Sartorius Stedim Biotech Biostat RM 200 Rocker User manual

85037-547-60
Operating Manual
Biostat®RM 200 Rocker
124.000 | 124.001
Fermenter | Bioreactor
*** TeDIS Valid on Date Printed Printed on: 20-09-2023 11:08:57 ***
185013007863

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Use start.html to run the application
The enclosed CD contains the operating instructions
as a 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
[email protected]
www.sartorius-stedim.com
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Operating Instructions Biostat®RM 200 Rocker 3
Contents
Contents
1. About This Document ............................................................6
1.1 Validity .......................................................................7
1.2 Accompanying Documents...................................................7
1.3 Symbols Used.................................................................8
1.4 Abbreviations.................................................................8
2. Safety Precautions ...............................................................9
2.1 General Safety Precautions ..................................................9
2.2 Informal Safety Measures ....................................................9
2.3 Symbols Used on the Device ............................................... 10
2.4 Intended Use and Foreseeable Misuse...................................... 11
2.5 Residual Risks from Use of the Unit........................................ 12
2.6 Danger Due to Electrical Power ............................................ 12
2.7 Danger Due to Components Under Pressure ............................... 13
2.8 Danger Due to Gases ....................................................... 14
2.9 Danger Due to Escaping Materials ......................................... 15
2.10 Danger Due to Hot Surfaces ............................................... 15
2.11 Danger Due to Moveable Components..................................... 15
2.12 Danger Due to Use of Incorrect Consumables ............................. 16
2.13 Hazards Due to Improper Safeguarding or Movement of the Device ..... 16
2.14 Hazards Due to System Failures ............................................ 16
2.15 Hazards Due to Non-compliance with the
Maintenance and Calibration Intervals .................................... 16
2.16 Safety and Protective Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
2.16.1 Main Switch........................................................ 17
2.16.2 On/Off Switch for the Power Supply.............................. 17
2.16.3 Overheating Protection ............................................ 17
2.17 Personal Protective Equipment............................................. 18
2.18 Emergency Instructions .................................................... 19
2.19 Operator Responsibilities................................................... 19
2.20 Personnel Requirements.................................................... 20
2.20.1 Personnel Qualification Requirements............................. 20
2.20.2 Personnel Responsibilities.......................................... 21
2.20.3 Responsibilities..................................................... 21
2.20.4 Unauthorized Personnel ........................................... 21
2.20.5 Instruction ......................................................... 22
3. Device Description.............................................................. 23
3.1 Operation................................................................... 23
3.1.1 Variants of the Control Unit ....................................... 24
3.1.2 Temperature Control............................................... 24
3.2 Setup ....................................................................... 25
3.2.1 Front View ......................................................... 25
3.2.2 Rocker Platform - Top View........................................ 26
3.2.3 Rear View .......................................................... 26
3.2.4 Connections (Left and Right Sides of the Device) ................. 27
3.3 Device Components ........................................................ 28
3.3.1 Rocker Platform / Guide Rails ..................................... 28
3.3.2 The Hood of the Device ............................................ 28
3.3.3 Aeration............................................................ 28
3.3.4 Temperature Regulator ............................................ 29
3.3.5 Filter Heater........................................................ 30
3.3.6 Load Cell (Optional) ................................................ 30
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4 Operating Instructions Biostat®RM 200 Rocker
Contents
3.4 Sensors ..................................................................... 31
3.4.1 Surface Temperature Sensor ....................................... 31
3.4.2 DO and pH Sensors................................................. 31
3.5 Equipment Supplied........................................................ 31
3.6 Culture Bags Flexsafe®RM ................................................. 32
4. Transport........................................................................ 33
4.1 Ambient Conditions During Transport ..................................... 33
4.2 Shipping Instructions....................................................... 33
4.3 Inspection Upon Acceptance by the Recipient............................. 34
4.3.1 Reporting and Documenting Transport Damage .................. 34
4.3.2 Checking Completeness of the Delivery ........................... 34
4.3.3 Packaging .......................................................... 34
5. Setup ............................................................................ 35
5.1 Delivery Check.............................................................. 35
5.2 Acclimatizing the Device ................................................... 36
5.3 Ambient Conditions ........................................................ 36
5.4 Work Area Preparation..................................................... 36
5.4.1 Work Surfaces and Loads .......................................... 36
5.4.2 Laboratory Energy Sources ........................................ 37
5.5 Setting Up the Device ...................................................... 41
5.5.1 Remove the Transport Lock (Devices with Load Cells) ............. 41
5.6 Setting up the Control Unit ................................................ 41
6. Getting Started ................................................................. 42
6.1 Installation Kit.............................................................. 42
6.2 Connecting the Hood of the Device........................................ 42
6.3 Connecting the Load Cells.................................................. 42
6.4 Connecting the Temperature Control ...................................... 43
6.4.1 Connecting the Heating Plates .................................... 43
6.4.2 Connecting the Heating / Cooling Plates ......................... 43
6.4.3 Connecting the Surface Temperature Sensors..................... 45
6.4.4 Connecting the Compressed Air and CO2Feeds ................... 46
6.5 Connecting the Device to the Power Supply............................... 46
6.6 Connecting the Device to the Control Unit ................................ 47
6.7 Turning the Device On and Off............................................. 47
7. Preparing and Running the Process........................................... 48
7.1 Overview.................................................................... 48
7.2 General Notes on Running the Process .................................... 48
7.3 Installing Culture Bags ..................................................... 49
7.3.1 Placing the Culture Bag in the Rocker Platform................... 49
7.3.2 Assembling the Filter Heaters with the Culture Bag............... 50
7.3.3 Connecting the Aeration System to the Culture Bag ............. 51
7.3.4 Inflating the Culture Bag .......................................... 51
7.3.5 Connecting the pH and DO Sensors ............................... 52
7.3.6 Filling the Culture Bag with Culture Medium ..................... 53
7.4 Setting the Cultivation Parameters and Starting Cultivation.............. 54
7.4.1 Cultivation Parameters (Overview) ................................ 54
7.4.2 Turning the Device On ............................................. 54
7.4.3 Selecting the Unit (Twin Variant of Control Unit) ................. 55
7.4.4 Setting the Cultivation Parameters................................ 56
7.5 Process Monitoring......................................................... 57
7.6 Sampling and Inoculation.................................................. 58
7.6.1 Preparing for Sampling or Inoculation ............................ 58
7.6.2 Inoculation......................................................... 59
7.6.3 Sampling ........................................................... 59
7.7 Completing the Process, Cell Harvesting and Shutting Down the Device . 60
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Operating Instructions Biostat®RM 200 Rocker 5
Contents
8. Malfunctions.................................................................... 61
8.1 Safety Instructions ......................................................... 61
8.2 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
8.3 Breakdown of Communication Between Device and Control Unit ........ 62
8.4 Hardware-related Faults.................................................... 63
8.4.1 Troubleshooting Table “Contamination”........................... 63
8.4.2 Troubleshooting Table “Tempering”................................ 64
8.4.3 Troubleshooting Table “Tempering Module”....................... 65
8.5 Alarm Messages ............................................................ 66
9. Cleaning and Maintenance .................................................... 67
9.1 Preliminary Steps........................................................... 68
9.2 Cleaning .................................................................... 68
9.3 Maintenance ............................................................... 69
9.3.1 Device Servicing by Operating Personnel.......................... 69
9.3.2 Device Servicing by the Operator.................................. 70
9.3.3 Device Servicing by Authorized Personnel......................... 71
10. Storage.......................................................................... 72
11. Disposal.......................................................................... 73
11.1 General Notes .............................................................. 73
11.2 Hazardous Materials........................................................ 73
11.3 Decommissioning the Unit ................................................. 74
11.4 Disposing of the Device .................................................... 75
12. Technical Specifications........................................................ 76
12.1 Dimensions and Weights ................................................... 76
12.2 Electrical Characteristics ................................................... 76
12.2.1 Biostat®RM 200 Rocker / 124.000................................. 76
12.2.2 Biostat®RM 200 Rocker / 124.001................................. 76
12.2.3 Aeration............................................................ 77
12.3 Measurement and Control Ranges ......................................... 77
12.3.1 Rocker Function.................................................... 77
12.3.2 Aeration............................................................ 77
12.3.3 Temperature Control............................................... 77
12.3.4 Measurement of pH- and DO Values .............................. 78
12.4 Device Components ........................................................ 78
12.4.1 Filter Heater........................................................ 78
12.4.2 Heating Plate ...................................................... 78
12.4.3 Heating / Cooling Plate ............................................ 78
12.4.4 Load Cell ........................................................... 78
12.4.5 Surface Temperature Sensor....................................... 79
12.5 Acoustic Emission .......................................................... 79
12.6 Ambient Conditions ........................................................ 79
12.7 Minimum Distances ........................................................ 79
12.8 Consumables ............................................................... 79
12.9 Accessories ................................................................. 79
13. Conformity & Licenses ......................................................... 80
14. Appendix ........................................................................ 82
14.1 Service...................................................................... 82
14.2 Decontamination Declaration.............................................. 82
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6 Operating Instructions Biostat®RM 200 Rocker
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
and operate the Biostat
®RM 200 Rocker (referred to as “device” or simply “rocker” in
the following).
The operating instructions inform you about how to:
− operate the unit safely,
− service the unit according to guidelines,
− clean the unit according to guidelines,
− take appropriate measures should a fault occur.
The operating instructions must be read, understood and used by all personnel
entrusted with the operation, maintenance, cleaning and troubleshooting of the
device. This applies particularly to the safety instructions listed.
t Please read these operating instructions carefully and completely before using
this device.
t These instructions are part of the product. Keep them in a safe and easily
accessible place near the device’s site of installation.
t If the instructions should be lost or misplaced, please contact Sartorius for a
replacement or download the latest version from our website: www.sartorius.com
The device may only be used with the equipment and under the operating
conditions described in [Chapter “3. Device Description”, page 23and in
Chapter “12. Technical Specifications”, page 76].
The user must be qualified to handle the device, media and cultures and be aware
of the hazards potentially associated with the process.
The process may make it necessary to equip the device or the work area with
additional safety equipment or to take other measures for the protection of
personnel and the work environment.
The documentation does not include more detail about such conditions or legal or
otherwise obligatory guidelines.
Safety and danger instructions in the documentation only apply to this unit and
supplement the guidelines of the operator in the work area for the process in
question.
In addition to the operating manual, all generally valid, legal and otherwise binding
regulations for accident protection and environmental protection of the country of
use must be observed.
− Any guarantees and warranties shall apply to manufacturing-related defects and
malfunctions.
− The unit is designed for usual laboratory conditions and techniques.
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Operating Instructions Biostat®RM 200 Rocker 7
About This Document
1.1 Validity
The operating instructions apply to the Biostat® RM 200 Rocker:
− Version
− 124.000 (230 V)
− 124.001 (120 V)
− in combination with the control unit Biostat®B
− in combination with the culture bags
− Flexsafe®RM 100L basic / optical / perfusion ATF
− ®RM 100L basic / optical / perfusion ATF
1.2 Accompanying Documents
This operating manual contains the instructions for operating the device with the
standard equipment intended for this purpose.
In addition to this operating manual, you can find all necessary technical
documentation on the device, e.g. P&I diagrams, a spare parts list, installation plans,
technical drawings etc., in the folder “Technical Documentation”.
If customer-specific modifications were implemented, the appropriate documents
can either be integrated into the “Technical Documentation” folder or they can be
delivered together with the device as separate documents.
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:
− the notes in the documentation of the culture bags.
− the notes in the operating instructions of the control unit “Biostat®B”.
− the notes in the documentation of other components.
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8 Operating Instructions Biostat®RM 200 Rocker
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.
This symbol denotes a possible danger with risk that moderate or minor injury may
result if it is not avoided.
This symbol denotes a danger with low risk that can result in property damage if the
risk is not avoided.
This symbol
− is an indication of a function or setting on the device.
− is an indication that caution should be exercised while working.
− identifies useful information.
The following presentations will also be used:
– Texts that follow this mark are lists.
tTexts that follow this mark describe activities that must be carried out in the
specified order.
yTexts that follow this mark describe the result of an action.
” “ Texts in quotes are references to other chapters or sections.
1.4 Abbreviations
PLC Programmable logic control
vvm Volume of the flow of gas per volume of liquid per minute
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Operating Instructions Biostat®RM 200 Rocker 9
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.
In addition to the instructions in this operating manual, also observe all generally
valid safety and accident protection guidelines.
In addition to the instructions in this operating manual, the operator / user must
observe all existing national, workplace, operating and safety guidelines.
Existing internal plant guidelines must also be observed.
2.1 General Safety Precautions
− The device may only be set up, started, or serviced after gaining familiarity with
this operating manual.
− Use the device only for its intended purpose (see Chapter “2.4 Intended Use and
Foreseeable Misuse”, page 11).
− The device is not ATEX (ATmosphère EXplosive)-certified. The device may not be
operated in potentially explosive atmospheres.
− During operation of the unit, do not permit any work method that hinders the
safety of the unit.
− Always keep the working area of the unit clean and orderly, in order to avoid
danger from dirt or scattered parts.
− Always squat to work on low-lying components; do not bend over. Carry out
work on high components in an upright, straight body position.
− Do not exceed the technical performance data (see data sheet for the unit).
− Keep all safety precautions and hazard notices on the device in a legible
condition, and replace them as needed.
− Operation as well as work on the device may only be carried out by authorized
specialists.
− Do not start the unit if other people are in the danger zone.
− In case of malfunction, immediately stop the device. Have the fault corrected by
appropriately trained personnel or by your Sartorius Service Center.
2.2 Informal Safety Measures
− Always keep the operating manual in the location where the device is in use.
− In addition to the operating manual, follow all general and local regulations for
accident prevention and environmental protection.
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10 Operating Instructions Biostat®RM 200 Rocker
Safety Precautions
2.3 Symbols Used on the Device
The following symbols are affixed to the device:
Electrical hazard from voltage or current!
Work on the electrical equipment of the device may only be carried out by Sartorius
Service or authorized technicians.
Electrical hazard from voltage or current!
Before opening the casing disconnect the unit from power supply.
− The device may be opened only by authorized personnel of Sartorius Stedim
Biotech.
− Disconnect the device from the power supply before carrying out any work on
the device.
Danger of burns!
The equipment may become hot when in operation.
− Avoid accidental, unintentional contact.
− Use protective gloves when operating the equipment.
− Let the heating elements and equipment cool down before carrying out assembly
work.
− Please ensure that the surface temperature sensor is correctly installed.
Danger of crushing!
There is a danger of crushing with the rocker device.
− Proceed carefully when closing the hood of the device. Use the handle on the
hood of the device.
− Keep the hood of the device closed during operation.
Transport locking device
The device is provided with a transport locking device. The transport locking device
must be removed before using 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.
t Keep all safety precautions and hazard notices on the device in a legible
condition, and replace them as needed.
*** TeDIS Valid on Date Printed Printed on: 20-09-2023 11:08:57 ***