Pall iCELLis 500+ Instructions For Use Manual Download Page 47

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Appendix A: Abbreviations and Symbols

Abbreviation, Symbol

Signification

Ampere

Barg, mbarg

Bar, millibar, gauge pressure

Declaration of European conformity

Dissolved Oxygen

GMP

Good Manufacturing Practice

HMI

Human Machine Interface

Hertz

IPA

Isopropyl Alcohol

m, mm

Meter, millimeter

MFC

Mass Flow Controller

Outer Diameter

P&ID

Piping and Instrumentation Diagram

PET

Polyethylene terephthalate

PETG

Polyethylene Terephthalate Glycol

PLC

Programmable Logic Controller

PSIG

Pounds per Square Inch gauge pressure

rpm

Revolution per minute

TCU

Temperature Control Unit

TFT

Thin Film Transistor

Vac,

Volt alternating current

Watt

Summary of Contents for iCELLis 500+

Page 1: ...lution SM 1 1 1 1 Instructions for Use Part A Hardware USD3310 iCELLis 500 Bioreactor Control System Part Number ICL500CSSSIP Instructions For Use Part A Hardware USD 3310 iCELLis 500 control system P...

Page 2: ...___________________22 5 6 Fitting Communication and Sensor Cables to the iCELLis 500 Control System _________23 5 6 1 Connecting the Double Jacket Pressure Sensor Cable _______________________________...

Page 3: ...osal __________________________________________________________ 45 10 Technical Assistance _______________________________________________ 46 Appendix A Abbreviations and Symbols _____________________...

Page 4: ...used in accordance with instructions detailed in this manual Utilization must be carried out only by authorized persons trained to the iCELLis 500 control system operation Operation of the equipment m...

Page 5: ...ol notifies a risk of electric shock Crush WARNING icon This symbol notifies a risk of a crushing event Hot Surface WARNING and CAUTION icon This symbol notifies a risk of burn Magnetic field DANGER i...

Page 6: ...CAUTION wiring color differs from the NFPA 79 Standards The electric wire colour used in the iCELLis 500 control system is listed on the label and conformed to the IEC 60445 2 2 Hazard Level Hazard ic...

Page 7: ...t the weight of the system the ancillary equipment and their content such as cell culture media ALERT Risk of damage to equipment Never use the equipment in a manner not specified by or clearly prohib...

Page 8: ...or damage to equipment User is responsible for performing assessment on the risks linked to liquids used in the iCELLis 500 control system and bioreactor Appropriate personal protective equipment mus...

Page 9: ...Lis 500 control system is powered ALERT Risk of damage to equipment Only exhaust filter heater provided by Pall should be used with the iCELLis 500 control system ALERT Risk of damage to equipment The...

Page 10: ...not change with the fixed bed volume and offers a maximum working volume of 74 L Further media volume can be added through perfusion recirculation Hence the same docking and controlling station is us...

Page 11: ...ps probe connections probe transmitters electrical connections emergency stop buttons and the touch screen panel An external TCU for bioreactor temperature control The bioreactor is placed on the dock...

Page 12: ...overview of the iCELLis 500 control system components in front rear right and left views are presented in Figure 3 Figure 4 and Figure 5 Optional High Flow peristaltic pumps Touch screen panel Middle...

Page 13: ...Page 13 of 48 Figure 3 iCELLis 500 control system front view Figure 4 iCELLis 500 control system rear view...

Page 14: ...Page 14 of 48 Figure 5 iCELLis 500 control system right and left views...

Page 15: ...isual alarm and tubing holders 2122 mm with visual alarm and tubing holders Width 955 mm excluding optional high flow pump 1038 mm with optional high flow pump Length 1609 mm Dry Weight without biorea...

Page 16: ...nd weight Table 3 Weight and dimensions of iCELLis 500 control system crates iCELLis 500 Control System Accessories and Documentation Crate weight 850 kg 300 kg Crate dimensions H x W x L 2135 x 1120...

Page 17: ...ted unit b Removing crate fixing clips c Lifting side panel d Removing side panel e Side panel removed f Unit with double plastic wrap g Unit with external wrap removed h Unit unwrapped and lifting po...

Page 18: ...nly the bottom assembly must be used to push or pull the unit Do not push or pull from the docking station Please do not move the equipment in any other way than instructed Unlocking Load Cells ALERT...

Page 19: ...the wheels should be turned and feet lowered to lock the casters Figure 8 When performing this step a spirit level should be used and placed on the bioreactor docking station to ensure the hardware is...

Page 20: ...lug the system from the AC power shut down gas supply disconnect gas lines remove the bioreactor remove the manifolds and all liquids The high speed pumps are packed in the crate for accessories and d...

Page 21: ...re 10a b Connect the base scale at the back of the iCELLis 500 control system to the scale connector Figure 10c Place the Base tray on the scale Figure 10d Level the scale by turning the blue feet of...

Page 22: ...e 11 Item number Description Quantity 1 Seal washer M16 4 2 Left tube holding channel 2 1 3 Left tube holding channel assembly 1 4 Hex drive button head screwed in 7380 Stainless steel A2 M16 x 30 mm...

Page 23: ...gure 12 Double jacket pressure sensor cable Connect the cable to the connector labeled DJ PRESSURE SENSOR located on the front of the iCELLis 500 control system Figure 13a Secure the connector by turn...

Page 24: ...d BIOREACTOR PRESSURE SENSOR located on the front of the iCELLis 500 control system Figure 15a Secure the connector by turning the metallic part of the connector Figure 15b a b Figure 15 Bioreactor pr...

Page 25: ...tion Figure 16 T1 grey cable and T2 white cable temperature probe Connect the T1 temperature probe cable to the connector labeled T1 located on the front of the iCELLis 500 control system Figure 17a S...

Page 26: ...nd pH1 short ones and after DO2 and pH2 long ones the packed bed are packed in the crate of the accessories and documentation Figure 18 Optical fibers before short and after long fix bed Connect the o...

Page 27: ...b c d e Figure 19 Connection of optical fibers before and after fixed bed a Optical connectors b Connection to the DO2 connector c Secured connection d Connection to the pH2 connector e All optical f...

Page 28: ...wer connector of the filter heater to the connector labeled POWER on the right side of the iCELLis 500 control system Figure 21a and b Secure the connector by turning the metallic part of the connecto...

Page 29: ...of 48 a c b d e Figure 21 Connectors of the filter heater a b Connection of the power connector c Secured power connection d Connection of the temperature sensor e Secured connection of the temperatur...

Page 30: ...upper part of the bag pre heater install the metric hex screws with a metric hex key of 5 mm locking the bottom part of the bag pre heater on the iCELLis 500 control system Figure 23b c a b c Figure...

Page 31: ...in the double jacket of the bioreactor DANGER Risk of injury to personnel and or damage to equipment The ingress protection of the TCU is IP 21 please refer TCU user manual for cleaning instructions W...

Page 32: ...30Vac 50Hz and the other must be supplied with 120Vac 60Hz The configuration of the TCU must be specified according to the client requirement during the purchasing of the iCELLis 500 control system Th...

Page 33: ...c d Take out the Profibus cable from crate and connect one end of the cable to right side of the TCU and other end to back of the iCELLis 500 control system tighten the connector on the TCU using a fl...

Page 34: ...nd touch panel e Connection of Profibus connector on TCU f Other end of Profibus cable on iCELLis 500 bioreactor g TCU rear side image h Power cable i Connecting power on rear side of TCU j Barbed con...

Page 35: ...er supply cable Only use the cable supplied with the unit Insure that the iCELLis 500 control system is connected to suitable overcurrent protection device Protective grounding for the system is provi...

Page 36: ...expert advice on the design of any system used to supply gases to the iCELLis 500 control system RELEVANT ONLY WHEN USING OXYGEN In the unlikely event of a tubing or connection failure oxygen may buil...

Page 37: ...n independent pressure regulator All materials in contact with the 4 gases are made of stainless steel or USP 88 Class VI material Figure 28 Gas supply inlets of iCELLis 500 control system Gas input p...

Page 38: ...SO9001 2008 The product is made in a manufacturing facility where the Quality Management System is ISO9001 2015 certified Waste Electrical and Electronic Equipment WEEE The hardware meets the requirem...

Page 39: ...ted impeller in the iCELLis disposable bioreactor The impeller is magnetically driven The impeller speed can be set via the iCELLis 500 software between 0 and 450 rpm Temperature control Bioreactor in...

Page 40: ...Compatible with FDA 21 CFR Part 11 and Eudralex Annex 11 Automation design Developed and tested in accordance with GAMP5 guidelines Data export Network communication Integrated OPC server for real tim...

Page 41: ...the fixed bed in mS cm 2 0 40 0 3 0 mS cm AT_06 Biomass of the fixed bed in pF cm 5 400 3 0 pF cm FT_01 CO2 flow transmitter 0 00 1 50 0 1 NL min FT_02 N2 flow transmitter 0 00 1 50 0 1 NL min FT_03...

Page 42: ...450 5 0 rpm ST_07 Speed fill pump optional Watson Marlow 630BpN 0 160 2 0 rpm ST_08 Speed drain pump optional Watson Marlow 630BpN 0 160 2 0 rpm 6 3 Temperature Control Unit Specifications Descriptio...

Page 43: ...olecular weight alcohol especially isopropyl alcohol to decontaminate the exterior of the iCELLis 500 bioreactor may in circumstances where significant stress repetitive bending and twisting is applie...

Page 44: ...any warranties Please contact Pall See Section 10 In any correspondence with Pall the model manufacturing part and serial numbers of the hardware should be recorded for reference It is recommended to...

Page 45: ...ical and electronic equipment WEEE According to these regulations any device supplied after August 13 2005 in the business to business sphere to which this product is assigned may no longer be dispose...

Page 46: ...bor Park Drive Port Washington NY 11050 USA 1 800 717 7255 toll free USA 1 516 484 5400 phone biopharm pall com e mail European Headquarters Avenue de Tivoli 3 1700 Fribourg Switzerland 41 0 26 350 53...

Page 47: ...I Human Machine Interface Hz Hertz IPA Isopropyl Alcohol m mm Meter millimeter MFC Mass Flow Controller OD Outer Diameter P ID Piping and Instrumentation Diagram PET Polyethylene terephthalate PETG Po...

Page 48: ...e time of publication Product data may be subject to change without notice For current information consult your local Pall distributor or contact Pall directly Asia Pacific Headquarters Singapore 65 6...

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