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Related Manuals for Sartorius Stedim Biotech BIOSTAT CultiBag RM 600
Summary of Contents for Sartorius Stedim Biotech BIOSTAT CultiBag RM 600
- Page 1 Operating Manual BIOSTAT ® CultiBag RM 600 85034-539-09 Vers. 10|2010...
- Page 2 Introduction This operating manual describes the installation and operation of the bioreactor BIOSTAT ® CultiBag RM 600. Disclosures The bioreactor BIOSTAT ® CultiBag RM 600 has been designed for the development and optimization of processes for the cultivation of cells or microorganisms in disposable systems with low shear.
- Page 3 Legend BIOHAZARD This symbol indicates process dependent risks for the staff. Possible hazards, either damages of equipment or effects on personal health, will depend on the process and the microorganisms or cells applied. This symbol indicates possible, either damages of equipment or effects on personal health caused by electricity.
- Page 4 General Safety Notes Organizational Issues The enterprise (i.e. the responsible authorities) shall ensure that the required (legal issues, staff & working place) conditions appropriate for the process are provided: 1. The personnel shall be qualified for the process, for which the bioreactor is applied, they shall know the hazards possible, and carefully familiarize themselves with the handling of all equipment, which is associated with the bioreactor.
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Page 5: Table Of Contents
Contents 1. Structure and Function ......6 4. Preparation and Inflation of the CultiBag RM 600 . . . 18 1.1 Usage of BIOSTAT ®... -
Page 6: Structure And Function
1. Structure and Function ® ® Usage of BIOSTAT CultiBag RM 600 The BIOSTAT CultiBag RM 600 is a large scale rocking platform for cultivation of cells and microbes in Disposable Bag Bioreactors (CultiBag RM 600). The Rocking platform is combined with the BIOSTAT ®... -
Page 7: System Structure
Quick Installation Guide hard copy CD ROM including User Manual and Quick Installation Guide CultiBag RM is not a part of delivery! Please specify and order separately. For further information please contact your Sartorius Stedim Biotech representative. Structure and Function... -
Page 8: Technical Data
Technical Data 1.4.1 Operation The BIOSTAT ® CultiBag RM 600 is a fully automated, PLC controlled system. Operation is via BIOSTAT ® RM Control Tower. 1.4.2 Gassing module The BIOSTAT ® CultiBag RM 600 contains a superior gassing system, which consists of 4 rotameters (Air, O , CO ), 1 mass flow controller for total flow and 1 mass flow... -
Page 9: Communication
® ® 1.4.7 Communication Ethernet connection in order in connect e.g. BioPAT MFCS/Win or BioPAT MFCS/DA. 1.4.8 Materials of Construction Electrical cabinet and frame, housing BIOSTAT ® RM Control Tower 200: Stainless steel 1.4301 (304), brushed, electropolished. Rocking table: Stainless steel 1.4435, brushed, electropolished. Lid: ABS with UV layer. -
Page 10: Delivery And Installation
2. Check all units and component parts for damage. 3. Report missing parts or damage in transit to your local Sartorius Stedim Biotech Representative. 4. Check the proper function of all units and component parts before the first cultivation process. -
Page 11: Connection Of The Supplies
If any of the units have incorrect mains version or power cords have wrong plugs, please contact your local Sartorius Stedim Biotech service person. The BIOSTAT ®... -
Page 12: Biostat Cultibag Rm 600
® BIOSTAT CultiBag RM 600 2.4.1 Connections, Interfaces Fig 2: BIOSTAT ® CultiBag RM 600: Schematic rear side view of electrical cabinet ® 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 heater ®... -
Page 13: Safety
2.4.2 Safety The area below the rocking table is protected by a laser scanner. It stops the rocking motion immediately when something enters the hazard area. For safety reasons you must switch off the system BIOSTAT ® CultiBag RM 600 before restarting the rocking motion after an Emergency stop. -
Page 14: Getting Started
6. Cleaning and maintenance work Installation Kit The scope of the delivery includes a kit for the required fittings and connections. 1. Use only fixtures and fittings supplied by Sartorius Stedim Biotech and released for use with the BIOSTAT ®... -
Page 15: Transportation, Unpack Equipment
Transportation, Unpack Equipment 3.3.1 Transportation 1. If BIOSTAT ® CultiBag RM 600 is moved on its wheels; take its weight into your consideration. Take precaution if moved up or down on ramp and make sure the ground is strong enough to support the weight. ®... -
Page 16: Room Of Installation
® 3.3.4 Room of Installation 1. The operator needs only access at the front of the BIOSTAT CultiBag RM 600. For calibration and maintenance, access from the rear side and left side is also required. The BIOSTAT ® CultiBag RM 600 is mobile, but must not be moved with a filled bag inside. -
Page 17: Filter Heater, Plug In
3.4.3 Filter heater, plug in Two filter heaters are supplied in individual boxes. Connection cables have to be plugged in for operation. Both filter heaters are identical and are operated only while the gasflow is supplied into the bag. 1. Place both filter heaters at the lid of the rocking table with corresponding magnets. -
Page 18: Preparation And Inflation Of The Cultibag Rm 600
4. Preparation and Inflation of the CultiBag RM 600 Unpacking the CultiBag RM 600 Risk of damaging the sterile cultivation chamber! NOTICE Remove the outer protective plastic film carefully. Take extra care when using sharp objects that may puncture the bag film. Place the sterile disposable CultiBag RM 600L bioreactor chamber in the middle of the rocking table before removing the protective plastic foil! Remove the sterile disposable CultiBag RM 600L bioreactor from the protective... - Page 19 Insert the both bag holders into the mount on the left and right side of the CultiBag RM 600L. Please avoid any damage at CultiBag RM 600L while fitting it on the rocking table! Click the two holders into the corresponding lock on both site of the rocking table. Inflate the CultiBag RM 600L until the air outlet filter has turned into an upright position.
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Page 20: Installing The Filter Heaters
Installing the Filter Heaters Place the sterile gas outlet filter inside the filter heater unit. (The air outlet filter is positioned on the left side of the bag). The proportional valve is mounted on the back side of the air outlet supporting plate. If the gas outlet filters are equipped with a tube extension with mounted female lure coupling, please remove the tube extension and the lure coupling, then connect the filter outlet to the delivered tube with a 90°-bend, as showed in the figure. -
Page 21: Connect Air Supply
Connect Air Supply Connect tubing to the gas outlet port of the BIOSTAT RM Control Tower and connect that to the inlet port of the measurement and safety valve, which is mounted on the right side of the air inlet supporting plate. Pressure Sensor Connect the pressure sensor by using the delivered cable with M12 plug. -
Page 22: Connect Optical Sensors
Connect Optical Sensors Observe the colour markers at the device, the aluminium clamp and the markers at the ends of the light fibre cables. The pH has a yellow sticker, the DO has a red sticker. Do not mix up the light fibre cables. -
Page 23: Cultivation
5. Cultivation Preparing for the Cultivation 5.1.1 Filling the CultiBag RM 600 with culture media For information regarding use of the intuitive Touch screen, please refer to the ® associated manual for BIOSTAT RM Control Tower. The CultiBag RM 600 should be inflated prior to filling with media, see section Inflation of the CultiBag RM 600. -
Page 24: Set Cultivation Parameters And Start
5.1.2 Set cultivation parameters and start For information regarding use of the intuitive Touch screen, please refer to the associated manual for BIOSTAT ® RM Control Tower. 1. Adjust required aeration rate. Start aeration if aeration is not already activated. For minimum and maximum aeration rate see section Aeration control and Aeration Flow rate. -
Page 25: Sampling And Inoculation
Sampling and Inoculation This operation requires a standard luer type syringe, whose luer septum is without hypodermic needle. It is not necessary to perform this procedure in a laminar flow cabinet. 5.2.1 Preparing for Sampling or Inoculation For information regarding use of the intuitive Touch screen, please refer to the ®... -
Page 26: Inoculation
5.2.2 Inoculation For information regarding use of the intuitive Touch screen, please refer to the ® associated manual for BIOSTAT RM Control Tower. 1. Inoculate the contents of the syringe via the Luer-Septum into the CultiBag RM 600. 2. Disinfect the Luer-Septum again and close it with the protective cap. 3. -
Page 27: Media Exchange
Media exchange For information regarding use of the intuitive Touch screen, please refer to the ® associated manual for BIOSTAT RM Control Tower. 1. Stop the rocking motion. The rocking table will stop automatically at horizontal position. 2. Clamp off the inlet and outlet filters. 3. -
Page 28: End Of The Process And Putting Out Of Service Safely
6. End of the process and putting out of service safely For information regarding use of the intuitive Touch screen, please refer to the ® associated manual for BIOSTAT RM Control Tower. 1. Stop the rocking motion in main menu. The rocking table will stop automatically at the horizontal position. -
Page 29: Cleaning And Maintenance Work
The maintenance work includes the replacement of battery if required. ® Service and calibration of BIOSTAT CultiBag RM 600 is restricted to qualified service personnel, trained and authorized to do so. Please contact your local Sartorius Stedim Biotech service engineer for more information. Supplement... -
Page 30: Supplement
8. Supplement Optimize Wave Motion Every cell line requires optimization of operating conditions. The attached graphs reflect a guide line. Tests estimating optimum formation of wave mixing are required. Specification of the CultiBag RM 600L optical: Min. working volume: 60 L Max. -
Page 31: Over Pressure Management
Over Pressure Management A pressure transmitter monitors the feedback pressure from the CultiBag RM 600L. In case of overpressure above +45 mbar ± 5 mbar for more than 3 minutes, the metering valve will close until pressure drops less than +45 mbar ± 5 mbar. Thereby providing additional culture safety and bag seal integrity. -
Page 32: Trouble Shooting Disturbances And Measures
Trouble Shooting Disturbances and Measures Frequently Asked Questions. For further information contact your local Sartorius Stedim Biotech representative. Disturbance Possible causes Measures Bag appears to be over inflated. The CultiBag RM 600 should be inflated If the bag is over inflated, check if firmly without creases. - Page 33 Disturbance Possible causes Measures Temperature control not accurately Temperature of media is not Ensure that the surface temperature controlled accurately. sensor is correctly positioned under the bag. Check that BIOSTAT ® CultiBag RM 600 is rocking. If the temperature is still not controlled properly, recalibration of temperature measurement might be required.
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Page 34: Provisions
Defective equipment cannot be repaired in a customers service shop. Defective equipment can also be returned to Sartorius Stedim Biotech. Repairs will be carried out in accordance with Sartorius Stedim Biotech’ Terms of Maintenance. For return of equipment please contact local Sartorius Stedim Biotech Representative. -
Page 35: Disposal Of Equipment
8.5.3 Disposal of Equipment CultiBags are disposable and are discharged after each cultivation. Sterilization may be required before disposal of bag. Treatment within national regulation of disposable of biohardazous equipment. 1. Switch off the power. Disconnect from power supply. 2. Disconnect pressurized air supply. 3. - Page 36 Sartorius Stedim Biotech GmbH August-Spindler-Str. 11 37079 Goettingen, Germany Phone +49.551.308.0 Fax +49.551.308.32 89 www.sartorius-stedim.com Copyright by Sartorius Stedim Biotech GmbH, Goettingen, Germany. All rights reserved. No part of this publication may be reprinted or translated in any form or by any...
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