Kvick Lab and Kvick Flow Cassettes User Manual
Contents
1. of 0 3 barg 5 psig 7 Optionally analyze a permeate sample to verify sufficient flushing for your specific application Flush with additional water if needed 8 Drain the water Add a sufficient volume of buffer to the feed tank to maintain an adequate working volume Circulate buffer through the filtration system for up to five minutes to condition it prior to addition of process fluid Drain the buffer Pressure Feed gauge tank Valve P Retentate Waste L gt lt Permeate gt c Cassette holder bea v D x Pump Drain line Figure 3 Typical setup for rinsing cassettes Operating conditions When using Kvick cassettes process optimization is highly recommended Typically an effective cross flow rate will range from 5 4 to 8 6 liters per m 600 800 ml per ft of membrane and the permeate pressure will be zero The maximum feed pressure for Kvick cassettes is 4 barg 60 psig at 50 C Before beginning a filtration it may be useful to generate a pump curve that relates pump speed to flow rate This curve allows easy adjustment of filtration flow rate eliminating the need to physically measure the flow rate and adjust through trial and error Alternatively a flowmeter may be used Product recovery The yield of product in the retentate is generally increased by using a product recirculation after filtration 1 Close the permeate valve 2 Reduce the cross flow to 10 of the process cross flow 32. 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 93 594 49 50 Fax 93 594 49 55 Sweden Tel 018 612 1900 Fax 018 612 1910 Switzerland Tel 0848 8028 12 Fax 0848 8028 13 UK Tel 0800 616928 Fax 0800 616927 USA Tel 800 526 3593 Fax 877 295 8102 imagination at work 18 1171 69 AG 06 2006 100 110626 RO7
3. GE Healthcare Kvick Lab and Kvick Flow Cassettes User Manual 18 1171 69 AG Table of contents Introduction About this user manual Audience Where to find more information Safety Section 1 Cassettes Package contents Cassette structure Product labeling Section 2 Using a cassette Introduction Cassette preparation Operating conditions Product recovery Cassette cleaning Storing a cassette Chemical compatibility Section 3 Product information 2 Ordering information Kvick Lab cassettes Kvick Flow cassettes Kvick Lab and Kvick Flow Cassettes User Manual WWW ON DAWN NHM MN NHN AA Introduction About this user manual This user manual describes how to use Kvick Lab and Kvick Flow membrane cassettes Topics include preparation operating condi tions cleaning and storing and product information Audience This user manual addresses personnel who have experience in cross flow filtration and who have the proper documentation knowledge and skills to safely operate cross flow equipment that is used with Kvick Lab and Kvick Flow cassettes Where to find more information For further information please contact us in the US at Voice 1 800 526 3593 Fax 1 877 295 8102 or visit our Web site at www gehealthcare com For additional contact information at our offices around the world refer to the listings on the back cover of this manual Please visit our Web site at www gehealthcar
4. KICK Lab Berit vreaoosoiosr Lot 03349 100 12661 5K OIL 1 2 10 Figure 2 Sample product label 4 Kvick Lab and Kvick Flow Cassettes User Manual Section 2 Using a cassette Introduction This section provides basic procedures for cassette preparation operation cleaning and storage This section does not cover process optimization Cassette preparation Before using a new or used and stored cassette rinse the storage solution from the cassette following these steps 1 Open the cassette bag drain the cassette and rinse the storage solution from the exterior of the cassette with high purity water Use appropriate personal protective equipment to avoid contact with the NaOH glycerin storage solution 2 Configure a filtration system according to Figure 3 Install the cassette in the cassette holder See the Cassette Holder User Manual for specific installation instructions Close the feed retentate and permeate valves 3 Direct the retentate and permeate lines to waste 4 Fill the reservoir with deionized DI water or water for injection WEI 5 liters per 0 09 m 1 0 ft of membrane area 5 Open the feed and retentate valves Close the permeate valve Pump about 10 of the water through the retentate line to waste at a feed pressure of 0 3 barg 5 psig 6 Open the permeate valve and close the retentate valve Pump the remaining water through the permeate line to waste at a transmembrane pressure TMP
5. Recirculate the fluid for 5 15 minutes To recover product from the feed tank use the drain valve that depending on system configuration may be before or after the pump To evacuate product from the remainder of the system specific system design will dictate whether to operate the pump Slowly in either the forward or reverse direction or to drain the system by gravity Kvick Lab and Kvick Flow Cassettes User Manual 5 Cassette cleaning Cassettes should be cleaned properly before reuse or storage Before cleaning cassettes should be rinsed with buffer and water It is highly recommended to optimize the cassette cleaning methods The following is a general cassette cleaning protocol 1 Direct the retentate and permeate lines to the feed tank Fig 4 Open the feed and retentate valves Close the permeate valve 2 Circulate a minimal volume of buffer across the retentate side for 5 10 minutes at 1 1 5x the process cross flow 3 Drain the system Add a minimal volume of water and circulate water across the retentate side for 5 10 minutes at 1 1 5x the process cross flow 4 Drain the system Add cleaning solution to the feed tank at a ratio of 15 20 liters per m 1 5 2 liters per ft of membrane area See Table 1 for typical cleaning conditions 5 Open the feed and retentate valves and pump about 10 of the cleaning solution through the retentate line to waste 6 Open the permeate valve close the retentate valve and pu
6. aterial safety data sheets for process solutions and follow the safety instructions The cassette storage solution contains 0 1 to 0 2 N NaOH and glycerin Follow the standard safety procedures for handling aque ous NaOH described in this user manual and wear appropriate per sonal protective equipment To avoid damaging the cassette do not drop use excessive feed pressure pressurize the permeate ports expose to incompatible chemicals run at greater than 50 C or 4 barg 60 psig dry the membrane or subject to freezing Kvick Lab and Kvick Flow Cassettes User Manual 3 Section 1 Cassettes Package contents Cassette boxes include the following components e Cassette in sealed plastic bag e Cassette gasket re e Certificate of compliance 5 5 i B 2 e Retrofit guide He e User manual amp Cassette structure The two sizes of Kvick Lab and Kvick Flow cassettes share design components including inlet and outlet ports labeling and alignment notches Fig 1 Inlet feed port Outlet retentate port Permeate port Cassette information Alignment notches Incorporated gasket aw eS Product labeling The cassette label is laser engraved on the side of the cassette It contains manufacturer lot number cassette type Kvick Lab or Kvick Flow part number nominal molecular weight cutoff NMWC and membrane area in square meters and square feet Fig 2 Figure 1 The main parts of a GE Healthcare cassette cc
7. bility Kvick Lab and Kvick Flow cassettes are resistant to most chemicals typically used in bioprocessing Because chemical compatibility is dependent on the chemical as well as the exposure time and temperature specific compatibility questions should be answered experimentally Section 3 Product information Ordering information Table 3 Kvick Lab cassettes Code number 56 4112 02 56 4112 06 56 4112 04 56 4112 08 56 4112 10 56 4112 14 56 4113 31 56 4113 26 56 4113 25 56 4113 27 56 4113 28 56 4113 29 Catalog number UFELA 0005 001 ST UFELA 0010 001 SE UFELA 0010 001 ST UFELA 0030 001 ST UFELA 0050 001 ST UFELA 0100 001 ST UFELA 0005 001 ST UFELA 0010 010 SE UFELA 0010 010 ST UFELA 0030 010 ST UFELA 0050 010 ST UFELA 0100 010 ST Nominal molecular weight cutoff 10 kD Select is a tighter 10 kD membrane Materials of construction Membrane Screen Encapsulent and gasket Wetting solution Table 4 Kvick Flow cassettes Code number 56 4113 49 56 4113 47 56 4113 50 56 4113 51 56 4113 52 56 4113 54 56 4113 37 50 4113 38 56 4113 39 56 4113 40 56 4113 41 56 4113 43 Catalog number UFEFL 0005 050 ST UFEFL OO10 050 SE UFEFL 0010 050 ST UFEFL 0030 050 ST UFEFL 0050 050 ST UFEFL 0100 050 ST UFEFL 0005 250 ST UFEFL 0010 250 SE UFEFL 0010 250 ST UFEFL 0030 250 ST UFEFL 0050 250 ST UFEFL 0100 250 ST Nominal molecular weight cutoff 10 kD Select is a tighter 10 kD membrane Mater
8. e com where you can learn about all of GE Healthcare chromatography and membrane products for biopharmaceutical processing The latest edition of this manual as well as other technical literature is available for download through links provided at this site Safety Kvick Lab and Kvick Flow cassettes are designed for use with Kvick Lab and Kvick Flow cassette holders under the specified process conditions stated in this and other GE Healthcare documentation Only trained personnel who understand the operating instructions should install and operate Kvick Lab and Kvick Flow cassettes Users should follow the safety regulations established by the US Occupational Safety and Health Administration OSHA other applicable federal state and local regulations company policy and the specific safety instructions provided in product documentation Overpressurizing a cross flow filtration system may rupture system components and cause bodily harm Install pressure gauges and regulator to limit the feed pressure to 4 barg 60 psig when testing and operating the system System leakage may release hazardous fluids and cause bodily harm To minimize this risk periodically inspect the gaskets seals and connections for wear depressurize the system before disas sembling and wear appropriate personal protective equipment when operating the system Mishandling potentially hazardous process or cleaning solutions can cause bodily harm Read the m
9. growth Introduce the storage solution into the cassette as per the instructions for cleaning steps 4 through 8 The recirculation time step 8 may be reduced to 10 15 minutes It is good practice to store cassettes under refrigeration and this is especially recommended for long term storage i e 1 12 months Store cassettes in air tight containers and add a small volume of storage solution to the containers to minimize evaporation Alternatively cassettes may be submerged in storage solution for up to one month For short term storage up to 3 days cassettes may be stored in holders that are compressed through a torquing mechanism In this case disconnect the electrical power to the feed pump and ensure that the feed tank is properly sealed Preferably the tie rod nuts should be loosened and retightened to a torque of 10 15 Nm 88 133 in lbs This step must only be done when the system is depressurized and the holder does not contain fluid It is not recommended to store cassettes in holders that are compressed through a hydraulic sealing mechanism Table 2 Recommended storage conditions Duration Temperature Chemical Up to 3 days Ambient 20 25 C Water or 1 3 NaOCl Up to 1 month Ambient 20 25 C 0 1 N NaOH Up to 12 months Refrigerated 4 C 0 05 N NaOH Pressure gauge Retentate Permeate Cassette Feed holder Drain line Figure 4 lypical setup Tor recirculation oT cleaning solution Chemical compati
10. he product described at any time without notice or obligation 2006 General Electric Company All rights reserved GE Healthcare Bio Sciences AB a General Electric Company GE Healthcare Bio Sciences AB Bj rkgatan 30 751 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 Tokyo 169 0073 Japan Asia Pacific Tel 65 6275 1830 Fax 65 6275 1829 Australasia Tel 61 2 9899 0999 Fax 61 2 9899 7511 Austria Tel 01 57606 1619 Fax 01 57606 1627 Belgium Tel 0800 73 888 Fax 02 416 82 06 Canada Tel 800 463 5800 Fax 800 567 1008 Central East amp South East Europe Tel 43 1 972720 Fax 43 1 97272 2750 Denmark Tel 45 16 2400 Fax 45 16 2424 Finland amp Baltics Tel 358 0 9 512 39 40 Fax 358 0 9 512 39 439 France Tel 01 69 35 67 00 Fax 01 69 41 96 77 Germany Tel 089 96281 660 Fax 089 96281 620 Greater China Tel 852 2100 6300 Fax 852 2100 6338 Italy Tel 02 27322 1 Fax 02 27302 212 Japan Tel 81 3 5331 9336 Fax 81 3 5331 9370 Latin America Tel 55 11 3933 7300 Fax 55 11 3933 7304 Middle East amp Africa Tel 30 210 9600 687 Fax 30 210 9600 693 Netherlands Tel 0800 82 82 82 1 Fax 0800 82 82 82 4 Norway Tel 815 65 555 Fax 815 65 666 Portugal Tel
11. ials of construction Membrane Screen Encapsulent and gasket Wetting solution Membrane area Rating m ft NMWC 0 01 0 1 5 kD 0 01 0 1 10 kD Select 0 01 0 1 10 kD 0 01 0 1 30 kD 0 01 0 1 50 kD 0 01 0 1 100 kD 0 11 1 2 5 kD 0 11 1 2 10 kD Select 0 11 1 2 10 kD 0 11 1 2 30 kD 0 11 1 2 50 kD 0 11 1 2 100 kD Polyethersulfone Polypropylene Silicone 0 1 0 2 N NaOH and 20 22 glycerin Membrane area Rating m ft NMWC 0 46 5 5 kD 0 46 5 10 kD Select 0 46 5 10 kD 0 46 5 30 kD 0 46 5 50 kD 0 46 5 100 kD 2 53 25 5 kD 2 33 25 10 kD Select 2 53 25 10 kD 2 53 25 30 kD 2 53 25 50 kD 2 53 25 100 kD Polyethersulfone Polypropylene Silicone 0 1 0 2 N NaOH and 20 22 glycerin Holdup volume ml PO PM MP P PO 20 20 20 20 20 Holdup volume ml 30 30 30 30 30 30 150 150 150 150 150 150 Kvick Lab and Kvick Flow Cassettes User Manual 7 www gehealthcare com Global Headquarters GE Healthcare Little Chalfont Buckinghamshire U K HP7 9NA GE imagination at work and GE monogram are trademarks of GE Healthcare Companies Kvick is a trademark of GE Healthcare Companies All goods and services are sold subject to the terms and conditions of sale of the company within GE Healthcare which supplies them GE Healthcare reserves the right subject to any regulatory and contractual approval if required to make changes in specifications and features shown herein or discontinue t
12. mp about 10 of the cleaning solution through permeate line to waste 7 Stop the pump and direct the retentate and permeate lines into the feed tank Open the feed retentate and permeate valves 8 Start the pump and adjust the cross flow to 1 1 5x the process cross flow Circulate the cleaning solution for 30 60 minutes 9 Drain the cleaning solution from the system 10 Flush the system using 15 20 liters of clean water per m 1 5 2 liters per 1 0 ft of membrane area and the same process described in steps 5 through 9 above The circulation time may be reduced to 15 minutes Cleaning efficacy is commonly evaluated by comparing clean water fluxes pre and post use It is good practice to record clean water flux after each cleaning Commonly users will discard cassettes if the water flux has reduced to 60 70 of original water flux Note that reduced water flux often does not indicate that process fluid flux will likewise be reduced Table 1 Recommended cleaning conditions Cleaning agent 0 1 0 5 N sodium hydroxide Cleaning conditions Contact time 60 minutes Temperature 40 C 113 F Contact time 60 minutes Temperature 20 C 68 F 0 5 N NaOH with 100 300 ppm sodium hypochlorite 6 Kvick Lab and Kvick Flow Cassettes User Manual Storing a cassette Cleaned cassettes should be stored according to the conditions outlined in Table 2 These conditions keep the membrane wetted and inhibit microbiological
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