Summary of Contents for Sartorius Stedim Biotech Biostat RM 200 Rocker
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185013007863 Operating Manual ® Biostat RM 200 Rocker 124.000 | 124.001 Fermenter | Bioreactor 85037-547-60 *** TeDIS Valid on Date Printed Printed on: 20-09-2023 11:08:57 ***...
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PDF file in various international languages. If the CD is missing, you can obtain a copy form us by specifying the order number: Order number: 85037-548-92 Sartorius Stedim Biotech GmbH Technical Editorial Department August-Spindler-Strasse 11 37079 Goettingen, Germany tech.pubs@sartorius-stedim.com...
About This Document 1. About This Document All information and instructions in this operating manual have been compiled in consideration of applicable standards and guidelines, the state of technology and our many years of experience and knowledge. These operating instructions provide you with all the information necessary to install ®...
If the documents supplied do not match the equipment delivered to you or if any documents are missing, please contact the person responsible for your area at Sartorius Stedim Biotech GmbH. In addition to the operating manual, please refer to the following: −...
About This Document 1.3 Symbols Used As a means of instruction and direct warning against hazards, all text statements to be particularly noted in these operating instructions will be marked as follows: This symbol denotes a possible danger with medium risk that death or severe injury may result if it is not avoided.
Safety Precautions 2. Safety Precautions Failure to observe the following safety precautions can have severe consequences: − danger to personnel due to electrical, mechanical, or chemical influences − failure of important functions of the device Read the safety precautions and dangers listed in this section thoroughly before starting the device.
Some of the markings and labels on the equipment were attached by the equipment manufacturers. These may not always match the safety signs conventionally used by Sartorius Stedim Biotech. Keep all safety precautions and hazard notices on the device in a legible condition, and replace them as needed.
Claims of any kind resulting from damages due to use other than the intended use are excluded. Sartorius Stedim Biotech bears no liability for damages caused by use other than the intended use.
Safety Precautions 2.5 Residual Risks from Use of the Unit This device is a state-of-the-art machine and is developed and built in accordance with recognized safety standards. Nevertheless, the use of the device may pose bodily or physical harm to users or third-parties as well as potentially cause impairments to the testing system itself or other material damage.
Safety Precautions 2.7 Danger Due to Components Under Pressure Danger of injury from leaked substances! If individual components are damaged, gaseous and liquid materials may escape under high pressure and e.g. cause injury to eyes. Therefore: − Turn the unit off and secure it against reactivation when working on pressurized components.
Safety Precautions 2.8 Danger Due to Gases Danger Due to Oxygen Danger of explosion and fire! − Keep pure oxygen away from flammable materials. − Avoid sparks in the vicinity of pure oxygen. − Keep pure oxygen away from ignition sources. −...
Safety Precautions 2.9 Danger Due to Escaping Materials Danger of scalding due to defective components! − Inspect the unit before starting the process. − Check the connections of the culture bags and the connections to the supply unit. − Regularly check all hoses for leaky places and replace any leaking hoses. Danger of injury from escaping feed and culture media! −...
− Incorrect or erroneous consumables can lead to damage, malfunction or the total failure of the unit, as well as affecting safety. − Use only original consumables. − Purchase consumables through Sartorius Stedim Biotech. You can find all necessary specifications for consumable materials in the folder “Technical Documentation”.
Safety Precautions 2.16 Safety and Protective Systems 2.16.1 Main Switch The main switch is located on the left side of the device. The activation of the main switch switches the machine off. 2.16.2 On / Off Switch for the Power Supply The power connection (2) is located on the rear side of the device designed to act as the physical on / off switch for the power supply.
Safety Precautions 2.17 Personal Protective Equipment When operating the device, personal protective equipment must be worn in order to minimize dangers to health. − During work, always wear the protective equipment needed for that work. − Follow any instructions posted in the work area pertaining to personal protective equipment.
Safety Precautions 2.18 Emergency Instructions Preventive Measures − Always be prepared for accidents or fire. − Keep first aid equipment (bandages, blankets, etc.) and fire extinguishers handy. − Familiarize personnel with accident reporting, first aid, fire extinguishing and rescue facilities. −...
Safety Precautions Furthermore, the operator is responsible for ensuring that the unit is always in technically perfect condition. The following therefore applies: − The operator must ensure that the maintenance intervals described in this operating manual are observed. − The operator must regularly have the safety systems tested for functionality. 2.20 Personnel Requirements Danger of injury if personnel qualifications are insufficient! Improper use can lead to significant personal injury and/or property damage.
Safety Precautions Electrician Due to his or her technical education, knowledge and experience, as well as knowledge of applicable standards and regulations, an electrician is capable of carrying out work on electrical equipment and independently detecting and avoiding possible dangers. The electrician is trained for the special operational site where he or she works and knows the relevant standards and regulations.
Safety Precautions 2.20.5 Instruction Personnel must regularly receive instruction from the operator. Log the performance of this training for better tracking. Date Name Type of training Training given by Signature ® Operating Instructions Biostat RM 200 Rocker *** TeDIS Valid on Date Printed Printed on: 20-09-2023 11:08:57 ***...
Device Description 3. Device Description ® The bio-reactor Biostat RM 200 Rocker is a rocking platform and is used for ® mounting Flexsafe RM culture bags. The shaft mixing process of the rocker platform ensures homogenous mixing of the cells. The low-shear rocking movement of the device ensures shaft-induced mixing of the cells in the cultivation medium.
Device Description 3.1.1 Variants of the Control Unit The control unit is available in two configurations: Single and Twin. − The single variant is suitable for operating with one culture bag (100L / 200L). − The twin variant is suitable for operating with one culture bag (100L / 200L) or with two culture bags (100L).
Outlet opening for tubing, e.g. filter heating, supply tube of the culture bag *The control cabinet may only be opened by specialist personnel authorized by Sartorius Stedim Biotech! ® Operating Instructions Biostat RM 200 Rocker *** TeDIS Valid on Date Printed...
Device Description 3.2.2 Rocker Platform - Top View Description Function Guide rail for fastening of the culture bag in the rocker platform Recess for leading out tubes and cables ® Recess for leading out tubes and cables, e.g. BioPAT ViaMass sensor cable Temperature Heating plate / Heating / cooling plate for temperature...
Device Description 3.2.4 Connections (Left and Right Sides of the Device) Fig. 2-1: Left hand side of the device Fig. 2-2: Right hand side of the device Description Description Monitoring - Device hood D Link 3 (not used) Filter heater Potential equalization Heating plate Heating plate...
Device Description 3.3 Device Components 3.3.1 Rocker Platform / Guide Rails The culture bags are placed in the rocker platform and fastened in place with the help of the guide rails (1). The rocker platform has four guide rails. The culture bags are provided with plastic rods which are placed in the opened guide rails of the rocker platform and fastened there.
Device Description 3.3.4 Temperature Regulator Depending upon the variant, the device is equipped with two heating plates or two heating / cooling plates respectively. Danger of burns in case of contact with the heating elements! Please note that in an uncontrolled state the surfaces of the heating elements can reach a temperature of up to 75 °C! −...
Device Description 3.3.5 Filter Heater Danger of severe personal injury and property damage due to absence of a filter heater! The device may not be operated without a filter heater. The control unit checks to ensure that the filter heater is inserted, prior to commencement of aeration. −...
The culture bags are not included in the equipment supplied, but must be ordered separately. − Specify the variant desired when placing your order (“basic”, “optical” or “perfusion ATF”). For more information, please contact your Sartorius Stedim Biotech representative. ® Operating Instructions Biostat RM 200 Rocker...
Device Description ® 3.6 Culture Bags Flexsafe Properties and specifications The culture bags are available in the variants “basic”, “optical” or “perfusion ATF” Size of the Number of the culture bags mounted / Aeration culture bag positioned in the rocker platform Min.
− Take the weight of the device into consideration when moving it over inclined surfaces. Danger of damage due to improper transport! Protect the unit during transport against: − moisture − impact, − falling, − damage. Operating Instructions Biostat RM 200 Rocker *** TeDIS Valid on Date Printed Printed on: 20-09-2023 11:08:57 ***...
In case of special requirements, additional fittings, fasteners, leads, hoses or cables are available. For more detailed information please get in touch with your contact person at Sartorius Stedim Biotech. 4.3.3 Packaging The packaging used for transport and protection of the device consists primarily of the following materials suitable for recycling: −...
Setup 5. Setup The guide for setup of the device is the setup drawing. The setup of the device is to take place according to the respective contract conditions: − by Sartorius Service, − by Sartorius authorized specialist personnel, Setting up the device involves the following main steps: −...
Setup Checking of the power cables supplied with the device. Two variants of the device are available: 124.000 (230 V) / 124.001 (120 V). Check whether the plug of the power cable matches your socket. Use the manufacturer’s ID label to check whether the correct power cable has been supplied and whether the supply lines match the connectors required in the laboratory (See Chapter “5.4.2.1 Manufacturer’s ID Label”, page 38).
Setup Minimum distances Ensure that the setup surface is dimensioned in such a way that the device is easily accessible for in-process operation, maintenance, and service work. − Follow the instructions in Chapter “12. Technical Specifications”, page 76. − The space requirements also depend on the peripheral devices to be connected.
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Setup Electricity Risk of death due to electrical shock! The power supply in the laboratory must meet the device specifications. − Check whether the devices match your voltage supply rating (see Chapter “5.4.2.1 Manufacturer’s ID Label”, page 38). − Do not switch on the device if the laboratory’s mains voltage is incorrect. −...
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− Faults resulting from contaminants or corrosion residues. Malfunctions and damages arising from unsuitable water quality are excluded from the warranty granted by Sartorius Stedim Biotech. Green microbes on the heating / cooling plates are a sign of algae formation caused by organic contaminants in the water.
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− Make sure that the supply gases are dry and free of dirt, oil and ammonia. − Install suitable filters, if necessary. − Malfunctions and damage arising from contaminated gas media are excluded from the warranty granted by Sartorius Stedim Biotech. ® Operating Instructions Biostat...
Setup 5.5 Setting Up the Device Danger of personal injury or property damage due to improper movement of the device! − Use the handles on the sides to move the device. − Wear personnel protective equipment. Danger of personal injury or property damage due to improper securing and movement of the device! −...
Stedim Biotech to install the device. Only replace connections and accessory parts with products that have been supplied and/or approved by Sartorius Stedim Biotech. 6.2 Connecting the Hood of the Device Connect the power line of the device hood to the device.
Getting Started 6.4 Connecting the Temperature Control 6.4.1 Connecting the Heating Plates The two heating plates are installed in the rocker platform upon delivery. Connect the heating plates to the device. Connect the two heating plates to the connection “Heating Plate” respectively. −...
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Getting Started 6.4.2.2 Connecting the Heating / Cooling Plates to the Control Unit Connecting the supply lines The supply lines for the cooling water feed and return can be connected to any of the heating / cooling plates via couplings to the connector hoses of the heating / cooling plates.
Getting Started 6.4.3 Connecting the Surface Temperature Sensors Incorrect assignment of the sensors can cause overheating of the heating plates. In this case, the heating will stop automatically via a bimetal trip when the temperature reaches 70 +/5 °C (overheating protection). The two surface temperature sensors are installed ex factory in the recess of the heating plate or the heating / cooling plate.
Getting Started 6.4.4 Connecting the Compressed Air and CO Feeds Danger of personal injury and property damage due to improper gas feed connections! − All types of gases (air, O and CO ) must be filtered. − The gas feed pressure must be reduced to 1.5 barg (21.76 psig). Danger of poisoning by escaping carbon dioxide.
Getting Started 6.6 Connecting the Device to the Control Unit Connect the connector “D Link 2” (1) on the left side of the device with the connector “Serial-C” on the control unit. − Use the connecting cable supplied for the control unit. −...
Preparing and Running the Process 7. Preparing and Running the Process Danger of injury due to improper operation of the device! The device may be operated only be authorized technicians who have been trained in the operation of the device. −...
Preparing and Running the Process 7.3 Installing Culture Bags Danger of severe personal injury and property damage due to installation of non-permissible objects! Only the culture bag may be installed in the rocker platform. The installation of other objects is not allowed. Due to the rocking movement of the rocker platform, such objects could be set in uncontrolled motion.
Preparing and Running the Process 7.3.2 Assembling the Filter Heaters with the Culture Bag The filter heater consists of two parts, which are placed around the exhaust filter of the culture bag. The two parts are held together by magnets. Both filter heaters of the device are identical and are activated automatically when the device is switched on.
Preparing and Running the Process 7.3.3 Connecting the Aeration System to the Culture Bag Danger of injury due to bursting of the culture bag! Direct connection of the culture bag to a source of gas or the use of an additional aeration unit can create overpressure and burst the culture bag.
Preparing and Running the Process 7.3.5 Connecting the pH and DO Sensors Measurement of pH and DO values is possible only with culture bags of the variants “optical” or “perfusion ATF”. Danger of damage due to incorrect connection of the fiber optic cable! The fiber optic cable connection to the control unit and the culture bag may not be interchanged.
Preparing and Running the Process 7.3.6 Filling the Culture Bag with Culture Medium Danger of infection due to leakage in the culture bag! − After a leakage, perform a sterilization to kill the live cells in the culture medium before removing the culture bag from the rocker platform. −...
Preparing and Running the Process 7.4 Setting the Cultivation Parameters and Starting Cultivation Starting the cultivation involves the following main steps: − Setting the rocker speed so as to create a wave movement (see Chapter “7.4.4.2 Setting the Rocker Speed and Rocker Angle”, page 56). −...
Preparing and Running the Process 7.4.3 Selecting the Unit (Twin Variant of Control Unit) In addition to the following steps, please observe the operating instructions of the control unit, in particular the chapter “Main menu, Main”. Three selection keys are displayed in the operating display (1) of the control unit, with which the cultivation parameters for Unit-1 and/or Unit-2 can be selected.
Preparing and Running the Process 7.4.4 Setting the Cultivation Parameters Twin variant of control unit: When using one culture bag of a size of 100 L you must set the process values for one Unit (e.g. Unit-1). The controllers for the other Unit must all be set to “off”. 7.4.4.1 Aeration Settings Please observe the operating instructions of the control unit for the following steps.
Preparing and Running the Process 7.4.4.3 Setting the Temperature Start the heating process only after you have made sure that the surface temperature sensor has been properly installed. Otherwise, there is a danger of overheating (see Chapter “3.4.1 Surface Temperature Sensor”, page 31). Activate the heating plate / heating/cooling plate only after the rocker motion has started, in order to ensure uniform heating of the culture medium.
Preparing and Running the Process 7.6 Sampling and Inoculation Danger of crushing due to the max. rocker angle while sampling or harvesting the product! Keep a sufficiently safe distance from the device when doing any work on the culture bag. This procedure requires a standard laboratory syringe with a Luer septum without a needle.
Preparing and Running the Process 7.6.2 Inoculation The connection of an ordinary Luer connector and MPC connector whose surfaces have come into contact with the atmosphere must be done on a sterile workbench. ® ® We recommend the use of a BioWelder or BioSealer in order to quickly create a reliable joint.
Preparing and Running the Process 7.7 Completing the Process, Cell Harvesting and Shutting Down the Device Danger of crushing due to max. rocker angle while sampling or harvesting the product! Keep a sufficiently safe distance from the device when doing any work on the culture bag.
Malfunctions 8. Malfunctions 8.1 Safety Instructions Danger to life caused by electrical voltage! Contact with parts under voltage represents a direct danger of death. − Work on the electrical equipment of the device may only be carried out by a competent electrician. −...
Malfunctions 8.3 Breakdown of Communication Between Device and Control Unit As soon as communications between the device and the control unit fail, the control unit halts the rocker and heating functions of the device. A breakdown of communications is possible for the following reasons: −...
Malfunctions 8.4 Hardware-related Faults. Danger of injury if personnel qualifications are insufficient! Improper use can lead to significant personal injury and/or property damage. It is therefore important that all troubleshooting activities be carried out by technical personnel. 8.4.1 Troubleshooting Table “Contamination” Contamination Potential Causes Corrective Measures...
Malfunctions 8.4.2 Troubleshooting Table “Tempering” Problem Potential Causes Corrective Measures The bioreactor heats up too slowly. The culture medium does − Check that the temperature sensor is positioned not heat up at all or only correctly. very slowly. − Make sure that the desired temperature is set correctly.
Malfunctions 8.4.3 Troubleshooting Table “Tempering Module” 8.4.3.1 Malfunction “Overheating” The temperature control unit of the control unit detects malfunctions which are triggered due to overheating. The preconfigured alarm is triggered at a temperature in excess of 42 °C. Tempering is switched off if the process temperature exceeds 42 °C.
A smaller rocker angle produces less foam and the rocker speed can again be increased slightly. For more information, please contact your contact person at Sartorius Stedim Biotech. For more information please contact your Sartorius Application Specialist. 8.5 Alarm Messages The control unit draws the attention of the operator to various malfunctions.
− Never open the device. The device may be opened only by authorized personnel of Sartorius Stedim Biotech. − Work on the electrical equipment of the device may only be carried out by Sartorius Service or authorized technicians.
Cleaning and Maintenance 9.1 Preliminary Steps Make sure to always perform the following preliminary steps during cleaning and maintenance: Turn the device off at the main switch (see Chapter “6.7 Turning the Device On and Off”, page 47). Unplug the power plug from the laboratory connection. Turn off all supply media in the lab (water and gas supply).
Cleaning and Maintenance 9.3 Maintenance 9.3.1 Device Servicing by Operating Personnel The maintenance activities to be carried out by operating personnel are limited to: − Replacing the aeration tubing between the control unit and the sterile air intake filter of the culture bag. −...
Cleaning and Maintenance 9.3.2 Device Servicing by the Operator 9.3.2.1 Check the Functioning of the Overheating Protection. The functionality of the overheating protection must be regularly checked in order to ensure safe operation of the device. Two thermometers are required for the test. Perform the test every 12 months.
Cleaning and Maintenance 9.3.3 Device Servicing by Authorized Personnel Service and calibration functions are reserved for qualified, trained and authorized service personnel. Maintenance Intervals Several components, such as bearings, require regular maintenance. It is recommended that maintenance be performed every 4000 working hours. This also includes the required calibration of all parameters.
Storage 10. Storage If the device is not set up immediately after delivery or temporarily not used, it must be stored under the conditions listed in the Chapter Chapter “12.6 Ambient Conditions”, page 79. Only store the device in dry buildings and do not leave the device outdoors. In case of improper storage, no liability will be assumed for resulting damage.
Disposal 11. Disposal 11.1 General Notes Packaging The packaging is made of environmentally friendly materials that can be used as secondary raw materials. If the packaging is no longer needed, it can be disposed of by local waste disposal authorities. Device The equipment, including accessories and empty non-rechargeable and rechargeable batteries, does not belong in your regular household waste;...
Decontamination Declaration Sartorius Stedim Biotech has a duty to protect its staff from hazardous substances. When returning devices and device components, the sender must enclose a decontamination declaration as proof of compliance with the safety regulations governing the area of application for which the devices were used.
Disposal 11.4 Disposing of the Device Danger of severe injury due to ejected or falling parts! When disassembling the unit, pay particular attention to those components that contain parts under mechanical tension that could spring out during scrapping, leading to injury. There is also danger due to moving parts and falling objects. −...
Technical Specifications 12. Technical Specifications 12.1 Dimensions and Weights Information Unit Value Weight (without culture bags) Dimensions (Width + Depth + Height) Rocker platform in the horizontal position 1940 × 1080 × 1155 Rocker platform in the 45° position, 1940 × 905 × with system rails 1285 Rocker platform in the 45°...
Technical Specifications 12.2.3 Aeration Information Unit Value Process gas supply*, regulated with Compressed air [AIR]: bar over- pressure bar over- pressure bar over- pressure bar over- pressure Supply rate (max.): Compressed air [AIR]: L/min L/min L/min L/min * All gases: Dry and free from particles Notes on the connection tubing can be found in the operating instructions of the control unit (see in particular the chapter “Preparing and Running the Process) 12.3 Measurement and Control Ranges...
Technical Specifications 12.3.4 Measurement of pH- and DO Values Information Unit Value pH value of the media* 5.5 – 9.0 ± 0.2 Reading accuracy ± 0.05 DO value of the media* 0 – 100 ± 2 * Deviations are possible, depending upon the configuration of the device. Observe the notes in the folder “Technical Documentation”.
Technical Specifications 12.4.5 Surface Temperature Sensor Information Unit Value Article number DZ-----R2PT Type Pt100 /3 Con- ductor / Class A Protection IP67 Material POM white, cable PFA, sensor surface chromium steel 1.4404 (AISI 316 ) 12.5 Acoustic Emission Information Unit Value At rest dB (A)
Conformity & Licenses 13. Conformity & Licenses EC Declaration of Conformity With the attached declaration of conformity (see the following pages) Sartorius ® Stedim Biotech confirms the compliance of the Biostat RM 200 Rocker with the directives cited. ® Operating Instructions Biostat RM 200 Rocker *** TeDIS Valid on Date Printed Printed on: 20-09-2023 11:08:57 ***...
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Conformity & Licenses ® Operating Instructions Biostat RM 200 Rocker *** TeDIS Valid on Date Printed Printed on: 20-09-2023 11:08:57 ***...
For equipping and retrofitting as well as repairs, you may only use parts approved by Sartorius Stedim Biotech for the unit. Sartorius Stedim Biotech shall not be liable for repairs made by the customer, nor any resulting damage. The warranty is invalidated particularly in the case of: −...
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Sartorius Stedim Biotech GmbH August-Spindler-Str. 11 37079 Goettingen, Germany Phone: +49.551.308.0 Fax: +49.551.308.3289 www.sartorius.com The information and figures contained in these instructions correspond to the version date specified below. Sartorius reserves the right to make changes to the technology, features, specifications and design of the equipment without notice.
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