Amendment to ÄKTAcrossflow User Manual Edition AB
Contents
1. 2 Select Specials as Instructions and scroll down to Reservoir Size Senilix Specials Instructions Instructions Reservoir_Size Parameters E Aane 1200 000 ia Size 350ml O 1100m Specials Monitors 1 150 000 ConstR ol_P P 50 000 Curves Size 350ml Set Selected Parameter To Strategy Default Value 3 Select Size of reservoir and click OK Senilix Specials Instructions Instructions Reservoir_Size Parameters Alarms A Size 350ml 1100ml Specials Monitors 1 150 000 ConstR ol_P P 50 000 Reservoir Size Curves Size 1100ml Set Selected Parameter To Strategy Default Value v 28 4093 47 AA 03 2006 Amendment to User Manual 11 0012 32 Edition AB2. 2 x 200 ml 3 Ifa purge is included in the method prepare 300 ml Milli Q water or equivalent and 100 ml 70 ethanol Note Instructions on how to perform the purge are included in the method as pop up dialogs 4 Replace the filter device with a three way connector 5 Replace the pH electrode with a dummy electrode 28 4093 47 AA 03 2006 Amendment to User Manual 11 0012 32 Edition AB 3 Amendment to AKTAcrossflow User Manual Edition AB 6 Remove the float from the reservoir 7 If anair filter is connected to the reservoir remove the filter 8 Connect a tubing to waste The tubing is included in the Reservoir cleaning kit 11 0033 86 Note To avoid siphoning back into the reservoir keep tubing free from solution in the waste bottle WARNING The reservoir is over filled during the sanitization It is important to have tubing to waste NaOH is corrosive and therefore dangerous to health Avoid spillage and wear safety glasses safety gloves and protective clothing 9 Disconnect the outlet tubing from the Retentate valve block outlets R VB Out1 2 and 3 28 4093 47 AA 03 2006 Amendment to User Manual 11 0012 32 Edition AB Amendment to AKTAcrossflow User Manual Edition AB 10 Assemble the manifold included in the Reservoir cleaning kit 11 0033 86 and connect appropriate tubing ends to the Retentate valve block outlets R VB Out1 2 and 3 11 Connect a tubing to the manifold outlet To e g R VB O
3. Amendment to AKTAcrossflow User Manual Edition AB Amendment to AKTAcrossflow User Manual Edition AB System sanitization Updated method and instruction If you want to be sure that the system is clean for example when a new filter is used or a process is changed it is recommended to perform a sanitization of the system If an air filter is connected to the reservoir remove the filter Connect the tubing included in the Reservoir cleaning kit 11 0033 86 at the reservoir top Place the tubing in waste A purge step is optional in the method which includes a pretreatment of the retentate valve block with water and ethanol Purge with water removes solid substances mechanically The following purge with 70 ethanol removes air bubbles of micro size The pretreatment of the retantate valve block improves the result of the system sanitization It is therefore recommended to include Purge in the method when the purpose is to sanitize the system Instructions on how to perform the purge are included in the method as pop up dialogs The stirrer should be present in the reservoir during sanitization However it should be replaced with a new aseptic one after the sanitization Note To make sure that there is no sample left in the system before performing the sanitization run the System sanitization method with Milli Q water or equivalent to rinse the system Note The System sanitization method can also be used to pH neutralize the sys
4. OH is corrosive and therefore dangerous to health Avoid spillage and wear safety glasses safety gloves and protective clothing WARNING The reservoir is over filled during the sanitization It is important to have tubing to waste NaOH is corrosive and therefore dangerous to health Avoid spillage and wear safety glasses safety gloves and protective clothing 12 Inthe Close the reservoir dialog click Continue The system will now be sanitized with NaOH 13 Sanitize the previous disconnected R VB outlet tubing separately in 1M NaOH 28 4093 47 AA 03 2006 Amendment to User Manual 11 0012 32 Edition AB 7 Amendment to AKTAcrossflow User Manual Edition AB Completing sanitization procedure 1 Empty the system rinsing bottles and fill them with ordinary rinsing solution 20 ethanol in 10 mM NaOH 2 Disconnect the manifold from the Retentate valve block and reconnect the ordinary outlet tubing 3 After the System sanitization method repeat the method using Milli Q water or equivalent or buffer instead of sanitization solution 4 Empty the system rinsing bottles and fill them with rinsing solution 20 ethanol in 10 mM NaOH 5 Replace the stirrer with a new aseptic one Changing reservoir size in UNICORN The mounting of an alternative reservoir is described in AKTAcrossflow Instrument Handbook However it is also necessary to change the settings in UNICORN 1 Inthe System Control of UNICORN select System Settings
5. hod a number of pop up dialogs will be displayed and instruct how to perform the purge procedure To continue to next instruction click Continue 2 Pour 300 ml water into the reservoir 3 Check that the manifold is connected to the Retentate valve block 4 Open the reservoir lid and place the outlet tubing of the manifold into the reservoir f p a aoe 5 After approximately 20 minutes of purging with water a new dialog will be displayed Move the manifold outlet to waste 6 After the reservoir has been emptied to waste pour 100 ml of 70 ethanol into the reservoir 28 4093 47 AA 03 2006 Amendment to User Manual 11 0012 32 Edition AB Amendment to AKTAcrossflow User Manual Edition AB 7 Place the outlet tubing of the manifold into the reservoir Note Clean the outer surface of manifold outlet tubing with 70 ethanol before placing it into the reservoir 8 After approximately 10 minutes of purging with ethanol a new dialog will be displayed Move the manifold outlet to waste 9 After the reservoir has been emptied to waste clean with 70 ethanol the surfaces of the reservoir and the lid which will be in contact when the lid is closed 10 Close the reservoir lid 11 Check that the outlet tubing from reservoir top is placed in waste Note To avoid siphoning back into the reservoir keep tubing free from solution in the waste bottle WARNING Ensure the waste container can hold the produced waste volume Na
6. nded 5 Select to Purge with 70 ethanol i e purge with water and ethanol Note Itis not necessary to include a purge if the method is used for system rinsing or system storage solutions Recirculation Time min 0 599995 min Purge with 70 EtOH L Purge 28 4093 47 AA 03 2006 Amendment to User Manual 11 0012 32 Edition AB Amendment to AKTAcrossflow User Manual Edition AB 6 Select the Reservoir used System setup Reservar Size 350 ml 1100 mi Note Information on important preparations and notes before the method is run is displayed in the Basic Settings dialog All In and Outlet connections will be used 7 Click Finish 8 Inthe Summary dialog click Print to print the summary Click Finish to end the Method Wizard Note Do not edit any variables or method instructions 9 Save the method Preparing the System sanitization When running a method using a sanitization solution containing sodium hydroxide NaOH WARNING NaOH is corrosive and therefore dangerous to health Avoid spillage and wear safety glasses safety gloves and protective clothing CAUTION Always make sure that the system components are compatible with sodium hydroxide at the concentration time and temperature used 1 Prepare a sanitization solution which is compatible with the AKTAcrossflow system for example 1 M NaOH Reservoir 350 ml 5000 ml Reservoir 1100 ml 7000 ml 2 Fillthe Rinsing system bottles with 1 M NaOH
7. tem solutions after sanitization and to exchange the solution in the system to an appropriate storage solution for example 20 ethanol Sanitization of the pump piston rinsing system When performing system sanitization the pump piston rinsing system should be sanitized by using 1 M NaOH as liquid in the rinsing system bottles Sanitization of reservoir float The reservoir float has to be sanitized separately Remove it from the reservoir before system sanitization The float can be autoclaved or equivalent 28 4093 47 AA 03 2006 Amendment to User Manual 11 0012 32 Edition AB 1 Amendment to AKTAcrossflow User Manual Edition AB ate P Precautions CAUTION Instead of a filter use a three way connector 18 1170 59 Filters are not compatible with the used flows and pressures in the System Sanitization method Replace the pH electrode with a dummy electrode Remove the reservoir float WARNING The reservoir is over filled during the sanitization It is important to have tubing 11 0033 86 to waste NaOH is corrosive and therefore dangerous to health Avoid spillage and wear safety glasses safety gloves and protective clothing Creating a method 1 Inthe Method Editor of UNICORN open the Method Wizard 2 Select the System 3 Inthe Basic settings dialog select System Sanitization as method Basic Settings Method 4 Enter Recirculation time A minimum recirculation time of 30 min is recomme
8. ut2 To e g R VB Out3 To e g R VB Out1 T k T connector 1 T e T connector 2 To outlet tubing __ TE NAS Three way connector instead of a filter T connector 1 T connector 2 R VB Out 1 2 3 12 Place all inlet tubing in the prepared sanitization solution 13 Place all outlet tubing and Manifold outlet tubing in a waste container WARNING Ensure the waste container can hold the produced waste volume NaOH is corrosive and therefore dangerous to health Avoid spillage and wear safety glasses safety gloves and protective clothing 28 4093 47 AA 03 2006 Amendment to User Manual 11 0012 32 Edition AB 5 Amendment to AKTAcrossflow User Manual Edition AB Running the System sanitization method When running a method using a sanitization solution containing sodium hydroxide NaOH WARNING NaOH is corrosive and therefore dangerous to health Avoid spillage and wear safety glasses safety gloves and protective clothing CAUTION Always make sure that the system components are compatible with sodium hydroxide at the concentration time and temperature used Before performing system sanitization rinse the system by running the method without Purge using Milli Q water or eqvivalent 1 In UNICORN open the created System sanitization method and select Run Note Itis also possible to run System sanitization as an Instant Run see AKTAcrossflow User Manual When Purge is included in the met
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