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1. 23 4 Filter as P Steam Heater n l Exhaust 11 3 7 AR a Filter A pra j Steam a Block valve es E Condensate SERM O HX tf to Biowas te C 4 ty NA VA SS B E fne m WR D A E HE M fo Condensate de to Drain QE K x 9 apokkon BIOTECHNOLOG Y June 2009 JA Po A T A A A A A Y 4 SSS N D From Condenser HARDWARE MANUAL i Control for In Situ sterilizable Bioreactors AUXILIARI ES June 2009 6 3 SAMPLE VALVE AND DRAIN Samples can be taken from the bioreactor in two different ways e using the Applikon Sampling System e using the Applikon Bottom Drain During sterilization but also during cultivation both systems can be sterilized In Situ and re sterilized after sampling 6 3 1 SAMPLING SYSTEM The contained sampling system consists of 1 asample valve Tri Clamp connection 2 two additional valves V 17 01 and V 17 02 Valve 17 01 To Sample Bottle To Bio Waste V6LN33071 1 Contained Sampling System maximum particle size 1 mm sidewall DN 25 port 6 3 CONTAINED BOTTOM DRAIN The contained bottom drain consists of e a drain valve Tri
2. i Control for In Situ sterilizable 140L Bioreactor E al mi HARDWARE MANUAL Project 48560 140L Pilot System UC Davis June 2009 OODIKOCT BIOTECHNOLOGY e CONTENTS HARDWARE MANUAL i Contro for In Situ sterilizable Bioreactors June 2009 TABLE OF CONTENTS OCE NEAL S ABE AAA A 4 PNE DU M te aia E at ia are scene Ma lee lata need adi Mia tea aa 4 t2 NES c Me HR ML 5 PME CUBES VCI T T ee m alte DM oaia balul leat A Mara ea poala 7 3 TAB CONTRO D ee 8 Sl MEN PORNEA PRR CCR IN RA AN AER E A OR API ANR E II NORII A NIN NR N A N MORAR ASR 8 SM EE e A 8 A e o oe cz UI 9 Mele AO Tum 10 Odd EHSe SDOCHHCHUODS AA ne tn Bo alle eo ada to pla a sale aaa 11 ley JBIecHEICal onie HON eras aida 12 ALO o GG I O COMME MOINS asaya OE TUE 12 s JPneumguc 1 0 COMME LIOS AA E nastea anctor AE aa sase 13 lo Gas NETS iO E 14 3 1 9 Mains connection and Power Section ccccccccccssssssssecccceceaasesseececeseeaeeesecceeeeeeaaaeseeeess 14 22 ENVIRONMENTAL CONDITIONS e oousooeeaae zecea ate ei do reais dA ba BBB aha dacat inta 15 2 27 CLEANING INSTRUCTIONS S uictis due este aul ou al d ei baia pas bb ei baieti 15 Race cscs v 16 41 o5 5UPPLY EC it N aiii alada 16 4 2 ACTUATORS FOR TEMPERATURE CONTROL cere nnn 17 2o ZEN LET Ns EA RR RER e 0 RI RPR DR AA 18 gt AOL DBIOREACTOR
3. TN PU Rm 31 EU DECLARATION OF CONFORMIT Yen 32 Y Poor BIOTECHNOLOGY HARDWARE MANUAL SAFETY i Control for In Situ sterilizable Bioreactors June 2009 1 GENERAL SAFETY 1 1 SYMBOLS The following symbols are used on the equipment and in this manual WARNING Risk of personal injury or danger to life WARNING Risk of electrical shock hazard WARNING Risk of physical hand injury WARNING Risk of physical hand injury CAUTION Risk of damage to the equipment Additional information 9 apokkon BIOTECHNOLOG Y HARDWARE MANUAL i Control for In Situ sterilizable Bioreactors SAFETY June 2009 1 2 SAFETY CLASS EQUIPMENT A GENERAL e This set of equipment has been designed in accordance with EN61010 1 Safety Requirements for Electrical Equipment for Measurement Control and Laboratory Use and has been supplied in a safe condition e The Hardware manual contains information and warnings which have to be followed by the user to ensure safe installation operation and to retain the equipment in safe condition e Before switching on the equipment make sure that 1t 1s set to the line voltage e This equipment is designed for bioprocess control it must not be used for other purposes WARNING Risk of electrical shock hazard e Any interruption of the protective conductor inside or outside the apparatus or disconnection of the protective conductor terminal will make the apparatus dangerous Intentional inte
4. clockwise MAINS SUPPLY 208V 3 High Voltage Current CAUTION ELECTRICAL SHOCK HAZARD Connect the main supply cable to the power source according to brown bn LI black bk L grey gy L3 blue bu neutral green yellow gn ye earth The i Control is switched on by turning the power switch clockwise Caution Minimum specification of the mains cable 5 x 4 0 mm The i Control cabinet must ONLY be serviced by qualified personnel During service the i Control must be powered down In order to switch off the i Control completely for service purposes first switch off power supply to the cabinet then unplug the Mains Cable supplying power to the cabinet Using an earth of poor quality may cause malfunctioning of the control equipment 4 9 apokkon BIOTECHNOLOG Y HARDWARE MANUAL i Control for In Situ sterilizable Bioreactors TH E i CONTROL June 2009 Pushing the Emergency Stop mushroom button powers down all actuators The controller continues measuring process variables but process control is disabled during E stop intervals Reset the Emergency Stop status as follows Press the function key Unit Layer followed by the key Power ON System The I O hardware is now powered up again When the illumination button is pushed the inside of the reactor 1s illuminated for approx minute Note The timer range can be adjusted by qualified persons in the range 0 05 sec 1 hour 3 2 ENVIRONMENT
5. Clamp connection e two additional valves V 12 01 and V 12 02 Valva 12 02 e A Tube The contained bottom drain for the 140L bioreactor is welded on the vessel V6LF230181 Contained bottom drain maximum particle size 2 mm McC IKON BIOTECHNOLOGY AUXILIARIES 6 3 3 BIO WASTE The Bio Waste line is a manifold for condensate from the gas inlet filter sample valve bottom valve off gas filter etc Any unused connections are plugged Each condensate connection must contain a thermostatic steam trap V6KV432101 VOWAATRUD3 Thermostatic steam trap 6 4 ADDITION 6 4 1 PUSH VALVE ASSEMBLY Industrial Steam Condensate Skid Mounted HARDWARE MANUAL i Control for In Situ sterilizable Bioreactors June 2009 DS The push valve assembly is designed for easy aseptical through 27 mm ports in the top plate and the upper sidewall section of the 140L bioreactor See the i Control Operator Manual section Cultivation Push valves Z82324MT27 Push valve ID 3 mm OD 6mm 27 mm port Z82324M133 Adapter push valve 27mm port 6 4 2 CONTAINED ADDITION ASSEMBLY The contained addition assembly supports aerosol free operation and is used for addition of liquids and for inoculation The assembly is In Situ sterilizable It contains four manually operated membrane valves During sterilization the inlet part is replaced by the bent tube The inlet part is sterilized in an autocl
6. a E EN _ VY 2 06 2 08 ARE 2 1 y 8 15 18 19 SPARE SPARE F AN i E P B P A P A P TU d F fe x or X N f i 4 di pa fy Ah fi y Cw a di rai VN H y N OL 1l aM i 11 4 ot JW it ll Ct 41 i 1 Las F A i A he E F I MA A ql Fl 1 i A E t kaa Ng y bt e t ji The table below lists the pneumatic I O connections and their functions Circulation Valve Clean Steam Inlet Valve Circulation Valve Water Return Valve Drain Valve V 2 13 Main Steam Inlet Valve V 10 15 Steam to Inlet Filter Valve V 10 16 Condensate Valve Inlet Filter to Biowaste V 10 19 Gas Inlet Valve COOIkOr i BIOTECHNOLOGY HARDWARE MANUAL i Control for In Situ sterilizable Bioreactors June 2009 THE CONTROL 3 1 8 GAS INLETS AND OUTLET The gas inlet connections for carbon dioxide oxygen and nitrogen are Quick Connectors for tubing OD 10 mm The inlet connection for the externally located air MFC max 1000L min is a 12 mm pipe Required inlet pressure for the gasses 2 barg The gas inlet connections are located at the rear panel of the Control cabinet One bulkhead connection for gas out is present just below the electrical connections on the rear panel GAS INLET 3 1 9 MAINS CONNECTION AND POWER SECTION The power section is located at the front of the i Control mains switch and Emergency Stop button The power of the Bio Console is switched on by turning the power switch 90
7. for pressure sensor Two spare 5 pin audio connection for analog sensors Two spare 5 pin audio connection for feed pumps P 14 01 and P 14 02 Below the sensor connections two I O connections are located e 2 pin audio connector for the alarm e RJ45 Ethernet connection Supervisory Control And Data Acquisition SCADA program on a Host Remote access for remote control by a user 9 oopikori BIOTECHNOLOG Y HARDWARE MANUAL i Control for In Situ sterilizable Bioreactors TH E CONTROL June 2009 A SENSOR 1 AE B 81 TA o OW e eo J j Ve De E IHERNE a d par ERST b ra NN E u x ff 1 e emm GJ 1 L3 nt gt d a j A KA i f a AS FE kt i P E p hu dm ee Figure Sensor amp I O connections 3 1 7 PNEUMATIC I O CONNECTIONS Bulkhead connections for compressed air inlet and outlet and for actuation of the Back Pressure Control Valve B P C V are present at the exterior of the rear panel of the i Control cabinet Bulkhead connector size OD 6 mm air tubing Required air inlet pressure 4 6 barg Connections to the pneumatic valves in the system are located at the bottom side of the cabinet Wi 2 04 SPARE 2 409 FA a VY SPARE 18 16 SPARE SPARE E Fie MEA EAN po duit ey O LI h l M h 1 1 IL y BE LI 1 i iif MLA P Mi Mer jJ fi QA ML 1j mw d Do ag LA If Di ae AS ANS ut L m AUS E f AS ARE a A pa
8. section 3 1 for location of the mass flow controllers The mass flow controllers require a gas inlet pressure of 2 barg VOR2551100 Mass Flow Controller x3 max 100SL min VOR2551910 Mass Flow Controller x1 max 1000SL min Mass flow controllers are configured as shown Solenoid valve Gas Outlet Gas Inlet H an Return Valve hd ass Flow Controller A non return valve prevents pressure differences to cause backflow through the MFC A solenoid valve with inhibit function is always mounted in _ gt combination with a mass flow controller A digital output control signal is used to close the solenoid valve in case the controller output reaches its lower limit VOR5029312 Solenoid Valve x3 24 VDC VOR5029420 Solenoid Valve x1 24 VDC 9 apokkon BIOTECHNOLOG Y HARDWARE MANUAL i Control for In Situ sterilizable Bioreactors Junel 2009 ACTUATORS 4 2 ACTUATORS FOR TEMPERATURE CONTROL The wet part of the system contains actuators for temperature control during cultivation and sterilization During cultivation water is circulated through the jacket of the reactor The temperature in the reactor 1s controlled by either electrical heating or introducing cold water into the system During sterilization steam 1s introduced into the jacket of the reactor When the temperature in the reactor exceeds a pre programmed level steam is also injected in the reactor through the gas inlet filter KA X V 2 13 Steam S
9. AL CONDITIONS The i Control cabinet may be used at locations with the following environmental conditions Indoor use Altitude up to 2000 m Temperature 4 C to 45 C Maximum relative humidity 80 for temperatures up to 31 C decreasing linearly to 50 relative humidity at 45 C Mains supply voltage 208V 3 High Voltage Current Transient overvoltages according to INSTALLATION CATEGORIES II POLLUTION DEGREE 2 in accordance with IEC 664 P max 6900 VA 3 3 CLEANING INSTRUCTIONS The i Control cabinet may be cleaned with a moist tissue in combination with a non abrasive cleaner McC IKON i BIOTECHNOLOGY HARDWARE MANUAL ACTUATO RS i Control for In Situ sterilizable Bioreactors June 2009 4 ACTUATORS The i Control supports the following actuators e pH control acid base addition or aeration with carbon dioxide e DO control aeration with air nitrogen or oxygen stirrer speed control e Temperature control the wet part contains a heater tank for temperature control during cultivation and steam valves for In Situ sterilization e Level control Level Foam pump This chapter describes the applicable hardware inside the 1 Control cabinet and outside the bioreactor 4 1 GAS SUPPLY SECTION The gas supply section supports up to four mass flow controllers MFCs Three MFCs for for N2 O2 and CO2 are located inside the cabinet The fourth MFC for air is located at bottom of the cabinet Refer to
10. N e N RR RT INN RE PI ORA INN 21 O AUATLTARES iia 22 Oe NORI AI LON 22 OLI as AA Lese luand af s Portu lalea alta lee aie 22 5 1 7 ron e A 22 OS Moor and OBIPOIICE stan nte n ala al on iii ata ol ini at ti 23 Ole e Pe 3 A ideia E 23 Ce AERA TION PRR RI E RN RR E RARI NR NR 8 CI P 24 O21 Gas Inlet Filter AssemiOly S us ccodesuceieetenskGese clorosis nietos 24 022 parcer 010 O Ver El isa 25 AE AA T 26 3 SAMPLE ALVY EJSNO FIN rrr 27 OL AN A IA 2 Goa 3C 0 010210 ec Bottom Drailh iia iae an se ane at a a la 27 A A T UU En E tee ae Gel Al me oale 28 OP ADDIO e e RI OR AIR RR SNP N NR E RI NR E ARI NP MR 28 OAI II piece eta ati 28 642 Contained Addition Assembly ett alte oaia oaia so eee ia iata ani ala ali a ie aa aa ici 28 00 O DI DEV ICE Saco a a 29 Cor O GG 2102 E RT 29 6 5 2 Pressure Gauge and Relief Valve for Jacket sse 29 65 9 Rupture Disk and Discharge Pipe nuca e aa aa pi aaa lua ai oa iata ta i et 29 00 OTHERAUXILIARIE Santana 30 A AAA A 0 N DR 30 557 Y A NON RR CORE PE MONI SATE teste OO ed E PR RN EU DOES 30 E DEN OR din 31 A A 31 ie A m rU 31 25 NO PPP el nai ea nota va ai n ea aa i aaa isa olt a al 31 9 oopikori BIOTECHNOLOG Y HARDWARE MANUAL CONTENTS i Contro for In Situ sterilizable Bioreactor June 2009 A E s 31
11. NUAL i Control for In Situ sterilizable Bioreactors June 2009 3 THE CONTROL The i Control combines and supports actuators like pumps and valves in order to optimize the use of limited bench space A survey of the i Control for the 140L bioreactor is presented in the following sections 3 1 VIEWS 3 1 1 amp ie Cras out Gas inlet 0600 Compressed air ur e 500 Rear FRONT AND REAR VIEW Vent grill Electric connect ons mensor connections louch screen Power WE z illumination f E Fo os tal ung Lol iod section ZU a o 9 asl on lat Es a m Front Figure The front and rear exterior of the i Control cabinet 9 apokkon HARDWARE MANUAL THE i CONTROL i Control for In Situ sterilizable Bioreactors June 2009 3 1 2 BOTTOM VIEW MFC maz 1000L min sas solenoid valve AS Figure Bottom view Note the MFC max 1000L min is located on the bottom panel while the remaining MFCs are on the inside McC IKON BIOTECHNOLOGY THE CONTROL 3 1 3 INSIDE LEFT VIEW Fuses F1 F2 F3 Stirrer motor controller i H WIE as d XE hile ras ti mer Fuses F10 F13 F14 Solenoid gas valves Solenoid valves manifold le Figure In side left view with door open 9 apolkon BIOTECHNOLOG Y HARDWARE MANUAL i Control for In Situ sterilizable Bioreactors June 2009 Power s
12. Only apply these drives with the pump heads and tubing that are described in this chapter e Do not use the tubing pump drives for other purposes than displacement of fluids or gas e Switch off the power of the pump drive before replacing any tubes or pump heads e Verify the tube quality inside the pump head before every fermentation run e Application of damaged tubes may result in fluid leaking into the pump drive The Correct way to mount pump tubing WARNING Risk of physical injury while loading a pump tubing Start the pump head manually Carefully load the tubing in the pump head watch your fingers Pump head type 313D advanced Tube bend too Tube bend too Tube bend sharp upwards sharp downwards correctly Front view of the pump McC IKON 5 BIOTECHNOLOGY HARDWARE MANUAL ACTUATO RS i Control for In Situ sterilizable Bioreactors June 2009 Tube not bend Tube bend too sharp backwards Tube bend too sharp forewards Top view of the pump 9 apokkon BIOTECHNOLOG Y HARDWARE MANUAL i Control for In Situ sterilizable Bioreactors BIOREACTOR June 2009 5 140L BIOREACTOR The main components vessel jacket tubing frame of the Applikon 140L bioreactor are made of SS 316L 1 4404 stainless steel The sight glass is made of borosilicate and the gaskets and O rings are made of silicone EPDM or PTFE The rectangular sight glass in the vessel sidewall is mounted at working volume level The
13. ave separately The inlet connection is 6 35 mm The 140L bioreactor has two contained addition Steam Line l E po V 14 2 z4 ae r4 E X NU Je ICI A E 7 7 er k i I AS Autoclavable P X V 14 3 Ir Valve V 14 1 X J 3 H V 14 4 A AN Reactor Wall TOAN To Steam Trap Replacement Part assemblies mounted in 27 mm ports N24 and N25 at the upper part of the sidewall of the reactor Z82324MT21 Contained addition assembly 27 mm port n 9 apokkon BIOTECHNOLOG Y HARDWARE MANUAL i Control for In Situ sterilizable Bioreactors AUXILIARI ES June 2009 6 5 SAFETY DEVICES 6 5 1 PRESSURE GAUGE Z 1206PI10 Pressure gauge 1 to 4 barg 14 to 60 psig 1 5 TC port 6 5 2 PRESSURE GAUGE AND RELIEF VALVE FOR JACKET Z 1206PR21 Pressure gauge and relief valve forjacket 1 to 5 barg 6 5 3 RUPTURE DISK AND DISCHARGE PIPE The rupture disks will relieve the pressure at 2 barg The rupture disc together with the discharge pipe fits on a 1 5 TC port Tri Clamp 821302070 Rupture disc 1 5 TC ASME 2 barg 811302085 Discharge pipe 1 5 TC Rupture Disc Discharge Pipe McC IKON g BIOTECHNOLOGY HARDWARE MANUAL AUXILIARIES i Control for In Situ sterilizable Bioreactors June 2009 6 6 OTHER AUXILIARIES 6 6 1 ILLUMINATION The i
14. ection Fuses FS F8 F9 I O section PLC MFCs HARDWARE MANUAL i Control for In Situ sterilizable Bioreactors TH E CONTROL June 2009 3 1 4 FUSE SPECIFICATIONS Fuse number Application Type Rating Fuse Fl Main fuses x3 Ceramic 10 x38 mm 20A Fuse F2 Heating element x3 Ceramic 10 x38 mm 12A Fuse F3 Stirrer motor x3 Ceramic 10 x38 mm 12A McC IKON i BIOTECHNOLOGY HARDWARE MANUAL TH E CONTROL i Control for In Situ sterilizable Bioreactors June 2009 3 1 5 ELECTIRICAL CONNECTIONS Electrical connections for the mains illumination are located at the rear exterior of the i Control cabinet Figure Electrical connections The following electrical connections are present also shown in the figure M 601 P 2 41 Main SE 6 01 LL 0 03 TS 2 01 HE 2 71 Encorder cable connection Motor cable connection Connection for illumination in the reactor Connection for the circulation pump Temperature Switch connection Connection for the wet part heating element Main Entry 208V 3 connection 3 1 6 SENSOR amp I O CONNECTIONS Sensor and I O connections are externally located on the rear side of the 1 Control cabinet The following sensor connections are present also shown in the figure BNC connection for the pH sensor 3 pin audio connection for the DO sensor 3 pin audio connection for the Temperature sensor 2 pin audio connection for the Level sensor 5 pin audio connection
15. le Bioreactors AUXILIARI ES June 2009 6 2 2 SPARGERS AND OVERLAYS Spargers are used to sparge gas in the medium The air overlay assembly is used for headspace aeration The ring is placed around the shaft of a bottom drive stirrer assembly The 24 holes 91 5 mm in the ring are made in such a way that the gas 1s injected into the medium in the direction of the stirrer shaft The two ends of the sparger tube are blinded A drain hole 01 5 mm is located at the bottom side of each end Z82318R140 Ring Sparger The overlay assembly is used for headspace aeration It is mounted in the 27 mm port at the upper side wall of the 140L bioreactor V6KR733001 overlay inlet for 27 mm port McC IKON BIOTECHNOLOGY HARDWARE MANUAL AUXILIARIES i Control for In Situ sterilizable Bioreactors 6 2 3 GAS OUTLET SYSTEM The air outlet system is used for off gas It contains e An air outlet condenser e A steam heater e A filter e A manually operated block valve Condenser Z82308C061 Spiral condenser jacketed 3 0 TC A steam heater The steam heat exchanger heats up the gas exiting the condenser and thus prevents excessive condensation on the outlet filter Filter The filter is needed to prevent back growth contamination and contamination of the environment Z82308F010 Exhaust filter 3 4 TC VOM5221233 Gas outlet manually operated block valve
16. llumination assembly is used to illuminate the inside of the bioreactor allowing the pama contents to be viewed through the sight glass at the front side of the 140L bioreactor N The illumination assembly contains a 12 V 10 Watt halogen bulb and an illumination holder which is mounted at the head plate 7821320090 Illumination ass 27 mm port 6 6 2 BLIND STOPPERS Refer to general arrangement drawing of the 140L bioreactor for blind stoppers and other auxiliaries i 9 apokkon BIOTECHNOLOG Y HARDWARE MANUAL i Control for In Situ sterilizable Bioreactors June 2009 7 SENSORS SENSORS Sensors for measurement of process parameters are mounted in the head plate or in the lower sidewall ports 7 1 pH The gel filled sensor hardly needs maintenance except proper cleaning after cultivation It fits directly into a sensor holder for a lower DN 25 port Z001012051 Sensor pH Z100500040 Cable pH sensor L 5m Z101002512 Sensor Holder EASYFIX DN 25 port 7 2 TEMPERATURE Z 22200002 Sensor Pt 100 Temperature DN 25 port Z 10402120 Cable Temp sensor L 3 6m 7 3 DO This dissolved oxygen sensor operates on a polarographic principle This sensor fits directly into a lower DN 25 port For specific information concerning the sensor including information regarding maintenance and the detachable sensor cable refer to the sensor s user manual supplied with the sensor Z010007025 Sen
17. minimum working volume of a reactor is determined by the location of the sensor ports Design code and parameters The reactor 1s constructed in accordance with the codes e ASME American Society of Mechanical Engineers section VIII division 1 Finishing The internal reactor surface and the auxiliaries that are mounted inside the reactor are electrolytically polished to achieve a surface roughness of R lt 0 4 um The inner surfaces are free of crevices to facilitate cleaning and to avoid contamination The external reactor surface is mirror polished Specifications All insitu sterilizable bioreactors are designed to the following e Design pressure reactor 4 1 bar e Test pressure reactor 4 8 bar E e Design pressure jacket 6 2 bar e Test pressure jacket 11 2 bar E e Maximum temperature reactor 130 C Dimensions E Total volume 140 liter E Working volume 102 liter E Minimum working volume 22 liter E E Inner diameter 395 mm E Inner height maximum 1158 mm Liquid height working volume 850 mm a H D total 3 0 E H D working volume 22 Floor space W x D 1600 x 1000 mn Total system Height H 2900 mm McC IKON a BIOTECHNOLOGY HARDWARE MANUAL AUXILIARIES i Control for In Situ sterilizable Bioreactors June 2009 6 AUXILIARIES 6 1 AGITATION The bioreactor is provided with a stirring system consisting of a bottom stirrer assembly a stirrer motor a digital stirrer speed c
18. ontroller power supply 3 Rushton turbine impellers 2 Marine impellers one scoping one vortex 4 baffles 6 1 1 MAGNETIC BOTTOM STIRRER le Qc JI d Z8231B140 Magnetic bottom stirrer assembly for 140L reactor 6 1 2 IMPELLERS AND BAFFLES Z82313R650 6 bladed Rushton turbine impeller ID74 OD155 Z82313R651 6 bladed Rushton turbine impeller x2 ID30 OD155 V6LRL66301 Scoping Marine Impeller ID30 OD180 V6LRL66381 Vortex Marine Impeller ID30 0D180 Z82327K 140 Baffles x4 u 9 apokkon BIOTECHNOLOG Y HARDWARE MANUAL i Control for In Situ sterilizable Bioreactors AUXILIARI ES June 2009 6 1 8 MOTOR AND CONTROLLER V6RRL91203 SERVO Motor ENCODER 300V 28 8 Nm A digital stirrer speed controller located in the power section is used to T control the stirrer speed Stirrer Motor Controller 0R0564053 Motor Controller Tuba 20A 230V For detailed information concerning the controller and stirrer motor refer to the corresponding Technical Documentation binder or search at http www elmomc com WARNING e The stirrer motor is a machine with potential hazard moving parts e In order to avoid dangerous situations the stirrer motor should only be operated when properly installed in the stirrer assembly of the 140L pilot system e The stirrer motor must only be used as
19. part of the 140L Bioprocess with the control system 6 1 4 MAINTENANCE The stirrer motor is designed for low maintenance and can be operated for up to 20 OOO hours maintenance free For maintenance instructions contact the Service department of Applikon Biotechnology CAUTION e When carbon brushes are replaced it is advised also to replace the ball bearings of the motor e Operating the stirrer motor with worn out carbon brushes will cause irreversible damage e Installation maintenance and repair of the stirrer motor shall be carried out only by qualified personnel McC IKON BIOTECHNOLOGY HARDWARE MANUAL AUXILIARIES i Control for In Situ sterilizable Bioreactors June 2009 6 2 AERATION This section describes all reactor auxiliaries for gas supply inlet and outlet 6 2 1 GAS INLET FILTER ASSEMBLY The inlet filter assembly is used for aseptical supply of gasses to the bioreactor It contains a gas filter system stainless steel housing with a PTFE gas filter cartridge inside Filter Housing Steam par Ini et t J To Overlay O i i port VE GE ENG Ini Lo J Gas Inlet To Sparger port Condensate to Bio Waste V6KV431001 Automatically operated Inlet filter assembly a 9 apokkon BIOTECHNOLOG Y HARDWARE MANUAL i Control for In Situ sterilizab
20. rruption 1s prohibited e Capacitors inside the apparatus may still be charged even if the apparatus has been disconnected from all voltage sources e Any adjustment maintenance and repair of the opened apparatus under voltage must be avoided as far as possible and if inevitable the activities must only be carried out by qualified personnel e Make sure that only fuses with the required rated current and of the specified type IEC 127 are used for replacement The use of makeshift fuses and the short circuiting of fuse holders are prohibited e Itis not permitted to connect equipment to the i Control or the bioreactor without the qualification of double isolation or without the SELV Separated Extra Low Voltage qualification WARNING Risk of physical hand injury caused by pumps e In most cases one or more pumps are installed in the i Control e According to the European Community legislation on machinery a pump drive is a machine with potential hazard Only apply these drives with the pump heads and tubing that are described in this manual chapter pumps e Switch off the power of the pump drive before replacing any tubes or pump heads CAUTION Risk of damage to the equipment e Do not use the tubing pump drives for other purposes than displacement of fluids or gas e Application of damaged tubes may result in fluid leaking into the pump drive e Verify the tube quality inside the pump head before every fermentation r
21. sor In Situ DO L 70mm DN 25 port Z110500040 Cable DO sensor L 5m 7 4 FOAM Z 2205AF20 Sensor Level 16 mm port ZT 10402140 Cable Level sensor L 4 1m 7 9 PRESSURE The pressure sensor includes the cable Z 1206PS10 Sensor Pressure 1 to 3 bar Z71501PS10 Sensor Cable YOapokon BIOTECHNOLOGY 2 N E a j raa A UY 31 HARDWARE MANUAL EU DECLARION OF CON FORMITY i Control for In Situ sterilizable Bioreactors June 2009 EU DECLARATION OF CONFORMITY The company Applikon Biotechnology B V residing in Schiedam The Netherlands hereby certifies that the instrument i Controlxp for In Situ sterilizable Bioreactors meets the requirements of the following EU Directives Directive 73 23 EEC on Low Voltage Directive 89 336 EEC on Electromagnetic Compatibility amendment 93 68 EEC and Directive 98 37 EEC on Machinery A l ir A Oudshoorn MBA Director September 28 2005 Applikon Biotechnology De Brauwweg 13 3125 AE Schiedam The Netherlands Tel 31 0 10 2983555 Fax 31 0 10 4379648 E mail applikon applikon com BIOTECHNOLOG Y
22. un McC IKON BIOTECHNOLOGY HARDWARE MANUAL SAFETY i Control for In Situ sterilizable Bioreactors June 2009 Additional information e Do not apply an Earth Leakage Circuit Breaker in the power supply of the Applikon control equipment in an industrial environment or laboratory an earth leakage circuit breaker is not mandatory e Because of the built in main supply filters an Earth Leakage Circuit Breaker may be activated As a result the power will be switched off e Additional electrical protection can be realized by installing a separation transformer between the mains and the control equipment 9 oopikori BIOTECHNOLOG Y HARDWARE MANUAL i Control for In Situ sterilizable Bioreactors BIOREACTOR June 2009 2 140L PILOT SYSTEM The 140L Pilot System consist of the following parts e An In Situ sterilizable Bioreactor with the appropriate auxiliaries like a stirrer assembly baffles sensors an aeration assembly etc e A wet part for temperature control and steam sterilization e A Bioconsole the i Control for measurement and control of process variables pH temperature DO level pressure and stirrer speed with corresponding controller outputs in order to keep process conditions at set point e The isometric representation given below shows the main components of the 140L Pilot System on a skid iC ontrol cabinet L40L Bioreactor McC IKON BIOTECHNOLOGY THE CONTROL HARDWARE MA
23. upply Gas Supply Line x V 10 05 Steam to gas inlet filter Exhaust V 9 11 V 2 06 uN V 11 02 x lt Water Return vere Vent PS V 2 08 Water In R2 Heater A gt lt V 2 04 c En CN NY Bioreactor V 2 12 Steam Trap Figure Schematic layout of the wet part and gas in and outlet lines McC IKON BIOTECHNOLOGY HARDWARE MANUAL ACTUATO RS i Control for In Situ sterilizable Bioreactors June 2009 4 3 PUMPS AND TUBING Three pumps ACID BASE ANTIFOAM are installed at the pump section as shown the in the figure below d A 3s ET MANIAUTO oe NE MANIAUTO m na il H 2 Jl n a P EE E ey Pi sr sep se sr Me Dl E UTIL re pM cu erred fir UN i EE D ER i m i a Shs Blind Plate vd E ps ka a ure a i p 1 i lt a it LS Fixed speed pump drives for i Control V1LH127382 Tubing Pump Watson drive 20 rpm x3 External variable speed pumps with 120V power supply Z375548500 MasterFlex drive 100rpm x2 For specific information concerning the External variable speed pumps and pump heads refer to the Masterflex User Manuals that come with the pumps i 9 apolkon BIOTECHNOLOGY HARDWARE MANUAL i Control for In Situ sterilizable Bioreactors ACTUATO RS Junel 2009 CAUTION e According to the European Community legislation on machinery a pump drive is a machine with potential hazard

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