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UniFlux™ System - GE Healthcare Life Sciences

1. Parameter for UniFlux 400 System Filter skid Main Voltage L N PE 110 230 VAC 50 60 Hz power frequency supply Min fuse 16A 16 A SB 110 VAC rating 110 VAC 10 A SB 230 VAC 10A 230 VAC System Voltage L1 L2 L3 PE 400 480 VAC pump frequency 50 60 Hz N A power N A supply Min fuse 16 A SB 230 VAC 30 ASB rating 230 VAC Electrical inputs all Fixed installation Shielded cable 2 5 mm 14 AWG UL CE approved Overvoltage category Il Pollution degree 2 Weight AC 440 kg 540 kg 400 kg without HF 410kg 500kg 200 kg filters All options additional 38 kg 54 kg 400 kg N A weight 154 UniFlux System Operating Instructions 28 9617 49 AC 9 Reference information 9 1 Specifications Operating limits Feed pump pressure at 20 C max 4 14 bar g 60 psi g Transfer and Feed temperature Min 5 C permeate pumps a mE Outlet back pressure max 2 bar Battery limits back pressure Min 0 Max 0 2 bar 3 psi Process temperature Min 2 C 36 F Max 60 C 140 F Environmental limits Parameter Value Altitude Max 2000 m Relative Humidity Max 80 for temperatures up to 31 C decreasing linearly to 50 relative humidity at 40 C Ambient temperature Requirement regarding ambient temperature is spec ified in the General Specification included in the system documentation kit Ingress protection IP 55 Power consumpt
2. Section See page 4 5 1 Lock wheels 94 4 5 2 Operator console for UniFlux 30 120 and 400 95 4 5 3 Stand alone computer for UniFlux 10 98 4 5 4 Connect compressed air supply 99 4 5 5 Setup of control system and network 100 4 5 6 Filter setup feed pump and CFF filter protection 101 4 5 7 Process component connections for UniFlux 30 120 and 400 102 UniFlux System Operating Instructions 28 9617 49 AC 93 4 Installation 4 5 Setup 4 5 1 Lock wheels 4 5 1 Lock wheels After positioning the system at its designated location lock the wheels figure 94 UniFlux System Operating Instructions 28 9617 49 AC 4 Installation 4 5 Setup 4 5 2 Operator console for UniFlux 30 120 and 400 4 5 2 Operator console for UniFlux 30 120 and 400 Introduction The operator console is packed separately in a cardboard box which is enclosed in the system crate for UniFlux 30 and 120 All connections to and from the monitor and the keyboard DVI signal USB connection and power are included in one multi conductor cable ODU minisnap 24 pin connector One ODU minisnap 3 pin connector is used for the power supply These two cables are attached to the system located underneath the cabinet Precautions CAUTION Make sure that the console arm is firmly positioned with the top part of the handle fully inserted so that the bushing is able to ab sorb the weight of the console when the console arm is fully extend ed The console may f
3. Filter cassette holder feed inlet Filter cassette spillage waste outlet Hydraulic unit main power switch 10 Depressurize button 11 Pressurize button 12 Cassette holder distributor plate 13 Cassette holder upper guide pin 2 versions supplied for different types of filter 14 Cassette holder lower guide pin 15 Cassette holder movable pressurization plate 16 Cassette holder fixed pressurization plate 17 Hydraulic cylinder 18 Cassette holder bottom filter support 19 Filter cassette spillage collection plate 20 Hydraulic unit operation enabling button 21 Hydraulic unit spillage collection plate UniFlux System Operating Instructions 28 9617 49 AC 61 3 System description 3 5 Hollow fiber HF configuration 3 5 Hollow fiber HF configuration Overview When the UniFlux systems are operated with hollow fiber cartridges required components of the piping system must be installed The retentate line must be located in the upper position In this section This section contains the following subsections Section See page 3 5 1 UniFlux 10 HF configuration 63 3 5 2 UniFlux 30 HF configuration 64 3 5 3 UniFlux 120 HF configuration 66 62 UniFlux System Operating Instructions 28 9617 49 AC 3 System description 3 5 Hollow fiber HF configuration 3 5 1 UniFlux 10 HF configuration 3 5 1 UniFlux 10 HF config
4. No air supply to the system the alarm is caused by a compressed air failure see above UniFlux System Operating Instructions 28 9617 49 AC 143 8 Troubleshooting 144 Component Pump Possible cause Pump not working Corrective action Emergency button has been pressed No inlet or outlet valve open Check method and valves Incorrect method Check by entering Pump ManFlow gt 1 If none of the above contact GE Healthcare service personnel Little or no flow Check that connected inlet is actually used Inlet containers are placed too low rela tive to the pump Check inlet containers No liquid is supplied to the pump Check inlet containers Tubing from inlet container causes pres sure or flow loss Reasons may be too long tubing too small internal diameter tube may have a narrow section or is partly plugged Malfunctioning valve at container battery limit Too high outlet pres sure Check that connected outlet is actually used Outlet containers are placed too high relative to the pump Tubing to outlet container causes pres sure or flow loss Reasons may be too long tubing to small internal diameter tube may have a narrow section or is partly plugged Check also for non func tioning valvels Malfunctioning valve at container battery limit UniFlux System Operating Instructions 28 9617 49 AC UV curve Error symptom Ghost peak
5. Other issues not covered by this manual Contact information is found on the back cover of this manual UniFlux System Operating Instructions 28 9617 49 AC 159 Index Index 160 A Accessories 159 Assembly setup 95 Automation 40 57 B Battery limits 86 C CE Conformity 9 Marking 9 Checks final before start 125 Chemical resistance 157 CIP Hookup 133 Cleaning Cleaning agents 133 External surfaces 135 General 133 Cleaning in place CIP 133 Cleaning performance extend ed 134 Component descriptions flowchart 71 79 Compressed air 86 Computer 86 Conductivity trouble shoot ing 148 Connectors external 50 Cross flow filtering trou bleshooting 146 D Decontamination 36 Dimensions 150 Disassembly other compo nents 139 Disposal general instruc tions 36 Disposal of electrical compo nents 36 Documentation Software UNICORN 11 System specific 11 E Electrical power 85 Emergency Procedures 32 Restarting the system 35 Shutdown 34 Stop 34 Explosive environment precau tions 15 F Feed pump protection 101 ilter cassette holder 59 Filter cassette installation preparations 110 Filter cassette installation UniFlux 10 111 Filter cassette installation U F F F mn niFlux 30 113 ilters protection 101 ilters setup 101 ammable liquids precau tions 15 G General precautions 13 H Hollow fiber cartridg
6. Possible cause Dirt or residues in the flow path from previous runs 8 Troubleshooting Corrective action Clean the system Noisy UV signal signal drift or instability Bad UV fiber connec tions Check the connections of the UV cell optical fiber Replace if necessary Dirty UV cell Clean the UV cell as described in Section 7 2 Cleaning on page 133 Pressure curve Error symptom Erratic flow noisy base line signal irregular pressure trace Possible cause Gas bubbles passing through or trapped in the pump Corrective action Check that there is sufficient supply of liquid Check all connections for leaks Blockage or partial blockage of flow path Flush through to clear block age UniFlux System Operating Instructions 28 9617 49 AC 145 8 Troubleshooting Cross flow filtration Refer to Air integrity test on page 120 Component Problem Possible cause Corrective action Filter problems The flow is too high in the air in Clogged filter Clean the filter tegrity test The flow is too low in the air integri The pores in Change the filter ty test the membrane or fibers have become larger than the nomi nal size or the fibers or membranes are broken Hydraulic unit The pump does not operate The unit is not Plug the unit into the power connected to supply electrical pow er The power Turn the powe
7. e Connected to piping that allows maximum waste flow to be transported away from UniFlux System without pooling CAUTION Make sure that the console arm is firmly positioned with the top part of the handle fully inserted so that the bushing is able to ab sorb the weight of the console when the console arm is fully extend ed The console may fall and cause damage and or injury if the console arm is not properly positioned 18 UniFlux System Operating Instructions 28 9617 49 AC 2 Safety instructions 2 1 Safety precautions CAUTION When handling the operator console make sure that no body parts are caught between the sections of the console arm NOTICE Any computer used with the equipment shall comply with IEC 60950 and be installed and used according to the manufacturer s instruc tions Power supply WARNING Protective ground UniFlux System must always be connected to a grounded power outlet WARNING National Codes and standards NEC VDE BSI IEC UL etc and local codes outline provisions for safely installing electrical equipment Installation must comply with specifications regarding wire types conductor sizes plug branch circuit protection and disconnect devices Failure to do so may result in personal injury and or equipment damage WARNING All electrical installations must be performed by authorized personnel only UniFlux System O
8. UniFlux 400 Rear view Part Function 13 Emergency stop button 14 UNICORN status lights 15 Connectors on top UniFlux System Operating Instructions 28 9617 49 AC 55 3 System description 3 2 UniFlux systems layout 3 2 3 Illustrations of UniFlux 400 system Part Function 16 Main power switch 17 Skid maneouvering handle 18 CIP media outlet 19 Swivelling caster with brake 20 Adjustable floor supports UniFlux 400 External connectors Top connectors Part Function 1 UPS power failure alarm input 2 Remote alarm output 3 UNICORN Ethernet port 4 Digital level sensor input 54 UniFlux System Operating Instructions 28 9617 49 AC 3 System description 3 2 UniFlux systems layout 3 2 3 Illustrations of UniFlux 400 system Part Function 5 Air exhaust 6 Air inlet 7 Optional 1 0 interface 8 Analog level sensor input 9 Main power supply 10 Power supply P 201 Inner wall connectors Part Function 1 Control signal ZSO 065 2 Pressure signal hydraulic unit system side 3 Pluto safe bus 4 Control signal P 202 P 203 tank UniFlux System Operating Instructions 28 9617 49 AC 55 3 System description 3 2 UniFlux systems layout 3 2 3 Illustrations of UniFlux 400 system Part Function 56 5 Power supply transfer pump P 202 6 Power supply permeate pump P 203 7 Cont
9. 10 Tighten the cassette assembly Step Action iL Slide the back plate towards the cassettes until they make contact 2 Screw the 2 retaining nuts by hand until the backplate is pressing against the cassettes Make sure that the back plate is sliding orthogonally 3 Tighten the 2 retaining nuts in small increments in a cross wise pattern until the torque 20 Nm is reached Make sure that the nuts are tightened equally to prevent uneven pressure over the cassettes 112 UniFlux System Operating Instructions 28 9617 49 AC 5 Run preparations 5 2 Filter installation 5 2 4 Cassettes for UniFlux 30 120 and 400 5 2 4 Cassettes for UniFlux 30 120 and 400 Hydraulic pressure Make sure that the hydraulic pressure required to prevent filter leakage with sufficient margin is known NOTICE Too high hydraulic pressure will have a negative effect on the pressure drop caused by the cassette and can cause damages on the cassettes The hydraulic pressure shall be restricted to 140 bar 2000 psi to avoid overload of cassette holder For all filter cassettes empirical testing is needed to decide what hydraulic pressure to use Contact your GE Healthcare representative for advice Preparations Step Action 1 Prepare and check the cassettes according to the manufacturer s instruc tions UniFlux System Operating Instructions 28 9617 49 AC 113 5 Run preparations 5 2 Filter installation 5 2 4 Cassettes fo
10. 133 Absolute conductivity value is wrong Bad calibration Calibrate the conductivity cell see separate manual Calibration solution not correctly prepared Recalibrate using a new calibra tion solution Incorrect or unstable reading Bad pump or valve ac tion Check the pump and the valves Temperature compensa tion not properly set Check the temperature com pensation see separate manual Error symptom No response to pH changes Possible cause The cable to the elec trode not properly con nected Corrective action Check the cable connection The electrode mem brane might be cracked Replace the electrode Small or slow response to pH changes The electrode mem brane might be contam inated Clean the electrode refer to the manufacturer s manual pH reading appears to be incorrect pH sensor not properly calibrated Calibrate the pH sensor as de scribed in Section 7 5 pH cali bration on page 140 UniFlux System Operating Instructions 28 9617 49 AC 9 Reference information 9 Reference information About this chapter This chapter provides reference information that may become useful when installing operating maintaining and troubleshooting UniFlux System It also contains ordering information The UniFlux System is a modular built instrument that can be configured in many different ways To unders
11. and rinse it with distilled water UniFlux System Operating Instructions 28 9617 49 AC Step 7 Maintenance 7 5 pH calibration Action 10 ia Remove the cup with the first buffer from the holder and replace it with the cup with the second buffer Re locate the pH probe in the holder with the end submerged in the buffer Enter the pH value for the buffer in the Reference value 2 field wait for the value to stabilize and click Read value 2 Wait for response and if the electrode passed click Close Otherwise click Close refresh change the pH electrode and repeat the calibration procedure Remove the cup from the holder Relocate the pH probe in the flow cell as shown in the right image above UniFlux System Operating Instructions 28 9617 49 AC 141 8 Troubleshooting 8 Troubleshooting About this chapter This chapter provides required information to enable users and service personnel to identify and correct problems that may occur when operating UniFlux System If the suggested actions in this guide do not solve the problem or if the problem is not covered by this guide contact your GE Healthcare representative for advice Precautions WARNING Before attempting to perform any of the procedures described in this chapter you must read and understand all contents of the corresponding section s in the Chapter 2 Safety instructions on page 12 as listed below e General precautions o
12. and service personnel to unpack install move and transport UniFlux System Precautions WARNING Before attempting to perform any of the procedures described in this chapter you must read and understand all contents of the corresponding section s in the Chapter 2 Safety instructions on page 12 as listed below e General precautions on page 13 e Personal protection on page 15 Installing and moving on page 16 e Power supply on page 19 In this chapter This chapter contains the following sections Section See page 4 1 Site requirements 85 4 2 Transport 87 4 3 Unpacking 88 4 4 Power supply 90 4 5 Setup 93 84 UniFlux System Operating Instructions 28 9617 49 AC 4 Installation 4 1 Site requirements 4 1 Site requirements Space and floor load For space and floor requirement see external dimensions and weights in Section 9 1 Specifications on page 150 Make sure that the floor can handle the UniFlux System weight at fully loaded condi tions Please observe that for the weight to be equally distributed over all wheels the floor must be level and without irregularities In order to allow convenient working conditions for the operator sufficient space should be provided at all sides of the combined UniFlux System and UniFlux Tank when installed at the intended production location Environmental requirements The UniFlux System is intended for indoor use only The room must have for
13. end user is allowed to perform without support from GE Healthcare WARNING Only personnel authorized by GE Healthcare may open the cabinet doors There is high voltage inside the cabinet that can cause human injury or death WARNING The electric cabinet doors may only be opened when UniFlux System is taken out of operation and subject to LOCK OUT TAG OUT WARNING LOCK OUT TAG OUT Before any maintenance or decommission ing work is performed on UniFlux System make sure that e itis empty and depressurized e itis disconnected from process feed electrical power and pneumatic supply e itis prevented from accidentally becoming re energized during maintenance e itis clearly tagged as taken out of operation e all process wetted areas are clean and decontaminated WARNING For continued protection against injury risks due to fluid jets burst pipes or potentially explosive atmosphere the piping system must be tested for leakage at maximum pressure e After assembly or maintenance e Before operation or CIP 138 UniFlux System Operating Instructions 28 9617 49 AC 7 Maintenance 7 4 Disassembly and assembly Components for filter configurations NOTICE In order to reconfigure the system from cassette usage from hollow fiber HF to cassette usage or the other way round a number of components must be removed and installed While these operations can be performe
14. for the intended environment that might expose the computer to liquids and moisture NOTICE Any computer used with the equipment shall comply with IEC 60950 and be installed and used according to the manufacturer s instruc tions 86 UniFlux System Operating Instructions 28 9617 49 AC 4 Installation 4 2 Transport 4 2 Transport In the transport crate Use a pallet jack or fork lift with a minimum capacity to match the empty weight of the system plus the transport box Refer to Section 9 1 Specifications on page 150 regarding system weight Make sure that intended openings and apertures are large enough to allow passage of the box when lifted from the floor for transport For UniFlux 10 For minimum door aperture size refer to Section 9 1 Specifications on page 150 Unpacked WARNING Heavy object Because of the significant weight of UniFlux System great care must be taken not to cause squeezing or crushing in juries during movement At least two but preferably three or more persons are recommended when moving the unit UniFlux can be rolled by hand on hard and level surface with wheel brakes released If the floor quality does no allow rolling the UniFlux on its own wheels it can be moved with a pallet jack or fork lift For minimum door aperture size refer to Section 9 1 Specifications on page 150 UniFlux System Operating Instructions 28 9617 49 AC 87 4 Installation 4 3 U
15. time may be lost If only the system is affected by the power failure and not the computer UNICORN will display text saying that communication has been broken and that no data are recovered When power returns to normal the system will be in End state i e it will not resume the run Restart after emergency shut down or power failure Follow the instruction below to restart UniFlux after emergency shut down or power failure Step Action 1 Make sure that the condition that caused the power failure or emergency stop is corrected 34 UniFlux System Operating Instructions 28 9617 49 AC 2 Safety instructions 2 3 Emergency procedures Step Action 2 Reset the EMERGENCY STOP button by twisting it clock wise 3 Press the CONTINUE button in UNICORN UniFlux System Operating Instructions 28 9617 49 AC 35 2 Safety instructions 2 4 Recycling information 2 4 Recycling information Introduction This section contains information about the decommissioning of UniFlux System Decontamination UniFlux System shall be decontaminated before decommissioning and all local regulations shall be followed with regard to scrapping of the equipment Disposal general instructions When taking UniFlux System out of service the different materials must be separated and recycled according to national and local environmental regulations Recycling of hazardous substances UniFlux System contains hazardous substan
16. will not shut off mains power to the cabinet WARNING Alarm signals All alarm signals must be set within the limits specified in the system documentation Pressure and temperature control must be activated while the system is in use to prevent the piping system to leak or break WARNING Alarms signals Make sure to change back to the original alarm level after UNICORN alarm buzzer test CAUTION If an external Uninterruptible Power Supply UPS is used this unit must be powered before any other equipment CAUTION To safely operate UniFlux System knowledge of how to use UNICORN is required Refer to UNICORN user documentation as required CAUTION When handling the operator console make sure that no body parts are caught between the sections of the console arm CAUTION Do not insert your fingers or other objects into fans or other moving parts Pe Pee PP UniFlux System Operating Instructions 28 9617 49 AC 21 2 Safety instructions 2 1 Safety precautions Maintenance WARNING LOCK OUT TAG OUT Before any maintenance or decommission ing work is performed on UniFlux System make sure that e itis empty and depressurized e itis disconnected from process feed electrical power and pneumatic supply e itis prevented from accidentally becoming re energized during maintenance e itis clearly tagged as taken out of operation e all process wetted are
17. 1 Filter integrity test check valve FA 231 Filter integrity test sanitary filter FA 232 Tank vent sanitary filter FILTER Cross flow filter Can be either hollow fibre Not included in system HF cartridge or filter cassette provided by customer or sold separately FT 141 Feed flow meter FT 142 Permeate flow meter FT 143 Filter integrity test flow meter M 241 Feed tank agitator motor Option ME1 Tank vent ME2 Tank jacket connection ME3 Tank jacket connection P1 Permeate outlet P2 Permeate pump outlet Part of permeate pump op tion P3 Retentate drain P4 Feed drain CIP outlet PS Permeate drain P6 HF filter cartridge drain HF configuration only P 201 Feed pump 70 UniFlux System Operating Instructions 28 9617 49 AC 3 System description 3 6 Flow charts 3 6 1 UniFlux 10 Tag System Function Note P 202 Feed transfer pump Option P 203 Transfer and permeate pump Option PCV 341 Retentate pressure control PS 342 Filter integrity test pressure sensor PY 342 Filter integrity test pressure regulator PSE 371 Feed tank pressure relief safety valve PT 111 Feed pump outlet pressure meter PT 112 Feed pump outlet pressure meter PT 113 Retentate pressure meter PT 114 Permeate pressure meter TANK Feed tank T 342 Pressure regulator pulse damper TE 101 Permeate temperature meter Option Included in cond CE 101 WE 176 Tank load cell XV 001 Pump feed valve XV 031 Permea
18. 3 4 Cassette holders Description 3 System description 3 4 Cassette holders The cassette holder provides a convenient way to install and use the filter cassettes for a filtering run The cassette holder follow industry standard cassette dimensions and accepts other cassettes of standard layout When pressure is applied the package of installed cassettes forms a single filtering block More information regarding the cassette holders are available in the Data File with article no 18 1171 61 Cassette holder for UniFlux 10 10 11 Part Function 1 Stationary filter distributor plate 2 Permeate outlet 3 Feed inlet UniFlux System Operating Instructions 28 9617 49 AC 59 3 System description 3 4 Cassette holders Part Function 4 Retentate outlet 5 Movable back plate 6 Filter retaining nut 2 7 Filter retaining threaded rod 2 8 9 Filter retaining spacers 4 10 Spillage plate drain outlet 11 Spillage plate Cassette holder for UniFlux30 120 and 400 it 1a 15 16 Part Function il Power on indicator light 2 Power on lock with key 3 Hydraulic unit pressure indicator 60 UniFlux System Operating Instructions 28 9617 49 AC 3 System description 3 4 Cassette holders Part Function 4 Hydraulic unit system label 5 Filter cassette holder permeate outlet 6 Filter cassette holder retentate outlet
19. 50 60 Hz Max current consumption system 5A Max current consumption pump 18A Min fuse rating system 10 ASB Min fuse rating pump 30 A SB Protection class IP 55 Ambient temperature range 2 30 C Process temperature range 2 60 C Max process pressure 4 15 bar g Pneumatic supply min max 6 10barg GE Healthcare GE Healthcare cine Sweden 28 UniFlux System Operating Instructions 28 9617 49 AC UniFlux 400 system label description 2 Safety instructions 2 2 Labels Label text Description CE The system complies with applicable European directives 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 equipment GE Healthcare Code no GE Healthcare Code no GE Healthcare Serial no GE Healthcare Serial no GE Healthcare Model no GE Healthcare Model no Year of manufacture Year of manufacture Power supply system Power supply system Power supply pump Power supply pump Frequency Supply voltage frequency Max current consump Max current consumption system tion system Max current consump Max current consumption pump tion pump Min fuse rating system Min fuse rating system Min fuse rating pump Min fuse rating pu
20. 617 49 AC Tag System XV 081 082 083 084 Function Quadruple inlet 1 2 3 and 4 valves 3 System description 3 6 Flow charts 3 6 2 UniFlux 30 120 and 400 Note Part of quadruple inlet op tion XY 342 Filter integrity test valve In the flow diagram for UniFlux 400 the gray box represents the filter skid UniFlux System Operating Instructions 28 9617 49 AC 79 3 System description 3 7 UNICORN control system 3 7 UNICORN control system Overview UniFlux System is controlled by UNICORN process control software UNICORN can save established processes as methods The methods include the instructions necessary for process operation and documentation UNICORN includes a comprehensive system of user access levels to be programmed limiting the operations a given user may perform on UniFlux System To secure safe operation of the system you should limit access to the system to those qualified and trained in its operation The UNICORN manual package provides complete instructions for programming and for using the software for process control System operators are responsible for designing methods which conform to standard operating procedures and Good Manufacturing Practice procedures UNICORN is compliant with FDA 21 CFR Part 11 Knowledge prerequisite At least basic knowledge of UNICORN is expected to operate UniFlux safely Information on how to use UNICORN can be obtained from
21. 80 AX T ADd TSO AX 20e d yaw 4 3W 431114 431114 YyT 14 27 amp Sd 75 UniFlux System Operating Instructions 28 9617 49 AC 3 System description 3 6 Flow charts 3 6 2 UniFlux 30 120 and 400 UniFlux 400 P 203 CE TE 101 EY E ne 221 FT 142 LL ern A es P 202 ME3 PCV 341 PS 342 FT 143 XV 051 XV 041 PY 342 XV 081 ME3 XV 082 XV 083 XV 084 B2 gt B3 gt B4 gt B5 gt 76 UniFlux System Operating Instructions 28 9617 49 AC 3 System description 3 6 Flow charts 3 6 2 UniFlux 30 120 and 400 Tag System Function Note AE 121 Permeate pH meter Option AE 131 Permeate UV meter Option B1 Feed pump inlet B2 B3 B4 Quadruple inlets 1 2 and 3 Part of quadruple inlet op B5 Quadruple inlet 4 Honi CE 101 Permeate conductivity meter with an inte Option grated temperature meter TE 101 CV 321 Filter integrity test check valve FA 231 Filter integrity test sanitary filter FILTER Cross flow filter Can be either hollow fibre Not included in system HF cartridge or filter cassette provided by customer or sold separately FT 141 Feed flow meter FT 142 Permeate flow meter FT 143 Filter integrity test flow meter ME1 Feed pump coolant connection ME2 Feed pump coolant connection ME3 Quadruple inlet option outlet Part of quadruple inlet op tion ME4 Transfer pum
22. Fault Circuit Breaker and it is not an option that is available from GE Healthcare However if ground fault protection for the system is desired e a Ground Fault Circuit Interruptor may be installed or e the system may be connected to an outlet that is protected by a permanently installed Ground Fault Circuit Breaker The tripping current for such an interrupter must be higher than the leak current as found in the test protocol in the system documentation kit Built in circuit breakers The mains power supply to the UniFlux system and the pumps are equipped with circuit breakers inside the cabinet Refer to the System Documentation for the specific types used in your system More information Voltage power fuse requirements and the tripping current for the fixed power supply ground fault protector can be found in the General Specification provided with the system document package 92 UniFlux System Operating Instructions 28 9617 49 AC 4 Installation 4 5 Setup 4 5 Setup Precautions WARNING To prevent bacterial growth UniFlux System may be partly filled with denatured Ethanol 18 C H OH Ethanol 2 C H OH Iso propanol and 80 H 0 water or 0 1 M NaOH Sodium Hydroxide at delivery Flush out the denatured Ethanol or Sodium Hydroxide before as sembling testing or integrating UniFlux into the intended process context In this section This section contains the following subsections
23. GE Healthcare Life Sciences UniFlux System Operating Instructions Original instructions Table of Contents Table of Contents L A 5 1 1 Important user information 6 1 2 Regulatory information 8 13 Associated documentation 11 2 Safety ag 9g Reo eee i ED re nine erp eee iiaiai oii ceai eii 12 21 SAFELY SECAUTIOMS nd annnnnraannnnn manne nids 13 2 2 Labels taime 24 2 3 Emergency procedures Be 32 24 Recycling informations enr Ann nan nine 36 2 5 Declaration of Hazardous Substances DOHS oeceeeccccssssssssssssssssssssessesseseecceceenceccenceeceenceceeseeees 37 3 System descripto Sreser anne nn E See 40 3 1 OVS VW EENE EE AEE A ETE OEE A AEE ARET 41 3 2 UNIFOR SYSTEMS OYO U pinupunasan aaa a 42 3 2 1 illustrations of UniFlux 10 system waeseeeeseesssssssssssssssssssssssssssssssssssssssesssccssesecseececseceeneeneccececeeeeeeeeees 43 3 2 2 Illustrations of UniFlux 30 and 120 systems ceeccecsssssssssssssssssssssssssssssssssesseseeesseesseseesessessssseseee 48 3 2 3 Illustrations of UniFlux 400 system 52 3 3 AUTOMATION lande wt 57 34 Cassette OIA SIS siaina rrai r a AAEE staan intl 59 3 5 Hollow fiber HF configuration 62 3 5 1 UniFlux 10 HF configuration E 63 3 5 2 UniFlux 30 HF configuration 64 3 5 3 UniFlux 120 HF configuration ee 66 36 RONCHI SR nn be da D 68 3 6 1 UNIFIUX TO nn ntm titine rate N NEARE 69 3 6 2 UniFlux 30 120 and 400 se 72 3 7 UNICORNCOntr
24. Outlet P7 System Permeate drain Outlet P8 System Filter drain Only mounted used in Hollow Outlet fiber systems TME3 Tank Tank jacket media supply and return N A TME4 Only mounted used in Hollow fiber sys tems TP2 Tank Feed drain Outlet Interface points Diagram color Green Interface points provide process connections between the UniFlux system and the op tional UniFlux tank Hoses for these connections are normally delivered by GE Healthcare as option to the tank delivery Tag ME5 TB1 Function Feed from optional transfer pump to tank Direction System gt Tank P1 TB2 Retentate recycle System gt Tank P3 TB3 Permeate recycle System gt Tank P5 TB4 CIP media supply to tank System gt Tank TP1 B1 Feed supply to system Tank gt System UniFlux System Operating Instructions 28 9617 49 AC 73 3 System description 3 6 Flow charts 3 6 2 UniFlux 30 120 and 400 Flowcharts UniFlux 30 p2 P 203 P3 XV 032 P2 CE TE 101 EO FT 142 LL PT 114 0 FILTER a N a gt e PCV 341 PS 342 FT 143 XV 051 XV 041 PY 342 un Ww P 202 ME4 74 UniFlux System Operating Instructions 28 9617 49 AC 3 System description 3 6 Flow charts 3 6 2 UniFlux 30 120 and 400 UniFlux 120 4 Sd td 4 90 AX 4 4 290 AX TO8d Yt90 nx A s Y80 AX 1 80 AX lt a 280 AX 29 T
25. Section 3 2 UniFlux systems layout on page 42 for location Make sure that UNICORN is started according to the instruction in Starting UNICORN on page 106 Wait for connection After this sequence is completed the following occurs e The computer is turned on e The POWER indicator lamp flashes e When communication with UNICORN software is established the POWER indicator lamp shows a steady green light Refer to Section 3 7 UNICORN control system on page 80 for more information regarding the UNICORN control system warnings and alarms Step Action 1 2 Switch on the computer Log on to Microsoft Windows Start UNICORN by double clicking on the UNICORN icon on the Windows desktop When the Logon dialog appears select a user from the Users list and enter the password If you log on for the very first time select default and enter the password default Click OK In the System Control module select System Connect UniFlux System Operating Instructions 28 9617 49 AC 5 Run preparations 5 1 Starting UniFlux Step Action 7 In the dialog shown select the appropriate system name and click OK The system name is specified during installation configuration 8 When UNICORN is connected to the system the Run button in the status bar is enabled The button initially has a green color indicating the system is ready to run UniFlux System Operating Instructions 28 9617 49 AC 107 5 Run prep
26. UNICORN pH Cond monitor Replace the pH electrode if difficulties are experienced during calibration UniFlux System Operating Instructions 28 9617 49 AC 131 7 Maintenance 7 1 User maintenance schedule Component Cond monitor Clean and calibrate the cond monitor 132 UniFlux System Operating Instructions 28 9617 49 AC 7 Maintenance 7 2 Cleaning 7 2 Cleaning General A suitable frequency of routine cleaning is determined by the nature of the starting material and the type of process However routine cleaning shall be performed at intervals aimed at prevention rather than cleaning UniFlux and connected equipment from growth or contamination Recommended cleaning agents All components can be cleaned with the most commonly used agents such as detergents Ethanol weak acids Sodium Hydroxide and salt solutions Refer to Section 9 3 Chemical resistance on page 157 NOTICE Avoid Sodium Chloride solutions below pH 4 0 Rinse UniFlux thor oughly with water immediately after contact with salt solutions to lessen the risk of corrosion Cleaning before maintenance service Before maintenance service is performed the system owner must first clean the system and complete a Health amp Safety Declaration Form Contact GE Healthcare for further information Cleaning in place CIP CIP hookup Applies to UniFlux 30 120 and 400 The UniFlux system and Tank combination is p
27. alic text A colon separates menu levels thus File Open refers to the Open command in the File menu Hardware items are identified in the text by bold text e g Power switch UniFlux System Operating Instructions 28 9617 49 AC 7 1 Introduction 1 2 Regulatory information 1 2 Regulatory information This section lists the directives and standards that are fulfilled by UniFlux System Manufacturing information Requirement Content Name and address of manufacturer GE Healthcare Bio Sciences AB Bjorkgatan 30 SE 751 84 Uppsala Sweden Place and date of declaration See EC Declaration of Conformity Identity of person authorized to sign DoC See EC Declaration of Conformity International standards The following standards have been applied Standard Description Notes IEC EN 61010 1 Safety requirements for electrical equipment for measurement control and laboratory use EN 61326 1 EMC emissions and immunity Harmonized with requirements for electrical equipment for 2004 108 EC measurement control and laboratory use Emission according to CISPR 11 Group 1 class A EN ISO 12100 Safety of machinery General principles Harmonized with for design Risk assessment and risk 2006 42 EC reduction Additional regulatory compliance In addition this product fulfils the following requirements Standard Description ASME BPE All steel piping welds including contact welds 8 Un
28. all and cause damage and or injury if the console arm is not properly positioned NOTICE Operator console e Do not use the operator console to push or drag the system Donotlean on the console The console arm is only designed to support the weight of the operator console Mount the console to the system At arrival to the production site the user console is packed separately and needs to be assembled to the system skid Refer to Section 4 5 2 Operator console for UniFlux 30 120 and 400 on page 95 Except for the console the UniFlux System is delivered fully assem bled at production site arrival No further specific assembly procedures are required Follow this sequence when mounting the operator console to the UniFlux 30 and 120 systems UniFlux System Operating Instructions 28 9617 49 AC 95 4 Installation 4 5 Setup 4 5 2 Operator console for UniFlux 30 120 and 400 96 Step Action 1 Open the box and remove the assembled console Do not remove the styro foam protection this can be used for lifting g Carefully slide the console arm over the system handle B until it is firmly attached Keep the styrofoam protection A in place when attaching the console arm 3 Remove the styrofoam protection UniFlux System Operating Instructions 28 9617 49 AC 4 Installation 4 5 Setup 4 5 2 Operator console for UniFlux 30 120 and 400 Step Action 4 Attach the two ODU minisnap connectors C t
29. amaged because of cavitation UniFlux System Operating Instructions 28 9617 49 AC 101 4 Installation 4 5 Setup 4 5 7 Process component connections for UniFlux 30 120 and 400 4 5 7 Process component connections for UniFlux 30 120 and 400 Introduction This section provides guidelines for the connection of process components to UniFlux 30 120 and 400 systems Typical hook up all options included The image shows the typical hook up for the UniFlux 30 and 120 systems Part Function 1 Permeate output UniFlux system perme Plant downstream pro ate pump cess or waste 2 Permeate recycle UniFlux system UniFlux tank 102 UniFlux System Operating Instructions 28 9617 49 AC 4 Installation 4 5 Setup 4 5 7 Process component connections for UniFlux 30 120 and 400 Part Function From To 3 Retentate recycle UniFlux system UniFlux tank 4 Transfer of media UniFlux system transfer UniFlux tank pump 5 Transfer of media not Plant upstream process UniFlux system transfer visible pump 6 Permeate output UniFlux system UniFlux system perme ate pump 7 CIP media UniFlux system UniFlux tank UniFlux System Operating Instructions 28 9617 49 AC 103 5 Run preparations 5 Run preparations About this chapter This chapter provides the information required to safely prepare the UniFlux System for operation Before the UniFlux System is tak
30. arations 5 2 Filter installation 5 2 Filter installation In this section This section contains the following subsections Section See page 5 2 1 Installing hollow fiber HF cartridges 109 5 2 2 General preparation of the cassettes 110 5 2 3 Cassettes for UniFlux 10 111 5 2 4 Cassettes for UniFlux 30 120 and 400 113 108 UniFlux System Operating Instructions 28 9617 49 AC 5 Run preparations 5 2 Filter installation 5 2 1 Installing hollow fiber HF cartridges 5 2 1 Installing hollow fiber HF cartridges Follow the instruction below to install the HF cartridges Step Action 1 Make sure that the system is configured for using HF cartridges and of the intended size 2 Prepare the HF cartridge s according to the manufacturer s instructions 3 Install the cartridge into the system refer to illustrations in Section 3 5 Hollow fiber HF configuration on page 62 UniFlux System Operating Instructions 28 9617 49 AC 109 5 Run preparations 5 2 Filter installation 5 2 2 General preparation of the cassettes 5 2 2 General preparation of the cassettes The table below describes general preparations before installing the cassettes Step Action 1 If the filter cassettes to be used are new it is strongly recommended to perform an air integrity test to establish its characteristic air or nitrogen flow See Air integrity test on page 120 for instructions 2 Prepare and check the cassettes according to th
31. as are clean and decontaminated WARNING Only personnel authorized by GE Healthcare may perform service installation and maintenance of components inside the UniFlux cabinet WARNING Only spare parts and accessories that are approved or supplied by GE Healthcare may be used for maintaining or servicing UniFlux WARNING For continued protection against injury risks due to fluid jets burst pipes or potentially explosive atmosphere the piping system must be tested for leakage at maximum pressure e After assembly or maintenance e Before operation or CIP 22 UniFlux System Operating Instructions 28 9617 49 AC 2 Safety instructions 2 1 Safety precautions CAUTION Do not climb on any parts of UniFlux except where clearly allowed Follow local regulations and make sure that equipment is properly secured when inspecting UniFlux at high level UniFlux System Operating Instructions 28 9617 49 AC 23 2 Safety instructions 2 2 Labels 2 2 Labels Introduction This section describes the various labels on UniFlux and their meaning System labels The illustrations below show examples of system labels for the UniFlux System Note The specific data shown on the system labels below are only examples Actual data is specific for each individual system and may vary from system to system UniFlux 10 system label illustration UniFlux Serial number Year of manufac
32. ation package 3 Attach the ramp on the cabinet side of the crate 4 Remove the brackets on the cabinet side 5 Carefully roll the system out of the crate UniFlux System Operating Instructions 28 9617 49 AC 89 4 Installation 4 4 Power supply 4 4 Power supply Power requirements The power supply requirements are specified in Section 9 1 Specifications on page 150 Installation Connect the system power cord to a fixed power supply by means of a permanent connection which can be detached only by the use of a tool WARNING Electrical power All electrical installations must be performed by authorized personnel only Grounding and protective earth e The protective earth wire must be connected to system ground e Ground impedance must conform to the requirements of national and local industrial safety regulations and or electrical codes e If the leak current exceeds 10 mA a high leakage current earth connection must be provided and confirmed before connecting power supply e The integrity of all ground connections must be periodically checked Circuit breaker A circuit breaker must be present in the fixed power supply Breaking the power supply to the UniFlux System by using this breaker must be equivalent to disconnecting the power cord for a non fixed connected instrument 90 UniFlux System Operating Instructions 28 9617 49 AC 4 Installation 4 4 Power supply Power supply cable T
33. before the system is started Inlets that are not in use shall be closed Outlets that are not in use shall be fitted with tubing and directed to waste Check the condition of all connections and gaskets Check that no chemicals that may be harmful to the system will be used Perform an alarm test according to Test on page 83 Starting Step Action 1 In the UNICORN System Control module select Run in the File menu 2 Select the method to start Click OK A Start Protocol is displayed consisting of a number of dialog boxes On the Variables page it is possible to fine tune the method before proceeding Checking the Show details box will display more detailed information 3 Check that the sample volume is correct 4 Click Next or Back to navigate through the dialog panels adding the infor mation required as well as your own comments 5 Click the START button in the Result Name dialog box This will initiate the method run Note The pump needs a completely open flow path to enable start Monitoring The progress of the run can be viewed in detail in the UNICORN System Control module Up to four different panels can simultaneously display different aspects of the run To customize content and layout of a panel right click in it and select Properties from the menu displayed By selecting Documentation Run notes it is possible to add notes during a run Entered notes will be included in the results More information regar
34. ced ventilation Requirement regarding ambient air temperature is specified in the General Specifi cation included in the system documentation kit Avoid Direct sunlight Strong magnetic or electric fields Vibrations Corrosive gas Dust Allowed ranges for environmental parameters are presented in Section 9 1 Specifications on page 150 Electrical power Refer to Section 4 4 Power supply on page 90 and Section 9 1 Specifications on page 150 for power voltage and phase requirements UniFlux System Operating Instructions 28 9617 49 AC 85 4 Installation 4 1 Site requirements Compressed air e Dry and particle free air for system supply e Refer to Section 9 1 Specifications on page 150 regarding capacity requirements Media supply Refer to Section 9 1 Specifications on page 150 regarding requirements on media supply and delivery Supply must be arranged so that piping dimensions piping lengths valves and height differences do not obstruct processing Battery limits Battery limits represents all interface points between the UniFlux and the customer process plant System battery limits require connections not included in the GE Healthcare delivery Computer An industrial built in computer can be ordered as an option for UniFlux 30 and 120 otherwise a stand alone computer shall be used When installing a stand alone computer ensure that it is installed with appropriate precautions
35. ced with filter cassette dummies 2 Place the UniFlux System in a dust free environment with well controlled climate The temperature should be in the range 4 C to 25 C and stable The air humidity and air temperature differences should be kept as low as possible to prevent condensation and corrosion 3 Remove TC connector rubber gaskets in good condition suitable for processing and place them in dark and cold storage while UniFlux is out of operation This prevents them from aging and drying out Use other sealings not in processing condition as replacement during the storage period To prevent microbial growth the storage solution shall be replaced regularly if the UniFlux is stored for long periods of time Filters e GE Healthcare Kvick Lab and Kvick Flow cassettes storage procedures are provided in the Kvick Lab and Kvick Flow Cassettes User Manual GE Healthcare article no 18 1171 69 e GE Healthcare Hollow fiber cartridges storage procedures are provided in the Hollow fiber cartridges for membrane separations Operating Handbook GE Healthcare article no 18 1165 30 e Filter units provided by other manufacturers shall be stored according to the instructions from the respective manufacturer UniFlux System Operating Instructions 28 9617 49 AC 137 7 Maintenance 7 4 Disassembly and assembly 7 4 Disassembly and assembly User allowed actions This section covers all disassembly and assembly procedures that the
36. ces Detailed information is available from your GE Healthcare representative Disposal of electrical components Waste 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 equipment 36 UniFlux System Operating Instructions 28 9617 49 AC 2 Safety instructions 2 5 Declaration of Hazardous Substances DoHS 2 5 Declaration of Hazardous Substances DoHS Introduction The following product pollution control information is provided according to J T11364 2006 Marking for Control of Pollution caused by Electronic Information Products RHESJ T11364 2006 BTiS MRSREMANURER BRAM PRR Bal 7m aS Symbols used in pollution control label Tisai eS RE PT 2 HL ER Label Meaning amp This symbol indicates the product contains hazardous materials in ex cess of the limits established by the Chinese standard J T11363 2006 Requirements for Concentration Limits for Certain Hazardous Sub stances in Electronic Information Products The number in the symbol is the Environment friendly Use Period EFUP which indicates the period during which the toxic or hazardous substances or elements contained in electronic information products will not leak or mutate under normal operating conditions so that the use of such electronic information products
37. ctive caps on all electrical and optical connectors when not in use NOTICE When UniFlux System is filled with a storage solution the temper ature must be high enough to prevent freezing and low enough to prevent evaporation Short term storage This procedure works for storage duration up to one month Step Action 1 2 Perform cleaning as described in Section 7 2 Cleaning on page 133 If the system is configured for filter cassettes release the pressure of the hydraulic unit to approximately 50 bar Replace the pH electrode with the pH plug The electrode should be stored in a 1 1 mixture on 4 0 pH buffer and 1 M KNO Place the pH electrode in the pH electrode holder with the end submerged in storage solution Note Do not store the pH electrode in water only Fill the UniFlux System with 20 Ethanol up to approximately one quarter of maximum operating volume to prevent microbial growth Make sure that the filter cassettes are at least partially wetted during the storage Seal off the UniFlux System to prevent contamination caused by the surrounding environment 136 UniFlux System Operating Instructions 28 9617 49 AC 7 Maintenance 7 3 Storage Long term storage This procedure is applicable for storage duration longer than one month Step Action 1 Perform the actions described for Short term storage above with the difference that the filter cassettes first shall be repla
38. d by a properly skilled user Technician GE Healthcare recommends that a GE Healthcare ser vice engineer is assigned for this work Contact your GE Healthcare representative for more information on changing filter configurations if required Other components Other than described in this chapter the UniFlux is not designed to be disassembled or assembled by the user If the need for further disassembly should arise always contact your GE Healthcare representative for advice before attempting any actions not described by this document UniFlux System Operating Instructions 28 9617 49 AC 139 7 Maintenance 7 5 pH calibration 1 pH calibration Required equipment pH reference solution for low pH measuring point preferably pH 4 00 pH reference solution for high pH measuring point preferably pH 7 00 Clean cloth Clean water in spray bottle Calibration procedure 140 Step Action 1 2 Prepare two cups with the buffers representing the actual required pH range Place one of the cups in the cup holder Locate the pH probe in the holder with the end submerged in the buffer Note Attach the cap to the pH flow cell when to prevent foreign objects to enter the flow path Select System Calibrate in UNICORN System Control module Enter the pH value for the first buffer in the Reference value 1 field wait for the value to stabilize and click Read value 1 Remove the pH probe from the holder
39. dicates 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 equipment C The system complies with the requirements for electromagnetic compliance EMC in Australia and New Zealand Serial number System serial number Vear of manufacture Manufacturing year Max system pressure temperature Max system pressure at temperature Pneumatic supply Pneumatic supply pressure requirement Overall protection class Overall protection class ingress protection according to IEC 60529 This cover all components of the system except the electric cabinet Supply voltage Supply voltage Supply voltage motor Supply voltage motor Frequency Supply voltage frequency Max current consumption system Max current consumption system Max current consumption motor Max current consumption motor UniFlux System Operating Instructions 28 9617 49 AC 27 2 Safety instructions 2 2 Labels UniFlux 400 system label illustration UniFlux C Xz System p GE Healthcare Code no 28982307 GE Healthcare Serial no 2777 GE Healthcare Model no UniFlux 400 Year of manufacture 2011 Power supply system 1ph110 230VAC Power supply pump 3ph400 480VAC Frequency
40. ding the monitoring possibilites that the UNICORN user interface offers is available in the UNICORN manual package 126 UniFlux System Operating Instructions 28 9617 49 AC 6 Operation 6 1 Perform the run Ending Normal completion If no unexpected events occur during the run UNICORN enters END state at method completion without need for user interaction End before method has finished To end the run before the method has finished click on the End button at the top of the Control module window This will produce a confirmation dialog Click OK in the dialog to end the run or click Cancel to keep running In the dialog you can choose to save the partial results from the run so far If the run is part of a scouting run you are also given the choice of ending this If you do not the next run will start automatically UniFlux System Operating Instructions 28 9617 49 AC 127 6 Operation 6 2 Procedures after usage 6 2 Procedures after usage Cleaning the filters The filters can be cleaned in place if the method is set within the specifie ranges for solutions temperature and pressure The filters should be cleaned as described in Filters on page 134 UNICORN shut down Step Action 1 In UNICORN select File Quit or click the Close icon in the Manager Admin istration module 2 Confirm that you want to quit and select to leave system locked or unlocked 3 Exit Windows 4 Turn off the system power switch Not
41. e Since the system power will be shut down the system cannot be operated from another workstation before the system is powered up again regardless if it is locked or unlocked at shut down Preparing for storage Prepare the system for storage as described in Section 7 3 Storage on page 136 as required 128 UniFlux System Operating Instructions 28 9617 49 AC 7 Maintenance 7 Maintenance About this chapter This chapter provides required information to enable users and service personnel to clean maintain calibrate and store the UniFlux System In this chapter This chapter contains the following sections Section See page 7 1 User maintenance schedule 131 7 2 Cleaning 133 7 3 Storage 136 7 4 Disassembly and assembly 138 7 5 pH calibration 140 UniFlux System Operating Instructions 28 9617 49 AC 129 7 Maintenance Precautions WARNING Before attempting to perform any of the procedures described in this chapter you must read and understand all contents of the corresponding section s in the Chapter 2 Safety instructions on page 12 as listed below e General precautions on page 13 e Personal protection on page 15 e Power supply on page 19 e Maintenance on page 22 130 UniFlux System Operating Instructions 28 9617 49 AC 7 Maintenance 7 1 User maintenance schedule 7 1 User maintenance schedule Before each run or weekly This section covers maintenance actions requi
42. e and cassettes towards the flow manifold ensuring the holes in the cassettes and gasket are aligned with the holes in the flow distribution manifold Pressurization WARNING 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 UniFlux System Operating Instructions 28 9617 49 AC 117 5 Run preparations 5 2 Filter installation 5 2 4 Cassettes for UniFlux 30 120 and 400 Using the hydraulic pump pressurize the hydraulic cylinder according to the previously performed calculation 118 UniFlux System Operating Instructions 28 9617 49 AC 5 Run preparations 5 3 Priming and testing 5 3 Priming and testing Introduction Before using your UniFlux system and cassette to process product do the following 1 For UniFlux 30 120 and 400 Prime the lobe rotor pump 2 Perform a leakage test 3 Perform an air integrity test Priming the lobe rotor pump Priming is done for UniFlux 30 120 and 400 NOTICE Do not start the lobe rotor pump before it is primed with the intended media The CIP valve XV 062 is used in order to prime the lobe rotor pump Step Action i 2 Connect the suction side of the pump to the intended feed supply Make sure that waste ejected from the CIP valve outlet is collected Open the CIP valve j Run the pump while
43. e manufacturer s instruc tions 110 UniFlux System Operating Instructions 28 9617 49 AC 5 Run preparations 5 2 Filter installation 5 2 3 Cassettes for UniFlux 10 5 2 3 Cassettes for UniFlux 10 Preparations Loosen the retaining nuts and slide the back plate far enough away from the forward fixed distribution plate to accomodate the total amount of Kvick Lab cassettes to be used for the filtration run Installation Note Step This assembly instruction applies to GE Healthcare cassettes only For informa tion on installing other cassettes please contact your local GE Healthcare representative Action To install one cassette clean and wet a silicone gasket by rinsing it with deionized DI water or water for injection WF 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 and slide the cassette against the gasket 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 No gasket required UniFlux System Operating Instructions 28 9617 49 AC 111 5 Run preparations 5 2 Filter installation 5 2 3 Cassettes for UniFlux
44. em description 3 5 Hollow fiber HF configuration 3 5 3 UniFlux 120 HF configuration 2 Retentate collector manifold 3 Hollow fiber cartridges 2 Permeate hoses 2 Permeate collector manifold Feed extension pipes 2 Permeate drain hoses 2 Permeate drain collector manifold 2 Permeate drain valve XV 065 UniFlux System Operating Instructions 28 9617 49 AC 67 3 System description 3 6 Flow charts 3 6 Flow charts Overview This section contains flow diagrams and component descriptions for the UniFlux System In this section This section contains the following subsections Section See page 3 6 1 UniFlux 10 69 3 6 2 UniFlux 30 120 and 400 72 68 UniFlux System Operating Instructions 28 9617 49 AC 3 System description 3 6 Flow charts 3 6 1 UniFlux 10 3 6 1 UniFlux 10 ii PO E 121 CE TE Ty ADd TSO AX YT 14 2 7 Sd 69 UniFlux System Operating Instructions 28 9617 49 AC 3 System description 3 6 Flow charts 3 6 1 UniFlux 10 Tag System Function Note AE 121 Permeate pH meter Option AE 131 Permeate UV meter Option B1 Tank feed inlet B2 B3 B4 Quadruple inlets 1 2 and 3 Part of quadruple inlet op B5 Quadruple inlet 4 di CE 101 Permeate conductivity meter with an inte Option grated temperature meter TE 101 CV 32
45. en into operation make sure that all procedures in the following chapter and section have been performed Chapter 4 Installation on page 84 and actions before operation in Section 7 1 User maintenance schedule on page 131 Precautions WARNING Before attempting to perform any of the procedures described in this chapter you must read and understand all contents of the corresponding section s in the Chapter 2 Safety instructions on page 12 as listed below General precautions on page 13 Personal protection on page 15 System operation on page 20 NOTICE Only use chemicals that have been proven not to be harmful to the wetted parts of the unit Refer to Section 9 3 Chemical resistance on page 157 for more information 104 UniFlux System Operating Instructions 28 9617 49 AC 5 Run preparations In this chapter This chapter contains the following sections Section See page 5 1 Starting UniFlux 106 5 2 Filter installation 108 5 3 Priming and testing 119 UniFlux System Operating Instructions 28 9617 49 AC 105 5 Run preparations 5 1 Starting UniFlux eH Starting UniFlux Starting UniFlux Starting UNICORN 106 Step Action 1 2 Make sure that the air supply to the system is turned on Turn on the UPS if used Make sure that the cabinet doors are closed and locked Switch on power to UniFlux by turning the Mains power switch to the I position See
46. erials can be found in Section 9 2 Process wetted materials on page 156 UniFlux System Operating Instructions 28 9617 49 AC 41 3 System description 3 2 UniFlux systems layout 3 2 UniFlux systems layout In this section This section contains the following subsections Section See page 3 2 1 Illustrations of UniFlux 10 system 43 3 2 2 Illustrations of UniFlux 30 and 120 systems 48 3 2 3 Illustrations of UniFlux 400 system 52 42 UniFlux System Operating Instructions 28 9617 49 AC 3 System description 3 2 UniFlux systems layout 3 2 1 Illustrations of UniFlux 10 system 3 2 1 Illustrations of UniFlux 10 system UniFlux 10 Front view UniFlux System Operating Instructions 28 9617 49 AC 43 3 System description 3 2 UniFlux systems layout 3 2 1 Illustrations of UniFlux 10 system Part Function 1 Permeate line equipment mounting beam 2 Tank and peristaltic pumps mounting beam 3 Filter cassette cassette configuration shown 4 EMERGENCY STOP button 5 PAUSE button 6 RUN PAUSE indicator light 7 POWER indicator light 8 MAIN SWITCH power 9 ALARM indictaor light 10 UNICORN CONTINUE button 11 Caster without brake 2 pcs 12 Caster with brake 2 pcs 44 UniFlux System Operating Instructions 28 9617 49 AC 3 System description 3 2 UniFlux systems layout 3 2 1 Illustrations of UniFlux 10 system UniFlux 10 Rear view Part Function 10 Electric cabin
47. es installa tion 109 Hydraulic pressure 113 Installing and moving precau tions 16 International standards 8 L Labels Safety labels 31 System label 24 layout UniFlux 30 48 Layout UniFlux System 10 44 Leakage test 120 UniFlux System Operating Instructions 28 9617 49 AC M aintenance precautions 22 Maintenance schedule 131 Manufacturing information 8 Material compliance 41 Media supply 86 Method optimization 159 More information 159 N otes and tips 7 O Operating limits 155 Ordering information 159 P Peristaltic pump trouble shooting 147 Personal protection 15 pH trouble shooting 148 pH calibration required equip ment 140 Power failure 34 Power supply precautions 19 Prerequisites 5 Priming 119 Procedures after usage 128 Process component connec tions 93 102 R Recycling of hazardous sub stances 36 Reference information 149 Regulatory information 8 Restart after emergency 35 Rinsing after CIP 134 Safety labels 31 Safety notices 7 UniFlux System Operating Instructions 28 9617 49 AC Index Safety precautions 13 Service 159 Space and floor load 85 Spare parts 159 Starting UNICORN 106 Starting UniFlux 106 Storage Long term 137 Short term 136 System Description 40 System label 24 System operation precau tions 20 T Training 159 Transport in the crate 87 Transport unpacked 87 Trouble
48. et door locks 2 11 Filter and fan for cabinet cooling 12 External device connectors UniFlux System Operating Instructions 28 9617 49 AC 45 3 System description 3 2 UniFlux systems layout 3 2 1 Illustrations of UniFlux 10 system UniFlux 10 External connectors Connectors in front recess Part Function M 241 Mixer motor control AIT 131 UV connector EXTERNAL SIGNALS Connector for user process site signal communications PROFIBUS Profibus connector AIR INLET System air inlet UNICORN ETHERNET UNICORN Ethernet connector AIR EXHAUST System air exhaust ZS0 064 Hollow fiber drain valve control signal connector ZSO 081 Quadruple valve option control signal connector ZS0 082 Quadruple valve option control signal connector ZS0 083 Quadruple valve option control signal connector ZS0 084 Quadruple valve option control signal connector 46 UniFlux System Operating Instructions 28 9617 49 AC 3 System description 3 2 UniFlux systems layout 3 2 1 Illustrations of UniFlux 10 system Connectors on rear side Part Function P 202 Transfer pump control P 203 Permeate pump control AIT 131 UV signal UniFlux System Operating Instructions 28 9617 49 AC 47 3 System description 3 2 UniFlux systems layout 3 2 2 Illustrations of UniFlux 30 and 120 systems 3 2 2 Illustrations of UniFlux 30 and 120 systems UniFlux 30 Front view The illustra
49. f the system Refer to Section 9 3 Chemical resistance on page 157 for more information In this chapter 124 This chapter contains the following sections Section See page 6 1 Perform the run 125 6 2 Procedures after usage 128 UniFlux System Operating Instructions 28 9617 49 AC 6 Operation 6 1 Perform the run 6 1 Perform the run Precautions WARNING During operation all doors must always be closed and locked CAUTION Use ear protection whenever working close to the system in oper ation NOTICE Operator console O e Do not use the operator console to push or drag the system Donotlean on the console The console arm is only designed to support the weight of the operator console NOTICE Excessive temperatures may damage the equipment Do not run the system at higher temperatures than the specified maximum operation temperature as stated on the system label Final checks before start NOTICE Make sure that the actions listed below are completed before UniFlux is started UniFlux System Operating Instructions 28 9617 49 AC 125 6 Operation 6 1 Perform the run Check that the pump is filled with correct lubricant oil before start refer to the pump supplier documentation found in the document package for details Check that all inlets and outlets to the system are connected closed or in the state that they are supposed to be
50. fluid through the system that has a temperature above the normal working temperature Do not touch the system until you are sure that this can be done without risk and when all components in the system have reached the normal working temperature range gt BE CAUTION Use ear protection whenever working close to the system in oper ation Installing and moving WARNING UniFlux must be installed and prepared by GE Healthcare personnel or third party authorized by GE Healthcare gt gt WARNING To prevent bacterial growth UniFlux System may be partly filled with denatured Ethanol 18 CHOH Ethanol 2 C3H7OH Iso propanol and 80 H 0 water or 0 1 M NaOH Sodium Hydroxide at delivery Flush out the denatured Ethanol or Sodium Hydroxide before as sembling testing or integrating UniFlux into the intended process context 16 UniFlux System Operating Instructions 28 9617 49 AC 2 Safety instructions 2 1 Safety precautions WARNING Move transport crates Make sure that the forklift has capacity to safely lift the crate weight Make sure that the crate is properly balanced so that it will not accidentally tip when moved WARNING Heavy object Because of the significant weight of UniFlux System great care must be taken not to cause squeezing or crushing in juries during movement At least two but preferably three or more persons are recommended when moving the un
51. formation Any use of UNICORN is subject to GE Healthcare Standard Software End User License Agreement for Life Sciences Software Products A copy of this Standard Software End User License Agreement is available on request GE Healthcare Europe GmbH Munzinger Strasse 5 D 79111 Freiburg Germany GE Healthcare UK Limited 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 Japan Corporation Sanken Bldg 3 25 1 Hyakunincho Shinjuku ku Tokyo 169 0073 Japan 28 9617 49 AC 07 2013
52. gand testih nasses anI Ere EAREN 119 6 Operation eee 123 6 1 Perform the run nsss 125 6 2 Procedures after usage 128 1 MONteNAN CE eranan eiiiai ie te naii en 129 71 User maintengnc schedul 8usisss nine nn aitenenannentires 131 7 2 Cleaning 133 LS Storage 136 TA Disassembly and assembly sn nn nine 138 To PACAID A ennaa AEE PE 140 TU SO iiare EERE en 142 9 Reference information sesssesesesesesseseseseseseseseesesesesesneesesesseseseseonenseosesesesesesnesee 149 FT Sh CICAtIONS nn tennis a A RAR NNN 150 9 2 Process wetted materials oeeeeeeccssssssssssssssssssssssssssessssseeecceecesseseeceeneeeseceeceeceenceeceeceeceeccecceseeeeeeseees 156 9 3 Chemical resistance oe eeesseessssssssssssessssssssssssessssssssssssssssntuassssnsssntinssstunsintsusnsnsstesuntaunsecneseeeees 157 9 4 More information nee 159 MENON a E E E E E E EE E E E dems deud ukiaueeiaesianatvtdestee 160 4 UniFlux System Operating Instructions 28 9617 49 AC 1 Introduction 1 Introduction Scope of this document This manual is valid for all variants of standard UniFlux systems Your system is CE classified and the system configuration for your system is described in the General Specification and on the system label Prerequisites In order to operate UniFlux System safely and according to the intended use the following prerequisites must be met e You should be acquainted with the use of general bioprocessing equipment and with handling of biologica
53. he mains power supply cable is shielded OLFLEX of type 150CY Quattro 3G x 2 5 mm G with PE conductor X without PE conductor If the cable needs to be replaced due to damage the same type of cable or equivalent must be used WARNING Only personnel authorized by GE Healthcare may perform service installation and maintenance of components inside the UniFlux cabinet Wire colors and tags All instrument power cord wires must be connected to the fixed power supply wires with corresponding colors and tags Function USA EU Marking Neutral White Blue N Live Black Black or E brown Protective Green Green yellow PE GND ground earth e Live and neutral wire cross section area All live and neutral wiring must have a cross section area equal to or more than the specification in this table Mains current Mains and neutral conductor up to minimum area 10 A 1 mm 16 A 1 5 mm 25A 2 5 mm UniFlux System Operating Instructions 28 9617 49 AC 91 4 Installation 4 4 Power supply Protective earth wire cross section area All protective earth wiring must have a cross section area equal to or more than the specification in this table Leak current PE conductor minimum area gt 10mA 10 mm copper or 16 mm aluminium lt 10mA Equal to or larger than the L and N wire Ground fault breaker UniFlux System is not equipped with a general Ground
54. iFlux System Operating Instructions 28 9617 49 AC 1 Introduction 1 2 Regulatory information Standard Description Notes USP class VI EN Traceability for process wetted and 10204 2 1 pressure retaining polymers and elastomers EN 287 1 1418 EN Welding ISO 15607 15609 1 15614 1 5817 6520 3834 2 CE Conformity This product complies with the European directives listed in the table by fulfilling the corresponding harmonized standards A copy of the Declaration of Conformity is available on request Directive Title 2006 42 EC Machinery Directive MD 2004 108 EC Electromagnetic Compatibility EMC Directive CE Marking CE The CE marking and the corresponding Declaration of conformity is valid for the instrument when it is e used as a stand alone unit or e connected to other CE marked instruments or e connected to other products recommended or described in the user documentation and used in the same state as it was delivered from GE Healthcare except for alterations described in the user documentation Le UniFlux System Operating Instructions 28 9617 49 AC 1 Introduction 1 2 Regulatory information Regulatory compliance of connected equipment Any equipment connected to the UniFlux System should meet the safety requirements of EN 61010 1 IEC 61010 1 or relevant harmonized standards Within EU connected equipment must be CE marked 10 UniFlux System Operat
55. ies of UniFlux In this chapter This chapter contains the following sections Section See page 3 1 Overview 41 3 2 UniFlux systems layout 42 3 3 Automation 57 3 4 Cassette holders 59 3 5 Hollow fiber HF configuration 62 3 6 Flow charts 68 3 7 UNICORN control system 80 40 UniFlux System Operating Instructions 28 9617 49 AC 3 System description 3 1 Overview 3 1 Overview General These Operating Instructions cover the UniFlux 10 30 120 and 400 systems The UniFlux series is a line of cross flow filtration CFF systems that utilizes UNICORN software for full automation with data logging capabilities over the entire cross flow process UniFlux systems are intended for pilot through production scale biological separations The systems are configured to operate hollow fiber cartridges suited for microfiltration applications such as cell clarification harvesting or cassettes hollow fibers for ultrafil tration applications such as protein concentration and diafiltration in downstream unit operations Material compliance All plastic and polymer materials that come in contact with buffers and samples are compliant with USP Class VI Used materials are traceable back to their production batches You can find information about the design and materials used in your system in the System Documentation Chemical resistance is described in Section 9 3 Chemical resistance on page 157 A list of process wetted mat
56. ing Instructions 28 9617 49 AC 1 Introduction 1 3 Associated documentation 13 Associated documentation System specific documentation The most important documents in the document package with regard to technical aspects of UniFlux System are Document Abbreviation Purpose Contents Piping and Instrument P amp ID Schematic overview of the entire process Diagram flow all components and instruments and the control system General Specification GS Technical data for UniFlux System Assembly Drawing AD Physical layout Provides all dimensional data Bill of Material BOM Detailed specifications for process related components Software documentation Together with each system the following software documentation is supplied providing additional information that applies to UniFlux System independent of the specific configuration Document Purpose Contents UNICORN manual package e The manuals contain detailed instructions on how to administer UNICORN work with methods perform runs and evaluate results e The Online help contains dialog descriptions for UNICORN The Online help is accessed from the Help menu Third party component documentation Documentation for components produced by a third party are if existent also included in the document package UniFlux System Operating Instructions 28 9617 49 AC 11 2 Safety instructions 2 Safety instructions About this cha
57. ion UniFlux 1 phase 110 230 VAC 3 phase 200 VAC 3 phase 400 480 VAC 10 3A x 30 120 3A 7 5A 5A 400 3A 18A UniFlux System Operating Instructions 28 9617 49 AC 155 9 Reference information 9 2 Process wetted materials 9 2 Process wetted materials For a complete list of wetted materials refer to the Bill of Material in the product documentation kit 156 UniFlux System Operating Instructions 28 9617 49 AC 9 Reference information 9 3 Chemical resistance 9 3 Chemical resistance Introduction The table below gives allowed exposure concentrations and times for various chemicals that may be used in GE Healthcare BioProcess instruments in general Some of the chemicals listed may not be applicable for your instrument WARNING Flammable liquids UniFlux System is not approved to handle flammable liquids WARNING Some of the chemicals used with UniFlux System may be flammable under certain conditions Make sure to use chemicals only under conditions where they are not flammable Refer to local and or national classifications of flammable liquids List of chemicals allowed Chemical Concentration Max time cycle Maxacc expos Usage Acetic acid 25 3h 3000 h CIP Acetone 10 1h Unlimited UV cell test Citric acid pH 2 to 2 5 1h at temp lt 60 C 1000 h CIP Ethanol 20 12 months Unlimited Storage Ethanol Acetic 20 3h 3000 h CIP acid Guanidi
58. ion 3 7 UNICORN control system Warnings are generated to warn operating personnel that process parameters have exceeded preset high and or low limits and that the process method continues Signals If equipment is connected that has lower limits than the system the alarm levels must be set accordingly If an analog or digital signal passes the predetermined alarm level several things happen at once e An audible alarm is sounded according to user preference settings e The system is set to Pause mode e The valves and other components on the system are set to their default positions Test The alarm buzzer can be tested from the control system using the buzzer test function Alarms BuzzerTest To test a specific instrument alarm it is possible to lower the alarm limit for the instrument below the current process value Reset The alarm is reset through the control system by acknowledging the alarm message The process can be started again using the Continue function in UNICORN if the situation has been rectified More information All required manuals are available from the UNICORN user interface Select Help Manuals from the UNICORN top menu The UNICORN user reference manual for BioProcess is especially suited for usage with BioProcess systems UniFlux System Operating Instructions 28 9617 49 AC 83 4 Installation 4 Installation About this chapter This chapter provides required information to enable users
59. it WARNING Access to power switch and power cord The power switch must always be easy to access The power cord must always be easy to disconnect WARNING The UniFlux shall only be lifted using the lower part of the skid The UniFlux is not fitted with lifting eye bolts or other devices for hoist lift CAUTION The wheels of UniFlux should be locked during normal use The wheels should be unlocked only when moving the unit CAUTION Make sure that all tubing hoses and cables are placed so that the risk for tripping accidents is minimized CAUTION UniFlux System is designed for indoor use only gt gt D D gt UniFlux System Operating Instructions 28 9617 49 AC 17 2 Safety instructions 2 1 Safety precautions CAUTION Do not use UniFlux System in a dusty atmosphere or close to spraying water CAUTION Make sure that correct air pressure is always maintained Too high or too low air pressure may be hazardous and may cause erroneous results and leakage CAUTION Before moving the UniFlux System the following must be done 1 Empty the UniFlux 2 Shut down the UniFlux and disconnect the power cord 3 Disconnect the air supply lines 4 Disconnect all process lines CAUTION Make sure that the common waste outlet is e Never exposed to back pressure e Connected to piping with at least the same diameter as the common waste outlet piping
60. ject to LOCK OUT TAG OUT 14 UniFlux System Operating Instructions 28 9617 49 AC 2 Safety instructions 2 1 Safety precautions Flammable liquids and explosive environment WARNING Flammable liquids UniFlux System is not approved to handle flammable liquids WARNING Explosive environment UniFlux System is not approved for work in a potentially explosive atmosphere in areas classified as Zone 0 to Zone 2 according to IEC 60079 10 2002 UniFlux System does not fulfill the requirements of the ATEX Directive Personal protection WARNING When using hazardous chemicals and biological agents take all suitable protective measures such as wearing protective glasses and gloves resistant to the substances used Follow local and or national regulations for safe operation and maintenance of UniFlux WARNING Personal Protective Equipment PPE Whenever packing unpack ing transporting or moving the system wear protective foot wear preferably with steel lining WARNING High pressure UniFlux System operates under high pressure Wear protective glasses and other required Personal Protective Equip ment PPE at all times UniFlux System Operating Instructions 28 9617 49 AC 15 2 Safety instructions 2 1 Safety precautions CAUTION Do not insert your fingers or other objects into fans or other moving parts CAUTION Do not touch the system while pumping
61. l materials UniFlux System must be installed according to the instructions in the Installation chapter of this manual About this chapter This chapter contains important user information description of safety notices regulatory information a general description of UniFlux System and its intended use and a list of associated documentation In this chapter This chapter contains the following sections Section See page 1 1 Important user information 6 1 2 Regulatory information 8 1 3 Associated documentation 11 UniFlux System Operating Instructions 28 9617 49 AC 5 1 Introduction 1 1 Important user information 1 1 Important user information Read this before using UniFlux System All users must read the Safety chapter of the Operating Instructions before installing using or maintaining UniFlux System Do not operate UniFlux System in any other way than described in the user documentation If you do you may be exposed to hazards that can lead to personal injury and you may cause damage to the equipment Intended use of UniFlux System UniFlux systems are intended for pilot through production scale biological separations The systems are configured to operate hollow fiber cartridges suited for microfiltration applications such as cell clarification harvesting or cassettes hollow fibers for ultrafil tration applications such as protein concentration and diafiltration in downstream unit operation
62. line or vessel at this point could result in the release of potentially haz ardous process or cleaning fluid and cause bodily harm When recovering from a power failure or emergency shutdown make sure all lines and vessels are depressurized before opening Emergency stop button and main power switch UniFlux 10 32 UniFlux System Operating Instructions 28 9617 49 AC 2 Safety instructions 2 3 Emergency procedures UniFlux 30 and 120 UniFlux 400 Part Function A EMERGENCY STOP button B MAIN SWITCH power UniFlux System Operating Instructions 28 9617 49 AC 33 2 Safety instructions 2 3 Emergency procedures Emergency shutdown Step Action Result 1 Press the EMERGENCY STOP amp All motors and externally moving button A components stop immediately e The built in computer and other components remain powered e No data is lost 2 If required also switch off the e The entire system including the mains power supply B discon computer becomes powerless nect the power cord or switch off the fixed power supply cir cuit breaker Data and run status may become lost Power failure The system power is lost if the MAIN SWITCH on the cabinet is turned off the mains cable disconnected or the power supply is lost All pumps stop if the electrical power to the system is lost All valves will immediately revert to default positions Any data that has not been saved at that
63. lve PCV 341 e Retentate valve XV 051 Open the Permeate valve XV 031 to Permeate UniFlux System Operating Instructions 28 9617 49 AC 5 Run preparations 5 3 Priming and testing Step Action 4 NOTICE Never let the test pressure exceed the maximum filter pressure as stated by the filter manufacturer If the fil ter is subjected to pressures exceeding this value un recoverable damage may occur Apply air pressure to the filter 1 Set the Integrity_Test_Pressure to the pressure specified by the filter manufacturer 2 Open the Integrity test valve XV 063 Note If the pressure as indicated by PT 113 takes more than 15 minutes to build up and stabilize this indicates that there is a leak somewhere in the system Identify and seal all leakages before proceeding with the test 5 When the specified test pressure has been reached 1 Wait for a stable air flow reading from the flow meter FT 143 2 Compare this value to the integrity air flow value specified by the filter manufacturer 6 Terminate the air integrity test 1 Set Integrity_Test_Pressure to zero 2 Close the integrity test valve XV 063 3 Open the retentate valve XV 051 4 Open the Retentate drain valve XV 052 7 Open the retentate pressure valve PCV 341 in small increments to protect the filter When the PT 113 pressure indicator reads zero the system is depressurized and the test procedure completed Unexpected flowrate If the flow deviates fr
64. mp Protection class Protection class ingress protection according to IEC 60529 This covers the electric cabinet only Ambient temperature range Ambient temperature range Process temperature range Process temperature range Max process pressure Max process pressure UniFlux System Operating Instructions 28 9617 49 AC 29 2 Safety instructions 2 2 Labels Label text Description Pneumatic supply min Pneumatic supply min max max Safety labels The table below describes the various safety labels that may be found on UniFlux Symbol text Description Warning Read the user documentation before using the system Do not open any covers or replace parts unless specifically stated in the user documentation Warning High Voltage Always make sure that the system is disconnected from electric power before opening the cabinet doors or disconnecting any electric device WARNING Max operating pressure as stated on the label EMERGENCY STOP label yellow with black text emergency stop button is red Refer to Section 2 3 Emergency procedures on page 32 for further information regarding the emergency stop WARNING High voltage inside cabinet Authorized personnel only For continued protection against fire only replace fuses with the same type and rating IMPORTANT Before service maintenance or return to GE Healthcare clean the equipment and accom
65. n existing method to meet your run objectives 2 Start the run using the method you created 3 Monitor the run s progress using the System Control module All the data about your runis displayed in the System Control module You have a choice of four different panes that can be open one at a time or all at once in sep arate parts of the window 4 After completing the run you can display the data in a detailed report using extensive tools provided by the UNICORN Evaluation Module UniFlux System Operating Instructions 28 9617 49 AC 81 3 System description 3 7 UNICORN control system Cabinet controls and indicators Typical image showing cabinet controls and indicators for UniFlux 30 and 120 systems Label PAUSE Type Button Color Red Function Sets UNICORN in PAUSE mode equal the PAUSE button in the UNICORN computer user interface CONTINUE Button Black Sets UNICORN in RUN mode equal the CONTINUE button in the UNICORN computer user interface POWER Indicator Green Power is on Flashing UNICORN starting up Steady UNICORN ready RUN PAUSE Indicator Yellow UNICORN method is active Flashing UNICORN in state pause Steady UNICORN in state run ALARM 82 Indicator Red System alarm Check UNICORN for detailed in formation UniFlux System Operating Instructions 28 9617 49 AC Warnings Alarms 3 System descript
66. n extension e 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 cylinder is pressurized Note Step This assembly instruction applies to GE Healthcare cassettes only For information on installing other cassettes please contact your local GE Healthcare representative Action To install one cassette clean and wet a silicone gasket by rinsing it with DI water or water for injection WF 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 UniFlux System Operating Instructions 28 9617 49 AC 5 Run preparations 5 2 Filter installation 5 2 4 Cassettes for UniFlux 30 120 and 400 Step Action 3 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 4 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 Gasket No gasket required 5 After you insert all the cassettes into the holder lower and lock the guide rod into its original position 6 Slide the backing plat
67. n page 13 e Personal protection on page 15 e Power supply on page 19 e Maintenance on page 22 Corrective action Make sure the system is switched on Check communication cable and connec tors Reboot PC shut down Windows switch off the system power switch wait at least 5 sec restart system System Component Possible cause Computer No system found when starting up UNICORN 142 UniFlux System Operating Instructions 28 9617 49 AC Component Computer Possible cause No connection be tween the system and UNICORN 8 Troubleshooting Corrective action 1 Open a System Control module 2 Select the System Connect menu command or e Click the Connect to system toolbar icon Result The System Connect dialog box opens 3 Select the system you want to connect 4 Click OK Power Power failure during a run Check circuit breaker both in system and for external supply as applicable Compressed air Compressed air fail ure during a run The alarm No air supply to the system is dis played and the sys tem enters PAUSE mode Insufficient air pressure caused by for in stance malfunctioning air supply equipment or a leaking air hose a Rectify the air supply problem b Restart the run by pressing the PAUSE CONTINUE button Valves Alarm Valve error is displayed If the Valve error alarm is accompanied by
68. ne 6M 5h 5000 h CIP hydrochloride Hydrochloric 0 1 M at pH 1 1h 1000 h CIP acid Phosphoricacid 5 Overnight Unlimited For SS passiva tion UniFlux System Operating Instructions 28 9617 49 AC 157 9 Reference information 9 3 Chemical resistance Chemical Concentration Max time cycle Maxacc expos Usage 2 propanol 30 th 1000 h CIP Sodium chloride Oto 3 M 3h 3000 h Purification CIP Sodium hydrox 1M at pH 14 24h attemp lt 40 C 1000 days CIP ide 0 5 M 3 h at temp lt 60 C 3000 h CIP 0 01 M at pH 12 12 months Unlimited Storage Sodium 300 ppm 3 hat temp lt 60 C 3000 h CIP hypochlorite Sodium 1M 20 3h 3000 h CIP hydroxide Ethanol Urea 8M 5h 5000 h Purification CIP Cleaning 1 to 6 Steris CIP 3 h at temp lt 60 C 3000 h CIP solutions 1007 0 5 Henkel P3 11 0 2 Micro 0 2 Terg A Zyme 0 1 Tween 80 158 UniFlux System Operating Instructions 28 9617 49 AC 9 Reference information 94 More information Spare parts and accessories Additional information regarding spare parts and acccessories can be found in the system documentation 9 4 More information Your local GE Healthcare representative will also be able to suggest recommended spare parts and accessories Remaining aspects Regarding Please contact your local GE Healthcare representative for advice Training Service Method optimization Ordering information
69. npacking 4 3 Unpacking Tools required e Suitable lifting device fork lift or similar Refer to Section 9 1 Specifications on page 150 for dimensions and weight to be handled e 13 mm wrench or ratchet with 13 mm socket e Electrical screwdriver with Phillips no 2 bit e Knife e Lever enclosed in crate Visual inspection Precautions 88 Check e that all equipment is enclosed in the crate according to the packing list e the equipment for any apparent damage and document carefully if found If any equipment is missing or damages are found contact your GE Healthcare repre sentative immediately WARNING To prevent bacterial growth UniFlux System may be partly filled with denatured Ethanol 18 C H OH Ethanol 2 C3H7OH Iso propanol and 80 H 0 water or 0 1 M NaOH Sodium Hydroxide at delivery Flush out the denatured Ethanol or Sodium Hydroxide before as sembling testing or integrating UniFlux into the intended process context UniFlux System Operating Instructions 28 9617 49 AC 4 Installation 4 3 Unpacking General unpacking instructions Note Refer to the unpacking instructions attached to the outside of the crate when unpacking the crate In absence of the unpacking instructions follow the general unpacking instructions below Step Action 1 Remove the front side and back panels by loosening the bolts 2 Remove the ramp accessories user console and document
70. o System nn saeco 80 4 WAS UNNI sinus hsnaianeinuimenmenmin ses 84 4 1 Site regure menis essnanoi nerna iiien E R R 85 4 2 TRONS POR ernaar E AEN NO aS 87 43 WUTC IA ps esacscassscsssccesctesscasassagsesnsioc ysvassbessbSbbcedcc vans uss A TAA AAI 88 44 Power supply w 90 4 5 SOU EE TE ETE E TAE EEE E na EA 93 AS EOCKWNEEIS nd a ne 94 4 5 2 Operator console for UniFlux 30 120 and 400 95 4 5 3 Stand alone computer for UniFlux 10 98 4 5 4 Connect compressed air supply A 99 4 5 5 Setup of control system and Network eeeeessssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssnsset 100 4 5 6 Filter setup feed pump and CFF filter protection u 101 4 5 7 Process component connections for UniFlux 30 120 and 400 o eeesssssssssssssssssssccsssssees 102 UniFlux System Operating Instructions 28 9617 49 AC 3 Table of Contents 5 RUM PPE PONAtlonS visssscsccessstssdeessbisasssteriasbadceasieatsashaaucaaestdus idvesestondeesstcoassaaevisseoaveed 104 SL Starting aE ss sce nn tes ssssausecc sevscezeassuibontso eoscnctezspossuaiisn sos a E RRR 106 52 Fiterinstalati Misean oii nanana n i ENE N ANER 108 5 2 1 Installing hollow fiber HF cartridges sssssssssssssssscssssssssssssssssssssssssssssssssssussesssssecsssssssssssseesssseees 109 5 2 2 General preparation of the cassettes 110 52 3 Cassettes for UniFl X TO ennemies ion 111 5 2 4 Cassettes for UNIFIUX 30 120 and 400 nee 113 523 Pimn
71. o the console as shown in the picture NOTICE The protective screw cap D should always be in place when the USB connector is not in use Press the Rotation Stop on to the console arm as shown in the picture and push it into place around the rotation center UniFlux System Operating Instructions 28 9617 49 AC 97 4 Installation 4 5 Setup 4 5 3 Stand alone computer for UniFlux 10 4 5 3 Stand alone computer for UniFlux 10 Connect a stand alone computer to UniFlux 10 Connect a stand alone computer with UNICORN to UniFlux by plugging in an Ethernet cable to the UNICORN ETHERNET connector illustrated below Note When installing a stand alone computer ensure that it is installed with appro priate precautions for the intended environment that might expose the com puter to liquids and moisture 98 UniFlux System Operating Instructions 28 9617 49 AC 4 Installation 4 5 Setup 4 5 4 Connect compressed air supply 4 54 Connect compressed air supply Locate your air inlet and air exhaust and connect to the compressed air supply For requirements on air supply refer to Section 4 1 Site requirements on page 85 UniFlux System Operating Instructions 28 9617 49 AC 99 4 Installation 4 5 Setup 4 5 5 Setup of control system and network 4 5 5 Setup of control system and network Introduction This section describes the steps that need to be performed to set up the UNICORN control system and net
72. om the characteristic flow during an air integrity test the following conclusions can be drawn UniFlux System Operating Instructions 28 9617 49 AC 121 5 Run preparations 5 3 Priming and testing 122 If The air nitrogen flow is signifi cantly lower than the character istic flow Then The filter is clogged and needs to be cleaned The air nitrogen flow is signifi cantly higher than the charac teristic flow The are pores in the membranes or fibers that have become larger than the nominal pore size or The fibers or membranes are broken The filter will allow larger particles than the nomi nal cut off size to pass to the permeate and must hence not be used for processing any more UniFlux System Operating Instructions 28 9617 49 AC 6 Operation 6 Operation About this chapter This chapter provides the information required to safely operate the UniFlux System Precautions WARNING Before attempting to perform any of the procedures described in this chapter you must read and understand all contents of the corresponding section s in the Chapter 2 Safety instructions on page 12 as listed below e General precautions on page 13 e Personal protection on page 15 e System operation on page 20 UniFlux System Operating Instructions 28 9617 49 AC 123 6 Operation NOTICE Only use chemicals that have been proven not to be harmful to the wetted parts o
73. on for each major part if substance exceeds limit Value Meaning O Indicates that this toxic or hazardous substance contained in all of the homogeneous materials for this part is below the limit requirement in J T11363 2006 RTS A SMREBZAEM ASRS NSB SJ T11363 2006 tr EAL TED PRS RAT Indicates that this toxic or hazardous substance contained in at least one of the homogeneous materials used for this part is above the limit requirement in SJ T11363 2006 e Data listed in the table represents best information available at the time of publication RRBASASMRASLSEBAEHR YRMAPhSssew SJ T11363 2006 Fr AN E H RER ERIRE RP AY PT BERR SRE fs 38 UniFlux System Operating Instructions 28 9617 49 AC 2 Safety instructions 2 5 Declaration of Hazardous Substances DoHS List of hazardous substances Component Hazardous substance name ABASYARLA BES Bn Pb Hg Cd Cr6 PBB PBDE R KR 7 7A OME BRA SRAM UniFlux 10 1 x o o o o el UniFlux 30 1 x o o o o 0 UniFlux 120 1 x o o o o 0 UniFlux 400 1 x o o lo o el 1 The product has not been tested as per the Chinese standard SJ T11363 2006 Requirements for Concentration Limits for Certain Hazardous Substances in Electronic Information Product UniFlux System Operating Instructions 28 9617 49 AC 39 3 System description 3 System description About this chapter This chapter provides an overview of the technical propert
74. p inlet from buffer Part of transfer pump op MES Transfer pump outlet to tank ou P1 Retentate outlet P2 Permeate outlet direct or by pump P3 Permeate recycle P4 Feed drain P5 CIP valve P6 Retentate drain P7 Permeate drain UniFlux System Operating Instructions 28 9617 49 AC 77 3 System description 3 6 Flow charts 3 6 2 UniFlux 30 120 and 400 Tag System Function Note P8 HF filter cartridge drain HF configuration only P 201 Feed pump P 202 Feed transfer pump Option P 203 Transfer and permeate pump Option PCV 341 Retentate pressure control PS 342 Filter integrity test pressure sensor PY 342 Filter integrity test pressure regulator PT 111 Feed pump outlet pressure meter PT 112 Feed pump outlet pressure meter PT 113 Retentate pressure meter PT 114 Permeate pressure meter TANK Not included in system Feed tank available as op tion T 342 Pressure regulator pulse damper TE 101 Permeate temperature meter Option Included in cond CE 101 XV 001 Pump feed valve XV 031 Permeate outlet valve XV 032 Permeate recycle valve XV 051 Retentate outlet valve XV 052 Retentate drain valve XV 061 Feed drain XV 062 Feed pressure outlet CIP valve XV 063 Filter integrity test valve XV 064 Permeate drain valve XV 065 HF filter cartridge drain valve HF configuration only 78 UniFlux System Operating Instructions 28 9
75. pany it with a decontamination statement specifying substances with which it has been in contact during use and the method of cleaning 30 UniFlux System Operating Instructions 28 9617 49 AC 2 Safety instructions 2 2 Labels Symbol text Description CAUTION Pressure control valve shall be set to 5 5 CAUTION 7 bar g for instrument air supply Pressure control valve shall be set to 5 5 7 barg for instrument air supply Warning Before connecting the system make sure that the system setting corresponds with the power supply Disconnect switch and branch circuit to be provided by installer NOTE Different power supply cables in CE UL systems CE UL P 1 Brown N 2 White Protective earth Yellow green Green Use ear protection whenever working close to the sys tem in operation Hot surface Risk of burning injuries UniFlux System Operating Instructions 28 9617 49 AC 34 2 Safety instructions 2 3 Emergency procedures 2 3 Emergency procedures Introduction This section describes how to do an emergency shutdown of UniFlux System and the result in the event of power failure Precautions WARNING Emergency stop Pressing the EMERGENCY STOP will not shut off mains power to the cabinet WARNING Power failure During a power failure or if the EMERGENCY STOP button is pressed UniFlux may remain pressurized Opening a
76. perating Instructions 28 9617 49 AC 19 2 Safety instructions 2 1 Safety precautions System operation WARNING Safe distance Always maintain a safe distance from UniFlux during drainage or other activities that may involve splashing WARNING During operation all doors must always be closed and locked WARNING Before operation all process connections and the piping system must be tested for leakage at maximum pressure for continued protection against injury risks due to fluid jets burst pipes or poten tially explosive atmosphere WARNING Operating limits Never exceed the operating limits stated in this document and on the system label Operation of UniFlux outside these limits may damage equipment and bodily harm or death may occur WARNING Power failure During a power failure or if the EMERGENCY STOP button is pressed UniFlux may remain pressurized Opening a line or vessel at this point could result in the release of potentially haz ardous process or cleaning fluid and cause bodily harm When recovering from a power failure or emergency shutdown make sure all lines and vessels are depressurized before opening WARNING Shutdown does not automatically result in depressurizing of the piping system 20 UniFlux System Operating Instructions 28 9617 49 AC 2 Safety instructions 2 1 Safety precautions WARNING Emergency stop Pressing the EMERGENCY STOP
77. pter This chapter describes safety precautions and emergency shutdown procedures for UniFlux The labels on the system and information regarding recycling are also described Important WARNING Before installing operating or maintaining UniFlux System all users must read and understand the entire contents of this chapter to become aware of the hazards involved Failure to do this may cause human injury or death or damage to the equipment In this chapter This chapter contains the following sections Section See page 2 1 Safety precautions 13 2 2 Labels 24 2 3 Emergency procedures 32 2 4 Recycling information 36 2 5 Declaration of Hazardous Substances DoHS 37 12 UniFlux System Operating Instructions 28 9617 49 AC 2 Safety instructions 2 1 Safety precautions 2 1 Safety precautions Introduction The safety precautions in this section are grouped in the following categories General precautions on page 13 Flammable liquids and explosive environment on page 15 Personal protection on page 15 Installing and moving on page 16 Power supply on page 19 System operation on page 20 Maintenance on page 22 Note Some of the safety precautions in this chapter may concern components or situations described in other UniFlux product documents General precautions WARNING Perform a risk assessment for any risks due to the process or pro cess environment Evaluate the effects the
78. pump option PROFIBUS Connection to UniFlux tank Profibus control or other con trolled external equipment CAN BUS TANK Connection to UniFlux tank CAN bus control 50 UniFlux System Operating Instructions 28 9617 49 AC 3 System description 3 2 UniFlux systems layout 3 2 2 Illustrations of UniFlux 30 and 120 systems Top connectors BEAL HI T T h T ae et Connector Function UNICORN ETHERNET Unicorn Ethernet connection LTS 166 Connection to external tank digital level sensors AIR EXHAUST System air exhaust AIR INLET System air inlet EXTERNAL SIGNALS Connection to process site signals UniFlux System Operating Instructions 28 9617 49 AC 51 3 System description 3 2 UniFlux systems layout 3 2 3 Illustrations of UniFlux 400 system 3 23 Illustrations of UniFlux 400 system UniFlux 400 Front view Part Function L Connectors on top 2 Filter skid connector pipes 3 Permeate outlet connection 4 Permeate recycle connection 5 Emergency stop button 6 User interface console 7 Skid maneouvering handle 8 Feed drain outlet connection 9 Feed inlet connection 52 UniFlux System Operating Instructions 28 9617 49 AC 3 System description 3 2 UniFlux systems layout 3 2 3 Illustrations of UniFlux 400 system Part Function 10 Retentate outlet connection TFI Retentate drain outlet connection 12 Filter drain
79. r UniFlux 30 120 and 400 Step Action 2 Make sure that UNICORN is started and the Yellow system status light RUN PAUSE is on and steady The hydraulic unit is switched on The key on the hydraulic unit front side is switched to ON and the white POW ER light is on 114 UniFlux System Operating Instructions 28 9617 49 AC 5 Run preparations 5 2 Filter installation 5 2 4 Cassettes for UniFlux 30 120 and 400 Step Action 3 Move the filter pressurization cylinder backwards by simultaneously pressing the ENABLE and DEPRESSURIZE buttons on the hydraulic unit 4 Remove any hydraulic piston extensions attached to the hydraulic piston by unscrewing the extensions 5 Slide the cassette holder pressurization back plate backwards by hand until it meets the hydraulic cylinder piston UniFlux System Operating Instructions 28 9617 49 AC 115 5 Run preparations 5 2 Filter installation 5 2 4 Cassettes for UniFlux 30 120 and 400 Installation 116 Step Action 6 Slide back the sleeve on the movable guide rod and lift the guide rod up Install one or both hydraulic piston extensions by screwing them into the end of the hydraulic piston using this schedule as a guide e 1to4 cassettes use the 2 inch and 4 inch extensions e 5to10 cassettes or 1 to 2 block cassettes block cassettes are the 2 33 m 25 ft2 use the 4 inch extension e 10to 15 cassettes or three block cassettes do not use a
80. r switch to the switch is inthe ON position OFF position The pump does not reach the de Theregulatoris Adjust the regulator so that sired pressure set below the the desired pressure can be desired pres reached sure Low oil level in Check the oil level and add the reservoir oil if the level is too low 146 UniFlux System Operating Instructions 28 9617 49 AC Peristaltic pump Component Peristaltic pump Problem Displayed error message P202 not healthy or P203 not healthy Possible cause The affected peristaltic pump is either disconnected faulty set up or not working 8 Troubleshooting Corrective action 1 Check all cables and connectors from the pump to the electric cabinet Run instruction P202_clear faults or P203_clear faults Contact your local GE Healthcare representa tive Little or no flow Broken or dam aged hose Check the pump hose Contact your local GE Healthcare representa tive UniFlux System Operating Instructions 28 9617 49 AC 147 8 Troubleshooting Conductivity pH curve 148 Error symptom Baseline drift or noisy signal Possible cause Leaking tube connec tions Corrective action Tighten the clamps If neces sary replace the clamps Bad pump See separate manual Dirty conductivity cell Clean the conductivity cell re fer to Section 7 2 Cleaning on page
81. red for each run or weekly depending on which happens first Component Action UV monitor Set auto zero by using the function in UNICORN pH monitor Clean calibrate and store the pH electrode adequately refer to Section 7 5 pH calibration on page 140 Alarm buzzer Check the function Alarms BuzzerTest Complete system Clean sanitize the system according to the procedure described in Cleaning in place CIP on page 133 Protective earth Make sure that the protective earth wiring is not disconnected or damaged Annually or as needed This section covers maintenance actions required annually or as needed Component Action Complete system A preventive maintenance test procedure on all instruments sensors pumps and valves should be performed annually by trained and certified personnel Contact your local GE Healthcare representative Replace all gaskets o rings and valve diaphragms Complete stainless steel system Inspect stainless steel systems for rust If needed passivate the steel by recirculating a solution of 5 phosphoric acid in the system overnight at room temperature and then rinse with purified water until the pH of the outlet liquid is neutral Pump Replace all wear and tear parts Replace drive element lubricant Refer to the System Documentation for details UV monitor Replace the UV lamp when the intensity is low or when a lamp failure is indicated in
82. referably cleaned together as one unit The UniFlux system feed outlet P5 CIP shall be connected to the tank CIP ball inlet TB4 CIP INLET using the provided hose Ensure proper position of the ball using the positioning marks UniFlux System Operating Instructions 28 9617 49 AC 133 7 Maintenance 7 2 Cleaning Filters 134 Refer to UniFlux Feed Tank Operating Instructions for information on how to clean the Tank CIP methods in UNICORN It is recommended that specific CIP protocols are developed to standardize the CIP procedure in a repeatable and reliable manner depending on the applied user application A routine cleaning method can be set up in UNICORN for regular cleaning and sanitizing of the system and connected components Refer to UNICORN manual package for comprehensive instructions on how to create a sanitizing CIP method in UNICORN Extended cleaning performance If the UniFlux System has been heavily contaminated and the normal CIP procedure is not sufficient cleaning performance can be improved by e Extending the total CIP time period e Changing to an alternative CIP agent e Filling the UniFlux System and attached components with cleaning agent to redissolve contaminants for an extended time period before applying CIP Rinsing After completed CIP rinse the UniFlux System interior and all cleaned components thoroughly with water of desired quality for example Water For Injection WF to remove all
83. rol signal operator console 8 Power supply operator console Function Power supply hydraulic unit HC 291 Power supply tank UniFlux System Operating Instructions 28 9617 49 AC 3 System description 3 3 Automation 3 3 Automation Control system The UniFlux System is fully automated by means of the UNICORN control system Once the required methods are created and approved a non expert user can safely operate the system Refer to Section 3 7 UNICORN control system on page 80 for information on the UNICORN control system Computer for UniFlux 30 120 and 400 The optional computer is built into the cabinet and fully protected from the outside envi ronment If the computer option is not ordered stand alone computers are used instead The computer automatically starts when the system power is turned on no specific starting procedure is required for the computer For computer specifications refer to the system documentation kit UniFlux System Operating Instructions 28 9617 49 AC 57 3 System description 3 3 Automation User console for UniFlux 30 120 and 400 The display and input devices are ergonomically designed for use in a clean production environment Communications All communication with controlled components mounted outside the cabinet uses the Profibus industry standard communication protocol and hardware 58 UniFlux System Operating Instructions 28 9617 49 AC
84. s UniFlux is not suitable for operation in a potentially explosive atmosphere or for handling flammable liquids UniFlux System shall not be used in any clinical procedures or for diagnostic purposes WARNING Do not operate UniFlux System in any other way than described in the Operating Instructions 6 UniFlux System Operating Instructions 28 9617 49 AC Safety notices 1 Introduction 1 1 Important user information This user documentation contains WARNINGS CAUTIONS and NOTICES concerning the safe use of the product See definitions below Warnings WARNING WARNING indicates a hazardous situation which if not avoided could result in death or serious injury It is important not to proceed until all stated conditions are met and clearly understood Cautions CAUTION CAUTION indicates a hazardous situation which if not avoided could result in minor or moderate injury It is important not to proceed until all stated conditions are met and clearly understood Notices NOTICE NOTICE indicates instructions that must be followed to avoid damage to the product or other equipment Notes and tips Note A note is used to indicate information that is important for trouble free and optimal use of the product Tip A tip contains useful information that can improve or optimize your procedures Typographical conventions Software items are identified in the text by bold it
85. shooting 142 Typographical conventions 7 U UNICORN Alarms 83 Control system 80 Documentation 11 Overview 80 Prerequisite 80 Software modules 81 System networks 80 Warnings 83 Work flow 81 Unpacking procedure 89 Unpacking tools required 88 Unpacking visual inspec tion 88 Use intended 41 User allowed actions 138 User information important 6 W Wetted materials 156 161 For local office contact information visit www gelifesciences com contact GE Healthcare Bio Sciences AB Bj rkgatan 30 751 84 Uppsala Sweden www gelifesciences com filtration imagination at work GE imagination at work and GE monogram are trademarks of General Electric Company BioProcess Kvick Flow Kvick Lab ULTA UNICORN and UniFlux are trademarks of GE Healthcare companies CIP 100 is a trademark of Steris Corporation Microsoft and Windows are trademarks of Microsoft Corporation P3 is a trademark of Henkel Profibus is a trademark of PROFIBUS Nutzerorganisation eV Terg A Zyme is a trademark of Alconox Inc Tween is a trademark of Uniqema Americas LLC 2009 2013 General Electric Company All rights reserved First published Sep 2009 All goods and services are sold subject to the terms and conditions of sale of the company within GE Healthcare which supplies them A copy of these terms and conditions is available on request Contact your local GE Healthcare repre sentative for the most current in
86. tand the specific configuration that applies to your UniFlux System please refer to the system documentation supplied with the instrument In this chapter This chapter contains the following sections Section See page 9 1 Specifications 150 9 2 Process wetted materials 156 9 3 Chemical resistance 157 9 4 More information 159 UniFlux System Operating Instructions 28 9617 49 AC 149 9 Reference information 9 1 Specifications 9 1 Specifications Dimensions Note e All dimensions are presented in cm where nothing else is noted e Dimensions and weights are valid for standard systems e Dimensions may vary for individual units by 1 cm e Weights may vary for individual units by 10 kg UniFlux 10 150 UniFlux System Operating Instructions 28 9617 49 AC 9 1 Specifications 9 Reference information UniFlux 30 F YST a LE AT ET HR ee H 21 fares 2 makes sos om gomme a de 208 UniFlux 120 151 UniFlux System Operating Instructions 28 9617 49 AC 9 Reference information 9 1 Specifications UniFlux 400 se EDINI 152 UniFlux System Operating Instructions 28 9617 49 AC 9 Reference information 9 1 Specifications UniFlux 400 HF configuration UniFlux System Operating Instructions 28 9617 49 AC 153 9 Reference information 9 1 Specifications Technical specifications
87. te outlet valve XV 032 Permeate recycle valve XV 051 Retentate outlet valve XV 052 Retentate drain valve XV 061 Feed drain XV 062 Filter integrity test valve XV 063 Permeate drain valve XV 064 HF filter cartridge drain valve HF configuration only XV 081 082 083 084 Quadruple inlet 1 2 3 and 4 valves Part of quadruple inlet op tion XY 342 Filter integrity test valve UniFlux System Operating Instructions 28 9617 49 AC 71 3 System description 3 6 Flow charts 3 6 2 UniFlux 30 120 and 400 3 6 2 UniFlux 30 120 and 400 External connections Description Blue Outlets lt Orange Inlets lt Cyan Non directional Green Interface points Battery limits Battery limits represents all interface points between the UniFlux and the customer process plant System battery limits require hose connections not provided by GE Healthcare Normally the user provides hoses for these connections 72 UniFlux System Operating Instructions 28 9617 49 AC 3 System description 3 6 Flow charts 3 6 2 UniFlux 30 120 and 400 Tag Location Function Direction AS System Air nitrogen supply for integrity test Inlet HTPN4 Tank Air nitrogen supply for pressurization Inlet optional ME4 System Feed supply to transfer pump optional Inlet P2 System Permeate Outlet P4 System Feed drain Outlet P6 System Retentate drain
88. the UNICORN User Manuals and available tutorials This manual does not cover how to use UNICORN Contact your local GE Healthcare representative for advice if required System networks 80 UNICORN can be installed on a stand alone computer to control one to four locally attached systems However the computer can only show one system at a time Multiple computers can view the output data from one system UNICORN can also be installed on a network UniFlux System Operating Instructions 28 9617 49 AC 3 System description 3 7 UNICORN control system Software modules The UNICORN control software consists of four modules Module Function UNICORN File handling and administration tasks for example definition Manager Adminis of systems and managing user profiles tration Method Editor Method creation and editing for preprogrammed control of UniFlux System System Control Process online control and monitoring using pre defined methods or manual control Evaluation Evaluation and presentation of stored results Note The modules are active when the program is operating and are not closed when minimized A minimized System Control unit may control a process Workflow The workflow for using UNICORN system for automatic control includes these general steps Step Action 1 Program an UniFlux System method run using the UNICORN software It is possible to use an existing method or modify a
89. tion class ingress protection according to IEC 60529 This cover all components of the system except the electric cabinet Supply voltage Supply voltage Frequency Supply voltage frequency Max power Max power consumption consumption Protection class Protection class ingress protection according to IEC 60529 This covers the electric cabinet only UniFlux System Operating Instructions 28 9617 49 AC 25 2 Safety instructions 2 2 Labels UniFlux 30 and 120 system label illustration UniFlux 120 Serial number Year of manufacture Max system pressure temperature Pneumatic supply Overall protection class Supply voltage Supply voltage motor Frequency Max current consumption system Max current consumption motor 4 14 bar g 2 30 C 6 10 bar IP 55 110 230 VAC 400 480 VAC 50 60 Hz GE Healthcare Bio Sciences AB Bjorkgatan 30 S 751 84 UPPSALA Sweden UniFlux 30 and 120 system label description Label text Description C The system complies with applicable European directives Ty This symbol indicates that the product contains hazardous 207 materials in excess of the limits established by the Chinese standard SJ T11363 2006 Requirements for Concentration Limits for Certain Hazardous Substances in Electronics 26 UniFlux System Operating Instructions 28 9617 49 AC 2 Safety instructions 2 2 Labels Label text Description This symbol in
90. tion shows UniFlux 30 but also applies to UniFlux 120 Part Function 1 Mounting plates for peristaltic pumps 2 CIP media outlet 3 Swivelling caster with brake 4 pcs 4 Filter cassette holder 5 Emergency stop button 6 User interface console 7 Skid maneouvering handles 8 Hydraulic manouvering unit for filter cassette holder 9 Adjustable floor supports 48 UniFlux System Operating Instructions 28 9617 49 AC UniFlux 30 Rear view 3 System description 3 2 UniFlux systems layout 3 2 2 Illustrations of UniFlux 30 and 120 systems The illustration shows UniFlux 30 but also applies to UniFlux 120 Part Function 10 Connectors on top 11 Electric cabinet 12 Permeate outlet connection 13 Permeate recycle connection 14 UNICORN status lights 15 Main power switch 16 System label 17 Retentate outlet cassette configuration 18 Electrical connectors UniFlux System Operating Instructions 28 9617 49 AC 49 3 System description 3 2 UniFlux systems layout 3 2 2 Illustrations of UniFlux 30 and 120 systems Function 19 Feed inlet connection 20 Feed drain outlet connection UniFlux 30 and 120 External connectors Rear wall connectors Connector Function POWER SUPPLY TANK Connection to UniFlux tank if provided P 202 Connection to transfer pump option P 203 Connection to permeate
91. traces of the cleaning agent e GE Healthcare Kvick Lab cassettes cleaning procedures are provided in the Kvick Lab and Kvick Flow Cassettes User Manual GE Healthcare article no 18 1171 69 GE Healthcare Kvick Lab and Kvick Flow cassettes cleaning procedures are provided in the Kvick Lab and Kvick Flow Cassettes User Manual GE Healthcare article no 18 1171 69 e GE Healthcare Hollow fiber cartridges cleaning procedures are provided in the Hollow fiber cartridges for membrane separations Operating Handbook GE Healthcare article no 18 1165 30 e Filter units provided by other manufacturers shall be cleaned according to the in structions from the respective manufacturer UniFlux System Operating Instructions 28 9617 49 AC 7 Maintenance 7 2 Cleaning External surfaces The UniFlux System is designed to be operated in a clean environment and the external surfaces should not normally accumulate any substantial amount of dust or dirt Regularly wipe the outside of the UniFlux System with a clean cloth Use a mild cleaning agent such as water followed by 70 Ethanol Regular wiping and care of the equipment will help keep the surfaces uncorroded It is not recommended to spray or splash liquids towards external surfaces Do not spray or splash liquids towards filters or the fan on the electric cabinet UniFlux System Operating Instructions 28 9617 49 AC 135 7 Maintenance 7 3 Storage 7 5 Storage NOTICE Fit prote
92. ture Max system pressure temperature Pneumatic supply Overall protection class UniFlux 10 Supply voltage Frequency Max power consumption Protection class 4 14 bar g 2 30 C 6 10 bar IP 55 230 110 V 50 60 Hz 600 VA P55 GE Healthcare Bio Sciences AB Bj rkgatan 30 S 751 84 UPPSALA Sweden 24 UniFlux System Operating Instructions 28 9617 49 AC 2 Safety instructions 2 2 Labels UniFlux 10 system label description Label text Description The system complies with applicable European directives This symbol indicates that the product contains hazardous 20 materials in excess of the limits established by the Chinese standard SJ T11363 2006 Requirements for Concentration Limits for Certain Hazardous Substances in Electronics 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 equipment The system complies with the requirements for electromagnetic compliance EMC in Australia and New Q bt OR Zealand Serial number System serial number Year of manufacture Manufacturing year Max system Max system pressure at temperature pressure temperature Pneumatic supply Pneumatic supply pressure requirement Overall protection class Overall protec
93. uration Illustration Li Fa Part Function 1 Retentate hose 2 Permeate hose 3 Hollow fiber cartridge size 5 or 6 is accepted 4 HF cartridge drain valve XV 064 5 HF cartridge drain hose UniFlux System Operating Instructions 28 9617 49 AC 63 3 System description 3 5 Hollow fiber HF configuration 3 5 2 UniFlux 30 HF configuration 3 5 2 UniFlux 30 HF configuration Illustration Hollow fiber size 75 An optional spool piece kit is needed to mount size 75 hollow fibers on the system 64 UniFlux System Operating Instructions 28 9617 49 AC 3 System description 3 5 Hollow fiber HF configuration 3 5 2 UniFlux 30 HF configuration Description of HF components Part Function 1 Retentate line re arranged to upper position for HF configuration 2 Hollow fiber cartridge 3 Permeate outlet hose 4 Feed line extension pipe 5 HF cartridge drain hose 6 HF cartridge drain valve XV 065 UniFlux System Operating Instructions 28 9617 49 AC 65 3 System description 3 5 Hollow fiber HF configuration 3 5 3 UniFlux 120 HF configuration 3 5 3 UniFlux 120 HF configuration Illustration Hollow fiber size 75 9 An optional spool piece kit is needed to mount size 75 hollow fibers on the system 66 UniFlux System Operating Instructions 28 9617 49 AC Description of HF components Part Function 1 Retentate line mounted in upper position 3 Syst
94. use of UniFlux System and the operational processes may have on the classification of the hazardous area The process might cause the area to increase or the zone classification to change Implement the risk reduction measures needed including use of personal protection equipment WARNING Make sure that all installation maintenance operation and inspec tion is carried out by qualified personnel who are adequately trained understand and adhere to local regulations and the oper ating instructions and have a thorough knowledge of UniFlux System and the entire process UniFlux System Operating Instructions 28 9617 49 AC 13 2 Safety instructions 2 1 Safety precautions WARNING Do not operate UniFlux System in any other way than described in the Operating Instructions WARNING Protective earth UniFlux System must always be connected to protective earth when energized WARNING Do not use UniFlux System if it is not working properly or if it has suffered any damage for example e damage to the power cord or its plug e damage caused by dropping the equipment e damage caused by splashing liquid onto it WARNING Only personnel authorized by GE Healthcare may open the cabinet doors There is high voltage inside the cabinet that can cause human injury or death WARNING The electric cabinet doors may only be opened when UniFlux System is taken out of operation and sub
95. watching the flow through the transparent waste hose from the CIP valve When liquid only and no air exits the CIP valve stop the pump and close the CIP valve UniFlux System Operating Instructions 28 9617 49 AC 119 5 Run preparations 5 3 Priming and testing Leakage test Step Action 1 Pressurize the system up to the maximum intended process pressure For GE Healthcare Kvick Flow and Kvick Lab cassettes maximum system pressure is 4 15 bar g 60 psi g Watch the system for leaks while maintaining this pressure Pay special attention to the filter installation If a leak free seal is not achieved at this pressure there may be a cassette gasket or surface finish irregularity Proceed as follows Remove the filters and inspect the sealing surfaces Correct any found problem reinstall the filters and perform the test again Air integrity test It is recommended to perform an air integrity test on each filter before usage All instructions below are performed in UNICORN Step Action 1 120 Prepare the system for the test 1 Flush the system and filter with water or buffer 2 Drain the system from all fluid 3 Make sure that process grade air supply to the integrity test is connected and turned on refer to Section 4 5 4 Connect compressed air supply on page 99 Isolate the upstream process by closing the following valves e Feed valve XV 001 e Retentate pressure control va
96. will not result in any severe environmental pollution any bodily injury or damage to any assets The unit of the period is Year In order to maintain the declared EFUP the product shall be operated normally according to the instructions and environmental conditions as defined in the product manual and periodic maintenance schedules specified in Product Maintenance Procedures shall be followed strictly Consumables or certain parts may have their own label with an EFUP value less than the product Periodic replacement of those consumables or parts to maintain the declared EFUP shall be done in accordance with the Product Maintenance Procedures This product must not be disposed of as unsorted municipal waste and must be collected separately and handled properly after decom missioning UniFlux System Operating Instructions 28 9617 49 AC 37 2 Safety instructions 2 5 Declaration of Hazardous Substances DoHS Label Meaning d BRERA MS ABWSI 711363 2006 ETES RARES ASYRHRBER PREDARE EYA MEPHRMEAA FROPREA RAR REL EAHA S5880 RASREXSRRRE APERIA RANI BK RHEA OFiak SRS RR AN ARIE RPA PR ERB RE ERR MAKHOE SER HP MEN Mee FA PAE NM EA RRER FER RABAT BE RAR SAMRAT FARM RIRE T L NS RASA REAR BRAS mn ESE EPIRA LOMME CREAT ANS ANT Gn AYER RE A ABR ANF 50 EBA aE RAN A A ED SB EAS RARE IN RLSM List of hazardous substances and their concentrations FRR S ESNRNTRN MR E Indicati
97. work connections Install UNICORN Make sure that the UniFlux control software UNICORN is installed on your computer A system must be defined and the UniFlux configuration or strategy must be installed Refer to UNICORN Administration and Technical manual for more information Install Controller Unit 960 CU 960 The CU 960 is part of the UniFlux system at the delivery It is an external control unit that communicates with UNICORN via Ethernet connection To use the Ethernet connection the CU 960 must be set up like a network device with IP address default gateway and subnet mask address Refer to the control unit manual for more information 100 UniFlux System Operating Instructions 28 9617 49 AC 4 Installation 4 5 Setup 4 5 6 Filter setup feed pump and CFF filter protection 4 5 6 Filter setup feed pump and CFF filter protection Filter setup If the system is configured for the intended filter type HF or cassette no need for further installations are required at arrival to the process site or between processing Feed pump and CFF filter protection To protect the system from feed containing particles that may clogg the CFF filter or damage the pump use upstream normal flow filtering NOTICE Do not use an in line filter screen on the piping between the recir culation tank and the feed pump If such a filter screen becomes clogged the flow to the feed pump will be restricted and the pump may be d

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UniFlux™ System - GE Healthcare Life Sciences