Operating Manual
BIOSTAT
®
CultiBag RM 600
85034-539-09
Vers. 10 | 2010
Page 1: ...Operating Manual BIOSTAT CultiBag RM 600 85034 539 09 Vers 10 2010...
Page 2: ...d equipment Such safety notes are supplementary to regulations distributed by the company or local authority for the process It does not refer to conditions and regulations on the protection of the st...
Page 3: ...y electricity NOTICE indicates property damage to the equipment This symbol indicates steps of operation which must be executed with special care or at which important aspects need to be considered e...
Page 4: ...minate disinfect and clean the work place 4 The enterprise i e the responsible authorities must issue safety regulations about hazards which can occur in the process at the work place for the staff an...
Page 5: ...rol Tower 16 3 4 2 Surface temperature sensor plug in 16 3 4 3 Filter heater plug in 17 3 4 4 Aeration Tube 17 3 4 5 Connect Optical Fibre Cables 17 3 4 6 Connect Power Supply 17 3 4 7 Connect Pressur...
Page 6: ...ed in the BIOSTAT RM Control Tower For further information regarding connection of the Rocker 600 to the BIOSTAT RM Control Tower see associated manuals for Control Tower 1 2 CultiBag RM 600 Cell cult...
Page 7: ...ature Sensor DS600L RMPT 2 Filter Heater for BIOSTAT CultiBag RM 600 DS600L RMFH Aeration tubes labelled Quick Installation Guide hard copy CD ROM including User Manual and Quick Installation Guide Cu...
Page 8: ...LC programmed PID controller built in the BIOSTAT CultiBag RM 600 Set temperature is adjusted at BIOSTAT RM Control Tower Cooling by ambient air only No cooling device required An electrical resistanc...
Page 9: ...600L Number of bags Min working Max working of CultiBag RM operation mounted volume in volume in modes RM Control Tower CultiBag RM 600 CultiBag RM 600 L L 1 CultiBag RM 600L 1 60 L 300 L CultiBag RM...
Page 10: ...t cultivation process 5 Record malfunctions carefully Return the claim report to your local Sartorius Stedim Biotech Representative 2 2 Space Requirements The table below details the space requirement...
Page 11: ...CAUTION Risk of voltage damage to equipment The mains supply must fulfill the specifications of the units Voltage fluctuations must not occur Verify that correct and interference free mains supply is...
Page 12: ...4 5 Fig 3 BIOSTAT CultiBag RM 600 Schematic view of the sockets Connectors and switches 1 Socket to connect surface temperature sensor red 2 Socket to connect filter heater 3 Socket to connect filter...
Page 13: ...he system BIOSTAT CultiBag RM 600 before restarting the rocking motion after an Emergency stop Attention Do not touch the area showed in the picture at any time It is not protected by the laser scanne...
Page 14: ...he process and putting out of service safely 6 Cleaning and maintenance work 3 2 Installation Kit The scope of the delivery includes a kit for the required fittings and connections 1 Use only fixtures...
Page 15: ...cabinet Note the weight and the dimensions of all devices Use appropriate transport carriers Do not lift the Rocker 600 with the BIOSTAT RM Control Tower mounted and or with liquid containing CultiBa...
Page 16: ...nted CultiBags Do not expose the Cultibag RM on direct sun beam 3 4 Equipping the system 3 4 1 Mount BIOSTAT RM Control Tower 1 Connect the BIOSTAT RM Control Tower with BIOSTAT CultiBag RM 600 using...
Page 17: ...Tower 3 4 5 Connect Optical Fibre Cables Two optical fibre cables are included with delivery to connect CultiBag RM 600L with BIOSTAT RM Control Tower 1 Place both optical fibers cables on the rockin...
Page 18: ...from the protective plastic foil as delivered Place the sterile disposable CultiBag RM 600L bioreactor chamber on the rocking table 4 2 Mounting the CultiBag RM 600L on the Rocking Table Make sure the...
Page 19: ...the rocking table Inflate the CultiBag RM 600L until the air outlet filter has turned into an upright position Do not inflate the CultiBag RM 600L to the maximum pressure until the lid is closed safe...
Page 20: ...ck pressure can be reduced through the outlet filters accordingly Both ends of the air outlet tubes are connected with one Y piece Connect the outlet of the Y piece to the inlet of the proportional va...
Page 21: ...r cannot feedback to an external source to stop aeration if overpressure is reached When there is no gas and liquid supply into the bag we suggest clamping the tube between bag and gas outlet filters...
Page 22: ...ultiBag RM 600 that is not inflated Put the clamps on both ports of the pH und DO measurement 2 Insert the optical fibre cables into the sensors ports on the bag Insert the optical fibre cable of DO m...
Page 23: ...gh the openings on the left and right sides of the rocking table Use of luer and MPC couplings may require moving the CultiBag RM 600 Bag into a bio safety laminar flow cabinet for aseptic connection...
Page 24: ...liquid is required Reduce the speed if you see excessive foaming Make sure that the bioreactor chamber is rigidly inflated otherwise excessive foam will be generated from turbulence caused by creases...
Page 25: ...table down by adjusting the angle to keep the dip tube of the sample port in the media Set angle in menu For minimum and maximum of adjustable angle see section Rocking angle Do not open lid of rockin...
Page 26: ...tmosphere have to connected in a laminar flow Use of BioWelder or BioSealer allows simple fast and reliable connections 5 2 3 Sampling The procedure is the same as that described for inoculation using...
Page 27: ...s to settle 4 Change the culture media Connect tubing to the C Flex line at the front fill line without dip tube The other end of this tubing should be connected to a sterile collection vessel Using a...
Page 28: ...up by adjusting the angle to 0 For minimum and maximum of adjustable angle see section Rocking angle 6 To drain all the contents via the harvest port with dip tube at rear side use a suitable peristal...
Page 29: ...quipment by liquids entering the housing 7 2 Maintenance by operators Maintenance by operators is restricted to Replace aeration tubing connecting the AIR OUT port of BIOSTAT RM Control Tower and the...
Page 30: ...minimal shear forces Well wave formation slight foaming small shear forces Very well oxygen transfer small shear forces Heavy wave formation with foaming middle shear forces Very well oxygen transfer...
Page 31: ...iate security access Please see also associated manuals for Control Tower System Power Failure In case of power failure the control tower keeps all controller states and setpoints within the FAIL TIME...
Page 32: ...rtain amount of foam is typical for If too much foam occurs check if the the BIOSTAT CultiBag RM 600 CultiBag RM 600 is correctly inflated But the foam shouldn t cover more Under inflation generates a...
Page 33: ...urement might be required Contact your local Sartorius Stedim Biotech representative Temperature appears to be incorrect Actual temperature shown in main menu Make sure that surface temperature does n...
Page 34: ...d its equipment if they are applied beyond their specifications or accompanying instructions are ignored at operation under unsuitable ambient conditions e g at the presence of corrosive acting media...
Page 35: ...ctive national regulations 8 6 Decontamination Declaration For return of faulty equipment to Sartorius Stedim Systems GmbH in case of warranty and for service the sender will have to enclose a deconta...
Page 36: ...written permission of Sartorius Stedim Biotech GmbH The status of the information specifications and illustrations in this manual is indicated by the date given below Sartorius Stedim Biotech GmbH res...
