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Learning to Use the Kvick Flow Cassette Holder

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2. 2 Toinstall one cassette clean and wet a silicone gasket by rinsing it with DI water or water for injection WFI Place the gasket against the flow distribution manifold aligning the holes in the gasket with the holes in the manifold The gasket will stick to the manifold From the top place the cassette into the holder with the gasket side of the cassette facing the backing plate hydraulic cylinder and slide the cassette against the gasket To install two or more cassettes complete the step above for installing one cassette Place the second cassette into the holder between the first cassette and the backing plate Ensure the gasket side of the second cassette faces the backing plate Place subsequent cassettes in the holder in similar fashion 3 Ensure the holes in the manifold gasket and cassettes line up Using the hydraulic pump pressurize the hydraulic cylinder to 172 barg 2 500 psig If a leak free seal is not achieved at this pressure there may be a cassette gasket or surface finish irregularity Discontinue pressurizing the system and inspect the sealing surfaces Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC 19 4 Installing Cassettes in the Holder WARNING If assistants have their hands or fingers between the backing plate and manifold when the N hydraulic pump is energized their fingers and hands can be crushed as the backing plate is pressed against the manifold To avoid the poss
3. 75 ft with three 2 33 m cassettes 10 5 Hydraulic Pump Maximum pressure for clamping cassettes 172 barg 2 500 psig Electricity supply requirements Model dependent 230 VAC 50 to 60 Hz single phase or 460 VAC 50 to 60 Hz 3 phase Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC Appendix 11 11 Appendix 11 1 Chemical compatibility You can damage a Kvick Flow cassette holder by exposing it to chemicals incompatible with stainless steel The recommended gaskets used to connect piping to the sanitary fittings of the holder are made of EPDM and are resistant to many types of chemicals Table 5 Consult the GE Healthcare Cassettes Instructions for Use manual for guidelines on the chemical compatibility of cassettes Table 5 Chemical SS 316L Resistance EPDM Resistance Acetic acid 1 7 M Resistan Resistan EtOH 2096 Resistan Resistan EtOH 4096 Resistan Resistan Ethylene glycol 50 Resistan Resistan Formaldehyde 1 7 M Resistan Resistan Formic acid 10 Resistan Resistan Glycerol 100 Resistan Resistan Hydrochloric acid 0 1 M Not recommended Resistan Isopropyl alcohol 30 Resistan Resistan Nitric acid 0 1 M Resistan Resistan Phosphoric acid 2596 Limited resistance Resistan Sodium chloride 0 5 M Resistant Resistan Sodium hydroxide 2 M Resistant Resistan Triflouroacetic acid 0 196 Resistan Resistan Triton X 100 10096 Resistan Resistan Urea 8 M Resistan R
4. Diafiltrate volume e Permeate flow rate e Permeate volume e Retentate cross flow rate e Various product quality analyses 6 4 Stage 3 Shutting the system down and recovering product Before shutting your cross flow system down you can complete two recovery methods to maximize the recovery of product One recovery method helps remove the buildup of product on the surface of the membrane inside the cassette The other method helps you recover the most product volume from the system piping and cassette 6 4 41 Capturing product from the membrane surface The first product recovery method involves reducing the cross flow rate at the end of your processing step For example as you approach the end of your processing run reduce the cross flow rate to 1 10 of the recommended processing cross flow rate Close the permeate valve or reduce the feed pressure to 0 3 barg 5 psig Retentate pressure should be O barg 0 psig Circulate the remaining product for 15 minutes This procedure will help recover product buildup from the surface of the membrane 6 442 Maximizing the volume of product recovered The second product recovery method maximizes the volume of product you can recover from the system piping and cassette The method involves slightly over concentrating the product then adding a small volume of permeate back into the system to flush concentrated product from the feed retentate loop This method is described below in the f
5. 18 1172 71 Edition AC Cassette Holder 2 2 4 Hydraulic pump A hydraulic pump is included to drive the Kvick Flow hydraulic cylinder and clamp the cassettes in the holder The hydraulic pump can generate the 172 barg 2500 psig of hydraulic pressure needed to clamp the cassettes in place 2 5 Operating the hydraulic pump The hydraulic pump provides hydraulic pressure to the hydraulic cylinder on the Kvick Flow holder The hydraulic cylinder presses the back plate against the cassette and manifold holding and sealing the cassette in place To energize the hydraulic pump locate the on off switch on the front of the hydraulic pump cover Turn the key to the right to the ON position Then press and hold the black button on the left side of the unit and the green button on the right side of the unit The hydraulic pump starts and displays the pressure on the pressure gauge located on the front panel of the pump When the pressure gauge shows the desired pressure release the buttons To release the pressure in the hydraulic system press and hold the black button on the left side of the unit and the red button on the right side of the unit The hydraulic pressure in the system decreases until you release the buttons When the hydraulic system is pressurized you can deactivate the control buttons and prevent unauthorized adjustment of the hydraulic pressure by turning the key switch to the left to the OFF position WARNING If assistants
6. Tokyo 169 0073 Japan Asia Pacific Tel 85 65 62751830 Fax 85 65 62751829 e Australasia Tel 61 2 8820 8299 Fax 61 2 8820 8200 Austria Tel 01 57606 1613 Fax 1 57606 1614 Belgium Tel 0800 73 890Fax 02 416 8206 Canada Tel 1 800 463 5800 Fax 1 800 567 1008 Central East amp South East Europe Tel 43 1 972 720 Fax 43 1 972 722 750 Denmark Tel 45 70 25 24 50 Fax 45 45 16 2424 e Eire TI 1 800 709992 Fax 44 1494 542010 Finland amp Baltics Tel 358 9 512 3940 Fax 358 9 512 39439 France Tel 01 69 35 67 00 Fax 01 69 41 98 77 Germany Tel 0800 9080 711Fax 0800 9080 712 Greater China Tel 852 2100 6300 Fax 852 2100 6338 Italy Tel 02 26001 320 Fax 02 26001 399 e Japan Tel 81 3 5331 9336 Fax 81 3 5331 9370 Korea Tel 82 2 6201 3700 Fax 82 2 6201 3803 Latin America Tel 55 11 3933 7300 Fax 55 11 3933 7304 Middle East amp Africa Tel 30 210 96 00 687 Fax 30 210 96 00 693 Netherlands Tel 0800 82 82 82 1 Fax 0800 82 82 82 4 Norway Tel 47 815 65 777 Fax 47 815 65 666 Portugal Tel 21 417 7035 Fax 21 417 3184 Russia amp other C I S amp N I S Tel 7 495 956 5177 Fax 7 495 956 5176 Spain Tel 902 11 72 65 Fax 935 94 49 65 Sweden Tel 018 612 1900 Fax 018 612 1910 Switzerland Tel 0848 8028 10 Fax 0848 8028 11 UK Tel 0800 515 313 Fax 0800 616 927 USA Tel 1 800 526 3593 Fax 1 877 295 8102 imagination at work 18 1172 71 AC 09 2006 E Elanders sterv la 2006
7. cleaning effectiveness Store the Cassette and Holder Storing the cassette and holder involves adding a storage solution and preparing the system for short term or long term storage The goal is to keep the membrane wet and to prevent microbial growth during storage protective glasses and gloves resistant to the chemicals used Follow local regulations and instructions for WARNING When using hazardous chemicals take all suitable protective measures such as wearing safe operation and maintenance of the system 7 2 Stage 1 Cleaning a cassette after use You can reuse a cassette if you clean and store it properly To clean a used cassette flush it with buffer WFI or DI water as described in the rinsing procedure on page 25 Then clean the cassette following these steps 1 Configure the system sothat the retentate and permeate lines discharge to waste Figure 10 Close the feed retentate and permeate valves 2 Prepare the appropriate volume of a cleaning solution 6 to 8 liters per 0 46 m 5 0 ft cassette Table 3 describes recommended cleaning solutions 3 Fill the feed reservoir with the cleaning solution 4 Open the feed and retentate valves and pump about 10 percent of the cleaning solution through the retentate line to waste Open the permeate valve and close the retentate valve and pump about 10 percent of the cleaning solution through permeate line to waste 5 Stop the pump and configure the system so that the re
8. cloth 9 3 Storing the holder To store the holder clean it as noted above and place several layers of a clean cloth between the flow manifold and the backing plate Manually slide the backing plate against the flow manifold to hold the cloth in place Disconnect the hydraulic pump from its power source To store the holder out of the system clean it as noted above and place several layers of a clean cloth between the flow manifold and the backing plate Manually slide the backing plate against the flow manifold to hold the Cloth in place Disconnect the holder from the system and the hydraulic pump from its power source Store the holder and hydraulic pump in a dry protected area 9 4 Recycling This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC 47 9 Maintenance 48 Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC Specifications 10 10 Specifications 10 1 Size and dimensions Feed retentate and permeate port fittings 1 inch sanitary Dimensions W x L x H 27 x 59 x 32 cm 10 5 x 23 x 12 5 in Estimated weight 36 3 kg 80 Ibs 10 2 Size and dimensions extended holder Feed ret
9. condition it with buffer Stage 5 or process product as required 9 If the Kvick Flow cassette fails the integrity test contact your GE Healthcare representative for help Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC Preparing a Cassette for Use 5 5 5 Stage 4 Sanitizing the cassette Clean and rinse the Kvick Flow cassette then follow these steps to sanitize the cassette 1 Configure the system so that the retentate and permeate lines discharge into the feed reservoir Figure 14 Close the drain valve 2 Choose a sanitizing agent See the Appendix for a list of sanitizing agents Fill the feed reservoir with the appropriate volume of sanitizing agent 1 5 liters per 0 09 m 1 0 ft of membrane areol 3 Open the feed retentate and permeate valves Start the pump Adjust the retentate valve and pump speed to obtain a retentate pressure of 0 7 barg 10 psig and the following retentate flow rate 3650 ml min for each 0 46 m 5 ft2 Kvick Flow cassette installed 4 Circulate the sanitizing solution at the temperature and for the time period stated in the Appendix Stop the pump If you are going to store the Kvick Flow cassette stop here and follow the cassette storage instructions in the GE Healthcare Cassettes Quick Reference Guide 5 Ifyou are sanitizing the Kvick Flow cassette before use drain the sanitizing solution from the system and then rinse the cassette following the rinsing pr
10. flow factor was measured was measured 4 567 25 0 890 5 519 26 0 871 6 472 27 0 851 7 428 28 0 833 8 386 29 0 815 9 346 30 0 798 0 307 31 0 781 1 271 32 0 765 2 235 33 0 749 3 202 34 0 734 4 169 35 0 719 5 139 36 0 705 6 109 37 0 692 7 081 38 0 678 8 053 39 0 665 9 027 40 0 653 20 000 41 0 641 21 0 978 42 0 629 22 0 955 43 0 618 23 0 933 44 0 607 24 0 911 45 0 596 Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC 29 5 Preparing a Cassette for Use 30 5 4 Stage 3 Test the Integrity of the cassette Before using your cross flow system and cassette to process product test the cross flow system to ensure it does not leak Then test the integrity of the cassette To test your cross flow system for leaks pressurize it with water and check the tubing or piping connections for leaks To test the integrity of the cassette pressurize the system with compressed air and measure the diffusional flow of air through the cassette membrane A high flow rate above the cassette s specification indicates there might be a hole or tear in the membrane Follow the instructions below to test the system for leaks and to test the integrity of the cassette 5 4 1 Test your system for leaks To test your cross flow system for leaks fill the system with clean water Open the feed valve Open the retentate valve Close the permeate valve Start the feed pump on slow speed and throttle the retentate valve
11. have their hands or fingers between the backing plate and manifold when the hydraulic pump is energized their fingers and hands can be crushed as the backing plate is pressed against the manifolds To avoid the possibility of crushing notify all assistants to clear the holder area and visually ensure no assistant is working on the holder before energizing the hydraulic pump Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC 15 2 Cassette Holder 16 2 6 Learning about cassettes GE Healthcare manufacturers Kvick Flow cassettes in two sizes 0 46 m 5 ft and 2 33 m 25 ft2 The Kvick Flow holder can hold one to seven 5 ft cassettes or one 25 ft cassettes The Kvick Flow extended holder can hold one to fifteen 5 ft cassettes or three 25 ft cassettes The two sizes of Kvick Flow cassettes share design components including feed and retentate channels labeling and alignment notches Fig 5 1 Feed retentate channel 2 Permeate channel 3 Alignment notch 4 Cassette side panel with imprinted information 5 2 33 m 25 ft Kvick Flow cassette 6 0 46 m 5 ft Kvick Flow cassette 7 For comparison purposes a 0 11 m 1 2 ft2 Kvick Lab cassette Fig 5 Three Kvick Flow cassettes shown with one Kvick Lab cassette in lower left of photo Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC Connecting the Holder to your System 3 3 Connecting the
12. inch extensions e 5to 10 cassettes or 1 to 2 block cassettes block cassettes are the 2 33 m 25 ft use the 4 inch extension 10to15 cassettes or three block cassettes do not use an extension Other combinations of cassettes choose a combination of extenders that will enable the backing plate to slide up to the cassettes while still providing about three inches of piston travel when the hydraulic culinder is pressurized Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC 21 4 Installing Cassettes in the Holder Hydraulic piston extender Fig 9 Kvick Flow extended holder with a 4 inch piston extender screwed into the hydraulic piston 9 Using the hydraulic pump pressurize the hydraulic cylinder to 172 barg 2 500 psig If a leak free seal is not achieved at this pressure there may be a cassette gasket or surface finish irregularity Discontinue pressurizing the system and inspect the sealing surfaces WARNING If assistants have their hands or fingers between the backing plate and manifold when the N hydraulic pump is energized their fingers and hands can be crushed as the backing plate is pressed against the manifold To avoid the possibility of crushing notify all assistants to clear the holder area and visually ensure no assistant is working on the holder before energizing the hydraulic pump EXPERT ADVICE The pressure regulator on your hydraulic pump should automatically m
13. piston by unscrewing the extensions 2 Slidethe back plate away from the manifold compressing the hydraulic piston fully into the hydraulic cylinder Fig 7 3 Slide back the sleeve on the movable guide rod and lift the guide rod up Fig 8 Movable guide rod Locking sleeve Fig 8 Sliding back the locking sleeve and moving the guide rod before installing the cassette 4 Clean and wet a silicone gasket by rinsing it with DI water or water for injection WFI Place the gasket against the flow distribution manifold aligning the holes in the gasket with the holes in the manifold The gasket will stick to the manifold 5 From the side place a cassette into the holder with the gasket side of the cassette facing the backing plate hydraulic cylinder If installing more than one cassette place them in the holder in similar fashion pushing the cassettes against the backing plate Ensure the gasket side of each cassette faces the ungasketed side of the preceding cassette 6 After you insert all the cassettes into the holder lower and lock the guide rod into its original position 7 Slidethe backing plate and cassettes towards the flow manifold ensuring the holes in the cassettes and gasket are aligned with the holes in the flow distribution manifold 8 Install one or both hydraulic piston extensions by screwing them into the end of the hydraulic piston using this schedule as a guide Fig 9 e 1to4 cassettes use the 2 inch and 4
14. product from the system by applying a low pressure nitrogen flow to the retentate side of the system Contact your GE Healthcare representative for additional details Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC 41 6 Using the Holder After recovering product from the drain line add a portion of the collected permeate circulate and drain into your product Retentate collection vessel Pressure gauge Kvick Flow holder Permeate As you near the end of processing collect 200 to 500 ml of permeate for flushing the system Fig 17 Typical process flow path for shutting the system down and recovering product 42 Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC Cleaning and Storing 7 7 Cleaning and Storing 71 Introduction You can reuse cassettes if you clean and store them properly The cleaning and storage stages include these Cleaning the Cassette Rinsing the cassettes with water prior to cleaning ensures the most effective use of the cleaning solution and prevents solubility changes that can prevent effective cleaning Circulating a cleaning solution dissolves and physically removes contaminates from the cassette Flushing with water removes the cleaning solution from the cassette Measure the Water Flux you measure the water flux and compare it to the water flux when the cassette was new You can then determine
15. the hydraulic system to 35 to 69 barg 500 to 1000 psig to prevent fluid from eaking from the cassette holder f you are not going to use the holder within ten days remove the cassette from the holder and place it into an air tight container Add storage solution to submerge the cassette Seal the container and place it in a protected ocation For storage longer than 6 months store the cassette at 4 C Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC 8 Troubleshooting 8 1 Troubleshooting guide If the Kvick Flow holder does not seem to work properly consult the troubleshooting guide Table 4 Table 4 Kvick Flow holder troubleshooting guide Symptom Possible Cause Troubleshooting 8 Solution Holder leaks from between flow manifold and backing plate Process solution leaks from sanitary connections Feed pressure is too high System leaks during integrity testing Insufficient clamping force System is being run at excessive operating pressures Cassette gasket damaged or not seated properly Cassette sealing surfaces damaged Sealing surface of the flow manifold or backing plate scratched Sanitary connection gasket missing worn damaged improperly mounted or wrong size Sanitary clamp loose Cassette fouled Obstruction in feed line or retentate line Feed inlet in cassette plugged Insufficient clamping force Improperly seated cassette or gasket Sealing
16. this user guide the term clean water means 0 2 m filtered water or WFI Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC Cassette Holder 2 2 Cassette Holder 2 1 Package Contents Each shipment of a Kvick Flow cassette holder includes the following components e Hydraulic pump and hydraulic hose e Kvick Flow holder with hydraulic pump and cylinder The extended holder includes two hydraulic piston extenders e User guide and safety guide e Certificate of analysis Fig 3 Piston extenders only included with extended holder Fig 3 Contents of Kvick Flow cassette holder package hydraulic pump not shown 2 2 Learning about the holder The Kvick Flow cassette holder is designed to hold 1 to 7 cassettes each cassette having 0 46 m 5 ft of membrane area The holder can also hold one 2 33 m 25 ft cassettes The Kvick Flow extended holder can hold 1to 15 cassettes each cassette having 0 46 m 5 ft of membrane area and can also hold three 2 33 m 25 ft cassettes Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC 13 2 Cassette Holder 14 2 3 Features The Kvick Flow holder simplifies operation with fewer parts and connections than other types of cross flow cassette holders GE Healthcare cassette holders share the following features 1 three forward facing ports for convenience 2 vertically oriented hardwar
17. valve and close the permeate valve Increase the retentate flow rate to the recommended operating cross flow rate 500 to 670 ml min per 0 09 m 1 ft of membrane area 6 Run until no bubbles appear in the retentate stream 7 Open the permeate valve Adjust the retentate valve until the retentate flow is about 10 percent of the feed flow Adjust the feed pump to maintain a feed pressure of 1 6 to 2 8 barg 25 to 40 psig for ultrafiltration cassettes 8 Circulate the buffer for four minutes to condition the system for pH and ionic stability If conditioning for temperature control continue circulating until the temperature of the system stabilizes 9 Remove the buffer from the feed reservoir Keep buffer in other parts of the system to prevent air from entering the system Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC Pressure gauge Retentate Permeate Y Fig 15 Typical configuration for conditioning the system with buffer Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC Preparing a Cassette for Use 5 Kvick Flow holder 35 5 Preparing a Cassette for Use 36 Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC Using the Holder 6 6 Using the Holder 6 1 Introduction Equipment configuration and process conditions for cross flow processes vary widely depending upon the application system design process objecti
18. your product to the system Conditioning minimizes unwanted reactions between your product and the wetted parts The buffer can also bring the system to the proper operating temperature before processing begins WARNING When using hazardous chemicals take all suitable protective measures such as wearing protective glasses and gloves resistant to the chemicals used Follow local regulations and instructions for safe operation and maintenance of the system WARNING The cassette and cassette bag contain an aqueous solution containing 0 1 to 0 2 N NaOH and N 20 to 2296 glycerin by weight When opening the cassette bag follow the standard safety procedures for handling aqueous NaOH including the use of safety glasses safety gloves and protective lab coat To avoid unexpected spilling hold the cassette package upright over a sink and trim the top of the cassette bag with scissors Drain and dispose of the excess storage solution in accordance with environmental regulations To avoid inadvertent contact with the storage solution after the cassette is removed from the bag rinse the outside surface of the cassette with high purity water EXPERT ADVICE Expert users normally establish pump curves for the system configuration they plan to use By establishing a pump curve they can quickly and accurately set the pump speed to achieve the recommended flow rate during processing To determine the flow rate without a pump curve you
19. 3 Wateridqualitja Aot neds ic Rance A uM UE MIL E LE EE 25 WebSite iia UU TUM 7 Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC www ge healthcare com Kvick Flow and Kvick Lab are trademarks of GE Healthcare companies GE imagination at work and GE monogram are trademarks of General Electric Company GE Healthcare Bio Sciences AB Triton is a trademark of Union Carbide Chemicals and Plastics Co Bj rkgatan 30 All goods and services are sold subject to the terms and conditions of sale of the company within 7518AU sala GE Healthcare which supplies them GE Healthcare reserves the right subject to any regulatory and pp contractual approval if required to make changes in specifications and features shown herein or Sweden discontinue the product described at any time without notice or obligation Contact your local GE Healthcare representative for the most current information O 2006 General Electric Company All rights reserved GE Healthcare Bio Sciences AB a General Electric Company GE Healthcare Bio Sciences AB Bj rkgatan 30 SE 751 84 Uppsala Sweden GE Healthcare Europe GmbH Munzinger Strasse 5 D 79111 Freiburg Germany GE Healthcare UK Ltd 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 Bio Sciences KK Sanken Bldg 3 25 1 Hyakunincho Shinjuku ku
20. 7CPM10 O7CPMORI 07DV10 KYFLGOO1011 KYFLGO01033 KFSYO 5 inch sanitary gasket EPDM 5 package KFSYO KFSYO 07TCG10 07TCG15 071CL15 KFHRO2RAM KFHRO4RAM 56 4 56 4 56 4 56 4 56 4 56 4 56 4 56 4 56 4 56 4 56 4 56 4 56 4 2 82 5 92 5 93 5 94 3 79 3 78 3 89 2 94 3 62 3 63 2 87 2 88 2 89 5 95 5 96 Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC Parts 12 54 12 Parts 54 Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC Index Index A Pool I RR Assistance Audience fo nus erguido recie e ten P ere ted RH ER RUE Dn B Buffer conditioning ede e been tel n ed aeta et eb e ore 23 34 SUSTO UA recte i dh e RR t qd 35 C Cassette cleaning agents s ua ae rites A Dee cR o y 51 Cassette holder chemicali otnpatibilitizss e ttt be de tee ada 51 features san ssepe et teet m ad tei abate eti dtp ede e ei edo 14 Dosen 17 18 MAKE AN theta tte outer eed 18 610116011 ios EE 39 PU ITEM ee ei e ees ee A inde 13 1010 fi c E 14 53 fecommiernded floW tt 37 49 shutting down a filtration process ttt nnne O ciere 47 troubleshooting ia eto tete eto tego d e te bete d trade eee 45 Cassette installation hydraulic pressure 19 22 C
21. Adjustthe feed pump and retentate valve to produce a transmembrane pressure of 1 barg 15 psig Using a graduated cylinder and stop watch measure and record the permeate flow rate in ml min Record the temperature of the water in the feed reservoir 6 Drain the system Pressure gauge Kvick Flow holder valve b Retentate Permeate gt lt reed y Optional flow meter Drain line v Graduated cylinder Fig 11 Typical configuration for measuring water flux 1 Transmembrane pressure feed pressure retentate pressure 2 permeate pressure If you do not have a pressure gauge on the permeate line and are not restricting the line assume the permeate pressure is zero Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC 27 5 Preparing a Cassette for Use 5 3 3 Calculate flux in l m hr Convert the permeate flow rate measurements to flux using this equation Flux in LMH l m hr permeate flow in ml min cassette surface area in square meters x 0 06 5 3 4 Plot flux and determine flux at 0 7 barg Plot the calculated flux values against the transmembrane pressure Fig 12 Determine the water flux in LMH at 0 7 barg 10 psig In fig 12 the flux at 0 7 barg 10 psig is 115 LMH 200 150 100 Flux LM H 50 5 10 15 20 25 Transmembrane Pressure PSIG Fig 12 Plot of water flux versus transmembrane pressure 28 Learing to Use t
22. GE Healthcare Learning to Use the Kvick Flow Cassette Holder User Manual Important user information All users must read this entire manual to fully understand the safe use of Kvick Flow Cassette Holder WARNING The WARNING sign highlights instructions that must be fol lowed to avoid personal injury It is important not to proceed until all stated conditions are met and clearly understood CAUTION The CAUTION sign highlights instructions that must be followed to avoid damage to the product or other equipment It is important not to proceed until all stated conditions are met and clearly understood Note The Note sign is used to indicate information important for trouble free and optimal use of the product CE Certifying This product meets the requirements of applicable CE directives A copy of the corresponding Declaration of Conformity is available on request The CE symbol and corresponding declaration of conformity is valid for the instrument when it is used as a stand alone unit or connected to other CE marked GE Healthcare instruments or connected to other products recommended or described in this manual and used in the same state as it was delivered from GE Healthcare except for alterations described in this manual Recucling This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately Pleas
23. Holder to your System 3 1 Where to install the holder The integration of the cassette holder into your cross flow system depends upon your application and cross flow goals You can complete many cross flow objectives using a basic cross flow configuration Fig 6 To learn about alternate system configurations for special applications contact GE Healthcare Pressure Vent gauge Diafiltration Valve solution Retentate Kvick Flow holder Hydraulic pump Feed reservoir Retentate Pump Feed Permeate Drain and product Collection recovery line vessel Fig 6 Basic cross flow system configuration Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC 17 3 Connecting the Holder to your System 18 3 2 How to install the holder 3 2 1 Gathering materials Gather the following materials to install your GE Healthcare cassette holder into your cross flow system e Across flow system including a feed reservoir feed pump a minimum of two glycerin dampened or mechanically dampened pressure gauges and three valves e System piping and fittings to connect the feed pump permeate collection vessel and feed reservoir to the holder The piping must terminate in either 1 inch or 1 5 inch sanitary fittings to connect to feed retentate and permeate ports 3 3 Making the connections Place the Kvick Flow holder on a sturdy lab bench near your cross flow system Stabilize and level the holder using the adjustable fee
24. afety instructions provided in this user guide and any original equipment manufacturer user guides provided with your system 1 In the United States OSHA is the Occupational Safety and Health Administration Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC 9 1 Introduction Only qualified personnel who are adequately trained and who understand the operating instructions should install operate maintain and inspect the Kvick Flow cassette holder 15 Warnings Cautions and Expert Advice This user guide uses symbols and blocks of text to provide you with safety warnings and other important information WARNING The WARNING sign highlights instructions that must be followed to avoid personal injury It is important not to proceed until all stated conditions are met and clearly understood CAUTION The CAUTION sign highlights instructions that must be followed to avoid damage to the product or other equipment It is important not to proceed until all stated conditions are met and clearly understood EXPERT ADVICE An expert advice sign provides you with information that can help you use your equipment efficiently or achieve the best results 10 Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC Introduction 1 WARNING when using hazardous chemicals take all suitable protective measures such as wearing protective glasses and gloves resista
25. aintain the proper hydraulic pressure and clamping force on the cassettes even when changes in temperature occur to the holder during processing 22 Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC Preparing a Cassette for Use 5 5 Preparing a Cassette for Use 5 1 Introduction Before using a new Kvick Flow cassette you have to flush it with DI water or WFI to remove the storage solution Many applications require that you complete several of the other preparatory stages listed below to ensure the cassette and the holder perform properly and consistently Rinse Storage Solution from the Cassette before using a new cassette or a used one that you cleaned and stored you must flush the storage solution from the cassette Determine the Water Flux you determine the water flux by measuring water flow through the cassette s membrane under controlled process conditions By measuring the water flow before and after use you can determine cleaning effectiveness and monitor the cassette s performance Test the System for Leaks and Integrity in this two part process you check the system and cassette for leaks or damage to the membrane Sanitize the Cassette when you require sanitary processing conditions you can sanitize the cassette with sanitizing agents Condition the System with Buffer conditioning exposes your cross flow system s wetted parts to an appropriate buffer before you introduce
26. and the feed flow rate it may be difficult to consistently achieve the process conditions you desire Therefore to ensure consistence performance and ease of use prepare a pump curve on your feed pump before processing so that you know the relationship between pump speed and flow rate 6 Monitor the product level in the feed tank to ensure the pump does not run dry As the level drops you can add additional product to the feed tank 7 If needed transfer diafiltration solution into the feed tank at a controlled rate to maintain a constant working volume in the feed tank The required number of diafiltration volume exchanges varies greatly with respect to the particular characteristics of a product Typically in biopharmaceutical processes six volume exchanges of buffer are commonly processed through the feed tank 8 Continue processing following the steps below in the section entitled Stage 2 Steady State Operation Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC 39 6 Using the Holder 40 6 3 Stage 2 Operating the system in a steady state During steady state operation you monitor the process and record the process information that you need for product development process development process validation or quality control Key operational data includes these e Transmembrane pressure Feed pressure e Retentate pressure e Product temperature e Feed volume initial and final e
27. assette SEONG Eni T b r 44 Cassette use recommended flow rate Cassettes Cleaning a AS E TE ENARE TEA E TROS AE eo lalo rne t t qe pc eh b beads cleaning solutions conditioning the system with buffer ettet 29 SG determine Water Tux saec a a ee qu a bud aet aia 23 how marny ou cat install ida teeth db e e bet e e 19 ihistallqtign e bt RR tete e d tdt tatu ed ai NER DUE 19 EA aeta 19 21 installation Extended iii cd 21 installation in regular holder ss ta ee C ceste 19 integrity testing csv e b eee acta eme ade dq m en dq di RUE 30 32 HOLUSITQ A AS Raa dentem Msc uat ee tb opening the bag sateluy sae ett tte eet rho qe t Prem dade 11 23 24 photograp rt dd Ee preparing TOR USe x ss tdt debt e de bet bebe Re et al ial SAE de teg etie O AE rinsing and cleaning rinsing the stordge SOlUtior oo o eb e sh aee E OR eas 24 SOTetU veronica 11 23 24 sanitization AA ES 45 storage solution 23 24 testing f r damage and systern lek SS russin n 23 VVO IKE ea OF AAEE AEE EE E A RAE 26 Caution signs pru E A A R EN AS M n IE Ghemlicalicompatibilitis 3 5 coe rn carte bea dte ea ird aa 51 Cleaning gets eee e teet qe te e ac ebd E Men tea aie Men pene 51 Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC 55 56 Index CIN ANSIOSO 43 o AR E AR a e PM eid 44 Cleaning cassettes Cleaning conditions Clean
28. d pressures measure the flux flow at the target pressure for your type of cassette 0 7 barg 10 psig for ultrafiltration cassettes and determine the cassette s water flux normalized to a water temperature of 20 C 7 5 1 Interpreting water flux values Compare the post cleaning flux value with the as new flux values If the post cleaning flux values are less than 60 to 80 percent of the new flux values you may have to repeat or change the cleaning procedure If after all cleaning attempts the post cleaning flux values are still less than 60 to 80 percent of the new flux values you may want to replace the cassette 7 4 Stage 3 Storing the cassette and holder 7 4 1 Storage Solution After completing stages 1 and 2 flush the cassette with a storage agent as described below to keep the membrane wet and minimize biological growth e For storage less than 3 days use 0 2 m filtered water e For storage less than 6 months use 0 1 N NaOH e For storage longer than 6 months use a storage solution of 0 1 N NaOH and store the cassette at 4 C 7 4 Storage In and Out of the Holder f you are going to use the cassette and holder within ten days you may keep the cassette in the holder Circulate the recommended storage solution water or sodium hydroxide see Storage Solution above for 10 to 15 minutes close the system valves disconnect the electrical power to the feed pump and ensure the feed reservoir is properly sealed Pressurize
29. de SN SS tese esed edax Ct stadt 34 Setup cassette installatioris esae e ee e nae ee E A how to install baths Ltd m ELE OE M Me a Ae ao Bel LO making the connections Von nc EL E med d xc nini re Era where to install a cassette holder 17 E Sens avtsen diate ERA 49 50 Starting the cross flow prOGesS tet ee ttr ero c items aate 99 Startup M Oil Steady state operation loas tio licita 40 Storage solution s no I Storge of holder and cassettes KENN OH A O S ERE ee Se E 44 Storinigthe hold8r s det ette ose npe te elc toc dat teda o bed plc 47 T Technical A e dc ed Rott a eese ate NR 7 Telephione assistance teet bo se oae c n ze an ed atcp lf Testing cassettes before use Testing for ledKS z ate ee dette e ie ea ea d ta titi Testing you system for leaks Al Tro ibleshooObHg meet e testes te titel ae date Ru ec e SA naan U User guide AROS Uea rO AEAEE EET EE 7 A e a a tbi a n dete eiiis 7 Using thecassettehelder s tete hotter ia 37 WwW W arbing SIOris x sascha ah A ei m E ME LOU S 10 Warnings cautions and expert advice ttt ttti LO RA ce tes SNUSA MT HENRI OA 44 Caleulatingss oe ctt mte e do end e RR 28 KOU Ste DS M 26 Water UR determination ete a RR eed erp 23 Water fl sxmesgsuretment a ot ie ea bate t eb bt e e NAR tte D Water flux measurement after use ce 4
30. der descripta etie iaa eben dime e RA 13 holder dimensions and weight older storage A A CIN 15 pressure regulator MU ydraulic pump operation ydraulic pump safety draulicpurps pressuresSettinigis so e tico ee Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC Index l A rbd ead tacv cease leauge web beaabu coc vccsuneddedad uate nd ceebacesempecee 7 Inspectionabholdet s citro eile tt hate ceu e etre dinde test al Installation COSS CULO M CE 19 21 how toinstallz a bees 18 making the connections 18 where toiristall arca sette holder eet eee RR gen dre Rd 17 nstalling cassettes number of cassettes ttt ttt treten tette ttttttttttotctctt 19 nitegritu TOS CIA ee ee bebe eee t et bti e ear eb E Ue ead e Ue 30 32 M RAP m aptas qan d sen Mud Ua HR ORE 49 asimizing productFeGoVerlju s ucc tetto eret ce eb a da e o attenta dde RR A Hu SAT 40 Gasuning the Water fIUX u oett IN 43 edsuring Water TIUX 0 oet ctt di ttn te b ett tea Hue Hee 26 N Nadia 11 23 24 NaOH Ta 0 A E 11 23 24 Normalizing water lx ene e be ooi be ei nte Here ete ele fed ed 29 O Opening cassette bags safely eese treten nc 11 23 24 Operatirig TOW TOC sut ete tet te EDO a dte Her a te a o ORT Le lcd 37 49 Operating the hydraulic PUMP a x35 celal trt od tree ettet LD Operation product r CoVelt
31. draulie PUMP isset tet er eee el b ente Appendix 111 Chemical comptibilitu tc ettet en ees Ti2Cassette saritiziriq agents ce teen hp tti e e HR RA HI ee eH tds Parts T2 T RarbDescriptiOHS a a P UNE IR MO La Index Learning to Use the Kvick Lab Cassette Holder User Manual 18 1172 69 Edition AG Introduction 1 1 Introduction 11 About this user guide This user guide describes how to use the GE Healthcare Kvick Flow cassette holder regular and extended models Topics include how to integrate and connect the holder to your cross flow system how to install cassettes and how to use and clean the holder and cassettes 12 Audience This user guide addresses the needs of scientists process engineers and technicians who operate laboratory and pilot cross flow systems The content and level of detail presented assumes the user possesses basic laboratory and technical skills and has the knowledge and documentation to safely and properly operate any user supplied equipment to which the cassette holder is attached If you need assistance with the instructions in this guide contact your sales representative or GE Healthcare for more information 13 Where to find more information You can consider this user guide as part of a set When you purchase Kvick Flow cassettes or a Kvick Flow cross flow system you receive the other documents in the set Fig 1 You can download technical documents and learn more about Kvick Flow casse
32. e contact an authorized representative of the manufacturer for ay information concerning the decommissioning of your equipment Ettan Spot Handling Workstation Site Preparation Guide 18 1153 53 Edition AC Contents Contents Introduction TL Aboutthis USO quide is tdt e A dit acted ee MR ri d tcrtia 7 I EP A Em 7 1 5 Where to find moreAnformationss utet trece aea oe aee e ite tee ha e br 7 VAY Safety A ate olea o t Go RR te oath ome optet to lero ete Oe 9 15 Warnings Cautions and Expert Advice eterne ttti LO Cassette Holder 21 Package ES A t be ER itd tea d Re e P ade 13 22 Eearning xaboutthe holders ad 13 2 5 FOOUUIOS a etae beet a e be dE nd b e bem bt ate bs 14 24 amp Hydraulic DUMP sse oet ee ie ete p e ee b e appen AN 15 25 Operating the hydraulic PUMP sic ed ettet hedera e HR Det ecu 15 2 6 Learning about cassettes Connecting the Holder to your System 3 1 Where to install the holder TURA 3 2 uHowstosinstallthiediolder ee RO TT 18 3 5 iMaking the confiectloris iret e dt de ee UR aoa atch buen seas Hu tete dd 18 Installing Cassettes in the Holder 4 amp 1 Introd ction aas ast ed oc ete e e ROREM nS S du a detiene dide augen de peeuos 19 4 2 Determining how many cassettes YOU can install entree 19 4 5 Installing the cassettes in the Regular Kvick Flow Holder 19 44 Installing the cassettes in the Extended Kvick Flow Holder e L Preparing a Cassette
33. e for best drainage and product recovery 3 uses state of the art GE Healthcare cassettes that include several patented and new to market features that increase safety facilitate use and improve process control and product quality and 4 highly competitive economics of use The main components include a flow distribution manifold backing plate and hydraulic culinder Fig 4 These components hold the cassettes in place and manage the flow of process fluids into and out of the cassettes To ensure ease of use the holder is mounted on a stand or frame and uses industrystandard sanitary fittings The extended holder includes a movable guide rod that enables operators to install cassettes from the side when the holders are stacked close together and space is limited The Kvick Flow holder can hold multiple Kvick Flow cassettes providing a maximum membrane area of 3 22 m 35 ft The Kvick Flow extended holder can hold cassettes providing a maximum membrane area of 6 99 m 75 ft2 GE Healthcare manufactures Kvick Flow cassettes with a wide range of molecular weight cutoffs to meet a variety of applications 1 Flow distribution manifold 2 Cassettes not supplied with holder 2 1 3 3 Back plate 4 4 Hydraulic cylinder 6 5 Hydraulic cylinder mounting plate 7 6 Permeate line valve not included 7 Feed retentate line Fig 4 Parts of a Kvick Flow cassette holder Learing to Use the Kvick Flow Cassette Holder User Manual
34. eets for the solutions you use Follow the material safety data sheet instructions for safe handling and use the personal protection equipment required by your company and local state and federal laws i WARNING Cassette holders are heavy Dropping a cassette holder on your feet or hands can cause Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC 11 1 12 Introduction AN WARNING If assistants have their hands or fingers between the backing plate and manifold when the hydraulic pump is energized their fingers and hands can be crushed as the backing plate is pressed against the manifold To avoid the possibility of crushing notify all assistants to clear the holder area and visually ensure no assistant is working on the holder before energizing the hydraulic pump CAUTION If the Kvick Flow system pump runs dry without any process fluid in it you can damage the pump To prevent damage to the pump ensure that fluid is present in the reservoir and feed line whenever you run the pump CAUTION Using tap water to rinse your cassette can plug the pores of membrane with the relatively large particulates rust dirt minerals bacteria etc found in tap water To prevent plugging the pores of the cassette always use 0 2 m filtered or water for injection WFI when rinsing or flushing a cassette or when making up cleaning solutions or adding dilution water to process fluids In
35. entate and permeate port fittings 1 inch sanitary Dimensions W x L x H 26 x 68 6 x 34 3 cm 10 25 x 27 x 13 5 in Estimated weight 45 4 kg 100 Ibs 10 3 Materials of construction Wetted parts Flow distribution manifold Polished 316L stainless steel Ra 0 8 um Back plate Polished 316L stainless steel Nonwetted parts Tie rods and stand Stainless steel Tie rod nuts Stainless steel 10 4 Operating parameters When using Kvick Flow cassettes fully open the permeate valve and adjust your pump speed and retentate valve to achieve the recommended cross flow rate The recommended operating conditions for many applications are Transmembrane pressure 1 7 to 2 4 barg 25 to 35 psig Cross flow rate 500 to 670 ml min per 0 09 m 1 0 ft of membrane area Recommended operating temperature 5 to 50 C Maximum operating temperature without cassettes 121 C 250 F Recommended operating pressure holder 0 34 to 4 barg 5 to 60 psig Operating pH 1 to 14 Hardware holdup volume including ports less than 2 ml Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC 49 10 Specifications 50 Type and number of cassettes Kvick Flow 0 46 m 5 ft maximum of 7 cassettes Kvick Flow 2 33 m 25 ft maximum of 1 cassette Kvick Flow Extended 0 46 m 5 ft maximum of 15 cassettes Kvick Flow Extended 2 33 m 25 ft maximum of 3 cassettes Maximum membrane area 6 99 m
36. er through the permeate and retentate ports to drain maintaining the 0 35 barg 5 psig feed pressure 7 Ifneededfor your application sample and analyze the last volume of drain water pumped from the system for traces of storage or cleaning solution Repeat steps 4 through 7 until you achieve the required level of storage solution removal 1 You can analyze the rinse water using analytical techniques or with residual indicator kits readily available from scientific equipment supply houses Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC 25 5 Preparing a Cassette for Use 26 5 5 Stage 2 Measuring water flux Measuring water flux involves measuring the flow of water through the cassette s membrane under controlled conditions You convert the measurement into units that represent water flux The water flux value you obtain provides an indicator of the performance of the cassette GE Healthcare recommends that you measure water flux when the cassette is new and before each use By tracking the water flux measurements you can 1 determine the effectiveness of cleaning cucles and 2 determine when a cassette reaches the end of its service life Measuring water flux manually requires about 30 minutes and this equipment graduated cylinder stopwatch thermometer calculator pen and paper If you have a flow meter installed on the permeate line you can use the flow meter for measuring flux 5 3 1 Key
37. esistan 1 Sodium chloride can cause corrosion on stainless steel at pH less than 5 Do not use sodium chloride in storage solutions Chemical resistance of Kvick Flow cassette holder wetted parts 11 2 Cassette sanitizing agents Sanitizing Agent Sanitizing Conditions 0 5 to 1 N sodium hydroxide Minimum contact time for sanitization 2 60 minutes Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC 51 11 Appendix 52 Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC 12 Parts 12 1 Part Descriptions Description Model Number Code Number Kvick Flow Holder with hydraulics 1 to 7 cassettes US style power cord Kvick Flow Holder with hydraulics 1 to 7 cassettes European style power cord Kvick Flow Holder with hydraulics 1 to 15 cassettes US style power cord Kvick Flow Holder with hydraulics 1 to 15 cassettes European style power cord Pressure gauge 0 to 6 8 barg 0 to 100 psig CPM style inch sanitary CPM style fitting for pressure gauge O rings for CPM fitting 6 package inch sanitary inline diaphragm valve Kvick Flow gasket 1 package Kvick Flow gasket 3 package inch sanitary gasket EPDM 5 package 5 inch sanitary clamp SS 2 inch hydraulic piston extension inch hydraulic piston extension gt KFHRO107000SS KFHRO107000SS20 KFHRO115000SS KFHRO115000SS20 KFSYO KFSYO KFSYO KFSYO 07APGA100 0
38. essed air supply and decompressing the system can result in bodily injury from the accidental starting of the pump or unexpected release of pressure To prevent bodily injury disconnect the power cable disconnect the compressed air line and depressurize the system before performing inspections and maintenance on the system WARNING When using hazardous chemicals take all suitable protective measures such as wearing protective glasses and gloves resistant to the chemicals used Follow local regulations and instructions for safe operation and maintenance of the system 9 1 Inspection Periodically based on usage you should make these inspections e Inspect hydraulic cylinder and line for leaks and wear e Inspect the mating surfaces of the flow manifold and backing plate for scratches e Inspect the sanitary connection gaskets for damage or wear and replace the gaskets as needed e Check the rigidity of the stand If the stand wobbles tighten the screws that hold the legs and cross braces together If the mating surfaces of the flow manifold and backing plate become excessively scratched contact your GE Healthcare representative for assistance 9 2 Maintenance After using the holder you should wash down the exterior components with clean water to remove dirt and residual process cleaning solutions Blow the wash water out of the flow manifold channels with compressed air Wipe the holder dry with a clean lint free
39. for Use O stasera A ONU HO u dene and dai tendis 23 5 2 Stage 1 Rinse storage solution from the cassette ttes LA 5 5 Stage 2 Meas ring Water TEX ee tie eee bete ee etn ea plorat 26 5 4 Stage 3 Test the Integrity of the cassette ete her itae ton tte e Rita 5 5 Stage 4 Sanitizing the cassette eo 33 5 6 Stage 5 Conditioning the system with buffer ttt ttt nennnnennenees OG Using the Holder 65 tro defe T o ad et 37 6 2 Stage 1 Starting the cross flow Process aa ss 39 6 3 Stage 2 Operating the system in a steady state m m 40 6 4 Stage 3 Shutting the system down and recovering product entente 40 Cleaning and Storing A A m M e eb p ab RE a b tale 43 1 2 Stage 1 Cleaning acassette dfter use dee gd betta 3 Stage 2 Measuring Water Tl X ais eee ete e e ette UT d deri 44 74 Stage 3 Storing the cassette and holder ette 4G Troubleshooting BL Troubleshooting guid teet e bte baee ir ie b teas 45 Learning to Use the Kvick Lab Cassette Holder User Manual 18 1172 69 Edition AG 5 Contents 10 11 12 13 Maintenance 9 1 PEI dd nde 9 25 e 937 Stoningthe holder e o eet e eee eet 94 RECUCIING enh sso tette teintes tete dh Specifications 10 1 Size and dimensions sette adaha 10 2 Size and dimensions extended holder tette ttti erre 10 3 Materials of construction ss 10 4 Operating parameters minenn eset netten sra 1 0 5 Hy
40. he Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC Preparing a Cassette for Use 5 5 3 5 Normalize water flux to 20 C and 1 psig Follow these steps to normalize the water flux value to 20 C and standardize to 1 psig to arrive at flux in LMH psig at 20 C 1 Multiply the calculated flux value by the appropriate viscosity correction factor in Table 1 For example if the flux at 0 7 barg 10 psig is 115 LMH and the temperature of the water during permeate flow measurement was 18 C then the flux normalized to 20 C is 115 LMH x 1 053 121 LMH 10 psig 2 Tostandardize the flux value to 1 psig divide the normalized water flux value by 10 psig For example 121 LMH 10 12 1 LMH psig 5 3 6 Record the Flux Value Record the normalized flux value in your laboratory notebook or production records as a benchmark for future comparison If the cassette is used compare the flux with previously obtained values to determine the performance of the cassette over time Many users replace cassettes when after cleaning the normalized water flux falls below 60 to 80 percent of the normalized flux value when the cassette was new If after cleaning the flux is low you can try alternative aggressive cleaning processes Contact GE Healthcare for more information Table 2 Viscosity correction factors Temperature in C Viscosity correction Temperature in C Viscosity correction when permeate flow factor when permeate
41. he compressed air valve is closed and the pressure regulator is set to O barg 0 psig Close the feed and drain valves and open the retentate and permeate valves 2 Remove water from the cassette feed retentate path by opening the compressed air valve and slowly adjusting the pressure regulator to 0 3 barg 5 psig Flow air through the system until water stops draining from the retentate line Close the retentate valve to allow the air pressure to drive the water from the permeate port and permeate line 3 Slowly adjust the pressure regulator to 1 barg 15 psig 4 Fillthe 250 ml graduated cylinder with water and place it inverted in the 1 000 ml beaker half filled with water Connect flexible tubing to the permeate outlet Fig 11 5 When the air bubble rate is stable note the time and the standing air volume in the graduated cylinder When 20 to 100 ml of air has collected in the graduate culinder record the time and air volume again 6 Usingthe time and air volume data calculate the air diffusion rate in ml min ft amp 1 barg 15 psig 7 Compare your results with the specifications below If your measured flow rate is less than the specification the Kvick Flow cassette is acceptable for use The specification is Less than 250 ml min per 0 46 m 5 ft Kvick Flow cassette at 1 barg This includes 10K and 10KS 30K 50K and 100K cassettes 8 When the Kvick Flow cassette passes integrity testing you can sanitize it Stage 4
42. ibility of crushing notify all assistants to clear the holder area and visually ensure no assistant is working on the holder before energizing the hydraulic pump EXPERT ADVICE The pressure regulator on your hydraulic pump should automatically maintain the proper hydraulic pressure and clamping force on the cassettes even when changes in temperature occur to the holder during processing EXPERT ADVICE If the hydraulic piston detaches from the backing plate you can easily reconnect the two components First ensure the hole at the end of the piston is lined up with the short rod on the backing plate Second manually push the backing towards the piston until they mate or pressurize the hydraulic cylinder driving the piston to mate with the backing plate 1 Flow distribution manifold 2 Backing plate 3 Hydraulic cylinder mounting plate o e e 4 Hydraulic cylinder 5 Hydraulic cylinder piston with or without extension on Kvick Flow extended holder 6 Gasket 7 Cassette with integral gasket facing the backing plate Fig 7 Top view of Kvick Flow holder showing assembly 20 Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC Installing Cassettes in the Holder 4 4 4 Installing the cassettes in the Extended Kvick Flow Holder Follow these steps to install cassettes in Kvick Flow extended cassette holders 1 Remove any hydraulic piston extensions attached to the hydraulic
43. ing solutions Cleaning the holder Conditioning the system with buffer System contigub tioriz so te te e tare ipee reed rcp b ta Noa score 5 COSS TOVE O top tomen 37 49 EROS TW systemi configurations an a bietet bcr D Cross flow systems testing for leaks eet ttt SO G storfier SUPPO rtan edere bre et EE ee b a E e tens CR Ee ere PUR REN eie 7 D Description of holders ds atat tio 13 Documentation eso eee Rt andate tee tal bt etre rece betreiben E Erriail dssistarice en b e bid edd pec detto pac edd bietet bed nel Expert adviee Sigls e p etre d b on elucet ette dete OR 10 F reed PUMP USE of PUMP CURVE sac cete eor o c lia 23 Filtration system shutdown iii es 40 Flow diagr CANINO o cioe tte ttn e et UR aste RO A Re dte tete e de 25 Fl xcmeas r mentrecordirig tette deste ta cta cen bees stetit G GU COTM read ire 11 23 24 H older chemical compatibilidad A EEEE A E EE 14 installation tipo gt peanut tutu d s I8 maintenace Making the EOMMECHIOMS acte eee tete te egeo Dre rdi ere estela LO O en a A eves 39 LS O IL DS e Lili LO PGMS NA ACCESO a O A A Lot C du a tu 53 r commended NOW kate s tone 37 49 shutting down a filtration process ttt tette nennen tnnt titel ST T elec M MM MG La TROUDIESHOOURG rca rtt dte e t bietet cde 45 ol
44. nt to the chemicals used Follow local regulations and instructions for safe operation and maintenance of the system WARNING If you overpressurize the cassette holder and cross flow filtration system with compressed air during integrity testing system components can rupture causing bodily harm To avoid the rupture of a system component due to over pressurization with compressed air use a pressure regulator to limit the pressure of your compressed air supply to the maximum operating pressure of your system components For the Kvick Flow cassette holder and Kvick Flow system the maximum operating pressure is 4 barg 60 psig Wear the appropriate personal protection devices when testing the system gt gt If a cross flow system leaks it can release potentially hazardous process fluids or cleaning fluids causing bodily harm To prevent leaks and the release of potentially hazardous process or cleaning fluids limit feed pressure to 4 barg 60 psig for Kvick Flow holders and systems Periodically check parts for wear and ensure you assemble the components correctly To monitor system pressure GE Healthcare recommends that you install pressure gauges on cross flow systems as illustrated in this user guide Isolate and depressurize your system before disassembling it Periodically inspect the system s gaskets seals and connections for wear Ensure you assemble the holder correctly following the instructions in this guide Wear the ap
45. ocedure on page 25 Pressure gauge Valve e Retentate Cassette Permeate holder Feed Drain line Fig 14 Typical setup for sanitizing a cassette and system Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC 33 5 Preparing a Cassette for Use 34 5 6 Stage 5 Conditioning the system with buffer Before processing your sample precondition the cross flow system with a buffer similar in pH and ionic strength to that of your sample Conditioning the system removes trapped air and minimizes unwanted chemical reactions between your sample and the wetted parts of the cross flow system You can also use buffer conditioning to stabilize the temperature of the cross flow system Follow these steps to condition the system with buffer 1 Setup your cross flow system to circulate the retentate and permeate back to the feed reservoir Fig 12 2 Prepare the buffer solution and if necessary condition it to the proper temperature The recommended volume of buffer solution is about 1 liter per square foot of membrane surface area 3 Putthe buffer in the feed reservoir Open the feed retentate and permeate valves Start the feed pump and increase the feed rate until solution flows from the retentate and permeate lines 4 Close the retentate valve to produce about 0 3 to 1 barg 5 to 15 psig of retentate pressure Run until no bubbles appear in the permeate stream 5 Open the retentate
46. ollowing steps 1 Asthe process nears completion decrease the pump speed to minimize flow rate vortexing in the feed tank and the possibility for product foaming 2 When you reach the slightly over concentrated volume collect about 500 to 1 000 ml of permeate in a container This volume may vary depending upon the working volume of the system Stop the pump and close the permeate valve 3 Attacha line to the feed pump drain valve and connect the other end aseptically to your collection vessel Fig 15 4 Open the drain valve and with the retentate valve open start up the pump at a slow speed Apply backpressure by slightly closing the retentate valve if needed to assist in removal of product from the drain line Stop the pump as the tank fully drains Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC Using the Holder 6 5 Close the drain valve Add a portion of saved permeate to the feed tank and circulate for two to three minutes Open the drain valve and circulate and apply backpressure by slightly closing the retentate valve if needed to drain the product from the feed retentate loop Stop the pump Repeat step 5 as needed to recover the maximum volume of product CAUTION Many types of pumps will be damaged if you run them dry Therefore monitor the liquid level in the tank and shut off the pump when the tank is empty EXPERT ADVICE If maximum recovery is required you can remove
47. ommended operating parameters include these pH range long term operating or storage 2 to 13 e pH range short term cleaning 1 to 14 e Maximum operating temperature 50 C e Maximum inlet pressure 4 barg 60 psig Diafiltration Solution Retentate Pressure gauge Valve Cassette holder Permeate Fig 16 Typical process flow path for cross flow processes Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC Using the Holder 6 6 2 Stage 1 Starting the cross flow process Follow these steps to start a typical cross flow process 1 Drain residual water from the system or condition the system with buffer 2 Close the permeate valve open the feed and retentate valves and close the drain valve if equipped 3 Direct the permeate line to an appropriate container or drain for example a permeate container waste container or process drain 4 Fillthe feed tank with product Start the feed pump and slowly circulate the product through the system for about three to four minutes Recirculation helps purge trapped air from the flow channels maximizing membrane performance 5 Open the permeate valve Slowly increase the pump speed until the optimal cross flow rate is achieved Using the retentate valve adjust the retentate backpressure until the system reaches the optimum transmembrane pressure EXPERT ADVICE If you do not know the relationship between your pump speed setting
48. propriate personal protection devices and clothing when operating and cleaning the system and 20 to 2296 glycerin by weight When opening the cassette bag follow the standard safety procedures for handling aqueous NaOH including the use of safety glasses safety gloves and protective lab coat To avoid unexpected spilling hold the cassette package upright over a sink and trim the top of the cassette bag with scissors Drain and dispose of the excess storage solution in accordance with environmental regulations l WARNING The cassette and cassette bag contain an aqueous solution containing 0 1 to 0 2 N NaOH To avoid inadvertent contact with the storage solution after the cassette is removed from the bag rinse the outside surface of the cassette with high purity water bodily injury To prevent injury from dropping a cassette holder on your feet or hands ensure you have a secure controlled grip and a sufficient number of people or the proper equipment to move the cassette holder Wear safety shoes The weight of cassette holders requires that you support them well especially when integrated into a cross flow system Ensure the holder and piping is properly supported and that piping supports meet local safety codes Mishandling potentially hazardous process and cleaning solutions can cause bodily harm To safely handle potentially hazardous process cleaning and storage solutions read the material safety data sh
49. steps in determining water flux The following steps summarize how to measure water flux 1 Measure the water flow from the permeate port at two transmembrane pressures 2 Calculate water flux in I m2 hr LMH for the two water flow measurements 3 Plot the two flux values Then interpolate Kvick Flow cassette water flux at 0 7 barg 10 psig transmembrane pressure 4 Normalize the water flux value to 20 C and 1 psig to arrive at flux in LMH psig E 20 C 5 Record the flux value as a benchmark for future comparison Compare the flux with previously obtained values The following text describes how to complete each step Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC Preparing a Cassette for Use 5 5 3 2 Measure flow from the permeate port Follow these steps to measure the water flow rate from the permeate port 1 Rinse the cassette following the instructions in Stage 1 Rinse the Kvick Flow cassette 2 Setup your cross flow system to circulate the retentate and permeate back to the feed reservoir Fig 11 3 Fill the feed reservoir with a volume of deionized water or WFI Fully open the feed retentate and permeate valves 4 Start the feed pump and adjust it and the retentate valve to obtain a transmembrane pressure of 0 3 barg 5 psig Using a graduated cylinder and stop watch measure and record the permeate flow rate in ml min Record the temperature of the water in the feed reservoir 5
50. surface of holder or cassette damaged Faulty valve Check hydraulic pressure Run system at proper operating pressures Remove and inspect gasket Reinstall gasket Remove and inspect sealing surfaces on the cassette Replace cassette if necessary Inspect sealing surface of flow manifold and backing plate for scratches Replace or have GE Healthcare polish the scratched surface Inspect gasket for wear damage and proper sizing Reinstall gasket Tighten sanitary clamp Clean cassette Inspect lines for obstruction Switch feed and retentate lines to reverse flow and flush with DI water or WFI Check hydraulic pressure Locate leaking area by feeling air leak with hand or by applying soapy water and looking for bubbles Remove inspect and reinstall cassette and gasket Locate leaking area by feeling air leak with hand or by applying soapy water and looking for bubbles Remove cassette and gasket and inspect sealing surface of flow manifold backing plate and cassette Check integrity of valves and replace as needed Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC 45 8 Troubleshooting 46 Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC 9 Maintenance 9 Maintenance AN AN WARNING Inspecting the cassette holder without shutting down the cross flow system to which it is attached disconnecting the power cable disconnecting the compr
51. t Keep piping runs short to minimize holdup volume Connect the holder s feed retentate and permeate ports to your system s piping using sanitary clamps Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC Installing Cassettes in the Holder 4 4 Installing Cassettes in the Holder 41 Introduction The following text describes two cassette installation procedures one for the regular Kvick Flow holder and one for the extended Kvick Flow holder To install a cassette in your holder you place the cassette and a gasket in the holder and clamp them in place by applying hydraulic pressure to the hydraulic cylinder You must apply the proper amount of hydraulic pressure to ensure the proper clamping force is applied to seal the cassette in place 42 Determining how many cassettes you can install The Kvick Flow holder can hold multiple cassettes depending upon the cassette type and the membrane area your application requires Table 1 Table 1 Cassette installation guide Number of Cassettes You Can Install Cassette Size Regular Kvick Flow Holder Extended Kvick Flow Holder Kvick Flow 0 46 m 5 ft 1to7 1to 15 Kvick Flow 2 33 m 25 ft 1 3 4 3 Installing the cassettes in the Regular Kvick Flow Holder Follow these steps to install cassettes in Kvick Flow cassette holders 1 Slide the back plate away from the manifold compressing the hydraulic piston fully into the hydraulic culinder Figure 7
52. tentate and permeate lines discharge into the feed reservoir Fully open the feed and retentate valves Crack open the permeate valve 6 Start the pump Adjust the retentate valve and pump speed to obtain 1 to 1 5 times your processing cross flow rate 7 Circulate the cleaning solution for 30 to 60 minutes 8 Drain the cleaning solution from the system using the drain line 9 Rinse the cassette and system with clean water as described in the rinsing procedure on page 25 Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC 43 7 Cleaning and Storing 44 Table 3 Recommended cleaning solutions Cleaning Agent Cleaning Conditions 0 5 M NaOH 30 minutes at room temperature 1 M NaOH 2 hours at 50 C 0 5 M NaOH with 300 ppm NaOCI 30 minutes at room temperature 0 5 M NaOH with 500 ppm NaOCI 30 minutes at room temperature 0 5 M NaOH then 0 5M H55SO 30 minutes at room temperature for each solution Double cleaning with 0 5 M NaOH with 30 minutes at room temperature for each cycle 300 ppm NaOCI 7 3 Stage 2 Measuring water flux To determine the effectiveness of cleaning and the end of the service life of the cassette you should measure the water flux after cleaning Compare the water flux measurement with the as new and historical flux measurements To determine the cassette s water flux follow the procedure described in this user guide However instead of measuring the flux at the two recommende
53. teps 1 Open the cassette bag and remove the cassette following the safety instructions above 2 Install the cassette in the cassette holder See your cassette holder s user guide for specific installation instructions 3 Configure the system so that the retentate and permeate lines discharge to waste Fig 10 Close the feed retentate and permeate valves Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC Preparing a Cassette for Use 5 Pressure gauge Retentate Cassette holder Permeate Drain line Fig 10 Typical setup for rinsing cassettes CAUTION Using tap water to rinse your cassette can plug the pores of membrane with the relatively large particulates rust dirt minerals bacteria etc found in tap water To prevent plugging the pores of the cassette always use 0 2 m filtered or water for injection WFI when rinsing or flushing a cassette or when making up cleaning solutions or adding dilution water to process fluids In this user guide the term clean water means 0 2 m filtered water or WFI 4 Fill the reservoir with an appropriate volume of clean water 5 liters per 0 09 m 1 0 ft of membrane area 5 Open the feed and retentate valves and close the permeate valve Pump about 10 percent of the water through the retentate line to waste maintaining a feed pressure of 0 35 barg 5 psig 6 Open the feed retentate and permeate valves and pump the remaining wat
54. thcare website Fig 1 Key documents for Kvick Flow products Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC Introduction 1 1 4 Safety Operators who work with the Kvick Flow holder should read understand and follow the instructions in this user guide and the safety guide entitled Cross Flow System Safety Multilingual Safety Instructions Fig 2 If an operator does not understand an instruction he or she should stop working with the Kvick Flow system and contact GE Healthcare for guidance Save the user and safety guides and make them available to all users of the Kvick Flow cassette holder 9 5 Cross Flow System Safety Multiingual Safety Instructions uUuvvVUUUUUUUUVUVUUVUUUVUVV Fig 2 Cross flow system safety guide GE Healthcare designs cassette holders for safe operation using GE Healthcare cassettes under the conditions stated in this user guide If you use cassette holders and cassettes in a manner not specified by GE Healthcare you may impair the protection provided by the holders and cassettes When using any laboratory pilot scale or production cross flow equipment the potential exists for personal injury unless you follow established safety procedures When using GE Healthcare products you should follow OSHA federal state and local safety regulations for equipment installation and operation You should follow your company s safety regulations You should follow the specific s
55. tte holders and cross flow systems by visiting our website www gehealthcare com In the USA you can contact our customer and technical support teams by calling 1 800 526 3593 Outside of the USA you can contact your local GE Healthcare representative using the telephone numbers listed at the back of this user guide You can also receive customer and technical support by emailing us at these addresses e Technical Support ts usa ge com e Customer Service cs usOge com e Europe Customer Service cust servde ge com Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC 7 1 Introduction deu emt Lening to Use fu Kick Pio Cassette Kvick Flow Cross Flow System Instructions for Use Describes how to install use and maintain the Kvick Flow cross flow system reservoir feed pump and accessories Supplied with Kvick Flow cross flow systems Learning to Use the Kvick Flow Cassette Holder Describes how to use the Kvick Flow cassette holder Topics include installation in a cross flow system operation and cleaning Supplied with Kvick Flow cassette holder GE Healthcare Cassettes Instructions for Use Describes basic operational procedures such as flushing cleaning and specifications Supplied with cassettes MSDSs for glycerin NaOH and Hydraulic Fluid Provides safe handling and disposal informat Available for printing and downloading from the GE Heal
56. u ice eU REROR RU RR RR M NER NA UR EE REN emi 40 shutdown STORED s Gies asia teres ON d ED d AE e el ELM P Parts and dccessorless ossa docto deni dai data d etian aditam dibus 53 Preparing a cassette dans 25 Process flow in a cross flow system esent ttt tette ttt tette tette tettinttttetcttt 37 Processing samples maximizing OU UA 40 OU Uta 40 shutting the system Di A E dde 40 O 0 m E RR Product recovery Productrecovery WIN iia di M da ab 41 Pump damage from Ary TUNNG stis Rr ree aet hebben estere F S de 6 RUMO GUI a etledns 23 39 P rnp UNNNG Erster pct D e ee b e medi dors ecd enc 41 Recommended flow rate e eiit ete Renee em mte ER entran 37 49 REUSING Cassettes a HAS RINSING cdSS ette koe reete nitet eon tentem Odes T hA n edes 23 RINSING storage solution from the cassette ttt neenetnnnncnccncecce LA dropping the holder glycerin hydraulic pump NIOLO a EERE EE E EEEE opening cassette bag vasos ninia coil ibid 11 23 24 A s cotone te unitamente doi eem e eb ma ead drei 11 Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC 57 Index 58 preparing holder for inspection testi dl SOME GUS iets E E 11 storage solution storage solution handling warnings CAUTIONS and expert advice eerte netten ttti ttti 10 Sanitizing cassettes 19 34 SANNA SOHO Naa as st aren
57. until the feed pressure reads 3 barg 45 psig Check all connections for leaks 5 4 2 Testthe integrity of the cassette To measure diffusional air flow through the membrane via the permeate port you will need to add a compressed air line pressure regulator and shutoff valve to your cross flow system You also need the following equipment a 1000 ml beaker 250 ml graduated cylinder stopwatch and a piece of flexible tubing Fig 13 Test the integrity of the system and cassette manually by following the procedure described below Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC Preparing a Cassette for Use 5 Inverted graduated cylinder filled Flexible tubing connected from with water permeate line and inserted into mouth of inverted graduated cylinder Beaker A filled with water Pressure gauge Kvick Flow cassette E gt lt 9 Retentate Permeate m e Feed gt lt A gt Air shut off valve E Pressure regulator Instrument quality compressed air Drain line Fig 13 Flow diagram for testing a cross flow system and cassette before use Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC 31 5 Preparing a Cassette for Use 32 5 4 3 Check the integrity of the Cassette When you establish that the system is leak free test the integrity of the Kvick Flow cassette by following these steps 1 Ensure t
58. ves and product objectives However many cross flow processes share three main stages Startup e Steady state operation e Shutdown and product recovery This chapter describes a general procedure for using your Kvick Flow holder You must adjust the procedures based on your specific goals and application If you need assistance contact your GE Healthcare representative protective glasses and gloves resistant to the chemicals used Follow local regulations and instructions for WARNING When using hazardous chemicals take all suitable protective measures such as wearing safe operation and maintenance of the system 6 1 1 Process flow in a cross flow system A typical system for many cross flow applications includes three pressure gauges for precise process control and safety feed tank permeate collection vessel and a drain line Fig 13 The operating procedures described in this chapter are based on Fig 13 6 1 2 Recommended operating cross flow rate When using Kvick Flow cassettes fully open the permeate valve and adjust your pump speed and retentate valve to achieve the recommended cross flow rate The recommended operating conditions for many applications are Transmembrane pressure 1 7 to 2 4 barg 25 to 35 psig Cross flow rate 500 to 670 ml min per 0 09 m 1 0 ft of membrane area Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC 37 38 Using the Holder Other rec
59. would have to disconnect the retentate line and measure the flow rate using a graduated cylinder and stop watch If you need help in developing a pump curve contact GE Healthcare technical support team Learing to Use the Kvick Flow Cassette Holder User Manual 18 1172 71 Edition AC 23 5 Preparing a Cassette for Use 24 5 2 Stage 1 Rinse storage solution from the cassette 5 2 1 Opening the cassette bag safely The cassette and cassette bag contain an aqueous solution containing 0 1 to 0 2 N NaOH and 20 to 2296 glycerin by weight When opening the cassette bag follow the standard safety procedures for handling aqueous NaOH including the use of safety glasses safety gloves and protective lab coat To avoid unexpected spilling hold the cassette package upright over a sink and trim the top of the cassette bag with scissors Drain and dispose of the excess storage solution in accordance with environmental regulations To avoid inadvertent contact with the storage solution after the cassette is removed from the bag rinse the outside surface of the cassette with high purity water If you allow an ultrafiltration cassette to dry out the membrane will be damaged Therefore do not store the cassette without rewetting it with an approved storage solution 5 2 2 Rinsing the storage solution from the cassette At a minimum before using a new or used and stored cassette rinse the storage solution from the cassette following these s

Learning to Use the Kvick Flow Cassette Holder

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