Kvick Pilot and Process cassettes
Contents
1. Nominal molecular weight cutoff Tighter 10kD membrane than the regular 10kD Materials of construction Membrane polyethersulfone Screen polypropylene Encapsulent and encapusulent gasket silicone Preservative solution 0 1 to 0 2 N NaOH and 20 to 22 glycerin Recommended operating conditions pH range long term storage 2 to 13 pH range short term cleaning 1 to 14 Maximum operating temperature 50 C Maximum inlet pressure 4 barg 60 psig User Manual 9 Chemical compatibility GE Healthcare Kvick Pilot and Kvick Process cassettes are resist ant to a wide range of chemicals However you can damage the cassettes by exposing them to chemicals incompatible with their materials of construction The following table provides a general guide to the chemical compatibility of polyethersulfone primary material of construction Solution Polyethersulfone Acetic acid 10 Acetic acid 1 7 M Ammonium hydroxide lt 5 Benzyl benzoate Butanol Butyl acetate Carbon tetrachloride Chloroform Citric acid 10 Dichloroethylene Diethyl ether Ethanol 10 Ethanol 20 Ethanol 40 Ethyl ether Ethylene glycol 50 Formaldehyde 1 7 M Formic acid 10 Fructose saturated Gelatine Glucose Glycerol Guanidine hydrochloride Hexane Resistant Resistant Resistant Limited resistance Resistant Limited resistance Limited resistance Limited resistance Resistant ot resis2. 5800 Fax 800 567 1008 Central East amp South East Europe Tel 43 1 972720 Fax 43 197272 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 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 11 0026 31 AB 09 2006
3. the clamping pressure as low a possible while avoiding leaks 8 User Manual Figure 4 Typical setup for extended recirculation of cleaning solution during cleaning Chapter 3 Cassette specifications Kvick Pilot specifications Ordering information Kvick Process specifications Ordering information Membrane Pore Membrane Pore area size area size Code number Model number m ft NMWC Code number Model number m ft NMWC 56 4115 69 UFEPT 0005 025 ST 0 23 2 5 5 000 56 4115 55 UFEPR 0005 300 ST 2 79 30 5 000 56 4115 70 UFEPT 0010 025 SE 0 23 25 10 000 56 4115 56 UFEPR 0010 300 SE 2 79 30 10 000 56 4115 71 UFEPT 0010 025 ST 0 23 25 10 000 56 4115 57 UFEPR 0010 300 ST 2 79 30 10 000 56 4115 72 UFEPT 0030 025 ST 0 23 2 5 30 000 56 4115 58 UFEPR 0030 300 ST 2 79 30 30 000 56 4115 73 UFEPT 0050 025 ST 0 23 2 5 50 000 56 4115 59 UFEPR 0050 300 ST 2 79 30 50 000 56 4115 75 UFEPT 0100 025 ST 0 23 2 5 100 000 56 4115 63 UFEPR 0100 300 ST 2 19 30 100 000 Nominal molecular weight cutoff Tighter 10kD membrane than the regular 10kD Materials of construction Membrane polyethersulfone Screen polypropylene Encapsulent and encapsulated gasket silicone Preservative solution 0 1 to 0 2 N NaOH and 20 to 22 glycerin Recommended operating conditions pH range long term storage 2 to 13 pH range short term cleaning 1 to 14 Maximum operating temperature 50 C Maximum inlet pressure 4 barg 60 psig
4. to 2 liters per 0 09 m 1 0 ft of membrane area Table 1 describes recommended cleaning solutions Fill the feed reservoir with the cleaning solution 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 per meate line to waste Stop the pump and configure the system so that the retentate and permeate lines discharge into the feed reservoir Figure 5 Open the feed retentate and permeate valves Start the pump Adjust the retentate valve and pump speed to obtain the cross flow rate required for cleaning 2 You can analyze the rinse water using analytical techniques or with residual indica tor kits readily available from scientific equipment supply houses User Manual 7 7 Circulate the cleaning solution for 30 to 60 minutes 8 Drain the cleaning solution from the system using the drain line 9 Flush it with buffer WFI or DI water as described in Preparing a cassette for use on page 00 Table 1 Recommended cleaning solutions Cleaning agent Cleaning conditions Membrane type 1 5 Terg A Zyme Contact time 60 minutes Polyethersulfone and Temperature 35 C 95 F PolysulfoneA 1 5 Alconox detergent Contact time 60 minutes Polyethersulfone and Temperature 40 C 95 F Polysulfone 0 1 to 0
5. 14 storing 18 Caution flags 7 Chemical compatibility of cassettes 22 Cleaning cassettes 17 Contact information 2 Contact information 4 Customer Support 4 D Damaging cassettes 9 Documentation 4 10 E Email address 4 Expert advice flags 7 G Glycerin 9 13 14 18 l Information 4 K Kvick Pilot specifications 20 Kvick Process specifications 21 L Labeling of cassettes 12 Literature 4 M Materials of construction Kvick Pilot 20 Kvick Process 21 Model numbers 20 21 N NaOH 9 13 14 18 NaOH safety 9 13 14 0 Opening cassette bags safely 9 13 14 Operating conditions 20 21 Operator qualifications 4 Optimizing product recovery 17 Ordering Information 20 21 P Package contents 10 Preparing a cassette for use 13 Product labeling 12 Proper use of cassette 6 Pump dry running damage 9 Recovering product of interest 17 Reusing cassettes 17 Rinsing storage solution from the cassette 14 S Safety 5 7 cleaning solutions 8 leaks 8 NaOH 9 13 14 opening cassette bags 9 13 14 overpressurization 8 storage solution 9 13 14 Specifications Kvick Pilot 20 Kvick Process 21 Storing casssettes 18 T Technical support 4 Temperature and pressure limits 16 U User guide introduction 4 User guides 4 10 W Warning flags 7 Warnings cautions and expert advice 7 Web site 4 Who should use this gui
6. 5N sodium Contact time 60 minutes Polyethersulfone and hydroxide Temperature 40 C 113 F Polysulfone 200 to 300 ppm sodium Contact time 60 minutes Polyethersulfone and hypochlorite in 0 1 to 0 5N Temperature 20 C 68 F Polysulfone sodium hydroxide A Polysulfone membrane is used in GE Healthcare Hollow Fiber cartridges Storing a cassette Before storing your cassette clean it see page 16 and flush it with a storage agent to keep the membrane wet and minimize biological growth e For storage less than 3 days use clean water or 0 1 N NaOH Pressure e For storage from 3 days to 6 months use 0 1N NaOH valve DB ne e For storage longer than 6 months use a storage solution of 0 1 N NaOH and store the cassette at 4 C Cassette For long term storage more than ten days remove the cassette a holder from the holder and place it into an air tight plastic tub or heavy duty zip lock type plastic bag Add about 50 to 100 ml of the stor gt age agent to the plastic bag and seal it Place the sealed bag in a protected location at a temperature less than 25 C 77 F Cold storage but above freezing provides the optimal storage condi i i tions For short term storage five to ten days keep the cassette in the holder and circulate the storage solution 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 Reduce
7. GE Healthcare Kvick Pilot and Process cassettes Instructions for use 11 0026 31 AB Table of contents About this user guide Audience Where to find more information Safety Warnings cautions and expert advice Section 1 Cassettes Package contents Learning about cassettes Product labeling Section 2 Using a cassette Introduction Preparing a cassette for use Recommended operating conditions Optimizing product recovery Cleaning a cassette after use Storing a cassette Section 3 Cassette specifications Kvick Pilot specifications Kvick Process specifications Chemical compatibility Index 2 User Manual on FF WW U ONNNAD No 10 11 About this user guide This user guide describes how to use Kvick Pilot and Kvick Process membrane cassettes Topics include preparation for use recommended operating conditions cleaning and storing and product specifications Audience This user guide addresses the needs of scientists process engi neers and technicians who operate pilot and process scale cross flow systems The level of information presented in this guide assumes the user possesses basic laboratory and technical skills and has the knowledge and documentation to safely oper ate any user supplied equipment used with the Kvick Pilot and Kvick Process cassettes If you need assistance with the instruc tions in this guide contact GE Healthcare for more information Where to find more in
8. de 4 User Manual 14 www gehealthcare com Global Headquarters GE Healthcare Little Chalfont Buckinghamshire U K HP7 9NA GE imagination at work and GE monogram are trademarks of General Electric Company Kvick is a trademark of GE Healthcare companies Alconox and Terg A Zyme are registered trademarks of Alconox Inc 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 the 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 PO 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
9. formation GE Healthcare publishes several user guides that may be helpful in using Kvick brand products Figure 1 You can download technical documents and learn more about GE Healthcare cassettes and cross flow systems by visiting our website www gehealthcare com Cross Flow System Safety Multilingual Safety Instructions Describes conditions and actions that can cause bodily injury or equipment damage when using cross flow systems Describes how to avoid the risks Supplied with GE Healthcare cassette holders and systems Available for downloading from the GE Healthcare website MSDSs for glycerin NaOH and hydraulic fluid Provides safe handling and disposal information Available for printing and downloading from the GE Healthcare website User Manual 3 Safety Anyone who works with the Kvick Pilot and Kvick Process cas settes should read understand and follow the instructions in this user guide If any operator does not understand an instruction they should stop working with the Kvick Pilot and Kvick Process cassettes and contact GE Healthcare for guidance You should save these instructions and make them available to all users of the cassettes GE Healthcare designed the Kvick Pilot and Kvick Process cas settes for laboratory and pilot scale filtration of biological solu tions using Kvick Pilot and Kvick Process cassette holders under the conditions stated in this user guide If you use the cassettes in a
10. g a cassette for use can be as simple as rinsing the cas sette with deionized water In critical applications cassette prepa ration may include 1 documenting the performance of the cas sette 2 ensuring the integrity of the cassette and 3 sanitizing the cassette This user guide describes how to open and rinse the cassette with water the most basic step of cassette preparation The user guides for GE Healthcare cassette holders describe the other preparatory steps you may want to complete for critical applications gt Safety WARNING The cassette and cassette bag contain an aqueous solution containing 0 1 to 0 2 N NaOH and 20 to 22 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 6 User Manual Preparing a cassette for use Opening the cassette bag safely The cassette and cassette bag contain an aqueous solution con taining 0 1 to 0 2 N NaOH and 20 to 22 glycerin by weight When opening
11. l safety data sheets 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 Warning The cassette and cassette bag contain an aqueous solution con taining 0 1 to 0 2 N NaOH and 20 to 22 glycerin by weight When opening the cassette bag follow the standard safety proce dures 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 Caution The following actions can damage cassettes dropping on hard surfaces other mechanical shock excessive feed pressure pres surizing the permeate ports exposure to harsh chemical solutions and freezing If the cassette is subjected to any of these condi tions you should perform integrity testing and water flux on the cassette to check for internal damage Caution Allowing ultrafiltration cassettes to dry out can permanently dam age the membrane To prevent damage from drying out during short periods of inactivity 1 to 3 day
12. manner not specified by GE Healthcare you may impair the pro tection provided by the system and cassettes When using any pilot or process scale cross flow equipment the potential exists for personal injury unless you follow established safety procedures When using GE Healthcare products you should follow OSHA1 federal state and local safety regulations for equipment installation and operation You should follow your company s safety regulations You should follow the specific safe ty instructions provided in this user guide and any original equip ment manufacturer user guides provided with your system Only qualified personnel who are adequately trained and who understand the operating instructions should install operate maintain and inspect Kvick Pilot and Kvick Process cassettes Warnings cautions and expert advice This user guide uses symbols and blocks of text to provide you with safety warnings and other important information gt Safety WARNING A safety warning flag describes conditions or actions that can cause bodily harm and describes how to avoid the risk gt Expert Advice CAUTION A caution flag describes conditions or actions that can damage equipment and describes how to avoid the risk gt Expert Advice TIP An expert advice flag provides you with information equipment efficiently or achieve the best results Warning If you overpressurize a cross flow system with compressed air during in
13. membrane area Fead gauge rse wr vake Retentabe Penmeate Fead Crain line A Cassette holder Figure 3 Typical setup for rinsing cassettes or the initial flow of cleaning solution at the start of cleaning gt Expert Advice CAUTION Using tap water to flush or rinse cassettes can plug the pores of the 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 deionized water or water for injec tion when rinsing or flushing the cassette or when making up cleaning solutions or adding dilution water to process fluids 5 Open the feed and retentate valves and close the permeate valve Pump about 10 percent of the water through the reten tate line to waste maintaining a transmembrane pressure of 0 35 barg 5 psig 6 Open the permeate valve and close the retentate valve and pump the remaining water through the permeate line to waste maintaining a feed pressure of the 0 35 barg 5 psig 7 If needed for your application sample and analyze the last vol ume of drain water pumped from the system for traces of stor age or cleaning solution 2 Repeat steps 4 through 7 until you achieve the needed level of storage solution removal 8 If needed circulate buffer to prepare the cassette and system for processing Recommended operating conditions When using your cassette fully open the permeate valve and adjus
14. s wet out the membrane with buffer or saline solution To prevent cracking of the mem brane during long term storage follow the storage procedure on page 17 To prevent cracking during use do not flow compressed air through the system for more than a few minutes Chapter 1 Cassettes Package contents Cassette boxes include the following components Cassette in sealed plastic bag Cassette gasket Certificate of compliance User Guide Learning about cassettes The two sizes of Kvick Pilot and Kvick Process cassettes share design components including inlet and outlet ports labeling and alignment notches Figure 2 1 Inlet feed port 2 Outlet retentate port 3 Permeate port 4 Cassette information see Figure 3 5 Alignment notches 6 Incorporated gasket Figure 1 The main parts of a Kvick Pilot cassette Product labeling Cassette identifying information is laser engraved on the side of the cassette The information describes the following manufactur er lot number cassette type Kvick Pilot or Kvick Process part number pore size 10K 30K 50K etc and the membrane area in square feet and square meters Figure 3 gt Amersham NET RETVNIE REE kvick PILOT PAP t UFEPTOOSOODssT BOK 0 23 Q M 2 5 SQ FT Biosciences LOT 03120 300 10999 Figure 2 Identifying information printed in the side of cassettes User Manual 5 Chapter 2 Using a cassette Introduction Preparin
15. t your pump speed and retentate valve to achieve the cross flow rate required by your process If your feed is particularly viscous or has other unusual physical characteristics contact the technical support team at GE Healthcare for assistance Other recommended operating param eters include these e pH range long term 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 Optimizing product recovery You can optimize product recovery by reducing the cross flow rate at the end of your process step When you are done concen trating your product reduce the cross flow rate to 1 10 of the rec ommended processing cross flow rate Close the filtrate valve or reduce the feed pressure to 0 3 barg 5 psig Retentate pressure should be 0 barg 0 psig Circulate the remaining product for 15 minutes This procedure will help recover product buildup from the surface of the membrane 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 Preparing a cassette for use on page 13 Then clean the cassette following these steps 1 Configure the system so that the retentate and permeate lines discharge to waste Figure 4 Close the feed retentate and per meate valves Prepare the appropriate volume of a cleaning solution 1 5
16. tant Resistant Resistant1 Resistant1 Resistant1 Resistant Resistant Resistant Resistant Resistant Resistant Resistant Resistant Limited resistance Limited resistance 1 As the concentration of ethanol increases cassette flux rate decreases 10 User Manual Solution Polyethersulfone Hydrochloric acid 0 1 Isopropyl alcohol Methanol 98 Mineral oil Nitric acid 0 1 M Ozone Limited Peracetatic acid 0 2 Phosphoric acid 25 Pyridine Limited Sodium chloride 0 5 M Sodium hydroxide 1M Sulfuric acid 25 Toluene Trichloroacetic acid 10 Triethanolamine Urea Limited Xylene Limited Limited resistance Resistant Resistant Resistant Resistan Resistance Resistant Limited resistance Resistance Resistant Resistant Limited resistance Limited resistant Limited resistant Resistant Resistance Resistance 1 Sodium chloride can cause corrosion on stainless steel at pH less than 5 Do not usesodium chloride in storage solutions 2 Maximum recommended exposure is 4 hours Index A Audience 4 C Cassettes 10 chemical compatibility 22 cleaning 17 damaging 9 design 10 identifying information 12 keeping wet to avoid damage 9 not using tap water 15 opening the bag safely 9 13 14 operating conditions 16 20 21 optimizing product recovery 17 preparing for use 13 rinsing the storage solution 14 safety 9 13 14 storage solution 9 13
17. tegrity 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 weakest component in your cross flow system Wear the appropriate per sonal protection devices when testing the system 1 In the United States OSHA is the Occupational Safety and Health Administration 4 User Manual If a cross flow system leaks it can release potentially hazardous process or cleaning fluids causing bodily harm To prevent leaks and the release of potentially hazardous fluids limit feed pressure on GE Healthcare cross flow systems to 4 barg 60 psig periodi cally check parts for wear and ensure you assemble the compo nents correctly To monitor system pressure GE Healthcare rec ommends that you install pressure gauges on the system as described 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 appro priate personal protection devices and clothing when operating and cleaning the system Warning Mishandling potentially hazardous process and cleaning solutions can cause bodily harm To safely handle potentially hazardous process cleaning and storage solutions read the materia
18. the cassette bag follow the standard safety proce dures for handling aqueous NaOH including the use of safety glasses safety gloves and protective lab coot 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 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 steps 1 Following the safety instructions above open the cassette bag drain the cassette and rinse the storage solution from the exte rior of the cassette with high purity water 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 Figure 4 Close the feed retentate and per meate valves 4 Fill the reservoir with an appropriate volume of DI water or WFI 5 liters per 0 09 m 1 0 ft of
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