Sartorius Stedim Biotech BIOSTAT B User manual

Operating Manual
BIOSTAT®B
Fermenter| Bioreactor
85037-545-02 Vers. 05|2014
*** TeDIS Valid on Date Printed Printed on: 20-09-2023 11:08:41 ***
185013007862

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: 85037-545-13
Sartorius Stedim Biotech GmbH
Technical Editorial Department
August-Spindler-Strasse 11
37079 Goettingen, Germany
[email protected]
www.sartorius-stedim.com
System Requirements:
– Windows, MacOS X
– Browser with JavaScript enabled
– PDF-Reader
Use start.html to run the application
*** TeDIS Valid on Date Printed Printed on: 20-09-2023 11:08:41 ***

Contents 3
Contents
1. About this Document ............................................................ 8
1.1 Validity....................................................................... 9
1.2 Accompanying Documents .................................................. 9
1.3 Symbols Used ................................................................ 10
2. Safety Instructions ............................................................... 11
2.1 General Safety Instructions .................................................. 11
2.2 Informal Safety Measures.................................................... 12
2.3 Symbols Used on the Unit.................................................... 12
2.4 Intended Use and Foreseeable Misuse ....................................... 13
2.5 Residual Risks from Use of the Unit.......................................... 14
2.6 Danger Due to Electrical Power.............................................. 14
2.7 Danger Due to Components Under Pressure................................. 15
2.8 Hazards Arising from Bursting Culture Vessel ............................... 15
2.9 Danger Due to Gases......................................................... 15
2.9.1 Danger Due to Oxygen .............................................. 15
2.9.2 Danger Due to Nitrogen ............................................. 16
2.9.3 Danger Due to Carbon Dioxide ...................................... 16
2.10 Danger Due to Escaping Materials ........................................... 16
2.11 Danger Due to Hot Surfaces ................................................. 17
2.12 Danger Due to Rotating Parts................................................ 17
2.13 Danger Due to Use of Incorrect Consumables ............................... 17
2.14 Safety and Protective Systems............................................... 18
2.14.1 Main Switch ......................................................... 18
2.14.2 Safety Valves and Pressure Reducer ................................. 18
2.14.3 Overheating Protection.............................................. 18
2.15 Personal Protective Equipment .............................................. 19
2.16 Emergency Instructions ...................................................... 20
2.17 Operator Responsibilities .................................................... 20
2.18 Personnel Requirements ..................................................... 21
2.18.1 Personnel Qualification Requirements .............................. 21
2.18.2 Personnel Responsibilities ........................................... 22
2.18.3 Responsibilities ...................................................... 22
2.18.4 Unauthorized Personnel ............................................. 22
2.18.5 Training and Instruction............................................. 23
3. Device Overview.................................................................. 24
3.1 Control/Supply Units......................................................... 25
3.1.1 BIOSTAT®B-MO Single/ Twin ........................................ 25
3.1.2 BIOSTAT®B-CC Single/ Twin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
3.1.3 Control Elements and Connections.................................. 27
3.1.4 Aeration Modules.................................................... 31
3.1.4.1 Modules “Additive Flow 2-Gas”
(BIOSTAT®B-MO Single/ Twin) ............................ 31
3.1.4.2 Modules “Additive Flow 4-Gas”
(BIOSTAT®B-CC Single /Twin) ............................. 32
3.1.5 Peristaltic Pumps .................................................... 33
3.2 Culture Vessels ............................................................... 34
3.2.1 UniVessel®Glass...................................................... 34
3.2.2 UniVessel®SU ........................................................ 35
3.2.3 RM Rocker 20| 50 ................................................... 36
3.3 Stirrer Driver ................................................................. 37
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4 Contents
4. Software .......................................................................... 38
4.1 User Information............................................................. 38
4.2 System Start ................................................................. 38
4.3 Principles of Operation ...................................................... 40
4.3.1 Device-specific User Interfaces...................................... 40
4.3.2 User Interface........................................................ 40
4.3.2.1 Header Line ............................................... 40
4.3.2.2 Work Area................................................. 41
4.3.2.3 Footer ..................................................... 42
4.3.3 Display ............................................................... 44
4.3.4 Overview of the Main Function Keys ................................ 45
4.3.5 Overview of Selection Keys.......................................... 46
4.3.6 Direct Function Keys for Selection of Submenus.................... 46
4.3.7 Selection Lists and Tables............................................ 49
4.4 Password Protection of Individual Functions ................................ 50
4.5 Error Handling and Troubleshooting......................................... 50
4.6 Locking Functions............................................................ 50
5. Transport ......................................................................... 51
5.1 Inspection Upon Acceptance by the Recipient............................... 51
5.1.1 Report and Document Transport Damage ........................... 51
5.1.2 Check Completeness of the Delivery ................................ 51
5.2 Packaging .................................................................... 51
5.3 Instructions for Transport Within the Company ............................. 52
6. Setup.............................................................................. 53
6.1 Acclimatization .............................................................. 53
6.2 Ambient Conditions.......................................................... 53
6.3 Work Surfaces and Loads .................................................... 54
6.4 Laboratory Energy Sources................................................... 57
6.4.1 Electricity............................................................ 57
6.4.2 Manufacturer’s ID Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
6.4.3 Tempering Medium .................................................. 59
6.4.4 Gas Supply........................................................... 60
7. Startup............................................................................ 62
7.1 Installation Material ......................................................... 62
7.2 Connecting the Device to the Power Supply................................. 63
7.3 Connecting Laboratory Water Supply to the Device......................... 64
7.4 Connecting Laboratory Gas Supply to the Device ........................... 65
7.5 Connecting the Stirrer Driver
(only UniVessel®Glass / UniVessel®SU)....................................... 66
7.6 Connecting the UniVessel®SU Holder........................................ 67
7.7 Connecting the Barcode Scanner ............................................ 67
7.8 Connect RM Rocker 20| 50 for CultiBag RM................................. 68
7.9 Connecting the Sensor Cable ................................................ 68
7.10 Connecting the Tubes for Aeration .......................................... 68
7.11 Connecting the Temperature Control........................................ 69
7.11.1 Jacketed Culture Vessels / Single-walled Culture Vessels with
Heating | Cooling Jacket (only UniVessel®Glass / UniVessel®SU).... 69
7.11.2 Cultibag RM Temperature Control................................... 71
7.11.3 Heating Jacket (only UniVessel®Glass / UniVessel®SU).............. 72
7.12 Connecting the Exhaust Cooling Hoses (only UniVessel®Glass).............. 73
7.13 Turning the Device On and Off .............................................. 74
8. Preparing and Running the Process............................................. 75
8.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
8.2 Preparing the Glass Culture Vessels.......................................... 75
8.3 Connecting Transfer Lines ................................................... 76
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Contents 5
8.4 Filling the Culture Vessel with Culture Medium ............................. 78
8.4.1 UniVessel®Glass / UniVessel®SU..................................... 78
8.4.2 CultiBag RM ......................................................... 78
8.5 Sterilizing Glass Culture Vessels.............................................. 78
8.6 Preparing the Cultivation Process ........................................... 79
8.6.1 Mounting the Agitator Drive ........................................ 80
8.6.2 Heating | Cooling Jacket Installation................................ 82
8.6.3 Installing the Heating Blanket....................................... 83
8.6.4 Connecting the Aeration Modules................................... 85
8.6.4.1 Conducting Preliminary Steps ............................ 85
8.6.4.2 UniVessel®SU Safety Valve Station ....................... 85
8.6.4.3 Connecting the “Additive Flow 2-gas” Aeration System.. 86
8.6.4.4 Connecting the “Additive Flow 4-gas” Aeration System.. 87
8.6.5 Preparing the Corrective Solution Supply ........................... 88
8.7 Performing a Process ........................................................ 90
8.7.1 Setting Up the Measurement and Control System .................. 91
8.7.2 Guaranteeing Sterility ............................................... 92
8.7.3 Carrying out the Cultivation Process ................................ 92
8.8 “Main” Menu................................................................. 93
8.8.1 General Information................................................. 93
8.8.2 Process Displays in the “Main” Menu................................ 94
8.8.3 Direct Access to Submenus .......................................... 94
8.9 “Trend” Menu ................................................................ 96
8.9.1 “Trend” Display ...................................................... 96
8.9.2 Configuring the “Trend” Display..................................... 97
8.9.2.1 Setting the Trend Display for Parameters................. 97
8.9.2.2 Setting the Parameter Display Range..................... 97
8.9.2.3 Resetting the Display Range .............................. 98
8.9.2.4 Setting the Trend Display Color........................... 98
8.9.2.5 Defining a New Time Range as “Time Range”............. 98
8.10 “Calibration” Menu .......................................................... 99
8.10.1 General Information................................................. 99
8.10.2 pH Calibration (conventional sensor)................................ 99
8.10.2.1 General Information on the pH Sensor ................... 99
8.10.2.2 “Calibration pH-#” Submenu ............................100
8.10.2.3 Perform Calibration......................................101
8.10.2.4 Direct Input of the Zero Offset and Slope ...............102
8.10.2.5 Perform Recalibration ...................................102
8.10.3 DO Calibration (conventional sensor) ..............................103
8.10.3.1 General Information on the pO2Sensors ................103
8.10.3.2 Submenu “Calibration pO2-#” ...........................103
8.10.3.3 Perform Calibration......................................104
8.10.3.4 Direct Input of the Zero Offset and Slope ...............105
8.10.4 Optical pH and pO2Sensors ........................................105
8.10.4.1 Signal Quality of the Optical Probes.....................106
8.10.4.2 Notes on Calibration.....................................107
8.10.5 pH Calibration (optical sensor) .....................................107
8.10.5.1 “Calibration pH-#” Submenu ............................108
8.10.5.2 Enter Initial Calibration Data ............................109
8.10.5.3 Performing Recalibration ................................110
8.10.5.4 Configuring the Measurement Cycle for
pH Measurement.........................................111
8.10.6 DO Calibration (optical sensor) .....................................111
8.10.6.1 Submenu “Calibration pO2-#”...........................112
8.10.6.2 Perform Initial Calibration...............................113
8.10.6.3 Performing Recalibration ................................114
8.10.6.4 Configuring Measurement Cycles for DO Measurement.114
8.10.7 Totalizer for Pumps and Valves .....................................115
8.10.8 Scale Taring.........................................................117
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6 Contents
8.11 “Controller” Menu ..........................................................119
8.11.1 Functional Principle and Equipment ...............................119
8.11.2 Controller Selection ................................................120
8.11.3 General Controller Operation.......................................121
8.11.4 Setpoint Profile.....................................................122
8.11.5 General Controller Parameterization...............................123
8.11.5.1 Output Limits ............................................124
8.11.5.2 Dead Zone................................................124
8.11.5.3 Controller Parameterization Menu Screen ..............124
8.11.5.4 PID Parameters...........................................125
8.11.5.5 PID Controller Optimization .............................125
8.11.6 Guide and Slave Controller (TEMP, JTEMP)
Temperature Measurement.........................................125
8.11.7 Temperature Measurement Without Slave Controller (TEMP)......127
8.11.8 Speed Regulation (STIRR)...........................................128
8.11.9 Antifoam Controller “FOAM” .......................................129
8.11.10 Level Control with Level Sensor (LEVEL) ............................130
8.11.11 Gravimetric Level Control (VWEIGHT) ..............................131
8.11.12 Gravimetric Filling Pump Controller “FLOW” .......................132
8.11.13 Filling Pump Controller (SUBS) .....................................133
8.11.14 Gas Controller (Gas Filling Controller / Gas Flow Controller).......134
8.11.15 pH Controller .......................................................135
8.11.15.1 Function .................................................135
8.11.15.2 Controller Operator Screen ..............................135
8.11.15.3 Parameter Settings ......................................136
8.11.15.4 Acid, Base, and CO2Supply-driven pH Control ..........136
8.11.16 DO Control Methods................................................137
8.11.16.1 pO2Controller CASCADE (cascade controller) ...........138
8.11.16.2 pO2Controller ADVANCED (polygon controller) .........141
8.11.16.3 Aeration Strategies ......................................147
8.11.17 RM Rocker 20 |50 Controller Functions ............................150
8.11.17.1 Introduction .............................................150
8.11.17.2 Angle Control ............................................151
8.11.17.3 Position Settings “POSITIONING” ........................152
8.11.17.4 Aeration Rate ............................................154
8.11.17.5 Additional Information ..................................155
8.12 “Settings” Menu.............................................................156
8.12.1 General Information................................................156
8.12.2 Settings.............................................................158
8.12.3 Measuring Range Settings..........................................158
8.12.4 Manual Operation ..................................................160
8.12.4.1 Manual Operation for Digital Inputs.....................161
8.12.4.2 Manual Operation for Analog Inputs ....................165
8.12.4.3 Manual Operation of Analog Outputs ...................166
8.12.4.4 Manual Operation for Controllers (“Control Loops”).....168
8.12.5 Manual Operation of Sequence Control (“Phases”).................169
8.12.6 Externally Connected Devices ......................................170
8.12.7 Service and Diagnosis...............................................171
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Contents 7
9. Faults ............................................................................172
9.1 Safety Instructions..........................................................172
9.2 Troubleshooting.............................................................172
9.3 Hardware-related Faults ....................................................173
9.3.1 Fault Table “Contamination” .......................................173
9.3.2 Troubleshooting Table “Counter Cooling System”..................174
9.3.3 Troubleshooting Table “Aeration and Ventilation” .................174
9.4 Process-related Faults / Alarms .............................................175
9.4.1 Alarm Triggering....................................................175
9.4.2 “Alarm Overview” Menu ............................................176
9.4.3 Process Value Alarms ...............................................176
9.4.4 Alarms for Digital Inputs ...........................................179
9.4.5 Alarms, Meaning and Corrective Measures.........................180
9.4.5.1 Process Alarms ...........................................180
9.4.5.2 System Alarms ...........................................181
10.Cleaning and Maintenance .....................................................182
10.1 Cleaning.....................................................................183
10.1.1 Cleaning the Device ................................................183
10.1.2 Cleaning the Culture Vessels........................................184
10.1.3 Cleaning and Maintaining Heating Jackets.........................184
10.2 Maintenance ................................................................186
10.2.1 Carry out Maintenance Work on Function Elements ...............186
10.2.2 Safety Component Maintenance ...................................186
10.2.3 Maintenance Intervals..............................................187
11.Storage ..........................................................................189
12.Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190
12.1 General Notes ...............................................................190
12.2 Hazardous Materials ........................................................190
12.3 Decontamination Declaration ..............................................191
12.4 Decommissioning the Unit..................................................191
12.5 Disposing of the Unit .......................................................192
13.Specifications ...................................................................193
13.1 Ambient Conditions.........................................................195
13.2 Water Hardness Conversion Table ..........................................195
14.Conformity & Licenses ..........................................................196
14.1 EC Declaration of Conformity...............................................196
14.2 GNU Licensing ..............................................................196
15.Appendix.........................................................................198
15.1 Service Center...............................................................198
15.2 Decontamination Declaration ..............................................198
15.3 Setup Drawings .............................................................200
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8 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®B-MO and BIOSTAT®B-CC (referred to as “device” in the
following).
The operating instructions inform you about how to
− operate the device according to safety requirements,
− maintain the device according to guidelines,
− clean the device 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.
tPlease read these operating instructions carefully and completely before using this
device.
tThese instructions are part of the product. Keep them in a safe and easily
accessible place near the device's site of installation.
tIf the instructions should be lost or misplaced, please contact Sartorius for a
replacement or download the latest version from our website: www.sartorius.com
This description is based on known bioreactor models. The equipment supplied does
not necessarily cover every available type of equipment; some may differ from the
description while others may contain equipment not described here. The names,
characteristics and information can differ from the ones in the technical
documentation because these are each adapted to the equipment supplied.
Documentation on customer-specific equipment can be delivered with the
documentation provided to the customer and | or separately supplied and are
available on request.
The device may only be used under the operating conditions described in the
Technical Data Sheet [¨Chapter “3. Device Overview“].
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.
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About this Document 9
The operating manual must always be kept at the place of use of the device.
− Any guarantees and warranties shall apply to manufacturing-related defects and
malfunctions.
− The unit is designed for usual laboratory conditions and techniques.
1.1 Validity
These operating instructions apply to the BIOSTAT®B-MO (microbial),
BIOSTAT®B-CC (cell culture) in single and twin variants in combination with the
following culture vessels (operating volume):
−UniVessel®Glass, single-walled (SW) / double-walled (jacketed - DW):
−1L
−2L
−5L
− 10 L
−UniVessel®SU Single Use Bioreactor, single-walled (SW):
−2L
− RM Rocker 20|50 with CultiBag RM:
− 20 L
− 50 L
A detailed overview of the available models can be found in [¨Chapter
“3. Device Overview“].
1.2 Accompanying Documents
The operating manual describes how to operate the device along 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 or get in
touch with Sartorius Stedim Biotech directly.
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10 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 instruction 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 could result in property damage
if the risk is not avoided.
This symbol
− is an indication of a function or setting on the device.
− 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.
[¨] Texts following this symbol make reference to other chapters, sections or
documents.
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Safety Instructions 111
1
2. Safety Instructions
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 unit
Read the safety precautions and dangers listed in this section thoroughly before
starting the unit.
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 Instructions
− The unit may only be set up, started or serviced after gaining familiarity with this
operating manual.
− Use the device only for its intended purpose [¨Chapter “2.4 Intended Use and
Foreseeable Misuse“].
− The device is not ATEX (ATmosphère EXplosive)-certified. The unit 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 danger descriptions at the unit in legible condition
and replace them as needed.
− Operation as well as work on the device may only be carried out by trained
personnel.
− Do not start the unit if other people are in the danger zone.
− In case of malfunction, immediately stop the unit.
Have the fault corrected by appropriately trained personnel or by your Sartorius
Stedim Service office.
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12 Safety Instructions
2.2 Informal Safety Measures
− Always keep the operating manual in the location where the unit is in use.
− In addition to the operating manual, follow all general and local regulations for
accident prevention and environmental protection.
2.3 Symbols Used on the Unit
The following symbols are used on the device:
Especially hazardous area or hazardous use of the peristaltic pump!
Follow the instructions in the accompanying documents.
Danger of crushing your hand or fingers in the peristaltic pump – do not
attempt to put your hand inside rotating parts, e.g. the pump head!
To thread the tubing or adjust the rollers, be sure to switch off the pump first.
− These pumps must be switched off in the measurement and control system (in the
main menu or associated controller operator screen).
Danger of burns!
Motor and culture vessel equipment becomes hot during operation.
− Avoid accidental, unintentional contact.
− Use protective gloves when operating the equipment.
− Prior to removing the motor from the stirrer drive, allow the motor housing to cool
down.
− Let the culture vessel and equipment cool down before carrying out assembly
work.
Some of the markings and labels on the equipment were attached by the equipment’s
manufacturers. These may not always correspond to the safety labels
commonly used by Sartorius Stedim Systems.
Be sure to follow the instructions given in this manual.
− Keep all safety precautions and danger descriptions at the unit in legible condition
and replace them as needed.
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Safety Instructions 131
3
2.4 Intended Use and Foreseeable Misuse
The operational safety of the unit is only ensured when it is used for its intended
purpose and operated by trained personnel.
The device is used for the cultivation of prokaryotic and eukaryotic cells solely in
aqueous solution.
The device may only be used indoors.
The intended use also includes:
− That all instructions in the operating manual are followed.
− Observation of inspection and maintenance intervals.
− The use of oils and greases which are suitable for use with oxygen.
− The use of operating and auxiliary materials according to applicable safety
guidelines.
− Observation of operating and repair conditions.
All other applications are not considered the intended use. They may include risks
that cannot be estimated and they are the sole responsibility of the operator.
Claims of any kind resulting from damages due to use other than the intended use are
excluded.
Sartorius Stedim Systems GmbH bears no liability for use other than the intended use.
Danger due to use other than the intended use!
Any use beyond and/or other than the intended use of the unit can lead to dangerous
situations. The following uses are considered not to be the intended use and are
strictly forbidden:
− Processes using biological materials in Safety Classes 3 and 4
− Cultivation in non-aqueous solutions
− Operation of the device outside the performance limits
− Operation outdoors
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14 Safety Instructions
2.5 Residual Risks from Use of the Unit
This unit is a state-of-the-art machine and was designed and built in accordance
with recognized safety standards. Nevertheless, 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.
Anyone assigned to the installation, commissioning, operation, maintenance or repair
of the device must have read and understood the operating manual.
The device may only be used:
− For its intended use,
− with its safety systems in perfect working order,
− by qualified and authorized personnel.
Furthermore, the following rules must be followed:
− All moving parts must be lubricated as required.
− All screw connections must be checked at regular intervals and tightened if
necessary.
2.6 Danger Due to Electrical Power
Danger to life caused by electrical voltage!
Electrical switching elements are installed in the device. Contact with parts under
voltage represents a direct danger of death. Damage to the insulation or individual
components can be fatally dangerous.
− Never open the device. The device may be opened only by authorized personnel
of the Sartorius Stedim Biotech Company.
− Work on the electrical equipment of the device may only be carried out by
Sartorius Stedim Service or authorized technicians.
− Check the electrical equipment of the device regularly for defects such as loose
connections or damage to the insulation.
− In case of defects, turn the power supply off immediately and have the defects
corrected by Sartorius Stedim Service or authorized technicians.
− If work is required on parts under voltage, ask a second person to be ready to turn
off the unit’s main switch if needed.
− During all work on the electrical equipment, disconnect it and check that voltage
is no longer applied.
− During maintenance, cleaning and repair work, turn the power supply off and
secure it against reactivation.
− Keep moisture away from parts under voltage, as it can lead to short circuits.
− Have the following tested by a qualified electrician according to the national
regulations: electrical components, connection cables with plugs and extension
and device connector cables with their sockets, given they are used.
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Safety Instructions 151
5
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:
− Do not start the culture vessel without a safety valve or comparable overpressure
safety (e.g. a burst disk).
− Turn the unit off and secure it against reactivation when working on pressurized
components.
− Release the pressure from system sections and pressure lines to be opened before
starting any repair work.
− Regularly check all lines, hoses and connections under pressure for leaks and
externally detectable damage.
2.8 Hazards Arising from Bursting Culture Vessel
Danger of injury from shattered glass!
Damaged and bursting glass can cause cuts and eye injuries.
Therefore:
− Provide operating personnel with training regarding glass breakage due to external
influences. Ensure the culture vessel remains stable at all times.
− Wear personnel protective equipment.
− Make sure that the culture vessel is properly connected to the supply and control
units.
− Ensure that the culture vessel remains within the maximum permissible pressure
limits.
− Make sure that the cooling water flows back without pressure.
− Regularly check all lines, hoses and connections under pressure for leaks and
externally detectable damage.
2.9 Danger Due to Gases
2.9.1 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.
− Keep the whole aeration segment free from oil and grease. Make sure that the
cooling water flows back without pressure.
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16 Safety Instructions
Reactions with other substances!
− Ensure that pure oxygen does not come into contact with oil or grease.
− Use only materials and substances suitable for use with pure oxygen.
2.9.2 Danger Due to Nitrogen
Danger of suffocation due to escaping nitrogen!
Escaping gas at high concentrations may force the
air out of closed rooms and can cause loss of consciousness, leading to suffocation.
− Check the gas lines and culture vessels for leaks.
− Ensure good ventilation of the installation site.
− Keep a breathing device independent of ambient air ready for emergencies.
− If personnel appear affected by symptoms of suffocation, immediately provide
them with a breathing device independent of ambient air. Bring them into fresh
air, make them comfortable and keep them warm. Call a doctor.
− If a person stops breathing, initiate first aid measures with artificial respiration.
− Monitor the limit values at the system and in the building
(sensors recommended).
− Check process gas lines and filters on leakages regularly.
2.9.3 Danger Due to Carbon Dioxide
Danger of poisoning by escaping carbon dioxide!
− Check the gas lines and culture vessels for leaks.
− Ensure good ventilation of the installation site.
2.10 Danger Due to Escaping Materials
Danger of scalding due to defective components!
− Inspect the unit before starting the process.
− Check the connections of containers and the connections to the supply unit.
− Regularly check hoses for leaky places and replace any leaking hoses.
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Safety Instructions 171
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Danger of injury from escaping feed and culture media!
− Use the specified hoses only.
− Use hose fastenings on connecting pieces.
− Empty the feed hoses before loosening the hose connection.
− Wear personnel protective clothing.
− Wear safety glasses.
Danger of contamination from escaping feed and culture media!
− Empty the feed hoses before loosening the hose connection.
− Wear personnel protective clothing.
− Wear safety glasses.
2.11 Danger Due to Hot Surfaces
Danger of burns upon contact with hot surfaces!
− Avoid contact with hot surfaces like temperature-controlled culture vessels and
motor housings.
− Block the danger zone off.
− Wear protective gloves when working with hot culture media.
2.12 Danger Due to Rotating Parts
Danger of limbs being pulled into the rotation pump and crushed!
− Do not remove the safety mechanisms.
− Allow only qualified and authorized personnel to work on the device.
− Disconnect the device from power when performing maintenance and cleaning
tasks.
− Block the danger zone off.
− Wear personnel protective equipment.
2.13 Danger Due to Use of Incorrect Consumables
Danger of injury due to incorrect consumables!
− 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 Systems GmbH. You can find all
necessary specifications for consumable materials in the folder “Technical
Documentation“.
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18 Safety Instructions
2.14 Safety and Protective Systems
2.14.1 Main Switch
The main switch is on the operator side of the control unit.
The main switch is simultaneously the emergency-off switch used to turn the unit on
and off.
2.14.2 Safety Valves and Pressure Reducer
Danger of injury from bursting culture vessels and lines!
− Do not start the unit without safety valves and pressure reducer or comparable
overpressure safety.
− Have your safety valves and the pressure reducer serviced regularly by the
Sartorius Stedim Service.
− Observe the information in the folder “Technical Documentation”.
Overpressure Valve Aeration Segment
Overpressure valves for the sparger and overlay aeration are installed into the
aeration segments within the unit.
The aeration pressure is limited to 1 bar using the overpressure valves.
When using the UniVessel®SU, connect the UniVessel®SU safety valve station with
the aeration segments of the BIOSTAT®B supply unit. The pressure is limited to
0.5 barg (7.25 psig) with the help of the UniVessel®SU safety valve station.
When using the CultiBags in conjunction with the BIOSTAT®RM 20|50, use only the
aeration module or a Sartorius Stedim DCU controller, as these have an overpressure
relief valve.
Pressure Reducer Cooling System
The pressure reducer is installed in the unit.
The cooling water within the temperature control and exhaust systems is limited to
1.2 bar using the pressure reducer.
2.14.3 Overheating Protection
Danger of burns from overheated components!
If individual components are damaged, gaseous and liquid materials may escape
under high pressure and e.g. cause injury to eyes.
− Do not start the unit without overheating protection.
− Have your overheating protection serviced regularly by the Sartorius Stedim
Service.
− Observe the information in the folder “Technical Documentation”.
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Safety Instructions 191
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The overheating protection within the unit limits the maximum permissible
temperature for the temperature control system. The following temperature control
systems can be used:
− Temperature control system water circulation system
− Temperature control system heating jacket
2.15 Personal Protective Equipment
When operating the unit, 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.
Wear the following personal protective gear
during all work:
Protective work clothes
Protective work clothing is tight-fitting work clothing with low tear resistance, tight
sleeves and without any projecting parts. It is primarily intended to protect you from
being caught by moving machine parts.
Do not wear rings, chains or other jewelry.
Head covering
To protect your hair from being caught and pulled into moving parts of the unit,
wear a head covering.
Safety gloves
Wear safety gloves to protect your hands from process materials.
Safety glasses
Wear safety glasses to protect yourself from media escaping under high pressure.
Safety boots
Wear non-slipping safety boots to protect against slipping on smooth floors.
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20 Safety Instructions
2.16 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.
− Keep entry and rescue routes free for rescue vehicles and rescue personnel.
Measures to be Taken After Accidents
− Trigger an emergency stop at the main switch.
− Save personnel from the danger zone.
− In case of stopped heart or breathing, initiate first aid measures immediately.
− Report personal injuries to the first aid officer and an emergency doctor and/or
the rescue service.
− Keep entry and rescue routes free for rescue vehicles and rescue personnel.
− Extinguish fires in the electrical equipment with a CO2extinguisher.
2.17 Operator Responsibilities
The device is used in the commercial sphere. The operator of the device is therefore
subject to the legal obligations for workplace safety.
In addition to the safety instructions in this operating manual, the safety, accident
prevention and environmental protection regulations valid for the location of use of
the device must also be observed.
This applies particularly:
− The operators must inform themselves of the applicable workplace safety
regulations and carry out a hazard evaluation to determine additional dangers
that may result due to the special working conditions at the location of use of
the unit. These must be expressed in the form of operational instructions for the
operation of the unit (hazard prevention plan).
− During the entire period of use of the unit, the operator must check whether the
operating instructions correspond to the current state of regulations and adapt
them as needed.
− The operator must clearly regulate and determine responsibilities for operation,
maintenance and cleaning.
− The operator may only allow trained and authorized individuals to work with the
device. Trainees such as apprentices or auxiliary staff members are only allowed
to work with the unit under supervision of qualified technicians [¨Chapter
“2.18 Personnel Requirements“].
− The operator must ensure that all employees involved with the unit are suitable in
terms of physical capacity, person and character to operate the unit responsibly.
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