Buffer Preparation with FlexAct® BP
Contents
1. 3 Open the clamps of the acid and base transfer line at the top port of the Flexel for Magnetic Mixer Before starting the automatic dosing process open the corresponding clamps A closed clamp can cause a crack of a tube This will set media free and can cause serious damages to equipment and injuries to persons 4 Put the Controller Mode Auto 5 If the controller mode selected to Auto the dosing of acid or base is running until the pH reaches the set point of the pH adjustment 6 If the set point has been reached set the controller mode to off Process Installation 15 7 Close the clamp of the acid base Transfer line 8 Stop mixing open top line 2 5 Setting up of the receiving bag and filter for filtration Inlet Outlet Sampling Connection of a Flexel 3D bag for storage Installed MaxiCap inside the filterholder of the FlexAct COM 16 Process Installation 2 6 Running the filtration FlexAct BP 2011 02 03 09 41 09 o 7 0 00 h m f no alarm PRESS smiali Start phase Filtration PUMP Filtration 0 0 Reverse Calibration u Settings JA Shutdown Cy Screenshot of DCU touchscreen All details of the DCU control system are described in the operating instruction of the DCU system User Manual FlexAct BP DCU After the filtration step is being started a modification of the weighing signal by taring the balance or removing adding parts of the eq2. Use only flawless parts All equipment must be assembled carefully and safely 1 Before every startup check the assembly and connections of all equipment Safety equipment e g the overpressure safety valves must meet the Specifications and be installed 2 Palletanks bags tubing and fittings must be leak tight Persons should only stand around the equipment for carrying out necessary work Barricade off the hazardous area and indicate this with signs If applicable ensure that the respective minimum volumes as described in the gt Operating Instructions Manual for LevMixer are not undershot Observe the operating limits and optimal settings for the process Only operate FlexAct BP using the allowable energy supplies power supply water or gas supplies Introduction 7 Safety at the End of Process 8 Introduction CAUTION aa IMPORTANT O BIOHAZARD hazards caused by media When working with hazardous materials observe the pertinent safety regulations and laws 1 Adjust the measurement and control system in strict accordance with the allowable performance data for the respective equipment gt Operating Instructions Manual for DCU FlexAct 2 Perform in process monitoring as to whether the process parameters are achieved as expected Take precautions to ensure that defects or disruptions cannot cause any hazards or damage After placing the tubing in the pump always make sure to press the STO
3. for Storage 1 to 2 Watson Marlow 520 R2 pumps Biosealer optional Sartocheck optional FlexAct BP bag assembly 4BP110B01AB11003 FLEXEL Bag for Magnetic Mixer 100L PROBE pH FLEXEL 3D Bioprocessing Bag for storage 100 L with Sartopore 2 Gamma Midicap Transfer Set TITRATION pH standards e g pH 4 7 Syringe with Luer connection sampling pH calibration Acid Base for pH correction Media powder WEI 2 Process Installation Process Start 2 1 Setting up of the mixing system network RTD pH sensor balance WM520 base WM520 acid 2 Process Installation Process Start The following equipment is to be used for the process of Buffer Preparation 1 Unpack the Flexel Bag for Magnetic Mixer Manual Flexel Bag for Magnetic Mixer Install the Flexel Bags for Magnetic Mixer in the Palletank for Magnetic Mixing with magnetic clamp from Magnetic Mixer drive unit toolbox Manual Flexel Bag for Magnetic Mixer Connect the cable of the pH electrode to the FlexAct COM sensor panel Connect the cable of the RTD to the FlexAct COM sensor panel Do not put the RTD in the thermowell of the bag Calibrate the pH electrode use pH standards and rinse with WFI finally Use the RTD for automatic temperature compensation during calibration gt Manual pH probe Manual DCU FlexAct Connect weighing signal from the Combics weighting controller to the FlexAct COM sensor pane
4. lt ii Sartorius stedim biotech Process Example Buffer Preparation with FlexAct BP OUT LOU 85032 539 69 Ver 04 2011 Contents Contents Legal Notices Impressum 0000 cece cece runnen erranaren Page 2 ENOUGH eivusttecceuteeneeeee ae E E E eeesee Page 3 Fig Front cover FlexAct BP COM Sartorius Stedim Biotech GmbH Technical Documentation Technische Dokumentation August Spindler Strasse 11 D 37079 Goettingen Germany Deutschland Internet www sartorius stedim com E mail tech pubs sartorius stedim com Printed in Germany on chlorine free paper If you require mandatory information regarding specific properties of your FlexAct COM that goes beyond that which is described here please contact us No part of this publication may be reprinted reproduced or translated in any form or by any means without the prior written permission of Sartorius Stedim Biotech GmbH FlexAct is a registered trademark of Sartorius Stedim Biotech GmbH Contents introduction 4 peicen denn shed nendeanient dee ndutadans ean AE ate ents 4 l MU UCO aaee Er E RE ER Ea 4 i ADBreVIatiONS sessi wwe s Rd neeme neen RA ERER es 4 We WCTIMINIONS messire erneer EA EEVEE 5 IV Operating Instructions Document Structure 0 00 cee eee 5 V Explanation of SVIWOOlS 44 2445 45 eceeaendenteueseesacehueasguersiae 6 ME Safety INSMUCHIONS 72 aces heon ered ucunan ates ectdabaceuseeceseaeuee 6 1 Setup and Equipment sodandcdga
5. table 1 for detailed values For 1 8 install pump at position 1 for 1 4 install at position 2 Install the required part of the Transfer set TITRATION in the WM 520 gt Manual Watson Marlow 520 R2 It is necessary to install the pump in position 2 when using the 1 4 tube The PlD controller for pH of the configuration is preconfigured with standard parameters for buffers 1 pH from pKa with an Xp of 2 Enter the correct process parameters into the DCU screen 2 4 Run the automated pH pH adjustment process _ 3 95 pit WARNING open top line Tank size 50 100 200 400 650 1000 Length of transfer set TITRATION 4m 4m 4m 5m 5m 5m Max pump speed 1 8 1 N HCI NaOH 20 40 80 Max pump speed 1 4 1 N HCI NaOH 20 45 75 100 Max pump speed 1 4 0 1 N HCI NaOH 100 100 100 100 100 Table 1 recommended set value for Magnetic Mixer drive unit and maximum pump speed of WM 520 recommended length of transfer set TITRATION Pump speed 20 40 60 80 100 Rom WM 520 44 88 132 176 220 Flow rate 1 8 80 ml min 160 ml min 240 ml min 320 ml min 400 ml min Flow rate 14 280ml min 560 ml min 840ml min 1120 ml min 1400 ml min Table 2 flow rates for 1 4 and 1 8 tube in relation to different pump speeds 1 Start the pH adjustment process by selecting the pH controller gt Manual DCU FlexAct COM 2 Enter the value of the pH Set point in the box of the controller
6. DCU microbox Touch screen Pump Filter holder Drip tray Pump head supporting plate and PT100 temperature sensor Setup and Equipment Description of all component steps required to set up FlexAct BP components which have to be supplied by the customer Process Installation Description of all steps required to start a process Process Start Process Capability Time at which the actual process for example buffer preparation or virus inactivation can be started Process capability is reached when the initial operations are setup to completion FlexAct BP COM may only be used with equipment and under operating conditions described in the present equipment documentation FlexAct COM is basically a work platform It accommodates all accessory parts necessary for transferring media within biotechnological applications Users must be qualified to handle the system and the process relevant media and be aware of the hazards potentially associated with the process Some processes may require that FlexAct or the workplace be equipped with additional safety features or that precautions be otherwise taken to protect personnel and working environment Additional the operator has to follow all of the contry specific safety laws and rules Safety and warning instructions given in this document only apply to the devices and supplement the rules and regulations the operator stipulates at the workplace for the respective process S
7. P key on the pump This resets the system and is indispensable for proper functioning of the pump All equipment must be assembled carefully and safely After concluding the process all affected components of FlexAct COM should be disposed of disinfected and cleaned in accordance with their use and as prescribed by the respectively valid laws and regulations 1 Setup and Equipment 1 Setup and Equipment 1 1 System Overview TT jy jan P iii _f T j j j o ol S e ms Al ja siz Hi sartbrius m EVE 10 9 13 11 8 12 5 4 15 3 6 7 16 14 Figure 1 1 Overview FlexAct BP COM Components FlexAct COM Useful accessory 1 Central Operating Module COM 9 Floor scale 15 Sartocheck 2 Dom with pressure transmitter 10 COMBICS1 indicator 16 BioWelder BioSealer 3 Main switch Emergency Power Switch identical for BP and MP 4 Pump 11 MagMixer with palletank 5 Pumphead support Media Preparation 6 Touch Panel 12 SU pH sensor 7 Filterholder MidiCaps MaxiCaps 13 Powder Bag 8 PT100 RTD 14 Palletank Storage FlexAct Buffer Preparation 9 1 2 Hardware 1 3 Single use 1 4 Customer supply 10 FlexAct Buffer Preparation FlexAct BP Central Operating Module Magnetic Mixer Drive Unit with toolbox Palletank for Magnetic Mixer with load cells FXC114155 or Palletank for Magnetic Mixing XC110821 on floor scale Palletank
8. artorius Stedim Biotech GmbH No guarantee is assumed for the information provided Sartorius reserves the right to make technical changes to the equipment or changes to this document without any prior notice No part of this document may be changed or reproduced nor is any other use permitted without obtaining prior written permission Introduction 5 V Explanation of Symbols VI Safety Instructions 6 Introduction WARNING IMPORTANT RI g y The Warning symbol and this formatting indicate hazards that can be expected with a high probability and can lead to severe injuries The Caution symbol and this formatting indicate hazards that can occur and can lead to severe injuries if the notes and instructions are not observed This warning indicates risks that can lead to material damage Instructions and notes labeled with this symbol indicate steps that must be performed with particular care or point to other especially important aspects to be observed The box indicates other important information Numbered paragraphs indicate steps that should be performed consecutively in the order listed This symbol points to information referenced in another section Organizational measures on the part of the operator gt The operator must point out the hazards to which personnel and the working environment may be subject during the process must provide the suitable safety equipment and must publish
9. dual buffer supplier 16 If required remove the powder bag by opening the 4 Triclamp connection and close the Bag for Magnetic Mixer with the 4 plug gasket and union clamp to minimize exposure Use a 4 plug kit FMA114179 to close as well the powder bag 17 Close the clamp at the fill line and disconnect the fill line from the water supply 18 Record the final pH temperature and weights values 19 If required retrieve a buffer sample with the Luer syringe through the needleless sampling port Process Installation 13 2 3 Setting up of automated 1 pH adjustment RTD pH sensor balance WM520 base WM520 acid MagMixer tank Pos 1 Pos2 acid 3 m base MIN MAX Speed for acid pump Speed for base pump XP Proportional share of PID controller DEADB Tl TD not required set to 0 14 Process Installation network 2 Connect the WM 520 R2 signal cable with the corresponding plug of the sensor field If there is a pH correction with base required connect it to the base jack for a correction with acid in the ACID jack Select the transfer line for acid base titration of the correct length For Flexel Bags for Magnetic Mixer of volumes up to 200 a 4 m is recommended above a length of 5 m is suitable The Transfer set Titration consists of a tube of 1 4 and a 18 ID in order to realize different flow rates necessary to adopt the system different buffers and titrations agents See
10. h a reduced pumpspeed If needed The Flexel Bag for Magnetic Mixer can be lifted at the end of the drainage for a full buffer recovery and to minimize air pumping upstream to the filter The filtration process stops automatically when the filtered weight was filtered into the Flexel 3D Bioprocessing Bags for Storage After the process is finished retrieve filtered buffer samples using the sampling line needleless sampling port with Luer syringe 3 Ending the Process CAUTION 3 Ending the Process Be aware that the filter capsule can be pressurized If so media will be set free and can cause serious damages to equipment and injuries to persons Be aware that the tube of the Transfer Set TITRATION can contain acid base Make sure that all acid bases will be collected safe and properly 1 Close the clamps of the Flexel for Magnetic Mixer drain line 2 Open the upstream drain valve of the filter capsule to release pressure from the capsule 3 Disconnect the TC connection at the filter inlet and install the blind cap to prevent draining liquid 4 Disconnect the SU pressure sensor and remove the transfer tube from the WM 720 5 Seal the TPE tubing line between the filter outlet and Flexel 3D Bioprocessing Bag for Storage with a BioSealer gt Manual BioSealer Alternatively close the clamp of the TPE tubing line 6 Cut the seal Alternatively cut the TPE tubing line between the filter and the cla
11. l Connect the WFI supply to the bag s inlet port Close the pinch clamps on the low port except the fill line Close the clamps of both acid base top ports Tare the load cell at the combics panel B Magnetic Mixer Palletank w load cells and Combics 1 Controller Process Installation 11 2 2 Filling of mixing bag 12 Process Installation Thermowell pH probe with connections for calibration buffer and transmission cable Clave connector for sampling Sw 2 Filling lines Drain line 3 m to FlexAct COM BP Connections at the low port of Flexel Bag for Magnetic Mixer probe pH 1 Fill the Flexel Bag for Magnetic Mixer with WFI up to 80 to 95 of the final volume Open the 8 top port and insert the top port into the stainless steel clamp holder Refer to the manual of Flexel Bag for Magnetic Mixer for the filling of the bag and the instructions for the preparing of the buffer 2 Remove the magnetic clamp from the bag and couple the Magnetic Mixer drive unit under the Palletank for Magnetic Mixer 3 Insert the RTD in the thermowell Insert the pH electrode inside the bag 5 Start impeller rotation with the Magnetic Mixer Drive Unit 6 The pH will be logged like all other process values automatically by the DCU TEE ypt ge me we mess of FlexAct COM and the diagram of the progress can be viewed by pressing the 150 0 12 00pH 1500 0kg 100 0 1500 0k9 4 50bar TREND button of
12. mp 7 Apply a post filtration integrity test if required Manual Sartopore 2 y Capsules MaxiCaps 8 Discard the Flexel for Magnetic Mixer 9 Transfer the filled buffer bag s to its further use Ending the Process 19 Sartorius Stedim Biotech GmbH August Spindler Str 11 37079 Goettingen Germany Phone 49 551 308 0 Fax 49 551 308 32 89 www sartorius stedim com Copyright by Sartorius Stedim Biotech GmbH Goettingen Germany All rights reserved No part of this publication may be reprinted or translated in any form or by any means without the prior written permission of Sartorius Stedim Biotech GmbH The status of the information specifications and illustrations in this manual is indicated by the date given below Sartorius Stedim Biotech GmbH reserves the right to make changes to the technology fea tures specifications and design of the equipment without notice Status April 2011 Sartorius Stedim Biotech GmbH Goettingen Germany Printed in Germany on paper that has been bleached without any use of chlorine W_FlexAct_BP KT Publication No SKG6002 e11041 Ver 04 2011
13. oduction side Want to disassemble peripheral installations When transporting or moving FlexAct BP components be fully aware that you are moving equipment with an extremely high weight Ensure that all necessary measures are taken e g warning information barriers safety gear ete to prevent any danger of crushing or roll over and thereby the risk of injury to persons When assembling the PT 100 temperature sensor make sure that the bag is filled and not to damage the sensor channel when inserting the sensor Pierced or damaged sensor channels will make the bag unusable 1 Ensure that all supply media on the laboratory or production sides e g water supply voltage etc match the specifications t P amp l Diagram 2 The workplace must be able to carry FlexAct COM and BP components with all equipment and the intended peripheral devices Observe the weight and the Space requirements gt Setup and Connection Use suitable transportation aids when transporting FlexAct BP components to the place of installation and or changing its location 3 Secure all laboratory connections connections on the production side carefully Use only the equipment provided or released for the device Never make any technical modifications unless Sartorius Stedim Biotech GmbH has expressly confirmed that this modification does not affect safe use 5 Loosen remove any transport locks 6 Check all equipment carefully for damage
14. paration operation Combined with a Flexel for Magnetic Mixer and Palletank the multifunctional Central Operating Module enables the user to install operate and monitor a fully single use unit operation This document describes different models and equipment of FlexAct COM that were available at the time of its creation The equipment supplied with a device does not necessarily cover every possible type of equipment some may differ from the descrip tion while others may contain additional equipment The descriptions for the fittings can differ from the ones in the related P amp l diagram and the equipment list because these documents are each adapted to the customer s specific requirements Documentation on customer specific designs and equipment can be separately Supplied or are available on request Sartorius Stedim Biotech GmbH Customer Service August Spindler Strasse 11 37079 Goettingen Germany Phone 49 551 308 3318 Fax 49 551 308 3755 www sartorius stedim com BP Buffer Preparation CDS Configurable Disposable Solution COM Central Operating Module DCU _FlexAct Sartorius Stedim Measurement and Control System I L Liter MP Media Preparation P tl Diagram Piping amp Instrumentation Diagram SSB Sartorius Stedim Biotech 1 This product uses ATMI patented Magnetic Mixer technology III Definitions IV Operating Instructions Intended Use FlexAct COM FlexAct COM ready to connect system with Trolley
15. tennddesacdetes et eeatuceiaewneenenies 9 Te SyStenrOVEVIEW oxc355 502 anGone ded RENS Ar EAN R A 9 P EE E E E E E N 10 Pe e SCO E E coe an E EE E E E 10 LA CUSTOMEF wceatadicmasmadttesnd neon Aa A EAT EER 10 2 Process Installation Process Start nananana nananana aeaaea 11 2 1 Setting up of the mixing system 22 exemace eee aduen Geoeene teases ae 11 2 2 Filling of mixing bag and powder addition 000e eee 12 2 3 Setting up of automated pH adjustment nannan aaan annann 14 2 4 Run the automated pH adjustment process 00e eee eee 15 2 5 Setting up of the receiving bag and filter for filtration 16 26 Running tne TOW pcatdaceans neea ud eee twice seeeeen tyes ee 17 3 Ending the PYOCCSS 464622 eee ba tan epa a E E A a erase 19 Contents 3 Introduction Instruction Il Abbreviations BI Basic Issue 4 Introduction Introduction The FlexAct BP is a standardized configurable disposable solution CDS dedicated to buffer preparation in biopharmaceutical processes The FlexAct BP addresses the entire development cycle and production capacity needs from 50 to 1 000L for buffer preparation The integration of monitoring amp control features for pH temperature pressure pump speed and fluid level control is a further milestone for the implemen tation of process relevant single use equipment The integrated control allows end users to perform other tasks during the buffer pre
16. the DCU touchscreen i i 0 0 c 2 00pH 1500 0kg 0 0 0 0kg 0 50bar 09 50 09 55 10 00 10 05 10 10 10 15 10 20 10 25 10 30 10 35 10 40 10 45 Main SUE trend EZ Remote Calibration L settings EJ an A E GY Powders can be mixed inside the same powder bag or multiple bags can be used if appropriate It is also possible to transfer the powder in multiple steps to facilitate rehydration dispersion and dissolution 7 Connect the 8 4 reducer FMA114007 to the 4 port of the powder bag and transport the powder transfer bag to the FlexAct COM BP system 8 Connect the powder transfer bag onto the 4 port of the Bag for Magnetic Mixer 9 Remove the pinch clamp from the powder Transfer Bag to transfer the powder inside the Flexel Bags for Magnetic Mixer 10 Mix until complete dissolution of the powders refer to preparation instructions provided by individual buffer supplier 11 If more than one Powder Transfer Bag is being used add content of the other Powder Transfer Bags to the Palletank for Magnetic Mixer 12 Keep the powder bag connected to the Bag for Magnetic Mixer and open one of the 1 4 top line for air removal during dilution 13 Tare the Magnetic Mixer Palletank w load cells and Combics Controller 14 Add the remaining quantity of WFI to reach the final buffer volume then close the top port 15 Mix until complete powder dissolution refer to preparation instructions provided by indivi
17. the stipulated safety requirements Only operating personnel qualified to run the process may be employed for working with FlexAct BP they must be aware of potential hazards and be thoroughly familiar with the handling of all devices Non authorized persons must be prohibited from working on FlexAct BP If hazards are associated with the process e g due to process relevant media the workplace must be labeled with suitable danger symbols e g BIOHAZARD and it should be possible to cordon it off or quarantine it if the circumstances require gt gt The workplace must be suitable for the process e g resistant to acids bases or media and must be easy to clean decontaminate and disinfect if contaminated gt In general operators must wear suitable personal protective equipment e g work clothes gloves safety goggles as well as a facemask if appropriate Workplace Setup Workplace and supply connections in the laboratory production facility must meet the requirements stipulated in the equipment specifications All intended equipment must be complete and free of defects and flaws Getting Started CAUTION aa IMPORTANT O WARNING Risk of injury if energy supply lines are inadvertently activated e g power supply water gas inlet supplies Energy supply lines must be blocked or secured against inadvertent startup whenever you Connect or disconnect laboratory connections or connections on the pr
18. uipment has to be strictly avoided in order to assure a correct working of the process sa 1 Start the phase Filtration by pushing the button on the DCU touchscreen and 5 follow the instructions on the screen The system will filter an adjustable volume of the buffer from the Flexel for Magnetic Mixer via a sterile filter capsule to the receiving bag The pump is stopped by the DCU automatically when the adjusted volume was transferred into the receiving bag It is not necessary to tare the bal ance prior filtration because the DCU will automatically calculates the weight being filtered into the Flexel 3D Bioprocessing Bag for Storage At the begin ning of the sequence there Is possibility to perform a pre filling of the tubing to assure an higher accuracy of the weight filled in the Flexel 3D Bioprocessing Bag for Storage There is also the possibility to repeat the filtration step in order to use a manifold consisting of several bags Process Installation 17 18 Process Installation During initial filling of the tubes the speed of the pump can be modified by change of parameter S_Pump Stop manually when the liquid has reached the last Flexel 3D Bioprocessing Bag for Storage Open the upstream venting valve of the MidiCaps MaxiCaps to fill MaxiCap for venting During filtration the speed of the WM 720 pump can be set up to 100 In case the unit will shut down due to inlet pressure alarm please start the process wit
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