere is a multimodal strong anion exchanger designed for post Protein A purifi cation of monoclonal antibodies Removal of leached Protein A aggregates host cell proteins nucleic acids and viruses from monoclonal antibodies is performed in flow through mode at which the antibodies pass directly through the column while the con taminants are adsorbed For best performance of Capto adhere screening optimization of loading conditions are required Capto MMC is a multimodal weak cation exchanger that allows binding of proteins even at high ionic strength This means that the resin may be used for direct load of clarified feedstocks without prior dilution to reduce the conductivity of the starting material The novel selectivity of Capto MMC can also be used to solve specific purification problems at high or at low ionic strength ReadyToProcess columns User Manual 28 9256 44 AE 7 Multimodal chromatography resins 7 1 Capto adhere and Capto MMC Pressure drop The pressure drop over the packed bed depends on the liquid velocity applied as well as the viscosity and temperature of the liquid A maximum pressure drop of 3 0 bar over the column shall not be exceeded in order to ensure integrity of the p
14. 0 12 14 Pressure bar ReadyToProcess columns User Manual 28 9256 44 AE 37 6 lon Exchange IEX chromatography resins 6 4 Sepharose Fast Flow IEX resin Characteristics Some of the characteristics of Sepharose Fast Flow IEX resin are summarized in the table below Characteristic Q Sepharose Fast Flow SP Sepharose Fast Flow DEAE Sepharose Fast Flow pH 5 5 Matrix Cross linked 6 agarose Average particle size 90 um dso 1 Ligand Quaternary amine Sulphopropyl Diethylaminoethyl strong anion exchanger strong cation exchanger weak anion ex changer pH working range 2 to 12 4 to 13 2to9 Working temperature 4 C to 40 C Storage temperature 4 C to 30 C Maximum pressure drop 7 1 2 bar 17 12 MP over packed bed eE peL g al Storage solution 20 ethanol containing 20 ethanol 0 2 M sodium acetate 20 ethanol 1 dso is the resin particle size of the cumulative volume distribution 38 ReadyToProcess columns User Manual 28 9256 44 AE 6 lon Exchange IEX chromatography resins 6 5 Sepharose High Performance IEX resin 6 5 Sepharose High Performance IEX resin lon exchangers SP Sepharose High Performance is a strong cation exchange BioProcess resin and Q Sepharose High Performance is a strong anion exchange Bioprocess resin both with high resolution designed for intermediate and polishing steps in downstream processing SP Sepharose High Performance and Q Se
15. 1 100 17 3717 02 1 17 3717 03 5 17 3717 04 Q Sepharose Fast Flow 25 17 0510 10 300 17 0510 01 5 17 0510 04 ReadyToProcess columns User Manual 28 9256 44 AE 75 11 Reference information 11 5 Ordering information Product Pack size ml L erlo ENT SP Sepharose Fast Flow 25 17 0729 10 300 17 0729 01 5 17 0729 04 DEAE Sepharose Fast Flow 25 17 0709 10 500 17 0709 01 10 17 0709 05 Q Sepharose High Performance 75 17 1014 01 1 17 1014 03 5 17 1014 04 SP Sepharose High Performance 75 17 1087 01 1 17 1087 03 5 17 1087 04 Capto adhere 25 17 5444 10 100 17 5444 01 1 17 5444 03 5 17 5444 04 Capto MMC 25 17 5317 10 100 17 5317 02 1 17 5317 03 5 17 5317 04 Capto adhere ImpRes 25 17 3715 01 100 17 3715 02 1 17 3715 03 5 17 3715 04 76 ReadyToProcess columns User Manual 28 9256 44 AE 11 Reference information 11 5 Ordering information Product Pack size ml L Code No Capto MMC ImpRes 25 17 3716 01 100 17 3716 02 1 17 3716 03 5 17 3716 04 Capto Phenyl ImpRes 25 17 5484 01 100 17 5484 02 1 17 5484 03 Phenyl Sepharose High Performance 75 17 1082 01 1 17 1082 03 5 17 1082 04 Phenyl Sepharose 6 FF low sub 25 17 0965 10 200 17 0965 05 1 17 0965 03 5 17 0965 04 MabSelect SuRe 25 17 5438 01 200 17 5438 02 1 17 5438 03 5 17 5438 04 ReadyToProcess column
16. 69 71 E E E E E E E E 80 ReadyToProcess columns User Manual 28 9256 44 AE 1 Introduction 1 Introduction About this chapter This chapter contains important user information descriptions of safety notices regula tory information and intended use of the ReadyToProcess columns In this chapter This chapter contains the following sections Section See page 1 1 About this manual 6 1 2 Important user information 7 1 3 Regulatory information 9 ReadyToProcess columns User Manual 28 9256 44 AE 5 1 Introduction 1 1 About this manual 1 1 About this manual Purpose of this manual The User Manual provides you with a general introduction and guide to ReadyToProcess column operation Typographical conventions Software items are identified in the text by bold italic text A colon separates menu levels thus File Open refers to the Open command in the File menu Hardware items are identified in the text by bold text for example Power 6 ReadyToProcess columns User Manual 28 9256 44 AE 1 Introduction 1 2 Important user information 1 2 Important user information Read this before using ReadyToProcess columns All users must read this entire manual to fully understand the safe use of ReadyToProcess columns Intended use of ReadyToProcess columns ReadyToProcess columns are designed for purification of biomolecules and may be suitable for production of material for clinical phase and phase
17. HP I L T T T T T T T 1 0 0 5 1 1 5 2 2 5 3 3 5 4 Pressure bar 50 ReadyToProcess columns User Manual 28 9256 44 AE Characteristics 8 Hydrophobic Interaction Chromatography HIC resins Some of the characteristics of Sepharose Fast Flow HIC resins are summarized in the table below Characteristic Phenyl Sepharose FF low sub 6 Phenyl Sepharose High Performance Capto Phenyl ImpRes Matrix Cross linked 6 agarose High Flow agarose Average particle size dso 90 um 34 um 34 um to 44 um Ligand Phenyl pH working range 3 to 13 2 to 13 Working temperature 4 C to 40 C Storage temperature 4 C to 30 C Maximum pressure drop over 1 2 bar 2 4 bar Change to 3 0 Bar 44 packed bed 17 psi 0 12 MPa 35 psi 0 24 MPa psi 0 3 MPa Storage solution 20 ethanol 1 deo is the resin particle size of the cumulative volume distribution ReadyToProcess columns User Manual 28 9256 44 AE 51 9 Operation 9 Operation About this chapter This chapter provides the information required to operate ReadyToProcess column in a safe way In this chapter This chapter contains the following sections Section See page 9 1 Connect the column 53 9 2 Clearance of storage solution and equilibration of the column 55 9 3 Regeneration of the column between purification cycles 56 9 4 Disconnect the column prior to dispo
18. II studies Depending on the scale of operations they may be suitable for full scale manufacturing as well as preclinical studies ReadyToProcess columns are recommended for upflow mode and primarily intended for use together with AKTA ready chromatography systems The ReadyToProcess columns can also be used with the standard systems AKTAprocess and AKTApilot WARNING The ReadyToProcess columns must not be used for any other pur pose than the intended use described in the User Manual WARNING EXPLOSION HAZARD The columns are not approved for work in a potentially explosive atmosphere in areas classified as Zone 0 to Zone 2 according to IEC 60079 10 2002 The products do not fulfill the requirements of the ATEX Directive Disposal When the column has been used it shall be disposed of as described in Section 2 3 Recy cling information on page 15 The ReadyToProcess columns cannot be repacked ReadyToProcess columns User Manual 28 9256 44 AE 7 1 Introduction 1 2 Important user information Safety notices This user documentation contains safety notices WARNING CAUTION and NOTICE concerning the safe use of the product See definitions below WARNING WARNING indicates a hazardous situation which if not avoided could result in death or serious injury It is important not to proceed until all stated conditions are met and clearly understood CAUTION CAUTION indicates a hazardous s
19. ReadyToProcess columns User Manual Page intentionally left blank Table of Contents Table of Contents 1 0 4013 2 10 0 Reet een teeter areata een nearer ee tr steer en tenet eee One ene ee nee 5 We ABOUT this manual csscccoccsssssadstcactsssoosenconzesseandecccosaseosbsecacbiesanseshoctbitesssssnsddeagsisnssitiessdtpeiosbensduidansssvessls 6 1 2 Important user information 7 1 3 Regulatory information 9 Safety INS trUCtONS erreen e e e a e a e ie 10 2 1 Safety precautions a 11 2 2 ODES secnunsitadaiinnn wes 14 23 Recycling informations naa AA A NARA 15 3 Colum description corrosie E AEE E E 16 3 1 General description 17 S22 NUSTROLOM 2xea taut csthnecha le AA AA NN 20 BH SUNN iisen ineen asennan aeaea Seeeeuiees ER 21 AL MUTA RUA sninen a A Ri 22 4 2 MOr e E N E A SANOA 24 AS Startusing the CONAN sssini niii iii 25 5 Affinity chromatography TOSIN sssrin 27 6 lon Exchange IEX chromatography resins s sssssssssessessessssesssssesseessesessees 30 6 Capto sS andi Capto O reissnyiianin na RAN ARNS 31 6 2 Capto SP ImpRes and Capto Q ImpRes aie 33 6 3 CULO SINAC ENTE EO AEA ENEA T EE EA EE T 33 6 4 Sepharose Fast Flow IEX resin w cssssesssssscssssssssssssseessssesssssssssssssssssessecescssssssssussssseceeceessssssssuseceeseees 37 6 5 Sepharose High Performance IEX resin ssssesssessssssccssssssssssssessessecssssssssassssessseseccesssnssseusesseeeees 39 7 Multimodal chro
20. ToProcess columns are prepacked pre qualified by efficiency testing and pre sanitized chromatography columns They are available with a range of BioProcess resins but can also be ordered packed with resin specifically selected by the customer The ollowing sizes columns are available in the Volume L Inner diameter mm Bed height mm 1 0 80 200 2 5 126 200 10 251 200 20 359 200 Note ReadyToProcess columns are intended for a limited number of cycles typically 5 10 cycles The length of use will however depend on the running conditions for example pressure properties of the applied liquids etc ReadyToProcess columns User Manual 28 9256 44 AE 17 3 Column description 3 1 General description Column testing Each ReadyToProcess column is packed in a cleanroom class ISO 8 environment and efficiency tested and sampled for testing endotoxin lt 0 25 EU ml and microbiological growth CFU lt 10 100 ml After efficiency testing chromatography resin compatible with the sanitization solution the columns are sanitized The columns are ready for immediate use when delivered The test results are presented in the Certificate of Analysis which are available for downloading from www gelifesciences com certificates Wetted parts All wetted parts of the ReadyToProcess columns are of USP class VI with all components traceable to their production batches Chemical resistance of column
21. acked bed Typically a liquid velocity of 500 cm h results in a pressure drop of less than 3 0 bar when using the largest column 20L with aqueous solutions at room temperature Pressure flow curves for 1 L and 20 L RTP Capto adhere and Capto MMC are shown in the figure below for operation with water at room temperature 20 C 900 800 Capto adhere 1L Capto adhere 20 L 700 _ Capto MMC 1L e Capto MMC 20 L wie 600 z Za Z p Aer 500 aS Pi 2 A S 400 a gt raf 300 Krt 7 200 aad FRE s 100 K 0 7 0 0 5 1 1 5 2 2 5 3 3 5 Pressure bar ReadyToProcess columns User Manual 28 9256 44 AE 43 7 Multimodal chromatography resins 7 1 Capto adhere and Capto MMC Characteristics Some of the characteristics of Capto adhere and Capto MMC are summarized in the table below Characteristic Matrix Capto adhere Capto MMC Highly cross linked agarose Average particle size dso 1 75 um Ligand N Benzyl N methyl ethanol N Benzoylhomocysteine amine multimodal weak cation ex multimodal strong anion ex changer changer pH stability operational 3 to 12 Working temperature 4 C to 30 C Storage temperature 4 C to 30 C Maximum pressure drop over packed bed 3 0 bar 44 psi 0 30 MPa Storage solution 20 ethanol 1 deo is the resin particle size of the cumulative volume distributio
22. alysis showing packing performance as well as endotoxin and microbiology test results for the delivered column The documentation is delivered with each column and the certificate of analysis can be downloaded on the web at www gelifesciences com cer tificates e Validation guide Validation guide gives access to product information of the ReadyToProcess column including stability and quality as well as a brief description of the preparation e Regulatory Support File RSF Current files include additional information on each BioProcess chromatography resin RSF addenda and RSF are available at www gelifesciences com rsf The polymer materials used to manufacture ReadyToProcess columns have been chosen for their biological and chemical compatibility with the samples buffers and solutions used during operation and during sanitization procedures The materials comply with the FDA Title 21 CFR 177 and the USP United States Pharmacopeia class VI requirements according to USP lt 88 gt Biological Reactivity Tests In Vivo The material is of non animal origin or has been produced under manufacturing conditions complying with EMEA 410 01 guidance The columns are designed to comply with hygienic requirements For a list of the wetted parts refer to Section 11 3 Wetted parts on page 68 ReadyToProcess columns User Manual 28 9256 44 AE 9 2 Safety instructions 2 Safety instructions About this chapter This chapter describe
23. and CM Sepharose FF DEAE Sepharose FF is a weak anion exchanger whereas SP Sepharose FF and Q Sepharose FF are strong ion exchangers cation and anion respectively CM Sepharose FF is a weak cation exchanger used for preparative protein separations in both research and industrial applications Sepharose Fast Flow ion exchangers are suitable for initial purification of protein extracts culture supernatants and other samples Usually conditions are chosen so that the components of interest bind to the ion exchanger while most contaminants pass through Pressure drop The pressure drop over the packed bed depends on the liquid velocity applied as well as the viscosity and temperature of the liquid A maximum pressure drop of 1 2 bar over the column shall not be exceeded in order to ensure integrity of the packed bed Typically a liquid velocity of 180 cm h results in a pressure drop of less than 1 2 bar when using the largest column 20L with aqueous solutions at room temperature Pressure flow curves for 1 Land 20 L RTP RTP Sepharose Fast Flow IEX are shown in the figure below for operation with water at room temperature 20 C 400 Q Sepharose FF 1 L a Q Sepharose FF 20 L P SP Sepharose FF 1 L amp SP Sepharose FF 20L DEAE Sepharose FF 1L DEAE Sepharose FF 20 L Velocity cm h N s 150 ce a a 100 ae we P gt 50 yl o 0 0 0 2 04 0 6 08 1
24. apto Q 10 10 28 9017 24 RTP Capto Q 20 20 28 9017 25 RTP Capto SP ImpRes 1 1 29 1016 61 RTP Capto SP ImpRes 2 5 25 29 1016 62 RTP Capto SP ImpRes 10 10 29 1016 63 RTP Capto SP ImpRes 20 20 29 1016 65 RTP Capto Q ImpRes 1 1 29 1016 54 RTP Capto Q ImpRes 2 5 2 5 29 1016 55 ReadyToProcess columns User Manual 28 9256 44 AE 71 11 Reference information 11 5 Ordering information 72 Product Column size L erlo CENTO RTP Capto Q ImpRes 10 10 29 1016 57 RTP Capto Q ImpRes 20 20 29 1016 58 RTP Capto S ImpAct HP 1 1 17 3717 61 RTP Capto S ImpAct 2 5 2 5 17 3717 62 RTP Capto S ImpAct 10 10 17 3717 63 RTP Capto S ImpAct 20 20 17 3717 64 RTP Q Sepharose FF 1 1 28 9511 25 RTP Q Sepharose FF 2 5 2 5 28 9290 76 RTP Q Sepharose FF 10 10 28 9290 79 RTP Q Sepharose FF 20 20 28 9290 82 RTP SP Sepharose FF 1 1 28 9510 97 RTP SP Sepharose FF 2 5 25 28 9291 05 RTP SP Sepharose FF 10 10 28 9291 06 RTP SP Sepharose FF 20 20 28 9291 07 RTP DEAE Sepharose FF 1 1 28 9511 26 RTP DEAE Sepharose FF 2 5 2 5 28 9291 14 RTP DEAE Sepharose FF 10 10 28 9291 15 RTP DEAE Sepharose FF 20 20 28 9291 16 RTP Q Sepharose HP 1 1 29 1017 15 RTP Q Sepharose HP 2 5 25 29 1017 16 RTP Q Sepharose HP 10 10 29 1017 17 RTP Q Sepharose HP 20 20 29 1017 18 RTP Q Sepharose XL 1 1 29 0326 70 RTP Q Sepharose XL 2 5 2 5 29 0005 45 RTP Q Sepharose XL 10 10 29 0156 16 RTP SP
25. ation of columns can be found in the Instructions and Validation Guide for the different resins see Related literature on page 78 56 ReadyToProcess columns User Manual 28 9256 44 AE 9 Operation 9 4 Disconnect the column prior to disposal 9 4 Disconnect the column prior to disposal Precautions WARNING Wash the column before disconnecting it from a system after use to ensure that no hazardous chemicals for example halogen containing salt buffers are left in the column prior to disposal WARNING Wash wipe off any NaOH residue from the surface of the column Disconnect the column Follow the steps below to disconnect the column before disposal Step Action 1 Using the system pump empty the column from liquid by pumping air through it Turn off the pump 2 Use the system indicators to verify that all pressure is released 3 Release any remaining pressure in the column by setting the system valves to column inline and opening a system outlet 4 Disconnect the column from the system 5 Seal the TC connectors using the welded pieces of tubing that were mounted on the column ot the delivery Result The column is now ready for disposal Disposal Refer to Section 2 3 Recycling information on page 15 regarding disposal of the column ReadyToProcess columns User Manual 28 9256 44 AE 57 9 Operation 9 5 Evaluation of the packed bed optional 9 5 Evaluation of the packed bed
26. ce information 11 5 Ordering information Product Title Code No Data file Capto MMC ImpRes 29 0356 74 nstruction Capto MMC ImpRes 29 0271 84 Data file Capto Phenyl ImpRes and Capto Butyl 29 0319 25 ImpRes Data file Q Sepharose High Performance and SP 18 1172 88 Sepharose High Performance nstruction Q Sepharose High Performance and SP 71 7128 00 Sepharose High Performance Data file Capto S ImpAct 29 0670 18 Instruction Capto S ImpAct 29 0925 01 ReadyToProcess columns User Manual 28 9256 44 AE 79 Index Index 80 A Affinity chromatograph characteristics 29 Affinity chromatography MabSelect SuRe 27 Pressure drop 28 B Backpressure 62 Bar code 14 C Capto adhere characteristics 44 pressure drop 43 Capto adhere ImpRes characteristics 47 pressure drop 46 Capto MMC characteristics 44 pressure drop 43 Capto MMC ImpRes characteristics 47 pressure drop 46 Capto Phenyl ImpRes characteristics 51 pressure drop 49 Capto Q characteristics 32 pressure drop 31 Capto Q ImpRes characteristics 34 pressuire drop 33 Capto S characteristics 32 pressure drop 31 Capto S ImpAct characteristics 36 pressure drop 35 Capto SP ImpRes characteristics 34 pressuire drop 33 CM Sepharose FF characteristics 38 pressure drop 37 Column connect to KTA ready 53 connect to standard sys tem 53 disconnect 57 efficiency testing 18 equilibrate 24 ill
27. d bed Velocity 30 cm h N m 5432 Asymmetry 1 13 Velocity 100 cm h N m 3635 Asymmetry 1 08 15000 16000 17000 18000 19000 20000 ml ReadyToProcess columns User Manual 28 9256 44 AE 61 10 Troubleshooting 10 Troubleshooting About this chapter This chapter provides information required to enable users and service personnel to identify and correct problems that may occur when operating ReadyToProcess columns If the suggested actions in this guide do not solve the problem or if the problem is not Column 62 covered by this guide contact your GE representative for advice Problem Air has entered into the column Comment During installation or dur ing run Action Apply a low liquid velocity upwards for example 30 cm h through the column Apply a pressure down stream column of approx 2 Bar and run the column for 6 column volumes CV Evaluate the column by running a HETP test If needed rerun the proce dure once more High backpressure The column is clogged during rerun e Perform regeneration of the column e Filter the sample be fore it is applied Efficiency test results are not acceptable Buffer and column do not have the same tempera ture Ensure that the column has the same temperature as the buffer and the am bient temperature where itis used Perform the effi ciency test again For more information see Section 9 2 Clearance of
28. eak b is partial peak width measured at 10 of the peak height for the tailing part of the peak The calculated plate number will vary depending on the test condi tions and it should therefore be used as a reference value only Keep conditions and equipment constant so that results are com parable Changes in solute solvent eluent sample volume liquid velocity cm h liquid pathway temperature etc will influence the results If an acceptance limit is defined in relation to column performance the column plate number can be used as part of the acceptance criteria for column use ReadyToProcess columns User Manual 28 9256 44 AE 59 9 Operation 9 5 Evaluation of the packed bed optional More information e For more information of the principles for efficiency testing in general see Process chromatography A guide to optimization scale up and validation e For more information about efficiency testing see the application note Efficiency test of ReadyToProcess columns see Related literature on page 78 Efficiency testing with a high liquid velocity Zone broadening in a chromatography column is related to hydrodynamic dispersion molecular diffusion and mass transfer resistance Because the extent of the hydrody namic dispersion will depend on column packing quality a typical protocol for assessing quality of column packing requires performing the quality test efficiency test at condi tions where the contributions
29. ected to a system and used WARNING Never exceed the maximum rated pressure of the column oP gt gt gt NOTICE Do not turn twist or break the inlet TC connection or the outlet TC connection Handle the connections with care ReadyToProcess columns User Manual 28 9256 44 AE 25 4 Installation 4 3 Start using the column Remove the packaging from the column The column is supplied in double bags The outer bag is opened first for example with a pair of scissors and the column in the unbroken inner bag is moved to the intended clean environment for example a cleanroom where the inner plastic bag is removed The column can now be moved to the location of use for example placed on an optional cart suitable for this purpose 26 ReadyToProcess columns User Manual 28 9256 44 AE 5 Affinity chromatography resin 5 Affinity chromatography resin About this chapter This chapter describes the affinity chromatography resins that can be used with ReadyToProcess columns Introduction MabSelect SuRe is a high flow alkali tolerant protein A derived resin for capturing monoclonal antibodies from large feed volumes The protein A derived MabSelect SuRe ligand is produced in Escherichia coli Fermentation and subsequent purification are performed in the absence of animal products The ligand has been specially engineered to create an affinity resin with enhanced alkali stability and high bindin
30. ed in the column docu mentation Storage conditions are indicated on the labels on the column Before using the column Before using the column it must be equilibrated with a running buffer or equivalent as described in Section 9 2 Clearance of storage solution and equilibration of the column on page 55 Columns stored in a cold room for example RTP MabSelect SuRe will at the same time as they are equilibrated to buffer also be adjusted to the temperature of the buffer Stored after use If the columns are stored after use they should be stored in a solution preventing micro bial growth for example 20 ethanol when applicable 20 ethanol containing 0 2 M sodium acetate The inlets and outlets must be sealed by blind flanges 24 ReadyToProcess columns User Manual 28 9256 44 AE 4 Installation 4 3 Start using the column 4 3 Start using the column Precautions WARNING To avoid risk of possible personal injury and damage to the column and other equipment never use the column without an appropriate pressure alarm WARNING Place the column where it is protected from possible damage and on an even surface where it cannot be unbalanced and fall to avoid personal injury or damage WARNING Do not disconnect or release the CPC sealing cap remove the tie rods or the protective rim Do not remove the welded tubing at tached to the column inlet and outlet until the column is ready to be conn
31. efer to the Data files or Instructions applicable for the resin listed in Related literature on page 78 30 ReadyToProcess columns User Manual 28 9256 44 AE 6 lon Exchange IEX chromatography resins 6 1 Capto S and Capto Q 6 1 CaptoS and Capto Q lon exchangers Capto S sulphopropyl is a strong cation exchanger and Capto Q quaternary amine is a strong anion exchanger Both resins have a surface extender for increased capacity and fast mass transfer and are intended for capture and intermediate large scale pu rification of proteins Pressure drop The pressure drop over the packed bed depends on the liquid velocity applied as well as the viscosity and temperature of the liquid A maximum pressure drop of 3 0 bar over the column shall not be exceeded in order to ensure integrity of the packed bed Typically a liquid velocity of 500 cm h results in a pressure drop of less than 3 0 bar when using the largest column 20L with aqueous solutions at room temperature Pressure flow curves for 1 L and 20 L RTP Capto S and Capto Q are shown in the illustra tion below for operation with water at room temperature 20 C 1000 900 CaptoS1l Capto 20L 800 Capto Q 1L Capto Q 20 L 700 pt 600 g gt 500 T x g 400 300 200 100 0 0 0 5 1 15 2 2 5 3 3 5 Pressure bar ReadyToProcess columns User Manual 28 9256 44 AE 31 6 lon Exchange IEX chromatography re
32. f the packing valve 7 Outlet TC connection marked Top Outlet 8 Top lid 9 Protective rim 10 Column tube 11 Bottom lid 20 ReadyToProcess columns User Manual 28 9256 44 AE 4 Installatio 4 Installation About this chapter This chapter contains information about unpacking ReadyToProcess columns storag before use and removing the packaging before use n e In this chapter This chapter contains the following sections Section See page 4 1 Unpacking 22 4 2 Storage 24 4 3 Start using the column 25 ReadyToProcess columns User Manual 28 9256 44 AE 21 4 Installation 4 1 Unpacking 4 1 Unpacking Precaution WARNING Appropriate transportation and lifting devices must be used when handling the larger columns for example carts telphers or pallet lifters All lifting must be performed in accordance with local regu lations Two to four persons are required to lift the larger columns manually Handling the column upon arrival 22 The column is delivered in a cardboard box Follow the steps below after the cardboard packaging is opened Step Action 1 Without opening the plastic bags lift the column using the handles on the top lid and remove it from the cardboard box Place the column on a cart or a similar device Note The large ReadyToProcess columns are packed with an expanded ethylene insert that is easily removed before the outer package is removed lea
33. for example 70 ethanol connect the system column outlet tubing to the column Top outlet At this stage air in the tubing will not be a problem since the column will be run in upflow mode later on Before connecting the column Bottom Inlet start the pump at a low liquid velocity for example 50 cm h with the system valves set to column inline and upflow to make sure that the system tubing is fully primed and ready to be connected to the column Bottom Inlet ReadyToProcess columns User Manual 28 9256 44 AE 53 9 Operation 9 1 Connect the column Step Action 5 Open the column TC connector marked Bottom Inlet and remove the welded piece of tubing save also this piece to be used for sealing the column before disposal If there is air in the Bottom Inlet tubing on the column use a squirt bottle and fill the tubing for example with running buffer or 20 ethanol 6 After spraying both the TC connectors with or dipping them in for example 70 ethanol connect the system column inlet tubing to the column Bottom Inlet 7 Turn off the pump or proceed to remove the storage solution 54 ReadyToProcess columns User Manual 28 9256 44 AE 9 Operation 9 2 Clearance of storage solution and equilibration of the column 9 2 Clearance of storage solution and equilibration of the column Wash the column The procedure to clear the column from storage solution is described in the AKTA ready wizard A ReadyToPr
34. g capacity for IgG The specificity of binding to the Fc region of IgG is similar to that of conventional Protein A and provides excellent purification in one step Additional features of MabSelect SuRe are a generic elution profile for different mono clonal antibodies and an enhanced protease resistance Alkali tolerance high capacity and low ligand leakage plus the rigid base matrix make MabSelect SuRe ideal for the purification of monoclonal antibodies for clinical applications For detailed information refer to the Data files or Instructions applicable for the resin listed in Related literature on page 78 ReadyToProcess columns User Manual 28 9256 44 AE 27 5 Affinity chromatography resin Pressure drop 28 The pressure drop over the packed bed depends on the liquid velocity applied as well as the viscosity and temperature of the liquid A maximum pressure drop of 2 0 bar over the column shall not be exceeded in order to ensure integrity of the packed bed Typically a liquid velocity of 350 cm h results in a pressure drop of less than 2 0 bar when using the largest column 20L with aqueous solutions at room temperature Pressure flow curves for 1 L and 20 L RTP MabSelect SuRe columns are shown in the figure below for operation with water at room temperature 20 C 700 Mab Select SuRe 1L 600 MabSelect SuRe 20 L 500 400 300 Velocity cm h 200 100 0 0 5 1 1 5 2 2 5 Pre
35. g temperature 4 C to 30 C Storage temperature 4 C to 30 C Maximum pressure drop over packed bed 3 0 Bar 44 psi 0 3MPa Storage solution 20 ethanol 20 ethanol 0 2 M sodium acetate pH 5 5 1 dso is the resin particle size of the cumulative volume distribution 34 ReadyToProcess columns User Manual 28 9256 44 AE 6 lon Exchange IEX chromatography resins 6 3 Capto S ImpAct 6 5 Capto S ImpAct lon exchanger Capto S ImpAct is a strong cation exchange chromatography resin developed for inter mediate purification and polishing of monoclonal antibodies MAbs and other biomolecules Capto S ImpAct is part of our platform of high resolution resin based on the Capto product line The polymeric ligand in combination with the attributes of the base matrix gives this cation exchanger a high binding capacity Furthermore the small bead size enables high resolution purifications The high flow characteristics of Capto resin allows for excellent pressure flow properties The exceptional binding capacity and resolution of Capto S ImpAct combined with the ability to run at high flow rates and bed heights increase productivity and flexibility in process design Pressure drop The pressure drop over the packed bed depends on the liquid velocity applied as well as the viscosity and temperature of the liquid A maximum pressure drop of 2 0 bar over the column shall not be exceeded in order to ensure integrity of the
36. he column inlet and outlet until the column is ready to be connected to a system and used 12 ReadyToProcess columns User Manual 28 9256 44 AE Column operation 2 Safety instructions 2 1 Safety precautions WARNING Do not operate ReadyToProcess columns in any other way than described in the User Manual WARNING Never exceed the maximum rated pressure of the column WARNING Make sure that there is no residual pressure in the column before any tubing is disconnected WARNING Wash the column before disconnecting it from a system after use to ensure that no hazardous chemicals for example halogen containing salt buffers are left in the column prior to disposal gt gt gt P gt WARNING Wash wipe off any NaOH residue from the surface of the column ReadyToProcess columns User Manual 28 9256 44 AE 13 2 Safety instructions 2 2 Labels 2 2 Labels Column label The column label contains the product name with information about the preservative and if it is flammable There are also information about maximum operating pressures and temperatures Note Lobel No 28916857 AE 28 9017 14 5 column ot 20140630 tore at 4 to 30 C JADE IN SWEDEN GE Healthcare Bio Sciences AB SE 751 84 Uppsala Sweden 46 18612 00 00 www gelifesciences com The information on the left part of the label is described in the table below GE Healthcare RTP Capto
37. id velocity of 200 cm h results in a pressure drop of less than 3 0 bar when using the 2 5L column with aqueous solutions at room temperature Pressure flow curves for 1 L RTP Capto adhere and Capto MMC are shown in the figure below for operation with water at room temperature 20 C 450 t Capto MMC ImpRes 1 L 400 e Capto adhere ImpRes 1 L 350 300 250 200 Velocity cm h 150 100 50 0 0 5 1 1 5 2 2 5 3 3 5 Pressure bar ReadyToProcess columns User Manual 28 9256 44 AE 7 Multimodal chromatography resins 7 2 Capto adhere ImpRes and Capto MMC ImpRes Characteristics Some of the characteristics of Capto adhere ImpRes and Capto MMC ImpRes are sum marized in the table below Characteristic Capto adhere ImpRes Capto MMC ImpRes Matrix High flow agarose Average particle size dso 1 40 um Ligand Multimodal strong anion ex Multimodal weak cation ex changer changer pH stability operational 3to 12 3 to 12 Working temperature 4 C to 30 C Storage temperature 4 C to 30 C Maximum pressure drop over packed 3 0 bar 53 psi 0 4 Mpo bed Storage solution 20 ethanol 20 ethanol 0 2 M sodium ac etate pH 5 5 1 dso is the resin particle size of the cumulative volume distribution ReadyToProcess columns User Manual 28 9256 44 AE 47 8 Hydrophobic Interaction Chromatography HIC resins 8 Hydr
38. ituation which if not avoided could result in minor or moderate injury It is important not to pro ceed until all stated conditions are met and clearly understood NOTICE NOTICE indicates instructions that must be followed to avoid damage to the product or other equipment Notes and tips Note A note is used to indicate information that is important for trouble free and optimal use of the product Tip A tip contains useful information that can improve or optimize your procedures ReadyToProcess columns User Manual 28 9256 44 AE 1 Introduction 1 3 Regulatory information 1 3 Regulatory information Regulatory product documentation Materials Each ReadyToProcess column is accompanied with an extensive documentation package to help customers register a production process in a GMP environment containing a chromatography step including a ReadyToProcess column The columns are validated both in terms of performance criteria stability and sanitization design and use materials classified according to current regulatory guidelines specified on the materials The documentation is divided into three parts e Product documentation Certificate of conformance is provided showing confor mance with 21CFR177 USP Class VI and animal free origin or E MEA 410 01 for each wetted part material The certificate of conformance also shows traceability of the materials The product documentation contains a certificate of an
39. l 28 9256 44 AE 69 11 Reference information 11 4 Flow conversion tables 10 Lcolumn Liquid velocity Flowrate Flowrate Residence time cm h ml min L h min 50 412 24 7 24 100 824 49 4 12 200 1649 98 9 6 300 2473 148 4 4 400 3297 197 8 3 500 4122 247 3 2 5 20 L column Liquid velocity Flowrate Flowrate Residence time cm h ml min L h min 50 843 50 6 24 100 1686 101 2 12 200 3372 202 3 6 300 5059 303 5 4 400 6745 404 7 3 500 8431 505 9 2 5 70 ReadyToProcess columns User Manual 28 9256 44 AE 11 Reference information 11 5 Ordering information 11 5 Ordering information ReadyToProcess columns The most popular ReadyToProcess columns are kept in stock The other listed columns are manufactured on request GE also can pack columns with other customized resins that use existing base matrices Product Column size L Code No RTP MabSelect SuRe 1 1 28 9511 10 RTP MabSelect SuRe 2 5 2 5 28 9017 17 RTP MabSelect SuRe 10 10 28 9017 18 RTP MabSelect SuRe 20 20 28 9017 19 RTP MabSelect 1 NS 1 28 9511 28 RTP MabSelect 2 5 NS 2 5 28 9415 22 RTP MabSelect 10 NS 10 28 9415 23 RTP MabSelect 20 NS 20 28 9415 24 RTP Capto S 1 1 28 9510 93 RTP Capto S 2 5 2 5 28 9017 29 RTP Capto S 10 10 28 9017 30 RTP Capto S 20 20 28 9017 31 RTP Capto Q 1 1 28 9510 90 RTP Capto Q 2 5 2 5 28 9017 23 RTP C
40. low shows the chemical resistance of the external surfaces of ReadyToProcess columns for exposure times up to a maximum of 24 hours Ethanol 70 2 propanol 70 Acetone 2 Chemical resistance wetted parts The table below shows the chemical resistance of the wetted parts of empty ReadyToProcess columns Chemical Concentration Acetone 2 Acetic acid 1M Aqueous buffers pH 2 12 lt 0 3M Arginine 2M Ammonium sulfate 4M Benzyl alcohol longtime exposure 2 DTE DTT dithioerythritol dithiothreitol 100 mM EDTA ethylenediaminetetraacetic acid 100 mM Ethanol longtime exposure 20 Ethylene glycol 50 Formaldehyde 0 1 Glycerol 10 Glycine 2M 66 ReadyToProcess columns User Manual 28 9256 44 AE 11 Reference information 11 2 Chemical resistance Chemical Concentration Guanidine hydrochloride 6M Imidazole 1M Mercaptoethanol 20 mM Phosphoric acid 0 1M Pluronic F 68 1 Polyethylene glycol PEG 500 5 Polyethylene glycol PEG 1000 1 Polyethylene glycol PEG 5000 1 Potassium phosphate 1M 1 propanol 5 2 propanol 30 SDS 1 Sodium acetate 1M Sodium chloride 4M Sodium citrate 1M Sodium sulfate 1M Sodium hydroxide 1M Sorbitol 1M Sucrose 1M Triton X 100 1 Tween 20 1 Tween 80 1 Urea 8M 1 The column is intended to be used for a limited number of purification cycles t
41. lumns User Manual 28 9256 44 AE 3 Column description 3 1 General description Non sanitized ReadyToProcess columns The ReadyToProcess NS columns are packed and qualified by efficiency testing but not sanitized The ReadyToProcess NS columns are tested and supplied with the same type of regulatory product documentation as the ReadyToProcess columns i e a certificate of conformance showing each wetted material s conformance with 21CFR177 USP Class VI and animal free origin or EMEA 410 01 The certificate of conformance ensures full traceability of materials The product documentation also contains a certificate of analysis showing packing performance as well as microbiology test results for the deliv ered column The difference in documentation between the ReadyToProcess columns and the ReadyToProcess NS columns is that the analytical specification limit regarding microbial contamination for the ReadyToProcess NS columns follows that of the bulk resin while the corresponding specification limits for the ReadyToProcess columns are stricter ReadyToProcess columns User Manual 28 9256 44 AE 19 3 Column description 3 2 Illustration 3 2 Illustration ReadyToProcess column The main parts of ReadyToProcess column are shown in the figure below Part Function 1 Plug at inlet tubing 2 Tie rod 3 Column label 4 Handle 5 Inlet TC connection marked Bottom Inlet 6 CPC sealing cap on top o
42. matography resins ssssssssesssssesssssesseesesresssssesssssesnessessessees 41 7 1 Capto adhere and Capto MMC wecccscssssssssssssusssesssesssssssssssssusssssessssssssssssnusssssssecsssssssssussesseseees 42 7 2 Capto adhere ImpRes and Capto MMC IMPReS aoecceccccsssssssssssssessssscessscssssssssessessesescesssnssneesees 45 8 Hydrophobic Interaction Chromatography HIC resins ssessssesssssssssesees 48 9 OPErdtiOR isos eiss toot ecerade cease tp aaa Sees cacdshse tes ouea aa iaoi esne ENE saae naos EE Siae sinai iieis 52 9 1 Connect the COLUMN oo eseesssesssssessesssessssssssssssnssssssnssssssssssesssssssssssseseseesceseceeseeneeseeeececeneeeceeeeeceeccenceceeeees 53 9 2 Clearance of storage solution and equilibration of the column 55 9 3 Regeneration of the column between purification cycles be 56 9 4 Disconnect the column prior to disposal eesesesssssssssssseeseee 57 9 5 Evaluation of the packed bed optional o sssssssssesssssccsssssssssssseessessscssssssssssssessesseesecsesssnsseesees 58 10 Troubleshoot 0 ganremrn eenen nee lene tanent enero een ene petra tNrsonrn ease ener ersee rete r 62 ReadyToProcess columns User Manual 28 9256 44 AE 3 Table of Contents 11 Reference information 11 1 11 2 11 3 11 4 11 5 Specifications Chemical resistance Wetted parts Flow conversion tables Ordering information E E E 64 E E EE AEE TEE AE 65 NE AO AE E A 66 SAARA ARAA A EAN AE 68
43. n 44 ReadyToProcess columns User Manual 28 9256 44 AE 7 Multimodal chromatography resins 7 2 Capto adhere ImpRes and Capto MMC ImpRes 7 2 Capto adhere ImpRes and Capto MMC ImpRes lon exchangers Capto adhere ImpRes is a strong anion exchange multimodal BioProcess chromatography resin designed to allow effective monoclonal antibody polishing in the second or third step of a purification scheme downstream of the protein A capture step Polishing can be performed in either bind and elute binding or flowthrough nonbinding modes Capto MMC ImpRes is a weak cation exchange multimodal BioProcess chromatography resin designed to meet the demands of modern large scale manufacturers for high resolution polishing of monoclonal antibodies and other biomolecules The weak cation exchange multimodal ligand enables high selectivity in a broad pH salt window compared with traditional ion exchangers which allows the use of Capto MMC ImpRes in a variety of process conditions to solve challenging purification problems ReadyToProcess columns User Manual 28 9256 44 AE 45 7 Multimodal chromatography resins 7 2 Capto adhere ImpRes and Capto MMC ImpRes Pressure drop 46 The pressure drop over the packed bed depends on the liquid velocity applied as well as the viscosity and temperature of the liquid A maximum pressure drop of 3 0 bar over the column shall not be exceeded in order to ensure integrity of the packed bed Typically a liqu
44. ns are not approved for work in a potentially explosive atmosphere in areas classified as Zone 0 to Zone 2 according to IEC 60079 10 2002 The products do not fulfill the requirements of the ATEX Directive ReadyToProcess columns User Manual 28 9256 44 AE 11 2 Safety instructions 2 1 Safety precautions Personal protection WARNING When using hazardous chemical and biological agents take all suitable protective measures such as wearing protective glasses and gloves resistant to the substances used Follow local and or national regulations for safe operation and maintenance of ReadyToProcess columns Installation and moving WARNING Appropriate transportation and lifting devices must be used when handling the larger columns for example carts telphers or pallet lifters All lifting must be performed in accordance with local regu lations Two to four persons are required to lift the larger columns manually WARNING Place the column where it is protected from possible damage and on an even surface where it cannot be unbalanced and fall to avoid personal injury or damage WARNING To avoid risk of possible personal injury and damage to the column and other equipment never use the column without an appropriate pressure alarm WARNING Do not disconnect or release the CPC sealing cap remove the tie rods or the protective rim Do not remove the welded tubing at tached to t
45. ocess column is delivered packed with chromatography resin in a storage solution consisting of 20 ethanol and for some columns 20 ethanol containing 0 2 M sodium acetate pH 5 5 The column needs to be washed to clear it from the storage solution before starting the purification process We recommend washing the column with 6 column volumes CV running buffer low salt containing buffers or H20 at a constant liquid velocity of 100 cm h Be sure not to exceed maximum working pressure for each resin therefore it is recommended to use 30 cm h when clearing and or equilibrating Sepharose High Performance columns By following the washing procedure the chromatography resin is cleared from storage solution The wash can in many cases be performed with the desired running buffer low salt containing buffers to save time equilibration of the column The wash will also adjust the temperature of the column to the running temperature important as an example for RTP MabSelect Sure columns which are recommended to be stored at 4 to 8 C Note It is not recommended to temperature adjust the column only by moving it into a room temperature environment Tests have shown that temperature adjustment of a 20 L ReadyToProcess column by moving it into a room tem perature environment could take several days Note Since they are less effective and consequently will be more expensive to use buffers containing high concentrations of salt are n
46. ophobic Interaction Chromatography HIC resins About this chapter This chapter describes the Hydrophobic Interaction Chromatography HIC chromatog raphy resins that can be used with ReadyToProcess columns Introduction Hydrophobic Interaction Chromatography HIC resins for ReadyToProcess columns include Phenyl Sepharose 6 Fast Flow low sub Phenyl Sepharose High Performance and Capto Phenyl ImpRes These resins contain no charged groups making true hydrophobic inter action chromatography possible without interfering ionic effects Phenyl Sepharose 6 Fast Flow low sub is suitable for the initial and intermediate stages of the separation process Phenyl Sepharose High Performance is an aromatic hydrophobic interaction chromatog raphy HIC resin designed for intermediate and polishing step purification steps when high resolution has priority Capto Phenyl ImpRes is a BioProcess chromatography resin developed for large scale purification of biopharmaceutical proteins Based on the well established Capto base matrix and with traditional phenyl group ligands it provides many opportunities for im proved productivity and straightforward process development For detailed information refer to the Data files or Instructions applicable for the resin listed in Related literature on page 78 48 ReadyToProcess columns User Manual 28 9256 44 AE 8 Hydrophobic Interaction Chromatography HIC resins Pressure drop The pre
47. optional Evaluation before delivery The ReadyToProcess column has been efficiency tested with 20 ethanol as mobile phase at a liquid velocity of 100 cm h at the production facility using a system compa rable with the AKTA ready system Note that apart from the system test results also depend on factors such as liquid velocity and type of mobile phase liquid used The stability of the packed ReadyToProcess column has been verified by transport testing For more information see the Validation Guide for ReadyToProcess columns Efficiency and A testing Astandard method of expressing the efficiency of a packed column is in terms of number of theoretical plates meter N m and the asymmetry factor A These values are easily determined by applying a tracer such as acetone 2 solution in 20 ethanol to the column using 20 ethanol as eluent The values are calculated as follows N 5 54 x Ve wy assuming a Gaussian peak where N number of theoretical plates Vp peak retention elution volume or time wh peak width at half height expressed in the same units as Vp 58 ReadyToProcess columns User Manual 28 9256 44 AE 9 Operation 9 5 Evaluation of the packed bed optional Typical test chromatogram showing asymmetry factor A value calculations is shown in the figure below 10 peak height Asymmetry factor As b a where a is partial peak width measured at 10 of the peak height for the leading part of the p
48. ot recommended for re moval of storage solutions Note Sepharose High Performance resins are pressure sensitive and therefore it is recommended that clearance of storage solutions and equilibrations is per formed at 30 cm h Note Capto DEAE in ReadyToProcess columns require additional column washes to clear out storage solution One of the following processes is recommended to use e The same number of column washes CV equilibration buffer after CIP and or SIP as recommended for equilibration of this resin e Wash until the column effluent shows stable conductivity and pH values before starting the purification process ReadyToProcess columns User Manual 28 9256 44 AE 55 9 Operation 9 3 Regeneration of the column between purification cycles 9 3 Regeneration of the column between purification cycles Regeneration Regeneration is the removal of very tightly bound precipitated or denatured substances from the purification system If such contaminants are allowed to accumulate they may affect the chromatographic properties of the column reduce the capacity and poten tially contaminate product in subsequent runs The number of cycles that can be run has to be investigated for each specific application and specific ReadyToProcess column If the fouling is severe it may block the column increase the pressure drop over the column and as a consequence limit the applicable liquid velocity Further details concerning regener
49. pharose High Performance are composed of crosslinked agarose beads with a mean diameter of 34 um modified with sulphopropyl SP strong cation exchange groups or quaternary amin Q strong anion exchange groups They are designed for intermediate purification and polishing applications and to be used when resolution and capacity have priority Both SP and Q Sepharose High Performance have high chemical stability and withstand effective CIP sanitization protocols using sodium hydroxide Pressure drop The pressure drop over the packed bed depends on the liquid velocity applied as well as the viscosity and temperature of the liquid A maximum pressure drop of 2 4 bar over the column shall not be exceeded in order to ensure integrity of the packed bed Typically a liquid velocity of 90 cm h results in a pressure drop of less than 2 4 bar when using the 2 5L column with aqueous solutions at room temperature Pressure flow curves for 1 L RTP SP Sepharose HP and Q Sepharose HP are shown in the figure below for operation with water at room temperature 20 C 180 160 SP Sepharose HP 1L 140 Q Sepharose HP 1L 120 100 80 Velocity cm h 60 40 20 0 0 0 5 1 1 5 2 2 5 3 Pressure bar ReadyToProcess columns User Manual 28 9256 44 AE 39 6 lon Exchange IEX chromatography resins 6 5 Sepharose High Performance IEX resin Characteristics Some
50. rporation Sanken Bldg 3 25 1 Hyakunincho Shinjuku ku Tokyo 169 0073 Japan 28 9256 44 AE 12 2014 a2061
51. s User Manual 28 9256 44 AE 77 11 Reference information 11 5 Ordering information Related literature 78 Product Title erlo CENTO Dota file ReadyToProcess Columns 28 9159 87 Data file Capto Q Capto S and Capto DEAE 11 0025 76 Instruction Capto Q Capto S and Capto DEAE 28 4074 52 Data file Capto adhere 28 9078 88 Instructions Capto adhere 28 9064 05 Data file Capto MMC 11 0035 45 Instruction Capto MMC 11 0035 05 Data file Sepharose Fast Flow ion Exchangers 18 1020 66 Instruction CM Sepharose Fast Flow 71 5009 64 DEAE Sepharose Fast Flow Q Sepharose Fast Flow SP Sepharose Fast Flow Data file MabSelect SuRe 11 0011 65 Instruction MabSelect SuRe 11 0026 01 Data file Phenyl Sepharose 6 Fast Flow low sub 18 1020 53 Phenyl Sepharose 6 FastFlow high sub Instructions Phenyl Sepharose 6 Fast Flow low sub 71 7027 00 Phenyl Sepharose 6 FastFlow high sub Handbook Process chromatography A guide to op 18 1121 56 timization scale up and validation Application Note Efficiency test of ReadyToProcess 28 9198 21 columns Application Note Purification of a monoclonal antibody 28 9198 56 using ReadyToProces columns Data file Capto SP ImpRes and Capto Q ImpRes 28 9837 63 Instruction Capto SP ImpRes and Capto Q ImpRes 28 9776 55 Data file Capto adhere ImpRes 29 0344 97 Instruction Capto adhere ImpRes 29 0271 82 ReadyToProcess columns User Manual 28 9256 44 AE 11 Referen
52. s safety precautions the column label and information regarding disposal of the column In this chapter This chapter contains the following sections Section See page 2 1 Safety precautions 11 2 2 Labels 14 2 3 Recycling information 15 10 ReadyToProcess columns User Manual 28 9256 44 AE 2 Safety instructions 2 1 Safety precautions 2 1 Safety precautions General precautions The columns must be used in accordance with the safety instructions and technical specifications given in this User Manual to avoid personal injury or possible damage to equipment This User Manual does not guarantee user safety it is the responsibility of the user s employer to ensure safe operation and provide appropriate training Information given in this User Manual is a suggested best working practice and shall in no way take precedence over individual responsibilities or local regulations Great effort has been made to design and manufacture the various parts of the equipment so that it will comply with all applicable safety aspects for this type of equipment During the operation and during other work with a column it is always each individual s responsibility to consider e their own and others personal safety e the safety of the equipment through correct use in accordance with the descriptions and instructions given in this User Manual Flammable liquids and explosive environment WARNING EXPLOSION HAZARD The colum
53. sal 57 9 5 Evaluation of the packed bed optional 58 Precautions WARNING Never exceed the maximum rated pressure of the column WARNING Make sure that there is no residual pressure in the column before any tubing is disconnected 52 ReadyToProcess columns User Manual 28 9256 44 AE 9 Operation 9 1 Connect the column 9 1 Connect the column Use with AKTA ready or standard systems ReadyToProcess columns can be used with AKTA ready or standard chromatography systems such as AKTAprocess or AKTApilot Connect to AKTA ready The steps to connect the column to AKTA ready are described in the AKTA ready wizard Note Note The column will be connected and run in upflow mode There are two different tubing kits available for use with AKTA ready Large columns i e 10 L and 20 L require a kit with an outlet tubing diameter of 9 5 mm Smaller columns require a kit with an outlet tubing diameter of 6 4 mm Connect to standard systems Perform the following steps to connect ReadyToProcess column to a standard system Step Action 1 Before connecting the column prime the system tubing with the running buffer by using the system pump Open the top TC connection of the column marked Top Outlet and remove the welded piece of tubing save the welded piece of tubing which will be used later to seal the column before disposal After spraying the TC connector with or dipping it in
54. sins 6 1 Capto S and Capto Q Characteristics Some of the characteristics of Capto S and Capto Q resins are summarized in the table below Characteristic Capto S ere To Ko KO Matrix Highly cross linked agarose with dextran surface extender Average particle size dso 1 90 um Ligand Sulphopropyl Quaternary amine strong cation exchanger strong anion exchanger pH working range 4 to 12 2 to 12 Working temperature 4 C to 30 C Storage temperature 4 C to 30 C Maximum pressure drop over packed bed 3 0 bar 44 psi 0 30 MPa Storage solution 20 ethanol 0 2 M sodium acetate pH 5 5 20 ethanol 1 dso is the resin particle size of the cumulative volume distribution 32 ReadyToProcess columns User Manual 28 9256 44 AE 6 lon Exchange IEX chromatography resins 6 2 Capto SP ImpRes and Capto Q ImpRes 6 2 Capto SP ImpRes and Capto Q ImpRes lon exchangers Capto SP ImpRes is a strong cation exchanger and Capto Q ImpRes is a strong anion exchanger Both resins are designed for the high throughput intermediate purification and polishing steps of a wide range of biomolecules This chromatography resin is part of an expanded high resolution platform based on the high flow agarose Capto product line By combining the high flow characteristics of Capto resin with a small particle size Capto SP ImpRes and Capto Q ImpRes deliver excellent pressure flow properties with
55. ssure bar ReadyToProcess columns User Manual 28 9256 44 AE 5 Affinity chromatography resin Characteristics Some of the characteristics of the resin are summarized in the table below Characteristic MabSelect SuRe Matrix Rigid highly cross linked agarose Average particle size d50v 85 um Ligand Alkali tolerant protein A derived E coli pH working range 3 to 12 Working temperature 4 C to 40 C Storage temperature 4 C to 8 C Maximum pressure drop over packed bed 2 0 bar 29 psi 0 20 MPa Storage solution 20 ethanol 1 d50vis the resin particle size of the cumulative volume distribution ReadyToProcess columns User Manual 28 9256 44 AE 29 6 lon Exchange IEX chromatography resins 6 lon Exchange IEX chromatography resins About this chapter This chapter describes the ion exchange chromatography resins that can be used with ReadyToProcess columns In this chapter This chapter contains the following sections Section See page 6 1 Capto S and Capto Q 31 6 2 Capto SP ImpRes and Capto Q ImpRes 39 6 3 Capto S ImpAct 35 6 4 Sepharose Fast Flow IEX resin 37 6 5 Sepharose High Performance IEX resin 39 Introduction Several IEX resin alternatives are available for ReadyToProcess columns The IEX resins can be divided into three groups based on the type of base matrix Capto Sepharose Fast Flow and Sepharose High Performance For detailed information r
56. ssure drop over the packed bed depends on the liquid velocity applied as well as the viscosity and temperature of the liquid The maximum pressure drop depends on the resin for Phenyl Sepharose 6 FF and Phenyl Sepharose High Performance it is 1 2 bar and for Capto Phenyl ImpRes it is 3 0 bar over the column To ensure the integrity of the packed bed this value shall not be exceeded For Phenyl Sepharose 6 FF a liquid velocity of 180 cm h results in a pressure drop of less than 1 2 bar for Phenyl Sepharose High Performance the velocity is less then 90 cm h for a pressure drop less then 2 4 bar and finally for Capto Phenyl ImpRes the velocity is less then 200 cm h for a pressure drop of less then 3 0 bar All applies when using the largest column 20L with aqueous solutions at room temperature Pressure flow curves for each resin is shown in the figures below for operation with water at room temperature 20 C ReadyToProcess columns User Manual 28 9256 44 AE 49 8 Hydrophobic Interaction Chromatography HIC resins Phenyl Sepharose 6 FF 400 350 300 250 200 Velocity cm h 150 100 50 Phenyl Sepharose 6 FF Is 2 5L Phenyl Sepharose 6 FF Is 20 L 0 2 0 4 0 6 0 8 1 1 2 14 Pressure bar Capto Phenyl ImpRes and Phenyl Separaose HP 500 450 400 350 300 250 Velocity cm h 200 150 100 50 0 Capto Phenyl ImpRes 1 L e Phenyl Sepharose
57. ustration 20 label 14 20 lids 20 non sanitized 19 packaging 26 plastic bag cover 22 prepacked 17 regeneration 56 RTP 16 size 14 storage solution 24 unpacking 22 wash 55 D DEAE Sepharose FF characteristics 38 pressure drop 37 Decontamination 15 Delivery 22 Disposal 15 57 E Efficiency of a packed col umn 58 Efficiency test 62 Efficiency testing 58 60 Expiry date 14 H HIC Capto Phenyl ImpRes 48 Phenyl Sepharose 6 48 Phenyl Sepharose HP 48 IEX resin Capto Q 31 Capto Q ImpRes 33 ReadyToProcess columns User Manual 28 9256 44 AE Capto S 31 Capto S ImpAct 35 Capto SP ImpRes 33 CM Sepharose FF 37 DEAE Sepharose FF 37 Q Sepharose FF 37 Q Sepharose HP FF IEX 39 SP Sepharose FF 37 SP Sepharose HP FF IEX 39 L Label 14 Lot number 14 M Multimodal Capto adhere 42 Capto adhere ImpRes 45 Capto MMC 42 Capto MMC ImpRes 45 N Notes and tips 8 P Phenyl Sepharose 6 FF characteristics 51 pressure drop 49 Phenyl Sepharose HP characteristics 51 ReadyToProcess columns User Manual 28 9256 44 AE Index pressure drop 49 Purpose of this manual 6 Q Q Sepharose FF characteristics 38 pressure drop 37 Q Sepharose HP characteristics 40 pressure drop 39 R Recycling 15 57 Reference information 64 S Safety notices 8 SP Sepharose FF characteristics 38 pressure drop 37 SP Sepharose HP characteristics 40 pressure
58. ving the column accessible on the pallet Check the contents against the packing list Without removing the plastic bags check the column for signs of damage that may have occurred during transportation If there is any damage contact your local GE representative Move it to a suitable place for keeping until it is time for the column to be used e Refer to Section 4 3 Start using the column on page 25 e Refer to Section 4 2 Storage on page 24 if the column is to be stored for more than a limited time before usage ReadyToProcess columns User Manual 28 9256 44 AE Step Action 4 Installation 4 1 Unpacking NOTICE To avoid contamination do not break the outer plastic bag or disturb the welded pieces of tubing mounted on the inlet and outlet TC connections of the column see Section 4 3 Start using the column on page 25 More information The User Manual and the Product Documentation specific for each individual column are enclosed with the column ReadyToProcess columns User Manual 28 9256 44 AE 23 4 Installation 4 2 Storage 4 2 Storage Precautions NOTICE gt Handle the column carefully to retain its performance Storage solution ReadyToProcess columns are supplied with 20 ethanol as storage solution For some columns the solution also contains sodium acetate Storage conditions are indicated on the labels on the column This applies unless otherwise stat
59. ypically 5 10 ReadyToProcess columns User Manual 28 9256 44 AE 67 11 Reference information 11 3 Wetted parts 113 Wetted parts Material certificates wetted components For information about the material certificates see Section 1 3 Regulatory information on page 9 List of wetted materials The table below lists the materials in ReadyToProcess Trade name Material Column part PP Polypropylene Column tube 1 connections support nets support screens stream stoppers connections PEEK Polyetheretherketone Plug at inlet tubing filter holder resin packing valve Tygon 2275 Polyolefin Hose inlet tubing welded tubing for inlet outlet protection FPM Fluorocarbon rubber O rings EPDM Ethylenepropylenediene TC gaskets 1 For the 20 L column the inner wetted surface of the column tube is PP 68 ReadyToProcess columns User Manual 28 9256 44 AE 11 Reference information 11 4 Flow conversion tables 11 4 Flow conversion tables 1 L column Liquid velocity Flow rate Flowrate Residence time cm h ml min A0 min 100 83 5 0 12 200 167 10 0 6 300 250 15 0 4 400 333 20 0 3 500 417 25 0 25 2 5 L column Liquid velocity Flow rate Flowrate Residence time cm h ml min L h min 50 104 6 25 24 100 208 12 5 12 200 415 24 9 6 300 623 37 4 4 400 831 49 9 5 500 1038 62 3 2 5 ReadyToProcess columns User Manua
Download Pdf Manuals
Related Search
Related Contents
DSC-QX100 Philips AS351 the HPS-120 User Manual - Industrial-Grade La vedette, « représentation spectaculaire de l`homme vivant » VAIO Recovery Center Guía del usuario HP XP7 Storage Family Copyright © All rights reserved.