185013007862
Operating Manual
BIOSTAT® B
Fermenter | Bioreactor
85037-545-02
*** TeDIS Valid on Date Printed
Vers. 05 | 2014
Printed on: 20-09-2023 11:08:41 ***
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
tech.pubs@sartorius-stedim.com
www.sartorius-stedim.com
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*** TeDIS Valid on Date Printed
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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
Contents
*** TeDIS Valid on Date Printed
Printed on: 20-09-2023 11:08:41 ***
3
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
4
Contents
*** TeDIS Valid on Date Printed
Printed on: 20-09-2023 11:08:41 ***
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 pO2 Sensors . . . . . . . . . . . . . . . . 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 pO2 Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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
Contents
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5
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 CO2 Supply-driven pH Control . . . . . . . . . . 136
8.11.16 DO Control Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
8.11.16.1 pO2 Controller CASCADE (cascade controller) . . . . . . . . . . . 138
8.11.16.2 pO2 Controller 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
6
Contents
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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
Contents
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7
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.
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
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.
8
About this Document
*** TeDIS Valid on Date Printed
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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.
About this Document
*** TeDIS Valid on Date Printed
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9
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.
t Texts that follow this mark describe activities that must be carried out in the
specified order.
y Texts 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.
10
About this Document
*** TeDIS Valid on Date Printed
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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.
Safety Instructions
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11
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.
12
Safety Instructions
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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
Safety Instructions
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13
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.
14
Safety Instructions
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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.
Safety Instructions
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15
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
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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“.
Safety Instructions
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17
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
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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.
Safety Instructions
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19
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 CO2 extinguisher.
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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Safety Instructions
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− The operator must also ensure that all employees are familiar with the basic
regulations concerning workplace safety and accident prevention, trained in
handling the unit and have read and understood the operating manual.
− Furthermore, the operator must evaluate the safety-conscious work of personnel
at regular intervals and demonstrate training of personnel and notification of
danger.
− The operator must avoid stress situations during operation of the unit by means
of technological and organizational work preparation.
− The operator must provide adequate workplace lighting in the place of operation
of the unit in accordance with locally applicable workplace guidelines.
− The operator must provide personnel with personal protective equipment.
− The operator must ensure that no-one works on the unit whose reaction time is
impaired, for example by drugs, alcohol, medications or the like.
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.
2.18 Personnel Requirements
Danger of injury if personnel qualifications are insufficient!
Improper use can lead to significant personal injury and/or property damage.
Have all activities performed only by qualified personnel.
Only those individuals are permitted of whom it can be expected that they will
carry out their work reliably. No-one may work on the unit whose reaction time is
impaired, for example by drugs, alcohol, medications or the like.
2.18.1 Personnel Qualification Requirements
In the operating manual, the following qualifications are cited for different areas of
activity:
Trainee
A trainee such as an apprentice or an auxiliary staff member does not know all the
dangers that can occur during operation of the unit. They may only perform work on
the unit under the supervision of technicians.
Trained Person
A trained person has been informed in a training session by the operator about the
tasks assigned to them and the possible dangers of improper behavior.
Safety Instructions
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21
Technician
Due to his or her technical education, knowledge and experience, as well as
knowledge of applicable regulations, a technician is capable of carrying out tasks
assigned to him or her and independently detecting and avoiding possible dangers.
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.
2.18.2 Personnel Responsibilities
Before undertaking any work with the unit, all personnel are obliged to:
− Pay attention to the basic occupational safety and accident prevention
regulations.
− Read the safety instructions and warnings in this operating manual and confirm by
signature that they have understood.
− Follow all safety and operation instructions in this operating manual.
2.18.3 Responsibilities
The areas of responsibility of the personnel concerning the operation, maintenance
and cleaning of the unit must be clearly defined.
2.18.4 Unauthorized Personnel
Danger to unauthorized personnel!
Unauthorized personnel who do not meet the qualification requirements for
personnel do not know the dangers in the work area.
Therefore:
− Keep unauthorized personnel away from the work area.
− In case of doubt, speak to personnel and instruct them to leave the work area.
− Stop work as long as unauthorized personnel remain in the work area.
22
Safety Instructions
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2.18.5 Training and 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
Safety Instructions
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23
3. Device Overview
The devices BIOSTAT® B-MO, BIOSTAT® B-CC are designed for the cultivation of
microorganisms and cells in discontinuous and continuous processes.
They were designed for cultivating microorganisms and cells at various reactor
volumes. The devices can be used to conduct studies on developing and optimizing
fermentation procedures and to perform limited-volume production fermentation
processes in a reproducible way.
The measurement and control systems permit measurement, control and evaluation
of process parameters (such as temperatures, pH and pO2 values) online, independent
monitoring of the progress of fermentation or cultivation in each culture vessel
(Twin variant), as well as reproducible process control in combination with the SCADA
software BioPAT®MFCS/win by performing the user-defined parameter sets specified
in the recipes.
The device is made up of the following components (the actual equipment depends
on configuration):
Control Unit
− Control unit in single and twin models
− DCU measurement and control system
− Aeration modules “MO” (BIOSTAT® B-MO) for aeration of the culture vessel with air
and oxygen, e.g. for microbial cultures
− Aeration modules “CC” (BIOSTAT® B-CC) for aeration of the culture vessel with air,
O2, N2 and CO2, e.g. tissue cell cultures containing animal cells in the suspension
culture
− Temperature control modules with associated fittings (e.g. heating jacket and
cooling finger)
− Cooling water circuit for the exhaust cooler
− Exhaust filter heating
− Peristaltic pump modules (up to 4 modules for single version | up to 8 modules for
twin version)
Culture Vessels
− UniVessel® Glass single-walled, jacketed, UniVessel® SU, RM Rocker
− Culture vessel volume
− UniVessel® Glass : 1 L, 2 L, 5 L, 10 L
− UniVessel® SU: 2 L
− CultiBag RM: 20 L, 50 L
− Equipment components for microbial cultures and cell cultures
Stirrer Driver
− Top drive with direct stirrer drive motor
− Drive with magnetic coupling between motor and stirrer
− 6-blade disk impeller or 3-blade disk impeller
The illustrations in the following sections show general system configurations.
The actual equipment depends on your configuration and may deviate from the
devices shown here.
24
Device Overview
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3.1
Control/Supply Units
3.1.1
BIOSTAT® B-MO Single / Twin
Fig. 3-1: Example of the BIOSTAT® B-MO Twin with UniVessel® Glass
3.1.2
BIOSTAT® B-CC Single / Twin
Fig. 3-2: Example of the BIOSTAT® B-CC Twin with UniVessel® Glass
Device Overview
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25
Variants with different culture vessels
26
UniVessel® Glass – UniVessel® Glass
UniVessel® SU – UniVessel® SU
RM Rocker 20 | 50 – RM Rocker 20 | 50
UniVessel® Glass – RM Rocker 20 | 50
UniVessel® Glass – UniVessel® SU
UniVessel® SU – RM Rocker 20 | 50
Device Overview
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3.1.3
Control Elements and Connections
Fig. 3-3: Front view / detail view BIOSTAT® B-CC Twin
Pos. Description
BIOSTAT® B-CC (MO) Twin
with UniVessel® Glass / UniVessel® SU
BIOSTAT® B-CC Twin
with RM Rocker 20 | 50
1
Operator display (touch panel)
Operator display (touch panel)
2
Main switch / power switch
Main switch / power switch
3
Flow meter (rotameter)
Flow meter (rotameter)
3a
AIR “Overlay” (BIOSTAT® B-CC)*
-
3b
AIR “Sparger” (BIOSTAT® B-CC, MO)
AIR “Overlay”
3c
O2 “Sparger” (BIOSTAT® B-CC, MO)
O2 “Overlay”
3d
N2 “Sparger” (BIOSTAT® B-CC)*
N2 “Overlay”
3e
CO2
“Sparger” (BIOSTAT® B-CC)*
CO2 “Overlay”
4
USB data interface
USB data interface
5
Peristaltic pump
Peristaltic pump
* BIOSTAT® B-MO screen
Device Overview
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27
Fig. 3-4: Back view / detail view BIOSTAT® B-CC Twin
Pos. Description
1
Power connection / Potential equalization
1a
Potential equalization (if available in lab)
1b
Power connection
2a
Network port
2b
Common alarm connection
3a
Tempering medium inlet d 10 mm, laboratory side connection
3b
Tempering medium return d 10 mm, laboratory side connection
4
Aeration (laboratory side connection)
4a
Air (BIOSTAT® B-CC, MO) Serto gland d 6 mm
4b
O2 (BIOSTAT® B-CC, MO) Serto gland d 6 mm
4c
N2 (BIOSTAT® B-CC)* Serto gland d 6 mm
4d
CO2 (BIOSTAT® B-CC)* Serto gland d 6 mm
* BIOSTAT® B-MO screen
28
Device Overview
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1a
1b
2a
2b
2c
2d
1
2e
2f
2g
2h
2
2i
2j
2k
2l
3
2m
3a
3c
3b
3d
3e
4
4
Fig. 3-5: Side view / detail view BIOSTAT® B-CC,
UniVessel® Glass, UniVessel® SU
Pos. Description
Comments
1
Aeration
1a
Overlay
(BIOSTAT® B-CC)* Serto gland d 6 mm
1b
Sparger
Serto-screw d 6 mm
2
Sensors
2a
Temp
Temperature sensor, M12 plug connection
2b
Serial-A
Scales connection (FWEIGHT), RS-232, M12 plug connection
2c
pH/Redox-A
pH sensor, Redox sensor, VP8 plug
2d
Serial-B
Scales connection (FWEIGHT / VWEIGHT), RS-232, M12 plug
connection.
2e
pO2-A
pO2 sensor, VP8 plug
2f
Serial-C
UniVessel® SU Holder, RS-232, M12 plug connection
2g
Foam
Foam sensor, M12 plug connection
2h
Serial-D1/
Turb-1
Turbidity sensor, RS-232, Lemo plug
2i
Level
Level sensor, M12 plug connection
2j
Ext.Sig. A/B
External signal input, M12 female connector
2k
Pump-B
External pump, M12 plug connection
2l
Ext.Sig. C/D
External signal input, M12 female connector
2m
Pump-B
External pump, M12 plug connection
3
Temperature control | cooling
3a
Exhaust
3b
Heating Blanket Heating jacket, Amphenol plug
3c
Exhaust
Exhaust cooling inlet, Serto gland d 10 mm
3d
Thermostat
Temperature control return, Serto gland d 10 mm
3e
Thermostat
Temperature control inlet, Serto gland d 10 mm
4
Exhaust cooling return, Serto gland d 10 mm
Stirrer motor connection
* BIOSTAT® B-MO screen
Device Overview
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29
2a
1a
2b
2c
1
2d
2e
2f
2
2g
2h
3
2i
3a
3b
Fig. 3-6: Side view / detail view BIOSTAT® B
30
Pos.
Description
Comments
1
Aeration
1a
Overlay
2
Sensors
2a
pH-A Opt.
Optical pH-sensor, VP8 plug
2b
Serial-A
Scales connection (FWEIGHT), RS-232, M12 plug connection
2c
Serial-B
Scales connection (FWEIGHT),
RS-232, M12 plug connection
2d
pO2-A Opt.
Optical pO2 sensor, VP8 plug
2e
Serial-C
RM Rocker 20 | 50, RS-232, M12 plug connection
2f
Serial-D
Serial interface, RS-232, M12 plug connection
2g
Ext.Sig. A/B
External signal input, M12 female connector
2h
Pump-B
External pump, M12 plug connection
2i
Pump-C
External pump, M12 plug connection
3
Temperature control | cooling
3a
Thermostat
Temperature control return, Serto gland d 10 mm
3b
Thermostat
Temperature control inlet, Serto gland d 10 mm
(BIOSTAT® B-CC) Serto gland d 6 mm
Device Overview
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3.1.4
Aeration Modules
The supply units of the devices can be equipped with a range of different aeration
modules. Every device can only be equipped with one of the aeration modules
described below.
The laboratory gas supplies for each of the gases must be preset to 1.5 barg (21.76 psig).
The pressure in the vessel supply lines is limited to max. 1 barg (14.5 psig) by the safety
valves in the aeration modules.
Supplemental Information
The built-in variable area flow meters are calibrated to the following standard
conditions.
Calibration Parameters
Gas type:
Air
Temperature:
20 °C = 293 K
Pressure:
1.21 bar (absolute)
When gases with deviating pressures pass through, higher
or lower values can be displayed. These must be recalculated to
evaluate the flow rates.
The manufacturer of the flow rate meters make tables with conversion factors
available. Using the conversion tables, flow rates for the different processes can be
recalculated.
Specific data for gas
Density [kg/m3]
Carbon dioxide (CO2)
1.977
Air (AIR)
1.293
Oxygen (O2)
1.429
Nitrogen (N2)
1.251
3.1.4.1
Modules “Additive Flow 2-Gas” (BIOSTAT® B-MO Single / Twin)
Aeration modules “MO” are used for air supply and oxygen enrichment, e.g. for
microbial cultures.
− Supplies air and O2 to each culture vessel through 2/2-way solenoid valves.
Flow regulated by DCU system pO2 controller:
− Operating modes available: “man”, “auto”, “off” in the operating menu.
Fig. 3-7: BIOSTAT® B-MO rotameter
− In the “man” operating mode, you can set the gas flow rate on the variable
area flow meter.
− Sparger outlet for supplying gas to the culture medium.
− Up to two mass flow controllers for air (AIR) and O2.
Device Overview
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31
Connections supply unit:
BIOSTAT® B-MO Single:
“Sparger-1”
“Sparger-1, -2”
BIOSTAT® B-MO Twin:
Fig. 3-8: BIOSTAT® B-MO connections
3.1.4.2
Modules “Additive Flow 4-Gas” (BIOSTAT® B-CC Single / Twin)
Module “Additive Flow 4-Gas” when an RM Rocker 20 | 50 is connected. Module
“Additive Flow 5-Gas” when a UniVessel® Glass or UniVessel® SU is connected.
Aeration modules “CC” are used to supply up to 4 gases.
These are by default:
− Supply of air
− N2 for decreasing the O2 content, or O2 for increasing the oxygen content;
Fig. 3-9: BIOSTAT® B-CC rotameter
− CO2 for adjusting the pH or use as a carbon (C) source
Air and CO2 can be fed both into the medium in the culture vessel (sparger) and into
the headspace (overlay), while the other gases are fed into the supply line for the
culture medium (sparger) by default.
These modules are designed for tissue cell cultures, e.g. suspension cultures that
contain animal cells. They are also suitable for use with cultures with special aeration
requirements (if CO2 needs to be used as the carbon source, e.g. in anaerobic bacteria
or algae cultures).
− Regulates N2 and O2 flow by means of 2/2-way solenoid valves, controlled by the
DCU system DO controller (pO2).
− Regulates CO2 flow by means of a solenoid valve that is controlled by the DCU
system pH controller (acidity controller).
− Operating modes available for selection in the controller operating menu:
man, auto, off
− Gas volume can be adjusted at the variable area flow meter or by means of
optional mass flow controllers.
Fig. 3-10: BIOSTAT® B-CC connections
− Sparger outlet for supplying gas to the media and overlay for supplying gas to
the headspace in the culture vessel.
− Up to four optional mass flow controllers.
Connections supply unit:
BIOSTAT® B-CC Single:
“Sparger-1” / “Overlay-1”
BIOSTAT® B-CC Twin:
“Sparger-1, -2” / “Overlay-1, -2”
32
Device Overview
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3.1.5
Peristaltic Pumps
The peristaltic pump units WM 114 are located on the supply unit and convey the
correction media and nutrient media through hoses into the vessel.
Up to 4 peristaltic pump modules can be installed on the BIOSTAT® B Single.
Up to 8 peristaltic pump modules can be installed on the BIOSTAT® B Twin.
External Pumps
External pumps can be connected to the supply unit. The connections for the external
pumps and the signal transmission are located at the sensor field of the supply unit
[¨ Chapter “3.1.3 Control Elements and Connections“].
The peristaltic pump modules can be installed to the supply unit in different
specifications (see following table).
Type
Fig. 3-11: Peristaltic pump module WM 114
WM 114
Speed control
5 - 150 rpm
24 V/DC
WM 114
Speed control
0.15 - 5 rpm
24 V/DC
Inner
diameter
of tube
Flow rate (ml/min)
Flow rate (ml/h)
Min
Max
Min
Max
0.50
0.10
3.0
6.0
180
0.80
0.20
6.0
12.0
360
1.60*
0.70*
21.0*
42.0*
1,260*
2.40
1.45
43.5
87.0
2,610
3.20*
2.35*
70.5*
141.0*
4,230*
4.80
4.25
127.5
255.0
7,650
0.50
0.003
0.10
0.18
6
0.80
0.006
0.20
0.36
12
1.60*
0.021*
0.70*
1.26*
42*
2.40
0.044
1.45
2.61
87
3.20*
0.071*
2.35*
4.23*
141*
4.80
0.128
4.25
7.65
255
* = tubing sizes delivered by default
Device Overview
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33
3.2
Culture Vessels
In the following figures, the functional elements will be displayed using examples of
the UniVessel® Glass 1 L and UniVessel® SU 2 L (made of pre-sterilized polycarbonate).
More information about the culture vessels (single-walled, jacketed, volumes) can be
found in the [¨UniVessel® Glass, UniVessel® SU culture vessel and BIOSTAT® RM 20 | 50
operating manuals].
3.2.1
UniVessel® Glass
Fig. 3-12: Functional elements, UniVessel® Glass 1 L
Pos. Description
34
1
Exhaust cooler
2
Stirrer driver
3
Cover plate with ports | retainers for sensors, supply media, sampling, aeration
4
Culture vessel support column
5
Glass vessel:
− temperature control by double wall (jacketed)
− heating jacket and cooling finger (single-walled)
6
Supply bottle with holding ring
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3.2.2
UniVessel® SU
1
2
3
4
Fig. 3-13: Functional elements, UniVessel® SU 2 L with holder
Pos. Description
1
Stirrer with connecting pieces for motor adapter of different control units
2
Cover plate with ports/retainers for sensors, supply media, sampling, aeration,
exhaust air
3
Plastic vessel (temperature control by heating jacket or heating/cooling jacket)
4
Holder
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35
3.2.3
RM Rocker 20 | 50
1
2
3
4
6
5
Fig. 3-14: Functional elements, RM Rocker 20 | 50 with CultiBag RM
Pos.
1
2
3
4
5
6
36
Description
Hood
CultiBag RM
Bag holder
Supply and control unit (RM Rocker 20 | 50)
Touch panel
Connections, left side
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3.3
Stirrer Driver
Fig. 3-15: Stirrer driver
Pos. Description
1
Stirrer driver for culture vessel coupling
2
Power supply
3
Sleeve
The top drive includes a direct drive for the stirrer shaft and a magnetic coupling.
Available drive motors:
− Motor 200 W, rpm range 20 ... 2000 1/min
Rpm Ranges
The standard stirrer shaft is sealed with a rotating mechanical seal. The optional
magnetic coupling is sealed with a rotating mechanical seal, too; the motor coupling
on the outer side, however, is sealed in an enclosure and attached to the driver motor
by means of a magnetic coupling [¨ UniVessel® Glass operating manual].
UniVessel® SU
Glass vessels
1 L/2 L
5L
10 L
0.53 gal
20 – 2000 1/min
20 – 1500 1/min
20 – 800 1/min
20 - 400 1/min
Operating the stirrer at impermissible high speeds can affect the culture vessel’s
stability and cause damage to its fittings. Depending on the size and equipment of
the culture vessels, the permissible speed may be limited, e.g. to max. 300 min-1 in
vessels with aeration rigs for bubble-free aeration.
Device Overview
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37
4. Software
4.1
User Information
This operating manual shows the standard functions of the DCU software.
DCU systems can be customized according to the customer’s specifications. Therefore,
this documentation may describe functions that a delivered configuration does not
contain or a system may contain functions that are not described here.
Information about the actual scope of functionality can be found in the configuration
documents. Additional functions can be described in the technical data sheet in the
“Technical Documentation”.
Illustrations, parameters and settings in this documentation are only examples. They
do not show the configuration or operation of a DCU system in terms of a particular
unit, unless they explicitly refer to that unit.
Information about the exact settings are provided in the configuration documents or
have to be obtained empirically.
Usage Instructions, Structure and Functions
The DCU system can be integrated into higher-level automation systems. For example,
the industrially tested MFCS/Win system can take on host PC functions like process
visualization, data storage, process logging etc.
This operating manual shows operating values and settings that are default values
and examples. Only if explicitly specified as such will they show settings for the
operation of a particular bioreactor.
The configuration documents contain the specifications on the settings permissible
for a bioreactor and the specifications for a customer’s system.
Only system administrators or authorized, trained and experienced users may
change the system configuration.
4.2
System Start
The control unit is turned on together with the whole system using the main switch.
After power on and program start (or restoration of voltage after a power outage),
the system starts in a defined basic state:
− The system configuration is loaded.
− Any user-defined parameters from a previous process are stored in a memory
(CF card) and can be used for the next process:
− Setpoints
− Calibration parameters
− Profiles (given there are any)
− All regulators are turned off and actuators (pumps, valves) are in the rest position.
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Software
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For interruptions in operation, the startup behavior of outputs and system functions
that have a direct effect on the associated end unit (regulators, timers, etc.) depend
on the type and duration of the interruption. There are several different types of
interruptions:
− Turning the unit off | on at the main switch of the control unit.
− Failure of power supplied from the connection in the laboratory (power outage).
In the “System Parameters” submenu of the main “Settings” menu, a maximum
duration for power interruptions can be set as “Fail Time”:
Fig. 4-1: “System Parameters” submenu, [¨ see Chapter “8.12 “Settings” Menu“].
In case of a power outage shorter than “Fail Time”, the system continues as follows:
− A “Power failure” error message shows the outage time.
− Controllers continue to work with the set target value and mode.
− Timer and setpoint profiles continue to be processed.
If the power outage lasts longer than the configured “Failtime”, the DCU system acts
as though the user had turned the unit off normally, that is, it starts in the defined
basic state.
After the next restart, an alarm message appears
[¨ alarm messages in Chapter “9. Faults“], specifying the date and time at which the
power failure occurred.
Software
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39
4.3
Principles of Operation
4.3.1
Device-specific User Interfaces
The user interfaces of the DCU are variable, depending on the device version and
culture vessel type.
The following versions are possible:
− BIOSTAT® B-MO Single UniVessel® Glass
− BIOSTAT® B-MO Twin UniVessel® Glass
− BIOSTAT® B-CC Single UniVessel® Glass
− BIOSTAT® B-CC Single UniVessel® SU
− BIOSTAT® B-CC Single RM Rocker
− BIOSTAT® B-CC Twin UniVessel® Glass | UniVessel® SU
− BIOSTAT® B-CC Twin UniVessel® Glass | RM Rocker
− BIOSTAT® B-CC Twin UniVessel® SU | RM Rocker
4.3.2
User Interface
The user interface offers a graphical overview of the controlled unit, with symbols for
the reactor, components of the gas supply (e.g. valves, mass flow controllers, probes,
pumps, dispensing counters, and if applicable, additional peripherals with their typical
locations relative to the reactor.
The user interface is divided into 3 sections:
− Header
− Work area
− Footer
4.3.2.1
Header Line
Display of the system status, time, date:
− Time in format [hh:mm:ss]
− Date in format [yyyy-mm-dd]
Alarm display (area marked in red / bell symbol):
− Time of the triggered alarm.
− Type of malfunction.
− Alarm triggered, information
on the triggered alarm in the alarm message [¨ see alarm messages section
“Alarm Overview Menu” in Chapter “9. Faults“].
− All alarm messages are shown in the “Alarm” menu.
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Software
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4.3.2.2
Work Area
Fig. 4-2: Example BIOSTAT® B-CC Twin: Menu “Main” for the Unit “1” (above illustration) and for Unit “1”
and Unit “2” (middle/lower illustrations)
Software
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41
The measuring range shows the function elements and submenus of the active main
function:
− Preselected process values with current measured or set value
− Pumps or dispenser counters with process values, e.g. flow rates or dispensing
volumes for correction materials and gases
− Controllers, e.g. for temperature, speed, mass flow controller (MFC) etc., with
current setpoints
− Probes, e.g. for pH, pO2, antifoam etc., with measured values
− Peripheral devices, e.g. weighing system, with measured values or current setpoints
* Function elements, tags, parameters and subsystems actually available depend on
configuration.
4.3.2.3
Footer
The footer shows the menu buttons [¨ Chapter “4.3.4 Overview of the Main Function
Keys“] for:
− Accessing the main menus of the associated menu buttons:
− “Main”
− “Calibration”
− “Controller”
− “Trend”
− “Setttings”
− Switching between the overviews for the two units (“All”) and for individual units
(“1” and “2”)
− Activation of additional functions:
− “Shutdown”
− “Remote” (operation through host interface)
− “Alarm” (with an overview of alarms)
Example
“Main” and “1”:
− Most important and most frequently used parameters for Unit “1”.
− Display of all parameters for Unit “1”.
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Display:
− Selected main function: Button light gray, activated
− Function not selected: Button dark gray, deactivated
Depending on the configuration, the BIOSTAT® B can be equipped with one or two
culture vessels. Operation is specific for any culture vessel:
− The DCU system is operated directly on the display by selecting a main function
and the associated submenus. The function elements in the work area and the
menu buttons in the footer contain touch buttons. By pressing them, you can
activate the assigned submenus; this is necessary e.g. for inputting data and
setpoints or selecting modes.
− Available functions, tag names, parameters and submenus depend on the culture
vessel used and the configuration (for example, heating and cooling system,
aeration type etc.).
Configuration of the process parameters and monitoring of the process values:
Process 1
(left culture vessel)
Process 2
(right culture vessel)
Process 1 and 2
(left and right culture vessel)
Software
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43
4.3.3
Display
The display of function elements is shown in the following table:
Symbol
Display
Meaning, use
Function element
Button with gray
underline
[PV tag]: Field for short name (“tag”) for the function element,
e.g. TEMP, STIRR, pH, pO2, ACID, SUBS, BALANCE
MV [Unit]: Field for measured or set value in its physical unit
− Submenu or function can be selected by pressing
Function element
Button with green
underline
Measured value collection or output of function element is active,
with measured value or set value as shown
(The button is not highlighted in green for pure data collection;
the button turns green if the controller is active).
Function element
Button with light
green underline
Output of function element is active, controller in cascade mode
Function element
Button with yellow
underline
Display of function if in “Manual” mode; (switched on or off);
automatic control not possible
[Tag PV]
MV [Unit]
No underline
No submenu assigned (function cannot be selected)
“U”, “V”, “Y”, “Z”
Arrow button
Move forward or back in specified menu or function
Pump off „ Auto on
Line gray „ green
Direct access to submenu to select the mode
Pump off „ Manual on
yellow underline,
pump gray „ green
Submenu to select mode
[¨ Example in Chapter “8.8 “Main” Menu“]
Valve off „ auto
on
Line gray „ green
Direct access to submenu to select mode, example for 2/2-way valve
Valve off „ Manual on
yellow underline,
flow direction green
Valve symbol also shows flow direction (possibly changed)
Submenu to select the operating mode [¨ Example in Chapter
“8.8 “Main” Menu“]
„
„
†
†
Additional functional elements, RM Rocker 20 | 50
Symbol
Display
Meaning, use
Gas supply pressure
Access to the menu where alarm limits can be configured
Shaker drive operation
[r/min]
Direct access to the submenus to:
− enter the setpoint for the shaker
− select the operating mode for the ROCKS controller
− switch to the controller menu ROCKS
Wobble angle in [°]
44
Access to the menu where alarm limits can be configured
Software
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Examples for function elements, short descriptions, measured values, working values
and submenus that can be called by selecting touch buttons [¨ see Chapter “8.8
“Main” Menu“ and Chapter “4.3.6 Direct Function Keys for Selection of Submenus“].
4.3.4
Overview of the Main Function Keys
Button, symbol
Meaning, use
Main function “Main”
Start screen with graphical overview of the culture vessel:
− Display of components of the current configuration
− Overview of measured values and process parameters
− Direct access to important menus for operating input
Main function “Calibration”
Menus for calibration functions, for example:
− Measurement sensors for pH, pO2
− Totalizer for all pumps (BASE, etc.)
− Totalizer for aeration rates for valves
− Scales
Main function “Controller”
Operating and configuration menus for controllers, for example:
− Temperature regulation TEMP
− Speed regulation STIRR
− pH adjustment and DO (pO2) controller
− Control of correction medium pumps (e.g. pH, SUBS)
− Aeration rate regulation (valves or mass flow controllers).
Main function “Trend”
Display of process sequences, selection of up to 8 parameters from:
− Process values
− Setpoints from control loops
− Outputs of controllers
Main function “Settings”
Basic system settings, e.g.:
− Measurement ranges of process values
− Manual operation, e.g. for inputs and outputs, controllers, etc.
− External communication (e.g. with printers, external computers)
− Selection, modification of configurations (password-protected, only for authorized service
technicians)
Main function “1”, “All”, “2”
Area selection:
− Area 1
− Both areas
− Area 2
Main function “Shutdown”
Shutdown function:
Pressing the “Shutdown” function switches all outputs in the defined safety position. This does
not affect any other functional sequences for controllers, timers, profiles, formulations or
sterilization cycles.
Main function “Remote”
Operation with external computer systems (central computer):
Pressing the menu button switches to remote operation; instructions on configuration
[¨ Chapter ““Settings” Menu“]
Main function “Alarm”
Overview table of alarms that have occurred:
− If alarms occur, the symbol changes color and an acoustic signal sounds.
− Display red: Table still contains unconfirmed alarms.
− Pressing the menu button opens an overview menu of all alarm messages.
Main functions can be selected at any time during a running process. The title of the
main function shown in the work area is also displayed in the header.
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45
4.3.5
Button
Overview of Selection Keys
Meaning, use
Cancel
Changes will not be saved
Confirmation of input
Further controller parameters
Cancel
Changes will not be saved
Deleting characters
Selection of sign when entering a value
Selection list of process values
4.3.6
Direct Function Keys for Selection of Submenus
The function elements in the work area of the “Main” main menu can contain
function keys that can be used to directly active submenus for important functions:
− for the numerical input of setpoints, conveying and flow rates etc.
− for the configuration of alarm limits
− for the selection of controller modes
Which functions can be reached from the main menu depends on the configuration.
Press the function keys to view the available functions in the supplied configuration.
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In this section, an example of screens and submenus accessible via direct function
keys is shown.
Detailed instructions for the associated functions and possible inputs can be found in
the Chapters “8.10 “Calibration” Menu“ and “8.11 “Controller” Menu“.
Example: Input of Temperature Setpoint
Fig. 4-3: Setpoint input and selection of the “TEMP” controller mode from the “Main” menu
t In the work area of the “Main” menu, press the TEMP function element or in the
work area of the “Controller” menu select the TEMP controller (TEMP function
element).
y When the “Main” menu is accessed, a submenu opens with a keypad on the left
side for data entry and a selection field for possible operating modes.
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47
Fig. 4-4: Set value input and selection of the “TEMP” controller mode from the “Controller” menu
y When the “Controller” menu is accessed, the “Setpoint” touch key can be used to
enter a set value (after pressing the touch key, a screen keyboard also opens).
The touch button “off” can be used to select the mode.
t Enter the new setpoint using the screen keyboard (note the permissible value
range under the input field). If you want to correct the value entered, press the
BS key. If you don’t want to save the new value, leave the submenu by pressing
the C key.
t Confirm by pressing the “OK” key. The submenu window closes. The setpoint is
active and is displayed.
Example: Selecting the Controller Mode “Mode”:
t In the work area of the main menu, press the “TEMP” function element or select
the “Controller” function and there the TEMP controller.
t Press the function key for the desired operating mode “Mode” on the right side.
t Confirm by pressing the “OK” key. The function (of the controller) is activated and
displayed.
You can access the full operator screen of the controller through
.
This corresponds to activating the “Controller” menu button and selecting the TEMP
controller there in the overview screen [¨ Chapter “8.11 “Controller” Menu“].
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4.3.7
Selection Lists and Tables
If submenus contain lists of elements, short names or parameters that cannot be
displayed in a window, a scrollbar with a position marker is displayed:
Fig. 4-5: Access to values accessible from the submenu after assignment of a channel in the trend display.
To page through lists that contain more entries than can be displayed in the window,
the following options are available:
t Press the arrow keys “V” (down) or “U” (up).
t Press the position mark (light gray field in the scrollbar) and push it.
t Press directly in the scrollbar at the relative height where the channel tag could be
located.
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49
4.4
Password Protection of Individual Functions
Only disclose this information to authorized users or service staff. If required,
remove this page from the manual and keep it in a special place.
Certain system functions and settings that should only be accessible for authorized
personnel are protected by a password. These include, in the regulator menu, the
settings for the regulator parameters (e.g. PID), in the “Settings” menu”:
− Process value setting “PV”
− At the manual operation level (“Manual Operation”), the interface parameter
setting for digital and analog process inputs and outputs or for simulation
controllers.
The “Service” submenu of the “Settings” menu is only accessible via a special service
password. This is only provided to authorized service technicians.
When selecting password-protected functions, a key field is displayed automatically
with a prompt to enter the password. The following passwords can be defined:
− Standard password (factory-set: 19)
− Customer-specific standard password1
− Service password
4.5
Error Handling and Troubleshooting
If the DCU system should encounter technical problems, contact Sartorius Stedim
Service.
4.6
Locking Functions
Locking functions are permanently configured; the user cannot change them. In the
“Settings” menu [¨ Chapter “8.12 “Settings” Menu“] locked inputs and outputs are
highlighted with a colored marking. The extent of the locking functionalities is
system-specific and is predefined during configuration. This is documented in the
configuration lists enclosed with every system.
1 You will receive this information by post or together with the Technical
Documentation
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5. Transport
The device will be delivered by the customer service of Sartorius Stedim Systems
GmbH or by a transport company engaged by Sartorius Stedim Systems GmbH.
5.1
Inspection Upon Acceptance by the Recipient
5.1.1
Report and Document Transport Damage
Upon acceptance of the unit by the customer, the unit must be inspected for visible
transport damage.
t Report transport damage immediately to the delivering office.
5.1.2
Check Completeness of the Delivery
The delivery includes all required valves, connector elements, lines, hoses and cables.
t Check that the delivery is complete by comparing it against your order.
Connection lines to supply facilities are not in the scope of delivery.
Components that do not correspond to the specifications of Sartorius Stedim Systems
GmbH may not be used.
5.2
Packaging
The packaging used for transport and protection of the device consists primarily of
the following materials suitable for recycling:
− Corrugated cardboard
− Styrofoam
− Polyethylene film
− Pressed particle board
− Wood
Do not dispose of the packaging in the garbage.
Dispose of all packaging material in accordance with local regulations.
Transport
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51
5.3
Instructions for Transport Within the Company
When moving the device, it is particularly important to do so in such a way as to
prevent damages by force or careless loading and unloading.
Danger of severe personal injury and property damage due to improper
transport!
− The device may only be moved by technical personnel.
− The load capacity of the lifting system (forklift) must be at least the weight of
the unit (you can find weight specifications in the data sheets in the “Technical
Documentation” folder).
− Wear protective work clothing, safety boots, safety gloves and a hard hat during
these tasks.
− The unit may only be transported with the transport locks in place. To install the
transport locks, contact Sartorius Stedim Service if necessary.
− Transport locks may only be removed at the place of installation.
− Lift the unit only at suitable points with lifting accessories.
− Always lift the device slowly and carefully, to ensure stability and safety.
− Secure the device from falling during transport.
− During transport of the unit, ensure that no personnel are in the path.
− These devices require two or more people to transport and set up.
− Wear protective work clothing and safety boots during these tasks.
− Lift the device only at suitable points.
− Always lift the device slowly and carefully, to ensure stability and safety.
− Secure the device from falling during transport.
Protect the device during transport against
− moisture,
− impact,
− falling,
− damage.
Loading | Unloading
When loading and unloading, pay attention to the following aspects:
− Do not unload the unit outdoors during rain or snow.
− If necessary, cover the unit with plastic sheeting.
− Do not leave the unit outdoors.
− Use only suitable, clean, undamaged load lifting accessories.
52
Transport
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6. Setup
The guide for setup of the device is the setup drawing. The setup of the device is to
take place according to contractual conditions,
− by Sartorius Stedim Service,
− by Sartorius authorized specialist personnel,
− by the customer’s authorized specialist personnel.
Setting up the bioreactor involves the following main steps:
− Ensuring that the ambient conditions have been fulfilled for the installation
location
[¨ Chapter “13. Specifications“].
− Ensuring that there is sufficient and suitable work space
[¨ Chapter “6.3 Work Surfaces and Loads“].
− Ensuring that the laboratory energy sources correspond to the specifications
[¨ Chapter “6.4 Laboratory Energy Sources“].
− Setting up the supply unit BIOSTAT® B, the culture vessels used and other
equipment and facilities needed for the process.
Danger of severe personal injury or property damage due to improper setup of
the unit!
The proper setup of the device is essential for the safe operation of the unit.
− Observe the guidelines for building and laboratory equipment.
− Observe the laboratory and process-related safety rules and guidelines on setting
up your workplace and securing it from access by non-authorized persons.
− This device requires two or more people to transport and set up or the use of
appropriately rated lifting equipment.
− Ensure that only authorized persons have access to the device.
− Follow the instructions in the following sections.
6.1
Acclimatization
Condensation from humidity can form on the surfaces of a cold device when it is
brought into a substantially warmer area. You should therefore let a device that has
been disconnected from its power source acclimatize for approximately 2 hours
before reconnecting it to the power.
6.2
Ambient Conditions
You will find information on ambient conditions in the [¨ Chapter “13.1 Ambient
Conditions“].
Setup
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6.3
Work Surfaces and Loads
The device is designed as a bench-top system and should be set up on a stable
laboratory table. The work surface must be big enough for the equipment required
for the fermentation process. It must be easy to clean and, where relevant, to
disinfect.
Danger of injury if access to emergency shutdown equipment and shut-off
devices is blocked!
Equipment for emergency shutdown and shut-off devices, e.g., for the power supply,
water or gas feed, as well as the particular equipment connections, must be kept clear
and easily accessible.
− Make sure that the device is set up with sufficient distance to the wall to
provide enough space for ventilation and easy access to the rear of the device.
The recommended wall distance is about 300 mm.
Danger of injury due to insufficient stability of the culture vessels!
− Follow any other manufacturer operating manuals for individual system parts and
additional components.
− Follow the construction guidelines required to ensure that the device stands stably.
− Ensure that the laboratory table is dimensioned sufficiently for the weight of the
device, the culture vessels and the process media in use [¨ Chapter “13.
Specifications“].
− Ensure that the laboratory table is level.
− Ensure that the workplace is dimensioned in such a way that the device is easily
accessible for in-process operation, maintenance and service work. The space
requirements also depend on the peripheral devices to be connected.
54
Setup
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Example setup for UniVessel® Glass, UniVessel® SU
Fig. 6-1: Example setup for BIOSTAT® B-CC Twin / Single
Pos. Description
1
Control unit, BIOSTAT® B-CC Twin
2
UniVessel® Glass (2 L, jacketed)
3
UniVessel® SU (2 L, Single Use)
4
Control unit, BIOSTAT® B-CC Single
Example setup, UniVessel® Glass, RM Rocker 20 | 50
Fig. 6-2: Example setup, BIOSTAT® B-CC Twin with UniVessel® Glass, 2 L and RM Rocker 20 | 50
Pos. Description
1
Control unit, BIOSTAT® B-CC Twin
2
UniVessel® Glass (2 L, jacketed)
3
RM Rocker 20 | 50
Setup
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55
Equipment for emergency shutdown and shut-off devices, e.g., for the power supply,
water or gas feed, as well as the particular equipment connections, must be kept clear
and easily accessible.
Set Up Dimensions
The required lab table dimensions and distances of the culture vessels to the device
are shown in the installation plans [¨ Chapter “15.3 Setup Drawings“].
The required installation area of the UniVessel® SU 2L holder corresponds to about the
installation area of the culture vessel UniVessel® Glass, 10 L DW.
The equipment (e.g. stirrer motor) can be stored on the storage dish (1).
1
Fig. 6-3: Storage dish for equipment
56
Setup
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6.4
Laboratory Energy Sources
The connections for energy and supply systems must be prepared before installation
of the device in the work area. They must be easily accessible, correctly installed,
set in accordance with the device’s specifications and ready to operate.
Risk of death from energy that is unexpectedly released, such as electric shocks!
Energy supply lines may be incorrectly dimensioned and not protected against
impermissible fluctuations and faults. Safety equipment must be available and fully
functional:
− Ground fault circuit interrupters (residual current protection) for mains
connections
− Fittings for shutting off water, compressed air and gas supplies.
Observe the energy specifications on the type plates
[¨ “6.4.2 Manufacturer’s ID Label“], [¨ Chapter “13. Specifications“].
The connections for supply media are located on the rear of the device.
The following supply media are connected to the device:
− Power supply, potential equalization
The RM Rocker 20 | 50 requires a separate power supply.
− Tempering medium
− Gases:
− Compressed air (Air)
− Oxygen (O2)
− Nitrogen (N2)
− Carbon dioxide (CO2)
Make sure that the inlets for electricity, water, compressed air and gases are
complying with the specifications of the device.
Ensure that the intakes are equipped with suitable valves for blocking
and emergency shutoff.
6.4.1
Electricity
Risk of death from electrical shock!
The power supply (mains) in your laboratory must meet the equipment specifications.
− Check whether the devices match your voltage supply rating
[¨ “6.4.2 Manufacturer’s ID Label“].
− Do not switch on the devices if the laboratory’s mains voltage is incorrect.
− The laboratory’s mains connections must be grounded, free from interference and
splash-protected.
− Emergency shut-off equipment (ground fault circuit interrupters, power switch)
must always be in perfect working order.
− The laboratory’s power supply [Mains wall outlet] must be equipped with a
protective grounding conductor.
− Do not use multiple socket outlets for connecting the bioreactor modules to an
AC power outlet (mains outlet).
Setup
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57
− The power cables must have the correct plugs that match your laboratory
AC outlet. Do not use any damaged mains cables, e.g. with broken insulation,
and in particular if the wires are exposed.
− Do not attempt to repair any defective power cables or replace incorrect plugs.
For this purpose, please be sure to contact a qualified service provider or technical
customer service at Sartorius Stedim Systems GmbH.
Risk of damage to the device from voltage dips and spikes!
The laboratory supply voltage may not fluctuate by more than 10% from its nominal
rating.
Keep access to the emergency shut-off devices inside the laboratory and the device’s
power connection clear.
If you need to switch off the device in an emergency, first press the emergency off
switch in the lab then disconnect the power cables from the device.
To clean and perform user maintenance, be sure to shut off the power to the device
and unplug the power cable from the outlet.
6.4.2
Manufacturer’s ID Label
All information concerning the correct power supply can be found on the
manufacturer’s ID label. The manufacturer’s ID label can be found at the rear of
the device.
Type
BB-8821051
Type
BB-8821050
No./
Year
01000 / 14
No./
Year
01000 / 14
V
230
V
120
A
10
A
12
Hz
50
Hz
60
Fig. 6-4: Manufacturer’s ID labels, version 230 V / 120 V
58
Setup
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6.4.3
Tempering Medium
Water is used as tempering medium for the device and applies to the following
functions:
− Temperature of a jacketed culture vessel,
− of a UniVessel® SU with heating | cooling jacket,
− of a CultiBag RM in connection with the optional tempering coil
− Cooling liquid of the exhaust cooler and the cooling finger (for single-walled glass
vessels)
Risk of damage to the heat circulation pump, fittings and thermostat system!
Inadequate water quality can affect the functioning of the heat circulation pump and
fittings in the thermostat system. The following impairments are possible:
− Formation of scale if water is hard
− Corrosion from distilled or demineralized water
− 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 inside the double wall are a sign of algae formation caused by
organic contaminants in the water. Do not use water contaminated in this way.
Water supply connection values
− Water pressure: 2 to 8 bar
− Flow volume: min. 10 L/min
− Drain: pressureless
t Check whether the water is clean before connecting it to the device.
t Flush the laboratory supply pipes.
t If necessary, fit a suitable prefilter in the laboratory or the supply pipe leading to
the device.
t Use tap water with max. 12 dH, no distilled or demineralized water.
Using water with a maximum hardness of 12 dH minimizes scale buildup in the
thermostat loop and in the double wall of the culture vessels.
Setup
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59
6.4.4
Gas Supply
Gas supply comprises the following gases (depending on the integrated aeration
module):
Aeration Modules
BIOSTAT® B-MO
BIOSTAT® B-CC /
RM Rocker 20 | 50
“Additive Flow 2-Gas”
“Additive Flow 5-Gas”
“Additive Flow 4-Gas”
AIR (air)
AIR (air)
Oxygen (O2)
Oxygen (O2)
Nitrogen (N2)
Carbon dioxide (CO2)
Danger of explosions and fire due to escaping oxygen!
There is danger of explosions and fire when high amounts of oxygen are released in
an uncontrolled manner. Pure oxygen can give rise to chemical reactions that could
cause substances to self-combust.
Escaping gases that contain C can cause chemical reactions and cause a 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.
− Check the tightness of the connections.
Danger of suffocation due to escaping gases!
There is danger of suffocation due to CO2.
− 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.
− Do not eat, drink or smoke during work.
− Monitor the limit values at the system and in the building (sensors recommended).
− Check process gas lines and filters regularly.
− Check the tightness of the connections.
60
Setup
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Risk of malfunctions and damages to gas-carrying components!
Soilings like oil and dust can impair the function of gas-carrying components
and lines.
− When corrosion-causing gases needed for certain processes are used in the gas
supply,
− The gas-carrying components have to be corrosion-resistant (e.g. ammonia can
cause corrosion to gas-carrying components made of brass).
− Make sure that the supply gases are dry and free of dirt, oil and ammonia.
− Install suitable filters, if necessary.
− Malfunctions and damages arising from contaminated gas media are excluded
from the warranty granted by Sartorius Stedim Biotech.
Setup
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61
7. Startup
Starting up the bioreactor involves the following main steps:
− Connecting of the device to the power supply
[¨ “7.2 Connecting the Device to the Power Supply“]
− Connecting the laboratory’s water supply
[¨ “7.3 Connecting Laboratory Water Supply to the Device“]
− Connecting the laboratory’s gas supply
[¨ “7.4 Connecting Laboratory Gas Supply to the Device“]
− Connecting the stirrer motor to the supply unit
[¨ “7.1 Installation Material“]
− Connecting the holder (UniVessel® SU)
[¨ “7.6 Connecting the UniVessel® SU Holder“]
− Connecting the barcode scanner
[¨ “7.7 Connecting the Barcode Scanner“]
− Connecting the RM Rocker 20 | 50 with CultiBag
[¨ operating manual BIOSTAT® RM 20 | 50]
− Connecting the sensor cable
[¨”7.9 Connecting the Sensor Cable“]
− Connecting the tubes for aeration
[¨”7.10 Connecting the Tubes for Aeration“]
− Connecting the temperature control system
(¨ “7.11 Connecting the Temperature Control“]
− Connecting the exhaust cooling
[¨ “7.12 Connecting the Exhaust Cooling Hoses (only UniVessel® Glass)“]
− Switching on the device
[¨ “7.13 Turning the Device On and Off“]
7.1
Installation Material
The equipment supplied with the bioreactor includes a connection kit.
− Only use lines and fittings approved for use with the bioreactor or whose
suitability has been confirmed in writing by Sartorius Stedim Systems GmbH.
− Only replace damaged components and wear parts with Sartorius Stedim Systems
approved parts.
Danger of operating faults and breakdowns!
Sartorius Stedim Systems GmbH does not accept any liability for operating faults and
breakdowns related to the use of equipment that has not been approved for use with
the bioreactor, as well as any secondary damage arising from this.
62
Startup
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7.2
Connecting the Device to the Power Supply
The connections for the power supply (2) and the potential equalization (1) can be
found on the rear of the device.
Mains Connection
− The device can be supplied in the following voltage versions:
− 230 V (± 10%), 50 Hz at a power consumption of 10 A or
− 120 V (± 10%), 60 Hz at a power consumption of 12 A
t Use the power cable supplied with the device in accordance with the power
specifications of your country.
t Connect the reserved mains connection cable to the device and connect the device
to the laboratory power supply.
Fig. 7-1: Mains and potential equalization connection
t Connect the reserved potential equalization to the device and connect the device
to the laboratory potential equalization if available.
Power Supply Malfunctions
t Check the position of the main switch.
Contact Sartorius Stedim Service if the power supply continues to malfunction.
Fig. 7-2: Main Switch
Information on operating the DCU system can be found starting in [¨ Chapter “4.3
Principles of Operation“].
Startup
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63
7.3
Connecting Laboratory Water Supply to the Device
Risk of injury due to bursting culture vessel!
If the pressure in the temperature control circuit is too high, there is a risk that the
double-walled versions of the culture vessels will burst.
Therefore:
− Make sure that the cooling water supply and cooling water return line (“Cooling
Water” connecting area) have been properly connected.
− Avoid creating kinks in the lines. The water must flow freely into the outlet.
− When connection to a closed (laboratory) cooling circuit system, the water must
not jam back and build up pressure on the outlet connection.
The water input pressure is limited by a pressure reducer. A flap valve does not allow
water to access the system if the water supply was inadvertently connected to the
water outlet.
The connections for tempering media are located on the rear of the supply unit
[¨ Fig. 7-3].
− For connecting the water supply, use the hose clips and hoses supplied (or
components with equivalent specifications).
− Carefully fasten the connections and protect them from accidentally coming loose.
− Make sure that the preliminary pressure of the laboratory is adjusted correctly
prior to opening the inlets to the supply unit.
− Make sure that there are no kinks in the hose and lay it in such a way that there is
no risk that water pockets form. Regularly check that any excess water can freely
drain off.
Water outlet
Water intake
Fig. 7-3: Water supply on the supply unit’s
connection panel
Connecting External Cooling Equipment
You can connect a laboratory cooling water circuit or cooling device to the “Cooling
water” inlet and outlet. For the external cooling devices, following specifications
apply:
− Water pressure: 2 to 8 bar
− Flow volume: min. 10 L/min
− Drain: pressureless
− Temperature min. = 4 °C
− Connection: Nozzle / outer diameter = 10 mm
Make sure that the inlet and outlet are connected in the right order:
− Connect the outlet of the external loop or the cooling device to the inlet of the
supply unit.
− Connect it from the outlet of the supply unit to the laboratory return pipe or the
inlet of the cooling device.
Operate the cooling device or the external cooling loop at ambient pressure.
Prevent the cooling medium from flowing back into the device’s outlet.
64
Startup
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7.4
Connecting Laboratory Gas Supply to the Device
The gases | compressed air supplied inside the laboratory must correspond to the
supply unit’s specifications. The connections for the gas supply are located at the
back of the supply media unit [¨ Fig. 7-4]. Please observe the following information
and the P&I diagram:
Specifications of the Supply Units
− Compressed air, preset to 1.5 positive pressure (29 psig)
− Gas flow rate 0.02 – 2 vvm (depending on the size of the culture vessel)
− Gas required, e.g. O2, N2 or CO2, preset to e.g. 1.5 barg (21.76 psig)
− Gases must be dry and clean, i.e., free of condensate and contaminants from the
tubing | piping.
− The unused inlets of the aeration modules “O2 Enrichment” and “Additive Flow
2-Gas” are sealed with dummy plugs.
Dimensions of Variable Area Flow Meters
The variable area flow meters must be designed for the planned gases. Their
measuring jets have been calibrated for standard conditions. You will find all
specifications labeled on the glass tube or holder, for example:
− Gas type: Air
− Temperature: 20° C = 293 K
− Pressure: max. 1.21 barg (21.76 psig)
If used with different gases with a different pressure or temperature, the variable
area flow meters’ flow rates may be too high or low. To determine the actual gas flow
volumes, you will need to convert the flow rates measured.
t Variable area flow meter manufacturers provide tables and monograms for
calculating the correction factors for flow rates under defined operating
conditions [¨ Manufacturer’s Information], e.g., the “Technical Documentation”
folder.
t Prepare the laboratory supply points, where necessary, by fitting suitable filters to
ensure that the supplied gas is free from oil and grease.
t Connect the laboratory supply points to the device using the appropriate adapters
[¨ Fig. 7-4].
1
2
3
1
Air
2
Oxygen (O2)
3
Nitrogen (N2)
4
Carbon dioxide (CO2)
4
Fig. 7-4: Gas inlets on the rear panel of the device
Startup
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65
7.5
Connecting the Stirrer Driver
(only UniVessel® Glass / UniVessel® SU)
Risk of injury when motor is running!
The motor can be started up for testing purposes before being fitted by switching on
the DCU system.
Reaching into the running drive can cause injuries to the fingers.
− Do not reach into the protective sleeve with your fingers.
− Leave the motor controller switched off (except if the power is switched off and
you are connecting the drive to perform a function test) until you have fastened
the motor to the stirrer shaft.
− Make sure that the motor control is turned off when you plug the motor plug into
the connection coupling on the motor.
Danger of damage to the stirrer drive!
The main switch must be turned off prior to fitting or detaching the motor cable;
otherwise there is risk of short circuits and the motor can be damaged.
Make sure that the motor is not yet fitted to the stirrer shaft.
The following figures show connecting cable plugs and their corresponding female
connectors on the stirrer motor.
The following illustrations show possible sleeve and stirrer shaft coupling models.
The actual model supplied may differ from the illustration.
1
2
t Connect the motor plug to the motor couplings as displayed in item (1) und firmly
tighten the connections (2).
1
2
Fig. 7-5: Stirrer driver power supply
66
Startup
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7.6
Connecting the UniVessel® SU Holder
The UniVessel® SU holder is for mounting the UniVessel® SU culture vessel and | or to
compile and analyze measurement signals from the optical pH and DO sensors in the
UniVessel® SU culture vessel. The holder transmits the measurement signals via the
digital interface.
The holder and adapter ring ensure the stability and proper operation of the culture
vessel. Furthermore, the process data are exchanged with the device via the interface.
Sensor plate
Serial-C
Conn.Cable UniVessel® SU
RS485, M12-8 | M12-8, 2m
UniVessel® SU Holder
Side View Front
Serial
Fig. 7-6: Connecting the UniVessel® SU Holder to the device
t Connect the data cable to the holder at the connection “Serial” and on the side of
the device at the connection “Serial-C” [¨ Chapter “3.1.3 Control Elements and
Connections“].
7.7
Connecting the Barcode Scanner
The calibration data is determined during production and delivered with the culture
vessel for optical single-use pH and DO sensors.
The pH and DO calibration data are located on the calibration sticker on the
UniVessel® SU cardboard box.
Fig. 7-7: Barcode scanner (optional equipment)
The calibration data can either be entered manually or with the barcode scanner and
then transmitted to the device via the USB port.
t Connect the barcode scanner to the USB port on the front side of the BIOSTAT® B.
t Before the process, carry out the pH and DO calibration
[¨Chapter “8.10 “Calibration” Menu“].
Startup
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67
Further information on the UniVessel® SU, UniVessel® SU Holder, adapter ring and
barcode scanner can be found in the following operating instructions:
− “UniVessel® SU culture vessel installation instructions”
− “UniVessel® SU Holder operating instructions”
− “Adapter ring installation instructions”
7.8
Connect RM Rocker 20 | 50 for CultiBag RM
t Connect “D-LINK 2” on the back side of the RM Rocker 20 | 50 to the connection
“Serial-C” on the BIOSTAT® B [¨ see also operating manual “BIOSTAT® RM 20 | 50”].
7.9
Connecting the Sensor Cable
t Connect the sensor cable to the side of the device
[¨ Chapter “3.1 Control/Supply Units“].
The temperature sensor Pt-100 is firmly attached with the connection cable.
7.10 Connecting the Tubes for Aeration
Risk to health from gases!
The gases used or formed during the fermentation process can be hazardous to
health.
− Make sure that there is adequate ventilation at the work site.
− If you are using large amounts of CO2, e.g. for regulating pH, or if CO2 is created as
a result of the cell’s metabolism, connect the exhaust air connection of the culture
vessel to a laboratory exhaust air treatment system.
− Establish the potential amounts of hazardous gases that might occur and could
escape.
− If necessary, fit suitable equipment for monitoring the air in the room.
The device is fitted with aeration systems that have independently controllable
spargers, depending on the specifications:
− The models “Additive Flow 2-Gas” only have one adjustable “Sparger” outlet for
medium aeration.
− The versions “Additive Flow 4-Gas” have an adjustable “Sparger” outlet for medium
aeration and an “Overlay” outlet for headspace aeration.
t Connect the hoses for aeration to the front of the device.
68
Startup
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7.11 Connecting the Temperature Control
7.11.1 Jacketed Culture Vessels / Single-walled Culture Vessels with Heating |
Cooling Jacket (only UniVessel® Glass / UniVessel® SU)
Danger of injury from shattered glass!
Excess pressure can cause the glass culture vessels to break. Bursting glass culture
vessels can cause cuts and damages to the eyes.
− Make sure that the hose on the return connection leading to the supply unit is not
kinked or disconnected.
Running the system on dry can damage the circulation pump in the temperature
control system!
Always fill the temperature control system before activating the temperature
controller.
To ensure optimum heat transfer, the double wall
must be completely filled. Check the filling level every time before the equipment is
sterilized and before starting a process.
Hose Kits
Hose kits to connect jacketed culture vessels or the UniVessel® SU heating | cooling
jacket are included with the equipment supplied.
The exhaust coolers are supplied with the hose kits needed for connecting to the
associated outlet of the device.
Startup
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69
1a
2
9
3
4
5
8
7
6
Fig. 7-8: Hose kit | temperature control for jacketed culture vessels
1b
2
3
4
5
9
8
7
6
Fig. 7-9: Hose kit | temperature control for single-walled culture vessels with heating | cooling jacket
Pos.
1a
1b
2
3
4
5
6
7
8
9
70
Description
Culture vessel, jacketed
Heating | cooling jacket
Hose with plug-in sleeve
Sealing coupling
Hose with sealing coupling for return (length 600 mm)
Supply unit connection (return)
Supply unit connection (inlet)
Hose with sealing clip for inlet (length 600 mm)
Plug-in sleeve
Hose with sealing coupling
Startup
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Fill Tempering Medium
The device is switched on [¨ Chapter “7.13 Turning the Device On and Off“].
t Connect the inlet hose (7) to supply unit connection (6) and then to connection (9).
t Connect the return hose to supply unit connection (5) and then to connection (2).
t Switch on the device.
t Activate the temperature control function via touchscreen of the controller.
5
t The filling process can be stopped as soon as the water is exiting from the
laboratory’s outlet.
6
Fig. 7-10: Temperature control connections
During the fermentation process, the cooling water is only fed into the temperature
control circuit if the vessel needs to be cooled. The cooling water supply to the
exhaust cooler is configured in such a way that, once the laboratory supply point
has been opened, there will be a constant flow of fresh water.
External Cooling Equipment
The minimum culture vessel temperature is around 8 °C above the ambient
temperature. To operate the bioreactor at lower temperatures, it needs to be
connected to an external cooling system.
If you are connecting the equipment to external cooling circuit in the laboratory or a
cooling thermostat, the temperature control circuit must be operated at zero pressure
(at ambient pressure).
7.11.2 Cultibag RM Temperature Control
Temperature control of the culture medium can be carried out using electrical
heating mats or tempering coils flushed with water.
The heating mats are part of the basic equipment included and are connected directly
to the RM Rocker 20 | 50 when starting it up [¨ “operating manual BIOSTAT® RM
20 | 50”].
The tempering coils are optionally available and are connected when the RM Rocker
20 | 50 is installed on the BIOSTAT® B [¨ “operating manual BIOSTAT® RM 20 | 50”].
Startup
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71
7.11.3 Heating Jacket (only UniVessel® Glass / UniVessel® SU)
The heating jackets are designed for heating single-walled culture vessels.
Danger to life caused by electric shock if heating blanket is defective!
The heating blankets have to be in perfect condition.
− Observe the accompanying safety instructions.
The power consumption of the heating blanket used may not exceed 780 watts.
− Only use the parts specified by Sartorius Stedim Systems.
Special versions and especially models from other suppliers require the prior written
agreement of Sartorius Stedim Systems.
Supplying the heating blanket with the wrong kind of voltage will damage the
heating blanket.
The heating jackets must only ever be connected to the female connector on the
supply unit – never to a power supply in the laboratory.
The only connection that provides the correct voltage is the “Heating blanket”
connection, which is controlled by the supply unit’s temperature controller.
Construction of Heating Jacket
3
1a
5
4
1
1b
2
3
5
1
4
1b
1a
Fig. 7-11: Heating jacket
Pos. Description
1
Power cable
1a
Cable connection with
overheating protection
1
1b
2
6-pin Amphenol power cord
Protective film of heating coil
Pos. Description
2
Protective film of heating coil
(vessel side)
3
4
5
Heating coil
Silicone foam sleeve
Velcro fastener
Fitting the Heating Jacket to the Device
t Make sure that the supply unit has been switched off at the main switch
[¨ Chapter “7.13 Turning the Device On and Off“].
t Insert the plug of the heating jacket connecting cable into the connector
“Heating Blanket” (1) on the device.
Fig. 7-12: “Heating Blanket” connection
72
Startup
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7.12 Connecting the Exhaust Cooling Hoses (only UniVessel® Glass)
1
2
5
3
4
Fig. 7-13: Hose kit, exhaust cooling for culture vessels
Pos.
1
2
3
4
5
Description
Exhaust cooler
Hose with sealing coupling for return
Supply unit connection (return)
Supply unit connection (supply line)
Hose with sealing clip for inlet
Connecting Hoses to the Supply Unit
t Connect the supply hose (5) to the supply unit connection (4).
t Connect the return hose (2) to supply unit connection (3).
3
4
Fig. 7-14: Exhaust cooling connections
During the fermentation process, the cooling water is only fed into the temperature
control circuit if the vessel needs to be cooled. The cooling water supply to the
exhaust cooler is configured in such a way that, once the laboratory supply point
has been opened, there will be a constant flow of fresh water.
Startup
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73
7.13 Turning the Device On and Off
Prerequisites
The system must be properly installed and connected in accordance with the
specifications. You must also have gained familiarity with the safety instructions
[¨ Chapter “2. Safety Instructions“].
t Ensure that all required supply energies are connected.
Switching On
You can carry out two independent processes on the BIOSTAT® B-MO and BIOSTAT®
B-CC twin variant.
t Turn the device on at the main switch [¨ Chapter”3. Device Overview“].
t Choose the culture vessel you wish to use for the process on the DCU operator
display [¨ starting in Chapter “8.8 “Main” Menu“].
If the CultiBag RM is used as a culture vessel, the RM Rocker 20 | 50 must also be
switched on [¨ operating manual BIOSTAT® RM 20 | 50].
Fig. 7-15: Main Switch
Switching Off the System
− If no other process is running (twin variant), turn the device(s) off at the main
switch upon completion of the process.
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Startup
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8. Preparing and Running the Process
Read the operating manual carefully before carrying out processes on the unit. This is
especially important for the safety instructions [¨ Chapter “2. Safety Instructions“].
8.1
Overview
Process preparation of the bioreactor during the relevant process involves the
following main steps, depending on the culture vessels used:
− Equipping and changing the equipment of the culture vessels [¨ UniVessel® Glass
Operating Manual].
− Connecting and installing the UniVessel® SU components
[¨ UniVessel® SU Holder Operating Manual and installation instructions for the
delivered UniVessel® SU components].
− Connecting the RM Rocker 20 | 50 with CultiBag RM
[¨ operating manual BIOSTAT® RM 20 | 50].
− Connecting the culture vessels and set up the bioreactor at the site designated for
the fermentation process.
− Autoclaving the UniVessel® Glass culture vessels and the accessories that are to be
connected aseptically [¨ UniVessel® Glass Operating Manual].
− Performing a process.
8.2
Preparing the Glass Culture Vessels
Risk of injury when handling heavy culture vessels!
Fully equipped and filled culture vessels are heavy, e.g. an UniVessel® Glass with an
operating volume of 5 liters weighs > 18 kg.
− The culture vessels must be handled with care.
− Use suitable transport equipment and lifting equipment.
− Only lift the culture vessels using the handles provided for this purpose.
Equip the culture vessels only with those components that are needed for the process
[¨ UniVessel® Glass operating manual].
General Measures
Make sure that the vessel equipment is in perfect condition and clean before
installing it in the culture vessel.
− Remove all residues, contaminations or microbes from the previous fermentation
process from the culture vessel and its fittings.
− Carefully check all equipment, and glass culture vessels, seals and silicone hoses in
particular, for damage. Replace all damaged and worn out parts.
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75
Measures Required Before Installing and Connecting Certain Parts
− pH sensor (see operating instructions of the manufacturer):
− Calibrate the pH sensor before autoclaving the culture vessel.
− Calibrate the zero point and slope of the sensors using the buffers in
accordance with the scheduled measuring range.
− pO2 sensor (see operating instructions of the manufacturer):
− Test the sensor as recommended by the manufacturer and service it if required.
For example, replace the membrane and the electrolyte for measurement.
− The DO sensor (pO2) must be calibrated after the culture vessels have been
sterilized in readiness for the fermentation process.
− Redox sensor (optional, where included):
− Test the sensor as recommended by the manufacturer using reference buffers.
8.3
Connecting Transfer Lines
The transfer lines are connected between the correction medium bottle(s) and the
culture vessel.
Transfer line for UniVessel® Glass , UniVessel® SU
Standard designation Material
Inner diameter of the hose Wall thickness
0.8 x 1.6;
VMQ 7621; 55° Shore
Silicone hose
transparent
0.8 mm
1.6 mm
1.6 x 1.6;
VMQ 7621; 55° Shore
Silicone hose
transparent
1.6 mm
1.6 mm
3.2 x 1.6;
VMQ 7621; 55° Shore
Silicone hose
transparent
3.2 mm
1.6 mm
Transfer line for RM Rocker 20 | 50
Standard designation Material
Inner diameter of the hose Wall thickness
0.8 x 1.6;
VMQ 7621; 55° Shore
Silicone hose
transparent
0.8 mm
1.6 mm
1.6 x 1.6;
VMQ 7621; 55° Shore
Silicone hose
transparent
1.6 mm
1.6 mm
Correction Media Bottles
t Prepare the bottles for acid, base, antifoaming agent or nutrient solutions and
connect the transfer lines.
Information about setup, equipment and installation of the corrective solution
bottles can be found in the [¨ UniVessel® Glass operating manual].
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Preparing and Running the Process
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Fitting the Transfer Lines
Risk of chemical burns from acids and bases!
If the hoses are not securely fastened, there is risk that they will slide off, in which
case the correction media will leak out.
− Wear personal protective equipment:
− Protective clothing, safety gloves, protective goggles
− Use the hoses included with the supplied equipment.
− Make sure that the hoses are securely fastened.
In the BIOSTAT® B, each of the culture vessels can be supplied with correction media
from up to 3 different bottles.
t Fit a piece of silicone hose onto the tube connection on the correction media
bottle to which the riser pipe is fitted.
t Connect the free end of the hose to the inlet on the culture vessel.
The hoses must be long enough to ensure that they can be easily fitted into the
associated hose pumps after having been set up at the supply unit.
t Secure all of the hose connections with hose clamps.
t Before autoclaving, clamp off the tubing connected to the immersion pipes using
tube clamps. The reason is that when positive pressure builds up in the bottles,
media can be forced out of the bottles, and this must be prevented.
t Put the corrective solution bottles in the bottle holder.
If the bottles need to be connected to the culture vessels at a later time, they can be
autoclaved separately. Fit the transfer lines with STT quick release couplings to create
a sterile connection to the culture vessel:
− Fit the STT quick release coupling plugs to the transfer line.
− Fit the coupling to the supply line of the culture vessel.
For detailed information on connecting the STT quick release couplings, please refer
to the [¨ UniVessel® Glass Operating Manual].
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77
8.4
Filling the Culture Vessel with Culture Medium
8.4.1
UniVessel® Glass / UniVessel® SU
Heat-Resistant Culture Medium
t Before autoclaving, fill the culture medium into the culture vessel via the lid port.
Non-Heat-Resistant Culture Medium
t Fill the culture vessel with a small amount of water (approx. 200 - 300 ml) and
autoclave the culture vessel.
t Fill the culture vessel with the culture medium after autoclaving.
t Be sure that the culture medium is sterile when fed in.
UniVessel® SU:
The UniVessel SU is delivered sterile. The culture vessel must not be autoclaved.
The culture vessel must be filled with sterile medium.
8.4.2
CultiBag RM
To fill the CultiBag RM with culture medium, follow the instructions in the
[¨ BIOSTAT® RM 20 | 50 operating instructions].
8.5
Sterilizing Glass Culture Vessels
Risk of breaking the culture vessels!
Excessive pressure during heating and any vacuum created during cooling can destroy
the glass vessels.
The sterile filter of the exhaust air segment makes sure that the pressure between the
inside of the vessel and the surrounding atmosphere is equalized in a sterile manner.
− These exhaust air paths may not be kinked.
In double wall vessels, pressure is equalized through the outlet (connection piece at
the top, piece of hose with the male end of the coupling).
− This piece of hose must not be kinked, disconnected or sealed.
Do not use vacuum autoclaves. At the end of the sterilization process, vacuum can
cause heavy foaming in the medium. Foam penetrating into the inlet or exhaust
filters can cause them to block and render them inoperable.
The double wall of the culture vessel must be filled for optimal heat transfer in the
autoclave and during the process.
t At the culture vessel, pinch off transfer lines connected to dip tubes and the hose
between air inlet filter and sparger pipe with hose clamps.
t Autoclave the culture vessels at 121°C. The autoclave dwell time required to ensure
sterilization must be empirically determined [¨ Documentation on the autoclave].
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To ensure reliable sterilization (e.g., to kill off thermophilic spores), the temperature
in the culture vessels must be maintained at sterilization temperature for at least
30 minutes.
8.6
Preparing the Cultivation Process
Danger of burns due to hot surfaces!
The premature removal of culture vessels from the autoclave can cause burns.
− Leave the culture vessels to cool down inside the autoclave.
− Wear protective gloves to transfer them afterwards.
Risk of injury when handling heavy culture vessels!
Fully equipped and filled culture vessels are heavy, e.g. an UniVessel® Glass with an
operating volume of 5 liters weighs > 18 kg.
− Use suitable transport equipment and lifting equipment.
− Only lift the culture vessels using the handles provided for this purpose.
t Carefully transport the culture vessels to the work site and place the culture
vessels in front of their supply unit in such a way that all of the lines and
peripheral devices can be easily connected.
t Fit the stirrer driver to the stirrer shaft
[¨ Chapter “8.6.1 Mounting the Agitator Drive“]
Temperature control system – UniVessel® Glass jacketed:
t Connect the supply and drain tubing of the temperature control system with the
ports on the culture vessel.
Temperature control system – UniVessel® Glass single-walled / UniVessel® SU
(Single Use):
t Connect the supply and drain lines of the temperature control system with the
heating | cooling jacket and fit to the culture vessel.
[¨ Chapter “8.6.2 Heating | Cooling Jacket Installation“] or (depending on the
equipment)
t Fit the heating jacket to the culture vessel.
[¨ Chapter “8.6.3 Installing the Heating Blanket“]
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79
Exhaust Cooling
t Connect the supply and return tubing of the exhaust cooling to the ports of the
exhaust cooler at the culture vessel.
Exhaust Heater – UniVessel® SU (Single Use):
t Fit the exhaust filter heater to one of the exhaust filters and connect the plug to
the mains supply [¨ installation instructions “Heater for Exhaust Filter”].
Sensors
t Connect the sensors to the associated cables.
Aeration Modules
t Connect the aeration to the culture vessel.
[¨ Chapter “8.6.4 Connecting the Aeration Modules“]
Corrective Solution Supply
t Place the transfer hoses in the peristaltic pumps on the device.
[¨ Chapter “8.6.5 Preparing the Corrective Solution Supply“].
Exhaust Filter Pressure Regulation
t Stick a silicone hose on the exhaust filter and connect it with the connection
“Press in” on the front of the supply unit.
8.6.1
Mounting the Agitator Drive
Risk of injury when motor is running!
The motor can be started up for testing purposes before being fitted by switching on
the DCU system.
Reaching into the running drive can cause injuries to the fingers.
− Do not reach into the protective sleeve with your fingers.
− Leave the motor controller switched off (except if the power is switched off and
you are connecting the drive to perform a function test) until you have fastened
the motor to the stirrer shaft.
The illustrations show possible sleeve and stirrer shaft coupling models. The actual
model supplied may differ from the illustration.
1
2
The coupling (1) of the motor is equipped with a rubber compensation element (2).
The compensation element establishes a positive connection to the coupling of the
stirrer shaft, ensuring silent force transmission of the drive.
The stirrer drive motor can be fitted to the following stirrer shafts:
− UniVessel® Glass (single-walled / jacketed)
− UniVessel® SU (with corresponding adapter)
Fig. 8-1: Motor Coupling
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Preparing and Running the Process
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Assembly of UniVessel® Glass Culture Vessels
1
2
3
4
Fig. 8-2: UniVessel® Glass stirrer coupling
t Prior to placing the device, take the motor (1) and connect the coupling with
the sleeve (2) to the stirrer shaft.
t Gently twist the motor housing to the left or right until the motor’s coupling
and the coupling (3) on the stirrer shaft engage.
t In order to fasten the motor securely to the stirrer shaft, tightly screw the
fastening screw (4) of the sleeve.
Assembly of UniVessel® SU Culture Vessels
It’s not possible to fit the motor for the stirrer shaft directly to the coupling when
using UniVessel® SU culture vessels. An adapter is required in order to fit the motor.
The adapter is not part of the device’s standard equipment.
You can order the adapter with enclosed installation instructions from Sartorius
Stedim Biotech.
3
1
4
5
2
Fig. 8-3: UniVessel® SU stirrer coupling
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81
t Fit the adapter (1) to the coupling of the stirrer shaft (2)
[¨ “Motor adapter installation instructions”].
t Prior to placing the device, take the motor (3) and connect the coupling with the
sleeve (4) to the adapter.
t Gently twist the motor housing to the left or right until the motor’s coupling and
the coupling on the adapter engage.
t In order to fasten the motor securely to the stirrer shaft, tightly screw the
fastening screw (5) of the sleeve.
8.6.2
Heating | Cooling Jacket Installation
Danger of burns upon contact with hot surfaces!
The heating | cooling jacket can heat up to 55° Celsius.
− Avoid contact with hot surfaces.
− Wear safety gloves when working with heaters and hot culture media.
1
2
3
5
4
Fig. 8-4: Heating | cooling jacket on the UniVessel® SU
Pos. Description
82
1
UniVessel® SU culture vessel or single-walled culture vessel
2
Heating | cooling jacket
3
Connection for return temperature control (Rectus quick connect coupling half)
4
Connection for supply temperature control (Rectus quick connect coupling half)
5
Velcro fastener of the jacket
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Fitting the Heating | Cooling Jacket to the Culture Vessel
The heating | cooling jacket is filled with tempering medium and connected to the
temperature control system hoses [¨ Chapter “7.11.1 Jacketed Culture Vessels /
Single-walled Culture Vessels with Heating | Cooling Jacket (only UniVessel® Glass /
UniVessel® SU)“].
t Place the jacket (2) around the culture vessel (1).
t Fasten the Velcro fasteners (5) such that the jacket lies closely around the culture
vessel.
Observe further notes in the installation instructions “Heating | cooling jacket for
culture vessel”.
8.6.3
Installing the Heating Blanket
Objects with points or sharp edges may damage the heating coils!
Sharp-edged or heavy objects can damage the heating coil and cause a short circuit.
Never put any objects on the heating jacket.
t Carefully lift and hold the jacket at the edge opposite to the cable connection.
Tensile stress can damage the cable attachment!
− Do not lift the heating and cooling jacket using the power cord. This can damage
the cable attachment.
− Do not roll the blanket together more tightly than the shape of the culture vessel
allows.
− Do not bend or fold up the heating jacket.
− When using the heating jacket on the UniVessel® SU, the heating jacket should be
installed in the lower part of the culture vessel for optimal heat transfer. Mount
the heating jacket such that the power cord can be fed upwards. This prevents the
connection cable from kinking.
t Wrap the heating blanket around the culture vessel with foil-shielded side
touching the vessel.
y The side insulated with silicone foam should face outwards. The isolated layer
prevents burns when touching the device.
t Secure the Velcro fasteners so that the blanket is lying flat on the culture vessel
without folds, warping or dents.
Fig. 8-5: Heating jacket at culture vessel
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83
Operating the Heating Jacket
Danger of burns at the heating jacket!
Depending on the operating temperature intended for the culture vessel, the heating
jacket can heat up to approx. 80°C.
− When in operation (above 40 °C), never touch the heating jacket with your bare
hands.
− When you have to handle the culture vessel, always use safety gloves.
t Switch on the device.
t Configure the temperature measurement on the user interface and activate it if
needed for the process.
Whenever the culture vessel needs to be heated up or cooled down, the measurement
and control system activates either the power supply of the heating jacket or the
cooling water supply for the cooling finger
Assembly of cooling fingers: [¨ UniVessel® Glass Operating Manual).
t During the process, check the heating jacket regularly.
Black discolorations occurring on the power cord connection or on the silicone foam
along the heating coil indicate that the heating coil and/or cable are defective.
Immediately interrupt the operation and replace the heating jacket.
t Whenever there is contact with splashing water or media, interrupt heating
operations, remove the heating jacket from the culture vessel, clean and dry it
thoroughly.
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8.6.4
Connecting the Aeration Modules
8.6.4.1
Conducting Preliminary Steps
The culture vessels must be fitted with the equipment needed for medium aeration
[¨ UniVessel® Glass operating manual]:
− Aeration pipe with ring sparger or microsparger or an aeration basket with a
silicon tube membrane,
− Supply air filter,
− Exhaust cooler with exhaust filter,
− Supply air filter for headspace aeration when using the “Additive Flow” aeration
module.
Aeration tubing Overlay/Sparger for UniVessel® Glass, UniVessel® SU
Standard designation Material
Inner diameter of the hose Wall thickness
3.2 x 1.6;
VMQ 7621; 55° Shore
3.2 mm
Silicone hose
transparent
1.6 mm
6 x 9;
Silicone
Transparent; 55° Shore rubber tubing
Aeration tubing Sparger for RM Rocker 20 | 50
Standard designation Material
Inner diameter of the hose Wall thickness
3.2 x 1.6;
VMQ 7621; 55° Shore
3.2 mm
Silicone hose
transparent
1.6 mm
6 x 9;
Silicone
Transparent; 55° Shore rubber tubing
Exhaust air hose for RM Rocker 20 | 50
Standard designation Material
Inner diameter of the hose Wall thickness
6 x 9;
Silicone
Transparent; 55° Shore rubber tubing
The culture vessels must be autoclaved together with the supply air and exhaust air
filters and then set up next to the associated supply unit.
Configure the calibration parameters for the DO sensor and select the aeration mode
using the DCU system [¨ Chapter “8.10 “Calibration” Menu“].
After autoclaving and before aeration with air and oxygen, you can carry out the zero
point calibration of the pO2 sensor with nitrogen.
Observe the instructions for zero point calibration of the pO2 sensor with nitrogen
in vessels with “O2 Enrichment” and “Gasflow Ratio” aeration modules [¨ Chapter
“8.6.4.3 Connecting the “Additive Flow 2-gas” Aeration System“].
8.6.4.2
UniVessel® SU Safety Valve Station
The safety valve station ensures that the specified maximum operating pressure of
the culture vessel UniVessel® SU is not exceeded.
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85
4
2
5
3
The safety valve station is interconnected between bioreactor control unit and
culture vessel. This prevents inadmissible overpressure in the culture vessel.
t Set up the safety valve station on a stable foundation in proximity to the
bioreactor control unit.
t Set up the safety valve station such that the front (1) is facing you.
1
t Connect the hoses on the outputs Overlay and Sparger with the inputs of the
safety valve station (2) and (3) [¨ safety valve station installation instructions].
t Connect the outlets of the safety valve station (4) and (5) to the corresponding
inlets of the culture vessel UniVessel® SU [¨ UniVessel® SU operating instructions].
When laying and connecting the hoses, make sure not to bend or stretch them.
8.6.4.3
1
2
Connecting the “Additive Flow 2-gas” Aeration System
Zero Point Calibration
To calibrate the DO sensor’s zero point by feeding nitrogen into the vessel through
the aeration system “O2 Enrichment” and “Gasflow Ratio”, proceed as follows:
t For the zero point calibration, connect the laboratory's nitrogen supply to the
“AIR” (3) connection at the rear of the supply unit.
t Connect the tubing from the outlet “Sparger” (1) to the supply air filter of the
culture vessel.
t Open the laboratory nitrogen supply and the variable area flow meter at the outlet
“Sparger” (2).
t Aerate the culture medium with nitrogen and calibrate the zero point
[¨ Chapter “8.10 “Calibration” Menu“].
t After zero point calibration, remove the laboratory’s nitrogen supply tubing from
the “AIR” (3) connection.
Fig. 8-6: Connection and gas flow control
3
t Connect the laboratory's air supply to the “AIR” (3) inlet on the supply unit.
t Aerate the culture medium with air and calibrate the slope
[¨ Chapter “8.10 “Calibration” Menu“].
t Set the gas flow rate that you want to use at the start of the process using the
“Sparger” variable area flow meter or the DCU System's gas flow controller. If the
supply unit is fitted with mass flow controllers for the gas supply, set the variable
area flow meter for the “Sparger” outlet to the maximum gas flow rate.
Fig. 8-7: Nitrogen supply connection to “AIR”
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8.6.4.4
1
2
3
Connecting the “Additive Flow 4-gas” Aeration System
t Connect the tubing from the outlet “Sparger” (1) to the supply air filter of the
culture vessel.
t Aerate the culture medium with nitrogen and calibrate the zero point
[¨ Chapter “8.10 “Calibration” Menu“].
t Aerate the culture medium with air and calibrate the slope.
t Connect the tubing from the outlet “Overlay” (2) to the supply air filter of the
culture vessel.
t Set the gas flow for your process at the variable area flow meters (1). If the supply
unit is fitted with mass flow controllers for the gas supply, set the variable area
flow meter for the “Sparger” and “Overlay” outlets to the maximum gas flow rate.
Fig. 8-8: Connection and gas flow control
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87
8.6.5
Preparing the Corrective Solution Supply
The supply unit is fitted with up to 8 integrated peristaltic pumps WM 114 for
supplying correction media (acid, base, anti-foam agents or nutrient solutions/
substrates).
Preliminary Steps:
The culture vessels must be fitted with the following equipment needed for supplying
correction media or media removal [UniVessel® Glass Operating Manual]:
− pH sensor, feed pipe for acid and base
− Anti-foam sensor, feed pipe for anti-foam agent
− Harvest pipe for removing the medium
The bottles must be prepared [¨ Chapter “8.3 Connecting Transfer Lines“].
Danger of limbs being pulled into the rotation pump and crushed!
− Allow only qualified personnel to work on the device.
− Prior to putting the hoses in, turn the peristaltic pumps to “off”.
Configuring the Tube Holder for the Peristaltic Pump
It's possible to put hoses with different hose diameters into the peristaltic pumps.
The tube holder must be set up according to the used hose diameter.
t In order to conduct adjustments, lift up the cover of the peristaltic pump.
The position of the tube holder can be determined with the markings on the tube
holder (1) and on the housing (2, 3).
1
2
The following table can be used to determine the position of the tube holder
depending on the inner diameter of the hose.
3
Inner diameter
of the hose
0.5 mm 0.8 mm 1.6 mm 2.4 mm 3.2 mm 4.0 mm 4.8 mm
Position of the
tube holder
3
3
2
2
2
2
2
Cross-section
1
2
3
Fig. 8-9: Position of the tube holder
Using bigger hoses (4.0 - 4.8 mm inner diameter) with the tube holder in position
(3; for small hoses) will result in decreasing feeding volumes and lifespan.
Using smaller hoses (0.5 - 0.8 mm inner diameter) with the tube holder in
position (2; for big hoses) will increase the risk that the hose gets into the pump
head and thus bursts.
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Changing Position of the Tube Holder
Changing to smaller hose diameter:
J
Prior to changing the tube holder position, turn off the pump. In order to re-position
the lower tube holders on both sides of the pump head, use a pointed object (e.g. a
ballpoint pen).
t Insert the pointed object into the recess (1) and push the instrument (e.g. a
ballpoint pen) downwards.
t Push the tube holder’s flange towards position (2), until the flange snaps into the
new position.
1
3
2
y By now, the marking of the tube holder should be covering the marking for the
small hose diameter (2).
t Reduce the pressure laid on the instrument.
y The flange should rise up and be aligned correctly.
If the flange does not rise up, repeat the procedure and maintain downward pressure
until release.
The tube holder on the other side of the pump head is adjusted accordingly.
Changing to bigger hose diameter:
J
Fig. 8-10: Position of the tube holder
Conduct the steps as described in the section above. Push the tube head towards the
opposite direction, allowing the flange to snap in position (3).
Soiling on the Peristaltic Pump Mechanisms
When no hose is inserted after setting up the tube holder position, the cover of
the peristaltic pump must be sealed.
Soilings in the mechanisms can result in malfunctions and decrease the lifespan
of the peristaltic pump.
Inserting and Removing Hoses
Check if the tube holders on both sides of the pump head are set up according to the
used hose size [¨ “Changing Position of the Tube Holder“].
t Lift up the cover completely.
t Make sure that there is sufficient hose available for the curvature inside the
pump's track. The hose must be positioned between the rotor-roller and the track;
press and hold it towards the inner wall of the pump head. The hose must not be
seated to the rolls in a twisted or bended manner.
t Tip down the cover until it snaps into the closed position.
y The track closes automatically and the hose will be properly bent.
t In order to remove the hose element, conduct the steps in reverse order.
Fig. 8-11: Inserting the hose
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8.7
Performing a Process
Danger of injury from shattered glass!
The culture vessel can burst due to unallowed overpressurization, resulting in cuts
and injury to the eyes inflicted by glass splinters.
− Only operate the temperature control circuit of double-walled culture vessels at
ambient pressure. Do not exceed a max. pressure of 0.8 barg (18.85 psig) when
aerating the culture vessels [¨ UniVessel® Glass operating manual).
− Make sure that the culture vessel is positioned stably.
− Wear personnel protective equipment.
− Make sure that the culture vessel is properly connected to the supply unit.
− Make sure that the culture vessel does not overflow.
− Observe the filling of the culture vessel and ensure that none of the connected
collection container exceed the volume available in the culture vessel.
− 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.
Danger of contamination from escaping feed and culture media!
Accidentally released hazardous substances, infectious cultures and corrosive media
can result in health hazards.
− Follow the company’s safety instructions (e.g. for processes which pose special
requirements to your workplace, the use of components or on handling of media
and contaminated components).
− Empty the feed hoses before loosening the hose connection.
− Wear personnel protective clothing.
− Wear safety glasses.
Danger of contamination from media and cultures used and products generated
in the process!
The media and cultures used for the fermentation process and the products generated
during it can be hazardous to health.
− Where necessary, always disinfect or sterilize contaminated equipment. This can
be done by filling the UniVessel® Glass and the accessories that have come into
contact with the culture with water before dismantling and cleaning it, and
autoclaving it again.
− It may be sufficient to heat the UniVessel® Glass to >65 °C for approx. 1 hour. This
will be sufficient for killing most live cells, but will not kill spores or thermopile
microorganisms.
− When using non-hazardous cultures and media, the UniVessel® Glass only needs to
be carefully rinsed with water.
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Danger of chemical burns from acids and bases!
Excess acids and alkalines in correction media bottles can cause chemical burns in the
event of uncontrolled leakage!
− In order to neutralize the acids and alkalines, empty the lines into appropriate
containers.
− All other equipment that has come into contact with acids, bases or (potentially)
hazardous media must be treated with appropriate cleaning solutions or safely
disposed of.
Danger of burns upon contact with hot surfaces of culture vessels!
In double wall vessels, the outlets on the temperature control module, the
temperature control system hoses and the culture vessel, can become very hot and
cause burns.
In single wall culture vessels, the heating jackets become hot.
t Wear protective gloves when working with hot culture media.
Danger of burns upon contact with hot surfaces of the stirrer drive motor!
The stirrer motors can become hot if operated over long periods of time, at high
speed and when stirring high viscosity media.
− Take note of the motor’s safety label. This label will become discolored at high
temperatures.
− Avoid accidental contact with the motor and only touch stirrer drive motors
during the fermentation process wearing gloves.
Operating the stirrer at impermissible high speeds can affect the culture vessel’s
stability and cause damage to its fittings.
Depending on the size and equipment of the culture vessels, the permissible speed
may be limited, e.g. to max. 300 min-1 in vessels with aeration rigs for bubble-free
aeration.
8.7.1
Setting Up the Measurement and Control System
Carry out the following steps:
t Switch on all peripheral devices (e.g. exhaust filter heater).
t Check for any malfunctioning or failure. Error messages from the DCU system are
shown on the operator display [¨ Chapter “9.4 Process-related Faults / Alarms“].
t Select the measurement and control system and enter the parameters required for
the process:
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8.7.2
Guaranteeing Sterility
Sterility Test
Before starting the fermentation process, it is possible to perform a sterility test.
The sterility test can be used to establish whether the culture vessels and the
connected equipment have been safely sterilized or are contaminated.
t Enter all of the process parameters as specified (temperature, speed, aeration,
pH regulation, etc.).
t Leave the bioreactor running for 24 hours and monitor it for signs of error, e.g.:
− change in the pH value
− unexpectedly high oxygen consumption
− cloudiness of the medium
− unusual odors in the exhaust air
These signs could indicate that the equipment has not been properly sterilized or that
germs from the environment have made their way inside through defective or
insufficiently tightened connections and seals.
Corrective measures:
t Sterilize with new medium for longer sterilization times.
Do not raise the sterilization temperature!
t When performing operations with a Single Use vessel (UniVessel® SU, CultiBag RM):
Dispose of this one and install a new one.
t Dismantle all of the vessel equipment and connections and check all of the seals
and lines for damage.
8.7.3
Carrying out the Cultivation Process
t Transfer the inoculation culture into the culture vessel.
t Perform the scheduled process steps.
t Take samples, given this is necessary to monitor the process flow.
t On completion of the process, harvest the culture and transfer it to the next point
of use (scale-up, processing, etc.).
Switching Off the System
t If no other processes are being performed using the supply unit, turn them off at
the main switch.
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8.8
“Main” Menu
8.8.1
General Information
The “Main” menu opens after the control unit has been switched on. This is the
central starting point for in-process operation.
Example with glass culture vessels:
Fig. 8-12: Start screen Twin variant “Main All” menu.
Fig. 8-13: Start screen single variant in “Main” menu.
The graphical display of the system structure simplifies the overview of the system
components and uses function elements implemented as touch buttons to provide
access to the submenus for the most important or most frequently used settings.
If practical, the function elements also show the currently entered or configured
data and settings.
Which function elements are actually shown depends on the configuration of
the DCU system, the unit controlled, e.g. the type of bioreactor, and customer
specifications.
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8.8.2
Process Displays in the “Main” Menu
The function elements can display associated process values:
− Values measured by connected probes such as pH, pO2, foam, etc.
− Calculated variables like pump filling amounts, calculated values of arithmetic
functions, etc.
− Process duration displays
− Measured data and key figures from the responses of external components such as
speed regulation, mass flow controllers, scales, etc.
8.8.3
Direct Access to Submenus
The following menu screens show examples of submenus accessible from the “Main”
menu and configuration options for the measurement and control system. Which
submenus are available and which parameters can be configured depends on the
configuration:
− Setpoint specifications and mode selection for headspace aeration (overlay) for
air and CO2
− Setpoint specifications and mode selection for supplying the media with gas
(sparger); for all gases, example menu “AIROV-#”
− Settings for alarm limits and activation of alarm monitoring for totalizer; example
“ACIDT-#”
− Mode selection for correction medium pumps, example “SUBS-A#”
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− Mode selection for agitator speed “STIRR-#”
− Mode selection for level control “LEVEL-#”
− Analogous for foam monitoring “FOAM-#”
− “LEVEL #” pump control mode selection (automatic and manual pump control)
Fig. 8-14: Menu screens for functions
accessible directly from the “Main”
menu
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8.9
“Trend” Menu
8.9.1
“Trend” Display
Using the “Trend” display, the user can graphically display process values for a
period of up to 72 hours. This overview of the process flow gives for example a quick
impression as to whether the process is running as expected or whether irregularities
or disruptions are present. The trend display works retroactively from the current
point in time and offers:
− Up to 8 (selectable) channels
− Time basis freely selectable from 1 to 72 hours
Trend readouts are not saved. Use a host system (e.g. MFCS) to log these data and
permanently document the process value time profiles.
Operator Screen
Fig. 8-15: Start screen “Trend” menu BIOSTAT® B (no recording active)
Field
Value
Function, entry required
Key line
1…8
Display and set channels
Diagram
1…8
Line chart of the selected channels (y) over time (x)
Upper
Upper limits of the selected display ranges for each
channel
Middle
Colored line chart
Lower
Lower limits of the selected display ranges for each
channel
HH:MM
Time scale
Subtitle
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8.9.2
8.9.2.1
Configuring the “Trend” Display
Setting the Trend Display for Parameters
t Select the “Trend” menu button.
t Press the key of the channel that you want to set:
y The “Channel # Settings” window opens.
Fig. 8-16: Menu for parameter selection
and setting
t To change the parameter for the channel, press “PV”.
y The “Select Buffered Channel” menu shows the default values:
t Press “Cfg” to display all parameters in the configuration. If the desired parameter
is not visible, you can scroll through the table.
t Press the key for the parameter to select it.
y The parameter will be activated immediately.
t To deselect a parameter without having to re-assign the channel, press “.....”.
Fig. 8-17: Overview table of default
parameters
8.9.2.2
Setting the Parameter Display Range
t Select the “Channel # Settings” window and press “Min” and | or “Max”.
t Enter the upper and | or lower limit. The display limit values for the parameter are
shown underneath the data window.
t Confirm the input with “OK”.
Fig. 8-18: Example for setting the upper
temperature limit
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8.9.2.3
Resetting the Display Range
t Press “Reset Range” on the “Channel # Settings” screen to reset a modified display
range back to the factory setting for “Max” and “Min”.
Fig. 8-19: Resetting a running trend recording
8.9.2.4
Setting the Trend Display Color
The color for every parameter can be selected from a table.
t Select the “Channel # Settings” screen and press the key with the name of the
preselected color.
t Press the key with the name of the new color to be used.
y The selection is instantly assigned and activated.
Fig. 8-20: Assigning a color to the selected parameter
8.9.2.5
Defining a New Time Range as “Time Range”
t Press the [“h”] key in the header.
t Select the desired time range.
y The time scale below in the working environment changes automatically.
y The parameter trend will be displayed over the new time range.
Fig. 8-21: Selecting the display range
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8.10 “Calibration” Menu
8.10.1 General Information
In the “Calibration” menu, all calibration actions required for routine operation can
be activated:
− Calibration routines for sensors: e.g. pH, pO2
− Calibration of pump filling counter: e.g. acid, base, substrate
− Calibration of gas filling counter: e.g. N2, O2, CO2
Fig. 8-22: “Calibration” menu (configuration example)
After pressing the “Calibration” menu button, the calibration menu opens. Selectable
touch buttons show the status of the associated calibration functions and open the
associated submenu to carry out calibration routines. Operating instructions on the
individual steps and required entries on the display lead the user through the menus.
The calibration parameters remain stored when the DCU system is switched off. After
power is restored, the DCU system uses the saved figures until a new calibration is
carried out.
8.10.2 pH Calibration (conventional sensor)
8.10.2.1
General Information on the pH Sensor
Conventional pH sensors are calibrated using a two-point calibration with buffer
solutions. During pH measurement, the system calculates the pH value based on the
sensor potential according to the Nernst equation while taking zero point deviation,
slope and temperature into consideration.
Sensors are calibrated before installation at the point of measurement, e.g. in the
culture vessel. Sterilization can alter the sensor zero point. To recalibrate the pH
sensors, you can measure the pH value externally in a sample taken from the process
and enter the value into the calibration menu. The calibration function compares the
pH value measured online with the one determined externally, calculates the
resulting zero offset and displays the corrected process value.
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The effects of heat during sterilization and reactions of the diaphragm and/or
electrolytes with components of the medium can influence the measurement
properties of the pH sensors. Test and calibrate the pH sensors before each use.
− Whenever possible, use buffer solutions manufactured by the sensor manufacturer
as contained in the equipment supplied with the pH sensor. Information on
reordering is available on request.
− If the “zero offset” and “slope” values are known and the process allows, you can
also enter these values directly into the relevant fields.
− The sensor’s service life is limited and depends on the in-process working and
operating conditions. Whenever a function check or calibration points to a
malfunction, the pH sensor should be serviced and replaced as needed.
− The pH sensors must be serviced or replaced when the following values are outside
the specified range*:
− Zero point offset (“zero”) outside – 30 to + 30 mV
− Depending on the type and design of the sensors supplied, the menus, sequence
and operation of the calibration function can differ from the information
provided herein. Please refer to the configuration documents or to the function
specifications of the bioreactor, if available.
* These values apply for pH sensors from the manufacturers Hamilton and Mettler
Toledo. If you use other manufacturers” products, please refer to the
manufacturer’s documentation.
8.10.2.2
“Calibration pH-#” Submenu
The submenu “Calibration pH-#” shows both the pH value and the measurement
chain voltage of the sensors, as well as the zero offset (“zero”) and slope sensor
parameters. That allows you to easily check the functionality of the pH sensors.
t Press the touch button of the sensor to be calibrated (“pH-#”) in the “Calibration”
menu.
y The submenu “Calibration pH-#” opens:
Field
Value
Function, entry required
Mode
Measure
− Open the submenu “Calibration pH-# Mode“
− Automatic switch to pH measurement after
calibration routine is completed
Calibrate
− Perform complete calibration
Recalibrate
− Perform recalibration
Calibrate Zero
− Perform zero point calibration as a single step
Calibrate Slope − Perform slope calibration as a single step
pH
pH
Display of pH measured value
Electrode
mV
Combination electrode voltage (raw signal)
TEMP
°C
Temperature value for temperature compensation
Zero
mV
Display / entry of the zero point offset
Slope
mV | pH
Display / entry of the slope
Manual
Auto
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Temperature compensation with entry of a temperature measured manually outside the culture vessel
Temperature compensation with the temperature
measured in the culture vessel (DCU system)
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t Press the touch button “Measure” in the submenu “Calibration pH-#”.
y The submenu “Calibration pH-# Mode” opens:
8.10.2.3
Perform Calibration
Depending on your choice, only the zero point (Calibrate Zero) or the slope (Calibrate
Slope) is calibrated, or a full calibration (Calibrate) is carried out.
Select/enter Temperature Compensation
t Press the touch button “Calibrate” in the submenu “Calibration pH-# Mode”.
t Select the type of temperature compensation.
t If “Manual” is selected: Enter the value for temperature compensation.
y The input window “pH-#: Zero Buffer” for zero point calibration is displayed.
Zero Point Calibration
t Hold the pH sensor in a buffer solution (generally 7.00 pH).
t In the input window “pH-#: Zero Buffer”, input the pH value of the buffer solution.
t Observe the measured value display in the window “pH-#: Zero Value”.
Once the display is stable, confirm the measurement with “OK”:
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Slope Calibration
t Hold the pH sensor in the second buffer solution.
t In the input window “pH-#: Slope Buffer”, input the pH value of the second buffer
solution.
t Observe the measured value display in the window “pH-#: Slope Value”.
Once the display is stable, confirm the measurement with “OK”:
y The pH sensor is calibrated.
8.10.2.4
Direct Input of the Zero Offset and Slope
Zero Offset
t Press the touch button “Zero” in the submenu “Calibration pH-#”.
t In the input window “pH-#: Zero Buffer”, input the pH value.
t In the input window “pH-#: Zero Value”, input the measured value for the zero
offset.
Slope
t Press the touch button “Slope” in the submenu “Calibration pH-#”.
t In the input window “pH-#: Slope Buffer”, input the pH value.
t In the input window “pH-#: Slope Value”, input the measured value for the slope.
8.10.2.5
Perform Recalibration
You can only recalibrate a single pH sensor.
By following the operating steps described below, you can adapt the calibration of a
pH sensor to changed measuring conditions after a sterilization cycle in the autoclave
or during the process as needed:
t Take a sample from the process.
t Measure the pH value of the sample with a calibrated pH measurement device.
t Press the touch button “Re-Calibrate” in the submenu “Calibration pH-# Mode”.
t Entered the pH value measured with the measurement device.
y The DCU system calculates the zero offset and displays the corrected pH value.
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8.10.3 DO Calibration (conventional sensor)
8.10.3.1
General Information on the pO2 Sensors
Calibration of the pO2 sensor is based on a two-point calibration. Measurement is
performed in [% oxygen saturation]. Calibration determines the sensor parameters
zero current (“zero”) and slope (“slope“). The reference parameter for “zero” is the
oxygen-free medium in the culture vessel. Air-saturated medium can be defined as
100 % saturated and be the basis for determination of the slope. Since you will be
calibrating the sensor after sterilization, take changes in the measuring properties
that can result from heat exposure or effects of the medium during sterilization into
consideration.
Special Notes
Prior to first use or whenever the pO2 sensor has been disconnected from the power
supply (measurement amplifier) for longer than 5 to 10 min., it has to be polarized.
Polarization can take up to 6 hours (less time when the sensor was only disconnected
from the measurement amplifier for a few minutes). This does not apply to optical
pO2 sensors (e.g. VISIFERM, Hamilton). Follow the sensor manufacturer’s instructions.
8.10.3.2
Submenu “Calibration pO2-#”
In addition to pO2 saturation, the submenu “Calibration pO2-#” also shows the
current sensor current as well as the zero current and slope with calibration
conditions. This allows easy regulation of the sensor’s functions.
t Press the touch button of the sensor to be calibrated (“pO2-#”) in the “Calibration”
menu.
y The submenu “Calibration pO2-#” opens:
Field
Value
Function, entry required
Mode
Measure
− Open submenu Mode
− Automatic switch to DO measurement after
calibration routine is completed
Calibrate
− Perform complete calibration
Calibrate Zero
− Perform zero point calibration as a single step
Calibrate Slope − Perform slope calibration as a single step
DO (pO2)
pH
Display DO saturation
Electrode
mV
Combination electrode voltage (raw signal)
TEMP
°C
Temperature value for temperature compensation
Zero
mV
Display / entry of the zero point offset
Slope
mV | pH
Manual
Auto
Display / entry of the slope
Temperature compensation with entry of a
temperature measured manually outside the
culture vessel
Temperature compensation with the temperature
measured in the culture vessel (DCU system)
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t Press the touch button “Measure” in the submenu “Calibration pO2-#”.
y The submenu “Calibration pO2-# Mode” opens:
8.10.3.3
Perform Calibration
Depending on your choice, only the zero point (Calibrate Zero) or the slope
(Calibrate Slope) is calibrated, or a full calibration (Calibrate) is carried out.
The pO2 sensor must be serviced if:
− the zero point is not within the range of 0 to … +10 nA (window “pO2-#: Zero
Value”),
− the sensor current at maximum aeration with air is lower than 30 nA (window
“pO2-#: Slope Value”).
Select/enter Temperature Compensation
t Press the touch button “Calibrate” in the submenu “Calibration pO2-# Mode”.
t Select the type of temperature compensation.
t If “Manual” is selected: Enter the value for the temperature compensation and
confirm the entry with “OK”.
y The input window “pO2-#: Zero Buffer” for zero point calibration is displayed.
Zero Point Calibration
Zero point calibration of the DO sensor can be performed as follows:
− on the laboratory table in a gel sample (0% oxygen saturation),
− in medium gassed with nitrogen (only BIOSTAT ® B-CC) (as described in the
following):
t Install the DO sensor on the culture vessel.
t Set the aeration “N2” to 100%, all other aeration to 0%.
t Set the stirrer speed (STIRR) to approx. 80% to 100%.
t In the input window “pO2-#: Zero Buffer”, input the pO2 value (typically 0%).
t Wait until the oxygen dissolved in the medium has been displaced.
y When the raw electrode signal stabilizes near the 0 nA value, the oxygen
saturation is approaching the minimum.
t Observe the measured value display in the window “pO2-#: Zero Value”.
Once the display is stable, confirm the measurement with “OK”:
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Slope Calibration
Slope calibration of the DO sensor can be performed as follows:
− on the laboratory table in the ambient air,
− in medium gassed with air (only BIOSTAT ® B-CC) (as described in the following):
t Set the aeration “AIR” to 100%, all other aeration to 0%.
t Set the stirrer speed (STIRR) to approx. 80% to 100%.
t In the input window “pO2-#: Slope Buffer”, input the pO2 value (typically 100 %).
y When the raw electrode signal stabilizes near the 60 nA value, the oxygen
saturation is approaching the maximum (this value is only applicable to Hamilton
sensors).
t Observe the measured value display in the window “pO2-#: Slope Value”.
Once the display is stable, confirm the measurement with “OK”:
y pO2 sensor is calibrated.
8.10.3.4
Direct Input of the Zero Offset and Slope
Zero Offset
t Press the touch button “Zero” in the submenu “Calibration pO2-#”.
t In the input window “pO2-#: Zero Buffer”, input the DO value.
t In the input window “pO2-#: Zero Value”, input the measured value for the zero
offset.
Slope
t Press the touch button “Slope” in the submenu “Calibration pO2-#”.
t In the input window “pO2-#: Slope Buffer”, input the DO value.
t In the input window “pO2-#: Slope Value”, input the measured value for the slope.
8.10.4 Optical pH and pO2 Sensors
Sartorius Stedim Biotech’s optical sensor technology makes it possible to measure
the pH and dissolved oxygen (DO) values non-invasively. The sensors are integrated
into various systems. On the UniVessel® SU, the sensor patches are located on the
bottom of the single-use vessels where they are read off directly via free-space
optoelectronics. In Cultibag RM and STR, the sensor patches are pre-installed on the
flexible bag wall or inserted through a sensor port. In this case, the readout takes
place via a flexible fiber cable. All systems are evaluated for the cultivation of cell
culture and microbial fermentations with scalability ranging from the process
development to the production scale.
Sunlight or long exposure to daylight damages the pH sensors.
The optical pH sensors are useless if they are exposed to approximately 8 days of
daylight or 2 hours of direct sunlight.
− Calibrate the optical pH sensor just before inoculation, after setting up the
CultiBag or the UniVessel® SU.
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8.10.4.1
Signal Quality of the Optical Probes
CultiBag RM bags are equipped with optical pH and DO disposable probes. An optical
fiber is used for the sensor connection. The sensor is located at the end of a hose, in
the interior of the bag. The fiber-optic cable transmits light at a specific wavelength
from the measurement amplifier to the sensor and the sensor’s luminescent response
back to the measurement amplifier.
Good contact between the optical fiber and the sensor is a prerequisite for accurate
measurement. The amplitude of the signal is indicative of the signal quality.
When the optical fiber is not properly inserted into the end of the tube, the signal
quality is adversely affected.
In the menu “Calibration” [¨ Fig. 8-23], the values for the pH and DO amplitudes are
displayed (without dimensions). You can accept values between 0 and >50000.
The value is displayed in steps of 1000.
Example: The display value “31” represents an amplitude value of 31,000.
− The PV “pO2_Ampl” shows the signal strength (amplitude) of the DO sensor.
− The PV “pH_Ampl” shows the signal strength (amplitude) of the pH sensor.
For precise measurement, the values “pO2_Ampl” and “pH_Ampl” should be greater
than 10,000 units, after the sensors were wettened for at least 2 hours. If the value is
less than 10,000 units, this indicates a fiber optic cable was not correctly installed.
t Make sure that the fiber optic cable is properly installed and secured with the
securing clips.
Fig. 8-23: Main menu “Calibration 2” (CultiBag RM) with display of the optical probe signal quality
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8.10.4.2
Notes on Calibration
The indicator strip for the measured value sensors decays when exposed to light.
The measured value drifts by approx. 0.13 pH based on 10,000 measurements.
To compensate for this drift, enhanced DCU configurations provide a “recalibration”
function. Measurements should therefore be taken as seldom as possible during the
process. Additionally, the acceptable measurement accuracy for the process and the
possible number of resulting measurements (measurement cycle duration) can be
determined empirically.
− pH sensor:
During typical pH calibration, reference values for zero point and slope are
measured in calibration buffers. This is not possible with disposable optical pH
sensors, as they are pre-sterilized before incorporation into the CultiBags or
UniVessel® SUs. Instead, a method was developed that determines the typical
measured values pH0 | pH and phase-angle f (min) | f (max) for a batch of sensors.
This information is provided with the CultiBags or UniVessel® SUs (label sticker with
calibration parameters) and entered in the pH calibration menu [¨ Chapter “8.10.5
pH Calibration (optical sensor)“].
− DO sensor (pO2):
The typical measured value at 0% and 100% DO (pO2) is determined for a batch of
sensors. This information is provided with the CultiBags or UniVessel® SUs (label
sticker with calibration parameters) and entered in the DO calibration menu
[¨ Chapter “8.10.6 DO Calibration (optical sensor)“].
8.10.5 pH Calibration (optical sensor)
General notes on optical sensors can be found in [¨ Chapter 8.10.4 on page 105].
To calibrate optical pH sensors, as follows:
t Enter the initial calibration data [¨ Chapter 8.10.5.2 on page 109].
t Wait until the medium has reached the process temperature.
Let the probes soak in the medium for at least 2 h.
t Take an offline sample and perform a re-calibration
[¨ Chapter 8.10.5.3 on page 110].
It is recommended to recalibrate the pH sensor daily. A recalibration is also necessary
if the ionic strength of the medium is changed by adding feed etc.
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8.10.5.1
“Calibration pH-#” Submenu
Field
Mode
Value
Function, entry required
Display of the active operating mode:
Measuring, Calibrating, Recalibrating
− Inactive
[Inactive]
Appears after commissioning, before the first
calibration
− Calibrate
[Calibrate]
Appears when going through the calibration
steps
− Measure
[Measure]
Indicates that the measurement is active in
process
− Hold
[Hold]
Indicates that the measurement in process has
been paused
− Re-Calibration [Re-Calibration] Appears during re-calibration in process
pH
pH
Current pH measured value
TEMP
°C
Type of temperature compensation; switch
between:
− Automatic compensation for pH measurement
in process
− Manual compensation to calibrate the pH
sensor (do not use during normal operation)
Samp. Rate
s
Lot No.
Measurement cycle (waiting time between
individual measurements)
− Setting range:
5 to 3600 s; recommended (default value) 30 s
− Choose a measurement cycle that produces
a maximum number of measurements at
acceptable accuracy [¨ Chapter “8.10.5.4
Configuring the Measurement Cycle for pH
Measurement“].
Manufacturer reference for released batch of
culture vessels
Temp Comp
°C
Reference temperature for calibration
f (max)
°
Phase reference, reference pH (reference
measurement deviating from the zero point)
f (min)
°
Phase reference, zero point pH (during reference
measurement for “zero point”)
dpH
pH
Reference pH for sensor batch (typical deviation)
pHO
pH
Typical zero point pH sensor batch
Meas. Cnts.
Number of measurements performed
Act. Sample
Re-calibration reference value
Parameter
Display of the calibration parameters
t Press the touch button of the sensor to be calibrated (“pH-#”).
y The operator screen “Calibration pH-#” opens:
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8.10.5.2
Enter Initial Calibration Data
The calibration data to be entered are printed on the CultiBag or UniVessel® SU used.
These data must be entered, as no (valid) pH measurement is possible beforehand.
(When using the UniVessel® SU, the calibration data can be scanned with the barcode
scanner).
t Press the button “Inactive” to bring up the window “Mode Calibration pH #”.
Entering the Parameters
t Press the touch button “Enter init. Parameters” to enter the parameters.
Parameters can be entered in two ways:
− Scanning the parameters with the barcode scanner (only in conjunction with
UniVessel® SU)
− Manual entry of the parameters
t Scanning the parameters from the culture vessel label.
(only in conjunction with UniVessel® SU)
y Wait until [ok] is active.
t [Manual]:
Check the scanned parameters or enter the following parameters from the culture
vessel label successively into the respective input window and confirm the entry
with [Enter] or [ok].
− “Lot-No.”
− Temperature compensation
− “pH f (max)”
− “pH f (min)”
− “pH dpH”
− “pH pHO”
t [ok]: Confirm the parameters.
t Check the parameters displayed.
t By pressing the respective key, the corresponding parameter can be modified as
necessary.
t Confirm the manually-entered | scanned parameters with [ok].
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109
Transferring the Parameters
y The data are transferred to the DCU system.
t Wait until the parameters have been transferred.
y The initial calibration of the pH sensor is now complete.
t Take a sample and recalibrate the pH sensor in case of deviations.
8.10.5.3
Performing Recalibration
t Press the button “Inactive” to bring up the window “Mode Calibration pH #”.
t Press the touch button “Re-Calibrate“ to begin recalibration.
t Press the touch button “Act. Sample”.
t Take a sample from the process.
t Measure the pH value of the sample taken with a calibrated pH measurement
device.
t Entere the pH value measured with the measurement device.
y Confirm the input with [ok]. The DCU system calculates the zero offset and
displays the corrected pH value.
Depending on the operating mode the device switches to the operating mode
[Measure] automatically or must be manually switched to the operating
mode [Measure].
− After successful initialization | calibration, the operating mode [Measure] is
switched to automatically.
− After the operating mode [Hold] the operating mode [Measure] must be switched
to manually.
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8.10.5.4
Configuring the Measurement Cycle for pH Measurement
Optical pH sensors show decay of the indicator dyes, e.g. photo-bleaching.
This degradation depends on the amount of light and increases with the pH value
(for alkaline media).
The pH sensors used in the CultiBag RM are designed for 20,000 measurement points.
Calculation of the Measurement Cycle
The measurement cycle can be configured so that 20,000 measurements are possible
over the total process time.
Example of calculation specifications:
− Overall process time = 666 hours (approx. 28 days)
− Maximum number of measurements = 20,000
Calculation:
20,000 measurement cycles / 666 hours = 30 measurement cycles / hour
= one 120-second measurement cycle
per measurement
Modification of the Measurement Cycle
t In the operator screen “Calibration pH-#”, press the touch button “Samp. Rate” to
modify the measurement cycle.
t Enter the standard password “19” and confirm with [ok].
t Change the value for the pH measurement cycle according to the above
calculation.
t Confirm the input with [ok].
8.10.6 DO Calibration (optical sensor)
General notes on optical sensors can be found in [¨ Chapter 8.10.4 on page 105].
To calibrate optical DO sensors, proceed as follows:
t Enter the initial calibration data [¨ Chapter 8.10.6.2 on page 113].
t Wait until the medium has reached the process temperature.
Let the probes soak in the medium for at least 2 h.
t Take an offline sample and perform a re-calibration
[¨ Chapter 8.10.6.3 on page 114].
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111
8.10.6.1
Submenu “Calibration pO2-#”
Field
Value
Mode
Function, entry required
Display of the active operating mode:
Measuring, Calibrating, Recalibrating
− Inactive
[Inactive]
Appears after commissioning, before the first
calibration
− Calibrate
[Calibrate]
Appears when going through the calibration steps
− Measure
[Measure]
Indicates that the measurement is active in process
− Hold
[Hold]
Indicates that the measurement in process has
been paused
− Re-Calibration [Re-Calibrate] Appears during re-calibration in process
DO (pO2)
%
Current DO measured value
TEMP
°C
Type of temperature compensation; switch
between:
− Automatic compensation for DO measurement
in process
− Manual compensation to calibrate the DO
electrode (do not use during normal operation)
Samp. Rate
s
Measurement cycle (waiting time between
individual measurements)
− Setting range:
5 to 3600 s; recommended (default value) 5 s
− Choose a measurement cycle that produces
a maximum number of measurements at
acceptable accuracy [¨ Chapter “8.10.6.4
Configuring Measurement Cycles for DO
Measurement“].
Lot No.
Manufacturer reference for released batch of
culture vessels
Temp Comp
°C
Reference temperature for calibration
0% sat
%
Typical reference zero point (zero DO) of the batch
100 % sat
%
Typical reference slope (slope DO) of the batch
Meas. Cnts.
Number of measurements performed
Act. Sample
Re-calibration reference value
Parameter
Display of the calibration parameters
t Press the touch button of the sensor to be calibrated (“pO2-#”).
y The submenu “Calibration pO2-#” opens.
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8.10.6.2
Perform Initial Calibration
The calibration data to be entered are printed on the CultiBag or UniVessel® SU used.
These data must be entered, as no (valid) DO measurement is possible beforehand.
(When using the UniVessel® SU, the calibration data can be scanned with the barcode
scanner).
t Press the touch button of the sensor to be calibrated (“pO2-B#”).
t Press the key “Inactive” to start initial calibration.
Entering the Parameters
t Press the touch button “Enter init. Parameters” to enter the parameters.
Parameters can be entered in two ways:
− Scanning the parameters with the barcode scanner (only in conjunction with
UniVessel® SU)
− Manual entry of the parameters
t Scanning the parameters from the culture vessel label.
(only in conjunction with UniVessel® SU)
y Wait until [ok] is active.
t [Manual]:
Check the scanned parameters or enter the following parameters from the culture
vessel label successively into the respective input window and confirm the entry
with [Enter] or [ok].
− “Lot-No.”
− Temperature compensation
− “pO2 0 %”
− “pO2 100 %”
t [ok]: Confirm the parameters.
t Check the parameters displayed.
t By pressing the respective key, the corresponding parameter can be modified as
necessary.
t Confirm the manually-entered | scanned parameters with [ok].
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Transferring Parameters
y The data are transferred to the DCU system.
t Wait until the parameters have been transferred.
y The initial calibration of the DO sensor is now complete.
8.10.6.3
Performing Recalibration
t Press the button “Inactive” to bring up the window “Mode Calibration pH #”.
t Press the touch button “Re-Calibrate“ to begin recalibration.
t Press the touch button “% sat”.
t Take a sample from the process.
t Measure the DO value of the sample taken with calibrated DO measuring
equipment.
t Enter the DO value measured with the measurement device.
t Confirm the input with [ok].
y The DCU system calculates the zero offset and displays the corrected DO value.
Depending on the operating mode the device switches to the operating mode
[Measure] automatically or must be manually switched to the operating
mode [Measure].
− After successful initialization | calibration, the operating mode [Measure] is
switched to automatically.
− After the operating mode [Hold] the operating mode [Measure] must be switched
to manually.
8.10.6.4
Configuring Measurement Cycles for DO Measurement
Optical DO sensors show decay of the indicator dyes, e.g. photo bleaching.
Calculation of the Measurement Cycle
The measurement cycle can be configured so that 200,000 measurements are possible
over the total process time.
Example of calculation specifications:
− Overall process time = 1666 hours (approx. 69 days)
− Maximum number of measurements = 200,000
Calculation:
200,000 measurement cycles / 1666 hours = 120 measurement cycles / hour
= two measurement cycles / minute
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Modification of the Measurement Cycle
t In the submenu “Calibration pO2-B#”, press the touch button “Samp. Rate” to
modify the measurement cycle.
t Enter the standard password “19” and confirm with [ok].
t Change the value for the pO2 measurement cycle according to the above
calculation.
t Confirm the input with “OK”.
8.10.7 Totalizer for Pumps and Valves
Function
To document the correction medium consumption, the DCU system adds up the
running times of the pumps or proportioning valves. It calculates the feed volumes
from the running times, taking the specific flow rates into account. You can
determine unknown pump feed rates using the calibration menus of the pumps or
proportioning valves. Depending on the hoses and pumps used, known specific
production rates can be entered directly into the calibration menu.
The calibration and filling counter functions are the same for all pumps and
proportioning valves. Calibration is described using the example “LEVELT-#”.
Submenu
Field
Mode
Value
Function, entry required
Calibrate
− Start calibration
Totalize
− After completion of “Calibrate”, the system
automatically switches to “Totalize”
Reset
− Reset the filling counter to zero
Display the volume of liquid being pumped for:
LEVELT-#
ml
Level pump (typically a digital pump)
FOAMT-#
ml
Antifoam pump (typically a digital pump)
ACIDT-#
ml
Acid pump (typically a digital pump)
BASET-#
ml
Base pump (typically a digital pump)
SUBST-A1...C1 ml
Substrate pump A to C (typically an analog pump)
Flow
Directly enter the specific feed rate of the pump or
the flow rate of the proportioning valve, if known
ml/min
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115
Preparing for Pump Calibration
Always use the same type of tubing with the same dimensions for calibrating and
pumping the media.
To calibrate, it is recommended that a suitable scale be used, as this is more accurate.
Prior to calibration, the hose must first be filled. To do this, proceed as follows:
t Insert the hose into the pump.
t Hang the hose end from the pump inlet into a water-filled beaker.
t Hang the hose from the pump outlet into a measuring cup that you can use to
measure the feed rate.
The analog pumps (SUBST-A1, B1, C1) must be controlled by the Subs controller.
t Activate the pump with “on”.
y Leave the pump activated until the hose is completely filled.
t Deactivate the pump.
Perform calibration
t Press the touch button of the pump to be calibrated (“LEVELT-#”).
Before the first calibration, the mode “Off” is displayed.
t Press the touch button “Calibrate” in the submenu “LEVELT-# Mode”.
y The “START calibration with OK” menu is displayed.
t Start the pump calibration with “OK”.
y The “STOP calibration with OK” menu is displayed. The pump pumps the medium.
t Wait until a sufficient volume has been pumped.
t Stop the calibration by pressing “ok”.
t Read the feed volume off the measuring beaker.
t In the input window “LEVELT-#: Volume”, enter the feed volume and confirm with
“OK”.
y The filling counter is reset and the display mode changes to “Totalize”.
The DCU system calculates the pumping rate automatically from the internally
registered pump run time and the feed volume calculated. The pumping rate is
displayed in the “Calibration LEVELT-#” submenu in the “Flow” field.
Direct Entry of the Feed Rate
If the flow rate as a function of the hoses and pumps used is known, the feed rate can
also be entered directly.
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t Press the touch button “Flow” in the submenu “Calibration LEVELT-#”.
t In the input window “LEVELT-#: Flow”, enter the feed rate and confirm with “OK”.
Resetting the Filling Counter
t Press the touch button “Reset” in the submenu “LEVELT-# Mode”.
y The filling counter is reset.
Activating the Filling Counter
The filling counter is reset after calibration.
The filling counter is automatically activated after switching on the pump and | or the
associated controller.
8.10.8 Scale Taring
Function
The weight of culture vessels, feed bottles or media or harvest containers can be
measured on weighing platforms or pressure gauges.
Any tare corrections required, e.g. after re-equipping the culture vessel or refilling a
holding bottle, can be made during running operations. To do so, determine the net
weight and adapt the tare weight to the change in weight caused by the changed
equipment.
Submenu “Calibration VWEIGHT-#“
Field
Value
Mode
Function, entry required
Display of the active operating mode
− Measure
[Measure] Indicates that the measurement is active in process
− Tare
[Tare]
Zero taring
− Hold
[Hold]
Indicates that the measurement in process has been
paused
Display net weight (WEIGHT = gross tare):
FWEIGHT-A#/B# g/kg
Substrate or harvest container weight
(UniVessel® Glass / UniVessel® SU)
VWEIGHT-B#
g/kg
Culture vessel weight
(UniVessel® Glass / UniVessel® SU)
RWEIGHT-#
g/kg
RM Rocker 20 | 50 weight
Tare
g/kg
Tare weight display or entry (DCU system)
Gross
g/kg
Gross weight display (measured value of the scale)
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117
Zero-taring on the example scale/culture vessel
t Press the touch button “tare” for zero-taring in the submenu “VWEIGHT-# Mode”.
y The display “Tare” (measured value in the DCU system) is set to zero.
The gross weight “Gross” (measured value of the scale) remains unchanged.
Tare Correction during Running Operations
t Press the touch button “Hold” in the submenu “VWEIGHT-# Mode”.
y The display “Tare” is frozen.
t Make changes to the equipment: for example, re-equipping the culture vessel
or refilling a holding bottle.
t Stop the tare correction by pressing “ok”.
y Despite a change in the gross weight, the display “Tare” remains.
Changing the Tare Weight via Direct Entry
t Press the touch button “Tare” in the submenu “VWEIGHT-# Mode”.
t In the input window “VWEIGHT-#: Tare”, input the new weight via the screen
keyboard.
t Confirm the weight change with “OK”.
y The display “Tare” (measured value in the DCU system) is set to the entered value.
The gross weight “Gross” (measured value of the scale) remains unchanged.
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8.11 “Controller” Menu
8.11.1 Functional Principle and Equipment
The control loops in the DCU system work as PID controllers, setpoint generators or
two-point controllers and are adapted to their control circuits. PID controllers can be
parameterized to match the control task. The controller outputs control their control
elements either continuously or using pulse-width modulation. Single-sided and split
range control are implemented.
Which controllers are implemented in a DCU system depends e.g. on the terminal unit
(e.g. bioreactor). Controllers can be customized. Available controllers in the DCU
software include:
Controllers
Function
“TEMP” temperature controller
PID cascade controller with pulse-width modulated split range outputs for the
control of the heater and | or valve on the cooling water intake with the measured
value of the culture vessel temperature as controlling value
“JTEMP” double wall temperature controller Slave controller for temperature control:
− with TEMP controller “off”, possible as setpoint generator for heating/cooling
Speed regulation (STIRR)
Setpoint generator for external motor controller controlling the agitator motor
Controller “ROCKS” (RM Rocker 20 | 50)
Setpoint controller for shaker
– Controller for the shaker speed ROCKS
Controller “ANGLE” (RM Rocker 20 | 50)
Setpoint controller for shaker
- Controller for rocker angle ANGLE
“pH” controller
PID controller with pulse-width modulated split range outputs:
− controls the acid pump and | or the CO2 supply and the alkaline pump
DO controller “pO2”
PID cascade controller for controlling up to 4 slave controllers:
− Gas filler controller Air, O2 or N2
− Gas flow controller
− Speed regulator
− Controller for substrate supply
Gas filler controller
Module “Additive Flow 4-Gas”
RM Rocker 20 | 50
− AIROV-#
Slave controller or setpoint generator for gas proportioning valves, pulsed feed:
− Air for the headspace (overlay)
− O2OV-#
− O2 for headspace aeration (Overlay)
− N2OV-#
− N2 for headspace aeration (Overlay)
− CO2OV-#
− CO2 for headspace aeration (Overlay)
Module “Additive Flow 4-Gas”
UniVessel® Glass / UniVessel® SU
− AIROV-#, AIRSP-#
Slave controller or setpoint generator for gas proportioning valves, pulsed feed:
− Air for headspace aeration (Overlay) and medium aeration (Sparger)
− O2OV-#
− O2 for headspace aeration (Overlay)
− N2OV-#
− N2 for headspace aeration (Overlay)
− CO2OV-#
− CO2 for headspace aeration (Overlay)
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Controllers
Function
Module “Additive Flow 5-Gas”
UniVessel® Glass / UniVessel® SU
− AIROV-#, AIRSP-#
Slave controller or setpoint generator for gas proportioning valves, pulsed feed:
− Air for headspace aeration (Overlay) and medium aeration (Sparger)
− O2OV-#, O2SP-#
− O2 for headspace aeration (Overlay) and medium aeration (Sparger)
− N2OV-#
− N2 for headspace aeration (Overlay)
− CO2OV-#
− CO2 for headspace aeration (Overlay)
Gas flow controller
Slave controller or setpoint generator for mass flow controller
− Each of the gases listed in each segment
Antifoam controller “FOAM”
Pulse pause controller for introduction of antifoam agent “AFOAM”
Level controller “Level-#”
Pulse pause controller for level controller “LEVEL”
Substrate controller “SUBS-A#, -B#, -C#”
Target value generator for filling pumps
Gravimetric level controller “VWEIGHT”,
“RWEIGHT”
PID controller with pulse-width modulated outlet for pump (harvest and filling
operation); works with the weight of the culture vessel “VWEIGHT“, “RWEIGHT” as
master variable
Gravimetric filling control “FLOW”
Setpoint generator for internal or external filling pump; works with the weight of
the substrate vessels “BWEIGHT”, “FWEIGHT” as master variable:
− Only controlled units with associated weight measurement
Controller Mode
You can switch between controller operating modes:
off
Controller switched off with defined output
Auto
Controller activated
Manual
Manual access to control element
profile
Selection of previously defined profile. If no profile is defined,
the controller automatically switches to “auto” mode
8.11.2 Controller Selection
You can access the operator screens on the controllers of a configuration in various
ways:
− For the controllers most frequently used, from the “Main” menu or from the
“Controller” menu, both in the “All” view.
− For other frequently used controllers, from the “Main” menu in the detail views for
“unit 1”, etc.
− For all controllers, from the “Controller” menu in the detail views for “unit 1”, etc.
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8.11.3 General Controller Operation
For the most part, operation of the controller is uniform. It comprises setting the
setpoints and alarm limits and the selection of the control operating mode. If a
controller can control more than one output, the controller output is assigned by
means of the parameterization functions accessible with a password. This also applies
to controller settings not required during routine operation.
Controller Operator Screen
Fig. 8-24: Example, selection of the temperature controller TEMP-1.
Field
Display
Function, entry required
Controller
mode
Selection
Input of the controller mode
Mode
off
Controller and slave controller switched off
Auto
Controller switched on, slave controller in “Cascade”
operating mode
Manual
Manual access to control output
profile
Selection of previously defined profile. If no profile
is defined, the controller automatically switches to
“auto” mode
Actual value
TEMP-1
Nominal value of the process value in its physical unit,
e.g. degC for temperature, rpm for revolutions per
minute, pH for pH value, etc.
Target
Setpoint
Setpoint of process value in the physical unit,
e.g. °C for temperature
Controller
output
Out
Display of controller output in %
Alarm
parameters
Alarm
parameters
Enter alarm limits (high limit, low limit) and alarm
status (enabled, disabled)
Profile
Parameter
Profile
Param.
Possibility to input a time-dependent setpoint profile
(max. 20 spikes)
Function key
Function key
Access to controller parameters (with password)
for cascade controllers: Selection of the slave
controller (see Chapter “8.11.5 General Controller
Parameterization“, Page 123)
ok
Confirm entries with “Ok”
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8.11.4 Setpoint Profile
Controller Profile
The “Profile Parameter” function can be used to navigate to the setpoints of the
individual controllers. Time-based setpoint profiles can be set up. Up to 20 steps can
be configured.
Any pre-installed DCU system can be additionally retrofitted with control functions
by changing the configuration. Moreover, control blocks available in the software can
also be used to configure special controllers.
These configuration changes may only be carried out by Sartorius Stedim service.
off
Controller switched off with defined output
auto
Controller activated
Manual
Manual access to control element
profile
Selection of previously defined profile. If no profile is defined, the
controller automatically switches to “auto” mode
Most control loops can be operated with time-dependent setpoint profiles (Control
Loop Profiles). The profile is input into a table using the operator terminal. Jumps and
ramps are possible in the profile; however, a profile can have a maximum of 20 spikes.
You can start and stop profiles at any time. The elapsed time is displayed for started
profiles.
Access Operator Screens
t Call up the appropriate controller.
t Call up the following operator screen using the button “Profile Param.”
Fig. 8-25: Operator screen using the example of the AIRSP Profile
Field
Value
Add
Mode
Setpoint
122
Function, entry required
Adding a profile spike
off
Setpoint profile not active
profile
Setpoint profile has been started and is being processed
[PV]
Display of the current controller setpoint in the physical
units of the process value, e.g. °C for temperature
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Field
Value
Function, entry required
Elapsed Time
h:m:s
Display of the elapsed time since the profile start in
[hours:minutes:seconds]
Graphical display of the elapsed time on the profile screen
No.
1-20
Number of the profile spike
Time
h:m:s
Input of the time for the profile spike
Setpoint
[PV]
Input of the setpoint for the profile spike in the physical
units of the process value, e.g. °C for temperature
Del
Deleting a profile spike
Operation
We recommend that you create a sketch with spikes and associated setpoints for your
profile. The time and setpoints to be programmed can be read directly from the spikes
entered into the sketch.
A profile must contain at least one profile spike with a non-zero time in order to be
started.
Special notes
− When starting the setpoint profile, the controller mode will automatically be
switched to “profile” in the “Controller” menu.
− If you do not input the time “00:00 h:m” for the first spike, the system will use the
current setpoint as the starting time.
− In the case of a setpoint jump, the same time is programmable for both spikes.
− When starting a “pO2” profile, whichever profile for “STIRR”, “AIR”, or “PRESS” has
been started will be automatically stopped and switched to “cascade” mode.
8.11.5 General Controller Parameterization
For optimum adaptation of the controller to each control segment, the controller
parameters can be changed using the parameterization screens:
Controller parameterization using the example of a TEMP controller
Field
Display
Function, entry required
MIN, MAX
Value in %
Minimum and maximum output limit for the controller
output
DEADB
Value
example: °C
Dead zone setting (PID controller only)
XP, TI, TD
Value in %, sec PID parameters (PID controller only)
Parameterization screens are accessible after selecting
in the controller operator
screen and password entry. DCU systems are configured at the factory with
parameters that ensure the stable operation of the control circuits in the bioreactor.
Factory-configured parameters can be found in the customer-specific configuration
documentation.
After entering the password, you have access to the parameterization screen to set
PID parameters, output limits, and if necessary a dead zone. In “Remote” operation,
the host PC defines the setpoints and operating modes.
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123
As a general rule, it is not required to change the control parameters. The exceptions
are controlled loop paths, the behavior of which is strongly influenced by the process,
e.g. pH and DO (pO2) control loops.
8.11.5.1
Output Limits
You can limit the controller output for the target value generator and PID controller
downwards (MIN) and upwards (MAX). In this way you can avoid unintentional,
extreme control element controls or limit the target value range for the slave
controller during cascade control.
− The limits are entered in the MIN (minimum limit) and MAX (maximum limit) fields.
The setting is made relative to the overall controller range in %.
− The following limits apply to the full modulation of the controller output:
− One-sided controller output: MIN = 0%, MAX = 100%
− Split-range controller output: MIN = -100 %, MAX = 100%
8.11.5.2
Dead Zone
A dead zone can be set up for PID controllers. If the control tolerance remains within
this dead zone, the controller output maintains a constant value and | or is set to zero
(pH controller). If the nominal values fluctuate stochastically, the dead zone enables
more stable control operations with minimized control element movements. For
controls with split-range outputs, this prevents oscillation of the controller output
(e.g. constantly changing acid/alkaline proportioning on the pH controller).
− The dead zone is displayed in the DEADB field or configured in the associated
submenu. Example for pH controller:
Set dead zone
± 0.1 pH
Set target value
6.0 pH
− In that case, the control loop is inactivated at nominal values between 5.9 pH and
6.1 pH.
Fig. 8-26: Submenu for controller parameterization
using the example of the pH controller
124
8.11.5.3
Controller Parameterization Menu Screen
Field
Value
Function, entry required
MIN
%
Minimum output limitation, limit value for switch to upstream
slave controller
MAX
%
Maximum output limitation, limit value for switch to downstream slave controller
DEADB
pH
Dead zone in the unit of the process value
XP
%
P share (proportional range); signal amplification of the control
response proportional to the input signal
TI
sec
Integral portion; time function. With a higher I portion control
will react more slowly (and vice versa)
TD
sec
Differential portion: Damping, greater D portion, damps the
controller response (and vice versa)
OUT
Controller output 1 (only in configurations in which the
switching of the output is provided)
OUT2
Controller output 2 (only in configurations in which the
switching of the output is provided)
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8.11.5.4
PID Parameters
The PID controllers can be optimized using the PID parameters XP, TI and TD. The
implemented digital controllers run according to the position control algorithm. They
allow structural toggles (P, PI, PD, PID) and changing the parameters during ongoing
operations.
− The controller structure can be configured by setting individual PID parameters to
zero:
P controller:
¨ TI = 0, TD = 0
PI controller:
¨ TD = 0
PD controller: ¨ TI = 0
PID controller: All PID parameters defined
8.11.5.5
PID Controller Optimization
Knowledge about control technology are prerequisite in order to be able to optimally
tune a PID controller to a controlled loop path; otherwise empirically tested tuning
methods (e.g. Ziegler Nichols) can be found in the pertinent literature. As a general
guideline:
− Only switch the D portion (TD) if the nominal values are relatively stable. For
stochastically variable actual values, the D portion makes fast, large changes to
the output. This causes unstable control.
− As a rule, the TI : TD ratio should be around 4 : 1.
− Periodic oscillations in the control circuit can be counteracted by increasing XP
and/or TI / TD.
− If the adjustments are too slow after setpoint jumps and/or in the case of nominal
value drift, you can lower XP and/or TI / TD.
8.11.6 Guide and Slave Controller (TEMP, JTEMP) Temperature Measurement
Temperature measurement with guide and slave controller is only possible in
conjunction with double wall vessels.
The temperature control works like a cascaded regulation. The TEMP controller uses
the temperature measured in the culture vessel as a master value and acts on the
mode of the JTEMP slave controller. JTEMP’s output controls the assigned control
elements through pulse-duration modulated or constant outputs in the split-range
operation.
Associated control elements can include:
− Cooling water supply valves
(double wall culture vessel, heating | cooling jacket, tempering coil)
When the value approaches the setpoint, the guide controller switches the controller
structure from “PD” (starting condition) to “PID”, preventing overshoot. In the
temperature control circuits, like on bioreactors, a digital output also switches off the
circulating pump as well as the heating protection when the temperature controller is
switched off.
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Master Controller TEMP Operator Screen
Fig. 8-27: Master Controller TEMP-1 Operator Screen
Refer to Chapter “8.11.3 General Controller Operation“for notes on the fields, entered
values and entries.
Operation
Observe the maximum permissible temperatures of the component groups and
fixtures your bioreactor is equipped with.
Culture vessel
Maximum permissible
temperatures for “TEMP”
master controller
UniVessel® Glass jacketed (thermostat)
80 °C
UniVessel® Glass single-walled (heating jacket)
60 °C
UniVessel® SU heating jacket
50 °C
UniVessel® SU ( heating | cooling jacket)
50 °C
CultiBag RM
Heating mat
Heating | cooling jacket
40 °C
58 °C
The temperature cascade controller is operated from the master controller. You can
only change setpoints and operating modes on the master controller “TEMP-#”.
All operations of the slave controller “JTEMP-#” are triggered automatically.
− For routine operation, you only need to configure the master controller “TEMP-#”
(setpoint, mode and alarm limits).
− Direct configuration for heating and cooling can be done on the slave controller
“JTEMP-#” when the master controller “TEMP-#” is turned off (“manual” mode).
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Special notes
− In “auto” mode of the “TEMP-#” master controller, the “JTEMP-#” slave controller
automatically switches to “cascade” mode. In the “off” setting of the master
controller, the slave controller is also automatically “off”.
− On certain systems, a setpoint limit must be parameterized for the slave controller
using the “MAX” output limit of the master controller.
− Example, UniVessel® Glass double wall:
max. out = 62 % for max. temperature = 80 °C
− The output limits required for safe operation are preset in the system
configuration. User-defined output limits that deviate from this must be reset
after a system reset.
8.11.7 Temperature Measurement Without Slave Controller (TEMP)
Fig. 8-28: Operator screen when called from “Controller – #”
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127
8.11.8 Speed Regulation (STIRR)
Function
The speed controller works like a target value generator for an external motor
controller, which controls the speed of the stirrer motor. In addition to its function as
a single controller, the speed controller can also be used as a slave controller in pO2
control.
Controller operator screen
Operator entries, output of the analog setpoint signal for the motor controller and
the display of the speed signal from the controller are all done on the controller
operator screen.
Field
Display
Function, entry required
STIRR-1
rpm
Display of the current stirrer speed
SetPoint
rpm
Configuration of the target speed in the mode “auto”
Out
%
Display of the speed limitation (MIN / MAX) and
setting configuration of the target speed in the
operating mode “manual”
Alarm
Param.
Entry of the alarm limits (Highlimit, Lowlimit) and
switching the alarm on/off
Profile
Param.
Input of a time-dependent setpoint profile
(max. 20 spikes)
Function key
Entry of the speed limitation (MIN/MAX)
Operation
High speeds can damage vessel attachments.
Sometimes, only a certain maximum stirrer speed is allowed depending on the vessel
type, volume and equipment. Higher stirrer speeds can damage vessel attachments,
e.g. a tubing aeration system. Vessels can become unstable and move across the
surface of the floor. Note the maximum permissible stirrer speed for your bioreactor:
Culture vessel
Maximum stirrer speeds BIOSTAT® B
UniVessel® Glass, 1 L, 2 L
2000 rpm
UniVessel® Glass, 5 L
1500 rpm
UniVessel® Glass, 10 L
800 rpm
UniVessel® SU, 2 L
400 rpm
More information can be found in the folder [¨ “Technical Documentation”].
When inputting MIN | MAX output limits or making direct entries into the OUT field,
the permissible speed controller range must be considered.
t Set the desired stirrer speed via “Setpoint”.
Speed limitation
When selecting the speed control MIN / MAX 0 - 100% for speed range 0 - 2000 rpm
and 1200 rpm as a permissible max. stirrer speed, a value of “OUT”: MAX 60% must be
configured.
If the MIN | MAX setting is changed after a system reset, you must reset them new
limits to the range permissible for the bioreactor!
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8.11.9 Antifoam Controller “FOAM”
Function
The autoclavable foam sensor is installed in the culture vessel. The sensor is adjustable
in height, so that the sensor tip can be adjusted to the maximum level of the medium.
A threshold signal generated by the foam sensor and amplified by a measurement
amplifier serves as the input signal of the foam regulator “Controller FOAM-#”.
This is activated, as long as the sensor is in foam. The trigger sensitivity “Sensitivity”
of the amplifier can be adjusted.
The output of the foam controller modulates a correction medium pump and switches
it on and off (Cycle / Pulse) periodically when a sensor signal is emitted.
Controller operator screen
Field
Display
Function, entry required
Mode
off
Controller switched off
auto
Controller switched on
Manual
Manual activation of the controller output; pump
runs permanently as a function of Cycle/Pulse
Cycle
hh:mm:ss
Total cycle time in
[hours: minutes: seconds]
Pulse
hh:mm:ss
Pump runtime (dispensign time) in
[hours: minutes: seconds]
Sensitivity
− Low
− Medium Low
− Medium High
− High
Trigger sensitivity for the foam sensor
Alarms
Param.
Switching the alarm on/off
Operation
t Set the cycle time “Cycle” and the pump runtime “Pulse” according to process
requirements.
t Configure the trigger sensitivity “Sensitivity” of the sensor.
To prevent proportioning errors resulting from leakage currents and sensor growth,
you should set the response sensitivity as low as possible.
t Switch the mode to “auto”.
In the operating mode “manual”, the pump periodically runs in continuous operation
as a function of the settings “Cycle” and “Pulse”.
Special notes
− The measurement amplifier is equipped with a response lag time mechanism
(approx. 5 sec), that prevents activation after splashing liquid.
− Switching to the “auto” or “manual” mode automatically also activates the filling
counter “FOAMT-#”.
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8.11.10 Level Control with Level Sensor (LEVEL)
Function
The autoclavable level sensor is installed in the culture vessel. The sensor is adjustable
in height, so that the sensor tip can be adjusted to the maximum level of the medium.
A threshold signal generated by the level sensor and amplified by a measurement
amplifier serves as the input signal of the level regulator “Controller LEVEL-#”.
It is active when the level of the medium rises to where it is in contact with the level
sensor. The trigger sensitivity “Sensitivity” of the amplifier can be adjusted.
The level controller is normally operated during the harvesting operation. By changing
the direction of hoses and switching from “Pump” to “Feed”, the level controller can
also be used during addition.
The harvesting operation is described in the following.
The output of the level controller controls a harvesting pump. The pump speed is
constant. If the medium has not been in contact with the level sensor, the pump
stops pumping after a specified period. If the level is controlled via the level sensor,
an additional harvesting pipe should be installed.
Controller operator screen
Field
Display
Function, entry required
Mode
off
Controller switched off
auto
Controller switched on
Manual
Manual activation of the controller output;
pump runs permanently
Pump
Harvest
Feed
Pump during the harvesting operation
Pump during addition
Pulse
hh:mm:ss
Pump runtime (harvest time) in
[hours: minutes: seconds]
Sensitivity
− Low
− Medium Low
− Medium High
− High
Trigger sensitivity for the sensor
Alarms
Param.
Switching the alarm on/off
Operation
t Select the pump operation “Harvest”.
t Set the harvest time “Pulse” according to the process requirements.
t Configure the trigger sensitivity “Sensitivity” of the sensor.
To prevent proportioning errors resulting from leakage currents and sensor growth,
you should set the response sensitivity as low as possible.
t Switch the mode to “auto”.
In the operating mode “manual”, the pump runs continuously.
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8.11.11 Gravimetric Level Control (VWEIGHT)
Function
With gravimetric leveling, a particular medium volume can be kept in the culture
vessel. The pump speed is controlled automatically by the weight change in the
culture vessel.
Adding:
Here you can define a minimum setpoint. As soon as the weight of the culture
vessel is lower than this reference value, a variable speed (analog) addition pump is
activated by the control equipment. The substrate is added to the culture vessel until
the setpoint is reached again.
Harvest:
Here you can define a maximum setpoint. When the weight of the culture vessel is
above this setpoint, a variable speed harvesting pump is activated by the control
equipment. The medium is harvested until the setpoint is reached again.
For the harvesting operation, an additional harvest pipe should be installed.
Controller operator screen
Field
Mode
Display
Function, entry required
off
Controller switched off
auto
Controller switched on
Manual
Manual activation of the controller output;
pump runs permanently
SetPoint
kg
If the set value is not reached / exceeded, the
pump goes into the addition operation / harvesting
operation (depending on the configuration)
VWEIGHT ##
kg
Display of current weight Medium with culture vessel
(UniVessel® Glass, UniVessel® SU)
RWEIGHT #
kg
Display of current weight Medium in the culture vessel
CultiBag including RM Rocker 20 | 50
Alarm
parameter
Entry of the alarm limits (Highlimit, Lowlimit) and
switching the alarm on/off
Profiles
Param.
Input of a time-dependent setpoint profile
(max. 20 spikes)
Function key
Entering the weight limit (MIN / MAX) and other
control parameters
Operation
t Set the desired weight via “Setpoint”.
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8.11.12 Gravimetric Filling Pump Controller “FLOW”
Function
The controller “FLOW-#” is a precise gravimetric filling pump controller.
It is used a weighing system and an analog filling pump.
Because the control algorithm in the DCU system works directly with the weight
measured on the scale/balance, the gravimetric filling controller allows accurate
proportioning over days and weeks.
Controller operator screens
Refer to Chapter “8.11.3 General Controller Operation“ for notes on the fields,
entered values and entries.
Operation
Operation with supply container and filling controller:
t Tare the scale to zero and place the vessel on the balance.
[¨ Chapter “8.10.8 Scale Taring“, Page 117]
t Set the desired quantity to add via “Setpoint”.
t Switch the mode of the filling pump controller to “auto”.
A negative weight readout on the scale | balance or on the DCU indicates the feed
volume.
Special notes
− The feed volume of the filling pump has an important influence on the controlled
loop path. The pump output must therefore be adjusted to the required flow
[Work Min]; [Work Max] in the parameter menu.
− For accurate proportioning, the working range of the controller output (“Out”)
must lie in the range from 5 to 90%. For that purpose, you can adapt the feed
range of the pump to the working range of the controller. You can use hoses with
a different diameter that offer the desired conveying range.
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8.11.13 Filling Pump Controller (SUBS)
Function
To introduce nutrient solution, the filling pump controller can control an internal or
external pump. The controller function works as a setpoint generator, handles control,
and emits an analog setpoint signal for the pump.
Controller operator screen
Fig. 8-29:
Fig. 17-32: Parameterization screen
Fig. 8-30: Operator screen for the controller
Refer to Section “8.11.3 General Controller Operation“ for notes on the fields, entered
values and entries.
Operation
t Set the desired quantity to add via “Setpoint”.
t Switch the mode of the filling pump controller to “auto”.
Special notes
− Matching connecting cables are available for certain pumps, like WM 120,
WM 323. Ordering information is available on request.
− Pumps from other manufacturers can be connected if they have an external
setpoint input from 0 to 10 V.
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8.11.14 Gas Controller (Gas Filling Controller / Gas Flow Controller)
Gas controllers control gas supply for the corresponding gas segment, e.g. “AirOV-#”,
“AirSp-#”, “O2SP-#”, “N2SP-#”, “CO2OV-#”, or “CO2Sp-#” and introduce gases into
the aeration segments “Overlay” or “Sparger”.
The following types of gas controllers can be used:
− Gas filling controllers (solenoid valves)
− Gas flow controllers (massflow controller)
The massflow controller makes it possible to aerate the culture vessel with
a continually changing gas flow.
The controllers normally work as slave controllers for the DO or pH control loop.
With the DO controller turned off, they can be used as setpoint generators.
Controller operator screen
Field
Display
Function, entry required
Mode
off
Controller switched off, output on stand-by
Manual
Manual access to control output
auto
Automatic operation, control with a predefined
target value
AIRSP-1
rpm
Display of current total gas flow
SetPoint
rpm
Configuration of a set point for the gas flow controller
%
Configuration of a set point for the gas filling
controller
Out
%
Alarm
parameter
Entry of the alarm limits (Highlimit, Lowlimit) and
switching the alarm on/off
Profiles
Param.
Input of a time-dependent setpoint profile
(max. 20 spikes)
Function key
Entry of the lower (MIN) and upper (MAX) output
limit, setting range 0 to 100% of the control range
and other control parameters
To operate the gas controller as a setpoint generator, the master controller must be
switched off. Check its operating mode in the “Main” or “Controller” menu, and
switch the mode of the master controller to “off” if it is active.
− Select the “Main” or “Controller” view in the detail view “1”... in which you want to
set up the gas filling controller.
− Select the function key with the current display of the setpoint “0.01 lpm”.
Enter the setpoint in the window with the numerical keypad.
− Set the alarm limits, if needed, and activate alarm monitoring.
− Select the function key for the operating mode and select the “auto” operating
mode.
− Press “OK” to activate the controller.
Special notes
− Select the setpoint of 100% to configure the flow rate on the variable area flow
meter (rotameter) and calibrate the filling counter (if the calibration function is
included in the configuration). Oxygen then flows continuously in the air supply.
− For manual gas supply, select the desired setpoint in the range 0..100 %.
− When activating the “auto” mode on the master controller, the gas filling
controller automatically switches to “cascade” mode. In that event, settings in
the gas filling controller are not possible or will be ignored.
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Follow the instructions regarding the “Parameter Settings in the System” in the
“Configuration Documentation”.
− MIN/MAX output limits are entered in % of the control range of the gas feed.
When entering values directly in the OUT field, take the measurement range for
the aeration rate into consideration.
− If the gas flow controller is a slave controlled in the DO control cascade, enter the
MIN | MAX values in the “DO controller” parameterization menu. The settings will
then act as a switching criterion for cascade control.
− Switching off the GASFL flow controller (select “off” and after an emergency shut
off due to overpressure) closes the control valve in the mass flow controller.
CultiBags are only pressure-resistant to a certain extent and may burst if
subjected to excess pressure.
The pressure is monitored in the gas supply. When the pressure limit is exceeded
(435.11 mpsig for standard CultiBags), e.g. by air blockage, the flow controller is shut
off. The gas supply remains closed as long as the pressure is too high (> 435.11 mpsig).
Note the specifications for the measurement|control range of the aeration rates
of the bioreactor.
With a bioreactor operated with overpressure, the counter pressure might cause
the maximum aeration rate not to be reached.
8.11.15 pH Controller
8.11.15.1 Function
The pH control normally works with PID control characteristics. It controls correction
medium pumps for acids and bases and/or proportioning valves or mass flow
controllers for CO2 in split-range mode using pulse-width modulated outputs.
This enables bilateral control.
− pH control with base is configured by default.
− pH control with acid and CO2 depends on the configuration.
− The negative controller output acts on the acid pump (or the CO2 feed) and the
positive output on the base pump.
− The pH controller does not activate the control signals until the control deviation
is located outside of a configurable dead zone. This prevents any unnecessary acid/
alkaline proportioning.
8.11.15.2 Controller Operator Screen
Refer to Chapter “8.11.3 General Controller Operation“ for notes on the fields,
entered values and entries.
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8.11.15.3 Parameter Settings
A DEADB dead zone can be entered in the pH controller parameterization screen.
The controller remains inactive as long as the measured value remains within the
dead zone around the setpoint.
Example:
Set dead zone:
± 0.05 pH
Set target value:
6.0 pH
y In that case, the control loop is inactivated at nominal values between 5.95 pH and
6.05 pH.
8.11.15.4 Acid, Base, and CO2 Supply-driven pH Control
Acid/base supply-driven control
The pH controller output “–Out” normally controls the acid pump with a negative
output signal (0 to -100 %). Correspondingly, the controller output “+Out” controls
the base pump with a positive output signal (0 - +100 %) and adds base. To disable
the addition of acid or base, the regulator value of 100% (+ / -) must be set to 0%.
For special configurations, the acid or alkaline pump can be assigned to substrate
controllers if they are not needed for pH regulation. To do this, “-Out” must be set to
“None” (instead of “Acid” or “CO2”) and “+Out” must also be set to “None”.
CO2 supply-driven Control
For bioreactors for cell culture, a CO2 valve or a CO2 massflow controller can work as
control element of the pH control in place of the acid pump.
CultiBags are only pressure-resistant to a certain extent and may burst if
subjected to excess pressure.
The pressure is monitored in the gas supply. When the pressure limit is exceeded
(435.11 mpsig for standard CultiBags), e.g. by air blockage of the exhaust filter, the
flow controller is shut off. The gas supply remains closed as long as the pressure is too
high (> 435.11 mpsig).
In configurations for cell culture, the output “–Out” can be connected to the CO2
feed. After switching to “CO2”, the output controls the CO2 valve (or the massflow
controller of the CO2 segment) to introduce CO2 into the culture vessel.
Special notes
− When the “auto” or “manual” operating modes are activated, the “ACIDT-#” /
“CO2T-#” and “BASET-#” filling counters automatically switch to the “Totalize”
operating mode.
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8.11.16 DO Control Methods
The DCU system features various methods of DO control. Which of them is possible,
required or sensible for the controlled terminal unit depends on the configuration or
process.
− When aerating with air, either the oxygen portion can be reduced by adding
nitrogen or the air can be enriched with oxygen.
− The mixture can be influenced e.g. by controlling the agitator speed.
− Cell growth can be influenced by adding or reducing substrate.
The DO control (pO2) works like a cascaded regulation. The output of the DO
controller (master controller) modulates the target value input of the slave controller,
which then acts on the control element (e.g. the valves or mass flow controllers for N2
or O2 or the stirrer). The following control strategies are possible:
− 1-stage control cascade, i.e. the pO2 control only affects one of the available
setting variables.
− Up to 4-stage simultaneous control cascade, during which the pO2 control is
affected up to 4 setting variables according to their priority.
A range (MIN | MAX) can be defined in the DO controller, in which the DO controller
defines the target value for each slave controller. In multi-stage cascaded regulation,
the output of the DO controller modulates the slave controller after sequential
switch-on as follows:
− The pO2 controller acts on the slave controller with the priority 1 (Cascade 1) and
defines its setpoint. The slave controller 2 receives the target value defined in the
DO controller as “MIN”.
− When the preset target value of the 1st slave controller (Cascade 1) reaches its
maximum, the output of the pO2 controller switches to the target value input of
the 2nd slave controller (Cascade 2) after an adjustable delay time “Hyst.” and
defines the following target values:
− Slave controller (cascade) 1: with defined maximum
− Slave controller (Cascade) 2: controlled output of the DO controller
− This sequence continues for the other control elements according to the
predefined priority “Cascade #”.
− If the need for oxygen drops, the controllers are reset to in the reverse order.
In this way, the control can regulate the in-process DO value, even if there are
considerable fluctuations in the need for oxygen in the culture. In order to still be
able to additionally optimally adapt the control to the behavior of the controlled loop
path, the PID parameters of the slave controller are parameterizable independently of
one another.
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8.11.16.1 pO2 Controller CASCADE (cascade controller)
Operator Screen
Fig. 8-31: pO2 cascade controller menu on the “Controller – All” operator screen
Refer to Chapter “8.11.3 General Controller Operation“ for notes on the fields,
entered values and entries.
The operator screen also include the following input fields:
Field
Value
Function, display, entry required
Setpoint
% sat
Preset Target Value in the Master Controller
Setpoint
Cascaded
Controller
Mode
Preset setpoint for the slave controller in the cascaded
regulation, in the sequence of the priority predefined
in the parameterization screen:
off
Selected slave controllers will automatically be
switched to “off”
auto
Selected slave controllers will automatically be
switched to “cascade” mode
profile
With the profile, selected slave controllers will
automatically be switched to “cascade” mode
Alarms param.
− Input of the limit values “High” “Low”
− Input of the time delay
− Enable/Disable Alarm
Profile Param.
Inputting the profile parameter
Sub-menu – parameterization screens
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DO Cascade Controller Parameterization Screen
Fig. 8-32: Example: Configuration of the operator screen
Field
Value
Function, display, entry required
DEADB
%
Entry of the deadband
Cascade #
[Controllers]
Slave controller with the relevant parameters
MIN
%
Minimum output limit, corresponding to the minimum
target value for the slave controller.
MAX
%
Maximum output limit, corresponding to the
maximum target value for the slave controller.
XP
%
P share (proportional range); signal amplification of
the control response proportional to the input signal
TI
sec
Integral portion; time function. With a higher I portion
control will react more slowly (and vice versa)
TD
sec
Differential portion; damping, greater D portion,
damps the controller response (and vice versa)
End Mode
off,
auto
Mode for slave controller when the master controller
is “off” or “disabled”.
Hyst.
m:s
Lag time for switching between the slave controllers.
Mode
off
Selected slave controllers will automatically be
switched to “off”
auto
Selected slave controllers will automatically be
switched to “cascade” mode
profile
With the profile, selected slave controllers will
automatically be switched to “cascade” mode
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Operation of the Multi-stage Cascade Controller
t Select the slave controller according to the desired priority in the “Cascade
Parameter pO2-#” submenu.
t Set each minimum and maximum controller setpoint limit for the selected slave
controller using the output limits MIN or MAX in the parameterization image of
the pO2 controller.
t When switching on the DO (pO2) controller, the slave controller modulated by the
DO (pO2) controller is displayed as “active”.
Special notes
− In modes “auto” and “profile” of the DO controller, the selected slave controllers
are automatically switched to “cascade” mode.
− In the “off” mode of the pO2 controller, the selected slave controllers remain in the
cascade last reached and may need to be switched off individually.
− Switching from slave controller 1 to the downstream controller and vice versa is
not done until the respective output limit for the time span defined in the “Hyst.”
field of the parameterization screen has been over or undershot. After this time
has elapsed, check the switch conditions once again and only switched back if they
have been met.
− An inverted control direction for slave controllers, such as the substrate controller,
can be achieved by inverting the setpoint limit (MIN > MAX).
− The DO master controller always uses the MIN | MAX limits of the respective slave
controller as the working range.
− The difference between MIN anx MAX must always be more than 2% of the
specific measurement range.
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8.11.16.2 pO2 Controller ADVANCED (polygon controller)
The advanced DO controller monitors and regulates the DO in the bioreactor or the
controlled end unit for which the DCU system was designed.
The “pO2 controller ADVANCED” is optional and available alternative to the “pO2
controller CASCADE”.
The controller acts as the master controller during DO control. It acts on a
configurable selection of slave controllers for the intake of media or to control
actuators that influence the DO in the process. Examples of such media include gases
like N2, air, O2 or nutrient solutions. The DO value measured in the process depends on
the media introduced, the oxygen consumed by cell growth and cell metabolism and
material distribution from mixing.
The master controller works as a PID controller with configurable control behavior.
It uses the DO measured at a measurement point (up to two measurement points can
be selected) as the actual value. In case of deviation from the setpoint, the master
controller sends an output signal to the slave controllers. Due to the variety of
possible slave controllers, the output signal is relative to the control range 0 to 100 %.
One configuration can include up to six slave controllers, of which five can be
selected simultaneously for the polygon controller. They control their actuators using
analog or digital output signals. Each slave controller can be assigned up to five
setpoints in the physical units of the set value, dependent on the output “Out” of the
master controller. The controller operator screen shows this graphically as a polygonal
curve above the output “Out”.
In comparison with conventional DO cascade controllers, the advanced DO polygon
controller supports the parallel operation of the slave controllers, that is, all actuators
are controlled simultaneously. In combination with the determination of multiple
setpoints dependent on the “Out” of the master controller, this results in an easy-tounderstand and convenient to operate DO control.
Operator Screen
Fig. 8-33: DO controller menu on the “Controller – All” operator screen
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Settings for the Advanced DO Controller
Operating Display and Input Window for the Master Controller
Field
Value
Function, display, entry required
Mode
off
Controller switched off, output on stand-by [¨ configuration]
auto
Controller active, controls the actuator if necessary
Manual
Manual access to controller output
DO (pO2)
Display of the DO
Setpoint
%
Setpoint; in % relative to the control range 0 to 100%
Out
%
Current controller output; in % relative to the control range 0 to 100%
Access to the parameterization menu with standard password
[ Cascade Param. ]
Access to the selection menu for the slave controllers, via standard password
Alarm PRESS
Alarm monitoring settings
High limit
%
Upper alarm limit
Low limit
%
Lower alarm limit
Alarm
state
Status: Alarm monitoring activated (enabled) or deactivated (disabled)
Operating Menus for Configuring Slave Controllers
Field
Value
Function, display, entry required
N2-SP1
tag
Slave controller assigned to this channel
N2, O2, AIR etc.
tag
Media feed (gas, substrate) or function (e.g. stirrer speed controller)
SP etc.
tag
Feed to the culture vessel or bag, e.g. sparger or overlay
1, 2 etc.
#
The unit assigned to the controller output, e.g. culture vessel 1, 2
End mode
[ off ]
[ auto ]
Mode for slave controllers when the master controller is “off” or “disabled”; mode
restored after emergency shut off or power-on
Mode
[ disable ]
[ enable ]
Manually switchable mode of the slave controllers (only available when the master
controller is in operating state “off” or “disabled”)
Example: Input (modification) of the DO setpoint:
Since the selection of slave controller can be changed according to process
requirements, the setpoint of the pO2 controller output is set in % relative to the
control range. The slave controllers control their actuators with setpoints in their
physical units.
t Press “pO2” in the “Controller” menu.
t Press “Setpoint” and enter the password. Access is password-protected in order to
prevent unauthorized changes [¨ see Chapter “4.4 Password Protection of
Individual Functions“, Page 50].
t Use the numeric keypad to enter the set value. Confirm with “OK”.
t Press the function key of the slave controller to be configured, e.g. “N2-SP1”. Enter
up to five setpoints that depend on the “Out” output of the master controller. The
settings are graphically displayed with a polygonal curve.
t Activate the DO controller by switching to the “auto” mode and confirming with
“OK”.
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Parameterization of the DO Master Controller
Fig. 8-34: Parameterization of the DO Master Controller
Elements of the Parameterization Screens
Field
Value
Function, display, entry required
Out
%
Current controller output “Out”, in % of maximum
control range
MIN
%
Minimum output, 0 to 100% of the control range
MAX
%
Maximum output, 0 to 100% of the control range
DEADB
[PV]
Dead zone; pressure regulation remains inactivate as
long as DO deviates from the setpoint by less than
DEADB
XP
%
P share (proportional range); signal amplification of
the control response proportional to the input signal;
in % of the measurement range
TI
s
Integral portion; time function of the control
response. With a higher I portion, the controller will
react more slowly (and vice versa)
TD
s
Differential portion; damping of the controller. With
a greater D portion, the controller response is reduced
(and vice versa)
Normally you only change the parameters “MIN”, “MAX”, and “DEADB”:
t In the “Controller” menu, select “DO” of the corresponding assembly to be
configured and open the controller operator screen.
t Press the parameter key
and enter the password. Access is password-protected
in order to prevent unauthorized changes [¨ see Section “4.4 Password Protection
of Individual Functions“, Page 50].
t Select the parameter to be set (“MIN”, “MAX”, or “DEADB”), enter the value and
confirm with “OK”.
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Setting the “P”, “I”, or “D” Controller Parameters:
The adaptation of PID controllers requires knowledge of control theory. The setting
options listed here are rough guidelines. Only qualified personnel should carry out
controller optimization.
Depending on the process (e.g. stability of gas intake or actuator), it may be necessary
to change the parameters “P”, “I”, or “D” to adapt control behavior. You can test the
following changes:
− If the measured DO value (process value) oscillates around the setpoint and does
not stabilize, you can reduce the “P” portion.
− If the actual value only approaches the setpoint very slowly or does not reach it,
you can increase the “P” portion.
− With a low “I” portion, the controller will react more quickly; as the “D” portion
falls, it will react more strongly to setpoint deviations. However, this can induce
the controller to tend to overshoot.
− By increasing the “I” portion, we make the controller react more slowly, and by
increasing the “D” it will react more weakly to deviations in actual value. This will
make the controller response (the control behavior) more sluggish.
Selection and Configuration of the Slave Controllers
Fig. 8-35: Selecting the slave controller
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Fig. 8-36: Configuring the slave controller
Elements of the Operator Screens for Selection and Configuration
Field
Value
Cascade #
Function, display, entry required
Slave controller to be assigned to the “Cascade #”
position; up to 6 slave controllers are possible
[¨ configuration, specification]
Up to five slave controllers can form a polygon
controller.
N2, O2, AIR
etc.
tag
Feed of media (gases, substrate) or actuators
(e.g. drives)
SP, OV
tag
Introduction to control segment (e.g. sparger “SP”,
headspace aeration “OV” in the culture vessel or
container, massflow controller “FL”)
1, 2
#
The unit assigned to the controller output, e.g. number
1, 2
Out
%
Output signal “Out” from master controller in control
range 0 to 100 % to which the setpoints of the slave
controllers should be assigned
Setpoint
PV
Setpoint of the slave controllers in their physical unit
End Mode
off,
auto
Mode for slave controller when the master controller
is “off” or “disabled”.
Mode
disable
enable
Manually switchable mode of the slave controllers
(only available when the master controller is in
operating state “off” or “disabled”)
Selection of Slave Controllers
t Activate “Cascade Param.” to open the submenu for selection of slave controllers
and change the previous selection.
t Enter the password. Access is password-protected in order to prevent unauthorized
changes [¨ see Section “4.4 Password Protection of Individual Functions“,
Page 50].
t Press the key for position “Cascade #” for which another slave controller should be
selected or the existing one deselected.
Changes to a controller “Cascade #” deletes the subsequent selection. You must
reassign all downstream controllers. Since the slave controllers control their actuators
simultaneously, the order of the controllers has no effect on the control.
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Configuration of Slave Controllers
t Activate the function key of the slave controller you want to configure,
e.g. “AIR-SP1”.
t Enter the password. Access is password-protected in order to prevent unauthorized
changes [¨ see Chapter “4.4 Password Protection of Individual Functions“,
Page 50].
t In the “Setpoint” column, activate the key for the “Out” segment of the master
controller you want to assign a setpoint. Enter the setpoint that should
proportionally act in the polygon controller, in the physical unit of the actuator.
t Enter the setpoint for the other “Out” segments.
y After closing the submenu with “OK”, the setpoints are graphically displayed as a
polygonal curve above the “Out” of the master controller.
t Activate the submenu for the other slave controllers and enter their setpoints for
the “Out” segments of the master controller.
Special notes
The slave controllers work as long as the master controller is active, that is, in “auto”
or “manual” mode. After the master controller is turned off (in state “off”), the slave
controllers can be operated manually, either individually or together in the selected
combination.
The behavior of the master controller is based on sampled settings for the delay time
and switching hysteresis. These settings are determined internally and not accessible
for user modification. If necessary, they must be changed in the configuration.
The following settings are saved for the master controller and slaves:
− The setpoint
− The settings for alarm monitoring
− The PID parameters for the master controller and slave controllers
− Their settings relative to the output of the master controller
That means that these settings are available after a power outage or after the DCU
system or the controlled unit is turned off. They will be restored for the next process
after power returns or the controller is switched back on.
A reset of the DCU system [¨ “Settings” menu] restores the factory settings.
You must therefore store process- or user-specific settings before the reset if you
want to use them again later.
After loading a new system configuration, the DCU system initially starts up with the
factory settings. Here, too, you must reenter any process- or user-specific settings.
Application Instructions and Examples of Applied Control Strategies
Other control strategies, such as Exclusive Flow, can be realized by selecting and
configuring the polygon controller:
Example
t Give “N2SP-#” a setpoint in the range “Out” = 0 to 20 %, with the maximum at
0 %.
t Give “AIRSP-#” a setpoint in the range “Out” = 0 to 20 %, with the maximum at
20 %. Leave “Out” constant for 20 to 100 %.
t Set “O2SP-#” between “Out” = 20 to 40 %, with the maximum at 40 %.
Leave “Out” constant for 40 to 100 %.
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t Set “STIRR-#” between “Out” = 0 to 40 % and increase to a maximum at 60 %.
Leave “Out” constant for 60 to 100 %.
t Leave “SUBS-A” constant in the range “Out” = 0 to 60 % and increase to a
maximum at 80 %.
y This activates the slave controller in the sequence shown, based on the deviation
between the actual and setpoints and the output signal of the master controller.
If the actual value approaches the setpoint, the slave controllers switch back in the
reverse order.
8.11.16.3 Aeration Strategies
Aeration strategy, “O2 Enrichment” (air, O2 for BIOSTAT® B-MO)
In the aeration strategy “O2 Enrichment”, air is first used for the enrichment of the
medium. If this is not sufficient, the air is then continuously enriched with pure
oxygen in order to ensure a sufficiently high content of oxygen in the medium.
t Select “AIRSP-1” and “O2SP-1” as slave controllers.
t For “AIRSP-1”, set a minimum setpoint for “Out” = 0% and a maximum setpoint in
the control range “Out” = 20 to 100% .
t For “O2SP-1”, set
− a minimum setpoint for “Out” = 0 to 20 % and
− a setpoint climbing to 100 % in the control range “Out” = 20 to 100 %.
Fig. 8-37: Configuration of the aeration strategy “O2 Enrichment”
y This cascade control initially leads to oxygen enrichment in the control range
“Out” = 0 to 20%.
Then, the oxygenation capacity in the control range “Out” = 20 is to 100% is
continuously increased via the addition of O2.
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Aeration Strategy “Exclusive Flow” (N2, air, O2 for BIOSTAT® B-CC)
The aeration strategy “Exclusive Flow” behaves like the aeration strategy “O2 Enrichment”. In addition, oxygen can be removed from the culture medium by adding
nitrogen.
t Select “N2SP-1”, “AIRSP-1” and “O2SP-1” as slave controllers.
The starting point of the polygon controller in this aeration strategy is located at
“Out” = 20%.
t For “N2SP-1”, set
− the maximum setpoint in the control range “Out” = 0 % and
− a minimum setpoint in the control range “Out” = 20 to 100 %.
t For “AIRSP-1“, set
− a minimum setpoint in the control range “Out” = 0 to 20 %
− a maximum climbing setpoint in the control range “Out” = 60 to 100 %.
t For “O2SP-1”, set
− a minimum setpoint in the control range “Out” = 0 to 60 %
− a maximum climbing setpoint in the control range “Out” = 60 to 100 %.
Fig. 8-38: Settings for the aeration strategy for “Exclusive flow”
y This control cascade dispenses N2 at a controller “Out” below 20 %.
Air is supplied to a controller “Out” starting at 20%.
The oxygen capacity is increased by the addition of O2 starting at a controller
“Out” = 60%.
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Aeration Strategy “Gasflow Ratio” (air, O2 for BIOSTAT® B-MO)
In the aeration strategy “Gas Flow Ratio”, a constant amount of gases is supplied to
the culture vessel.
t Select “AIRSP-1” and “O2SP” as slave controllers.
t For “AIRSP-1“, set
− a maximum setpoint for “Out” = 0 %
− a minimum sinking setpoint in the control range “Out“ = 100 %.
t For “O2SP-1”, set
− a minimum setpoint for “Out” = 0 %
− a maximum climbing setpoint in the control range “Out” = 100%.
Fig. 8-39: Configuration of the aeration strategy “Gasflow Ratio’
y In this cascade control, only air is supplied within the control range “Out” = 0%.
The supply of air is continuously reduced. To the same extent, the supply of O2 is
increased until solely oxygen is supplied within the control range “Out” = 100%.
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8.11.17 RM Rocker 20 | 50 Controller Functions
In this section, the special controller functions angle control, aeration rate, sensor
signal quality and additional features of the RM Rocker 20 | 50 in the version
“Optical” are described.
Fig. 8-40: Main screen “Controller” of a configuration with RM Rocker 20 | 50 and CultiBag RM
Additional Functional Elements, RM Rocker 20 | 50
Symbol
Display
Meaning, use
Gas supply pressure
Access to the menu where alarm limits
can be configured
Shaker drive operation
[r/min]
Direct access to the submenus to:
− Enter the setpoint for the shaker
− Select the operating mode for the
ROCKS controller
− switch to the controller menu ROCKS
Wobble angle in [°]
Access to the menu where alarm limits
can be configured
8.11.17.1 Introduction
Angle
Electronic configuration of the angle.
Manual positioning
The “Phasen“ function can be used to bring the bag holder into the its back or front
position. The angle can be configured from 4 to 10 °. This function can be used to
harvest the culture when cultivation has ended. It can also be used to carry out
sampling.
Fig. 8-41: RM Rocker 20 | 50 optical/perfusion
150
Aeration rates
Depending on bag size and the maximum desired pressure, different aeration rates
are recommended.
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Signal Quality of the Optical Sensors
Display of the raw sensor data in the menu “Calibration” for evaluation of the signal
quality of the optical sensors.
8.11.17.2 Angle Control
This bioreactor has electronic angle control (“ANGLE”)
Angle control
Fig. 8-42: Main menu of the BIOSTAT® B
Configuration of the process value “ANGLE”
t In the work area of the “Main” menu, press the “ANGLE” function key or select the
“Controller” main function and then the “ANGLE” controller.
y When the “Main” menu is accessed, a submenu (Fig. 2-2) opens with a keypad on
the left side for data entry and a selection field for possible operating modes.
t Enter the new setpoint (observe the permissible values between “Min” and “Max”).
If you don’t want to save the new value, leave the submenu and press the C key.
To turn on the controller, press the button “auto”.
Fig. 8-43: Direct access to input and selection of the
“Angle” controller mode
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t Press the parameter key
to view the graphic controller output.
t Pressing the parameter button again opens a password entry screen.
Fig. 8-44: Representation of the “Angle” controller
outputs
t Set the controller parameterization and confirm the entry with “OK”.
y The submenu window closes. The setpoint is active and is displayed.
8.11.17.3 Position Settings “POSITIONING”
The “POSITIONING” function is used to send position information to the
RM Rocker 20 | 50 and receive status information.
− The RM Rocker 20 | 50 platform can be moved into a front or rear position
− The angle can be configured between 4 to 10°.
− The sample function can be activated. If the “Sample” control button is pressed,
then the platform of the RM Rocker 20 | 50 moves into a 10 ° forward-inclined
position. In order to avoid local overheating, heating is switched off while the
Sample Function is active. After stopping the Sample Phase, the rocker moves into
its rear position again and the heater turns on. A safety feature ensures that the
process automatically starts after a period of time set by the user in the RM Rocker
20 | 50 PLC. This prevents the user from accidentally forgetting to manually start
the RM Rocker 20 | 50 after sampling.
− The HEAT_PID function is used to transfer the PID parameters of the heating
system to the RM Rocker 20 | 50, where they are stored locally.
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Fig. 8-45: Function “POSITIONING”
Configuration of the position:
t In the work area of the “Controller“ menu, press [¨ Fig. 8-45] the function key
“ANGLE”
y The menu “POSITIONING” is displayed in the upper right of the screen.
t Press the touch button “FRONT-#” (or “BACK-#”, “HEAT_PID-#”, “SAMPLING-#”).
Example
y The screen shows the phase “FRONT-#”.
t Press the touch button
.
t Enter the standard password and confirm with [ok].
y The “Phase Parameter FRONT-#” window opens.
t Press the input field “MANPOS-#”.
y A keypad appears.
t Enter the desired angle using the keypad and confirm with [ok].
t Close the window “Phase parameters FRONT-#”.
t Press the touch button “State”.
y The window “Phase Mode” opens.
t To start the phase, press the touch button “start”.
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y The phase window “Phase FRONT-#” opens.
t Confirm the start of the phase by pressing the touch button “YES”.
y The platform of the RM Rocker 20 | 50 now moves to the forward position, the
status changes to “Running”.
The operation of the phases “BACK-#”, “HEAT_PID-#”, and “SAMPLING-#” is
analogous to the described phase “FRONT-#”.
8.11.17.4 Aeration Rate
The flow range of the mass flow controller in the BIOSTAT® B can be chosen when
ordering. For operation with a Bag holder 20, a total flow mass flow controller with a
flow range of up to 1 slpm is offered by default. For a Bag holder 50, the flow area of
the BIOSTAT® B is restricted to a maximum of 3 slpm by default.
Depending on the selected aeration rate, the dynamic pressure in the bag changes
(see the following figure).
We recommend that the aeration rate to be chosen such that the dynamic pressure
remains well below 30 mbar and, where appropriate, to remove the reducing valve
from the exhaust filter.
Fig. 8-46: Dynamic pressure in the bag depending on the aeration rate
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8.11.17.5 Additional Information
Functions via RM Rocker 20 | 50 Touch Panel
Please observe that the following operations can be made solely on the
RM Rocker 20 | 50 Touch Panel:
− All calibration work on the RM Rocker 20 | 50
− The duration of the sampling position must be configured/changed in the
Settings menu
− The bag configuration
− Query of the service interval for the RM Rocker 20 | 50
− RM Rocker 20 | 50 functions in the menu “technician level”
You can find details about the above functions in the operating instructions for the
RM Rocker 20 | 50
Temperature Control Measuring and Control Range
The temperature control range of the RM Rocker 20 | 50 system is between 15 °C and
40 °C. In the DCU Control system, an input range from 0 to 40 °C is implemented.
Please observe that, when using a heating mat for temperature control, the temperature range 0 °C to 40 °C is used only for display. Temperature control in these ranges
is not possible.
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8.12 “Settings” Menu
The “Settings” menu permits changes to the system configuration.
Malfunctions that have unforeseeable impacts on safe operation can result from
settings that are not permissible or are unsuited for a certain terminal unit.
Settings that impact safe operation are password-protected. Only trained
and experienced persons may change these settings. The standard password
[¨ see Chapter “4.4 Password Protection of Individual Functions“] may only be
disclosed to authorized users and the service password [¨ separate notice] only
to authorized service technicians.
8.12.1 General Information
In the “Settings” menu, the DCU system provides various functions for system
maintenance and troubleshooting:
− General settings like date, time, fail time, password-protected screen saver,
parameter settings for communicating with external devices (“Internet
Configuration”).
− Defining Process Values (PV) and their ranges and limits.
− Manual operation of digital and analog inputs and outputs or simulation
controllers, for example.
− Service function, e.g., for resetting the system (Reset) or to select the system
configuration on multiple configurations.
“Settings” operator screen
Fig. 8-47: “Settings” menu (system settings)
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Functions Available for Selection
Touch button
Function
System parameters
Changing general system settings
[¨ see Chapter „8.12.2 Settings“]
PV Ranges
Configuring measurement ranges of process values
[¨ see Chapter „8.12.3 Measuring Range Settings“]
Manual Operation
Switch process inputs and outputs to manual
operation [¨ see Chapter „8.12.4 Manual Operation“]
External
View status of externally connected devices, e.g. scales
[¨ see Chapter „8.12.6 Externally Connected Devices“]
Service
Service and diagnostic interventions
[¨ see Chapter „8.12.7 Service and Diagnosis“]
System information displayed
Field
Hardware
Value
PCM 9363
Function, entry required
Version of the DCU hardware
Firmware
X.YY
Version of the system’s firmware
Configuration XX_YY_ZZZZ Version of the configuration
For inquiries about the system or for contacting the service department in the
event of a malfunction, please always state the firmware indicated here and the
configuration of your system.
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8.12.2 Settings
Using the “System Parameters” touch button, you can change general system settings,
for example setting the real-time clock on the DCU system.
To open the “System parameters” submenu, you will need to enter the standard
password [¨ see Chapter “4.4 Password Protection of Individual Functions“] .
Field
Value
Function, entry required
Time
hh:mm:ss
Enter the current time, format: hh:mm:ss
Time
Synchronize
Synchronize:
enabled/
Enable and disable time synchronization
disabled
IP Address
Entry of the IP-address
Time Zone
Select the time zone
Date
dd.mm.yyyy
Enter the current date, format: dd:mm:yy
Beeper
enabled/
disabled
Turns acoustic signals on | off, e.g. alarm tones
Fail time
hh:mm:ss
Enter power outage time to tell system how to behave
when switched back on, format: hh:mm:ss
Power outage time < FAILTIME: The system continues
to run on the previous settings
Fig. 8-48: Submenu “System Parameters”
Power outage time > FAILTIME: System switches to
default mode
Screensaver
hh:mm
Enter the time of inactivity after which the screen
saver will be turned on,
Format: hh:mm:ss (00:00:00 = switched off)
Internet
Config
12-digit
The DCU system’s address in the IP network
binary number
Changes to the date and time will only take effect in the first 5 minutes after
the DCU system is turned on.
8.12.3 Measuring Range Settings
The beginning and end of the measuring range (“PV Ranges”) for all process values
can be changed in the “Settings” menu. Measuring ranges configured specifically to
devices or customer specifications are factory-set in the bioreactor [¨ Configuration
Documentation].
Only personnel authorized to do so may change the menu settings. To make
settings in the menu, the standard password needs to be entered [¨ Chapter
“19 Appendix“].
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Operator screens
− After pressing the “PV ranges” touch button and entry of the standard password,
the “Process Value Ranges” submenu opens:
Fig. 8-49: Table of process values (or ranges) configured
− By pressing the “Ch.” (Channel) touch button, the process values (ranges) can be
configured:
Fig. 8-50: Manual configuration of process values using example “TEMP-1” (channel 1)
Field
Value
Ch.
Min
Max
Decimal Point
Alarm Low
°C
Alarm High
°C
Alarm
disabled
enabled
Delay
s
Function, entry required
Channel
Minimum value
Maximum value
Decimal point display
Lower alarm limit in the physical unit
Upper alarm limit in the physical unit
Alarm monitoring deactivated
Alarm monitoring alarms active
Alarm lag time
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8.12.4 Manual Operation
When starting up operations and troubleshooting, all analog and digital process
inputs and outputs as well as DCU internal parameters can be switched to manual
operation (“Manual Operation” touch button).
− To open the “Manual Operation” submenu, you will need to enter the standard
password [¨ see Chapter “4.4 Password Protection of Individual Functions“] .
− You can disconnect inputs from the external signal generators and preset input
values to simulate measuring signals.
− You can separate outputs from internal DCU functions and directly influence them
in the operator screen, for example, to test the effect of certain settings.
Settings during manual operation have the highest priority; their effects on the
inputs and outputs of the DCU system supersede those of other functions.
Color Displays of Inputs | Outputs
− If an input or output is in “Manual” operation, the display in the “Value” column
has a green background.
− If a controller is in cascade control mode, the display in the “Setpt” column has a
light green background (controllers only).
− If a phase is acting on an output, the display in the “Value” column has a turquoise
background.
− If an input or output is in “Manual” operation, the display in the “Value” column
has a yellow background.
− If an input/output is locked, the display in the “Value” column has a violet
background.
− If an emergency off is triggered during process, the displays of all outputs in the
“Value” column have a red background.
− If no function is accessing an input | output, the display in the “Value” column has
a gray background.
− If the process control system is accessing an output, the display in the “Value”
column has a white background.
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8.12.4.1
Manual Operation for Digital Inputs
− For manual operation, disconnect the digital input from the external sensor, e.g.
limit value sensors and simulate the input signal from the “ON” or “OFF” input.
Operator Screen
Fig. 8-51: Manual configuration of digital inputs, example “HEATC-1” (simulation for signal of the
power-on status of the heating)
Field
Value
Function, entry required
Day
Description
Display of digital input
Port
Description
Hardware address
Value
PV
Display of signal level of switching state
0 V = off
24 V = on,
Input for “AUTO” or “MANUAL ON | OFF”
operating modes:
“AUTO“: Normal operation, external input acts on DCU
“MANUAL”: Manual operation, manual specification of
digital input
A
Display active status
I: on = turned on (signal level 24 V)
N: on = turned on (signal level 0 V)
off : turned off
AL
Alarm state
A = activated
– = not activated
PV
Switch status of the digital input
off = turned off
on = turned on
Special notes
− The following signal levels apply to the switch status (status):
off
On
0V…
24 V for process inputs (DIP)
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After working on the manual level, you have to switch all inputs back to the
“AUTO” operating mode. Otherwise, the function of the DCU system will be
limited.
− During manual operation, disconnect the digital output from the internal DCU
function and manipulate it directly. For static digital outputs, e.g. controlling
valves, switch the output on or off. For pulse-duration modulated outputs, set the
switch-on ratio in [%] by hand.
− Multiple functions may act internally on a digital output.
After the field is selected, the currently active function will be displayed in the
VALUE column in the corresponding submenu. If several functions are activated
(e.g. on controller outputs that interact with sterilization), the following priority
applies:
Highest priority
Lowest priority
162
Shutdown
Manual Operation (Manual Level)
Locking
Pump calibration
Controllers, timers, sensors, scales/balances
Operating state (OPS)
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Operator Screen
Fig. 8-52: Manual configuration of digital outputs, example “HEAT-1”
(simulation for signal controlling the heating)
Field
Value
Function, entry required
Day
Description
Display of digital input
Port
Description
Hardware address
Val
off
on
nn %
Switch status of the digital output
off = turned off
on = turned on
% = power-on ratio (0 … 100 %) for pulse-duration
modulated digital outputs
Input for “AUTO” or “MANUAL ON | OFF”
operating modes:
“AUTO”: Normal operation, external input affects DCU
“MANUAL”: Manual operation, manual specification of
digital output
A
Display active status
I = turned on (signal level 24 V)
N = turned on (signal level 0 V)
off = turned off
Ty
Upstream function
cl = controller
expr = logical function
– = without
SRC
nn % | off
Upstream controller output
Display of output value:
off
–100 % to +100 %
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163
Special notes
− The following signal levels apply to the switch status (status):
off
on
0V…
24 V for process outputs (DO)
− On pulse-width modulated digital outputs, the relative power-on time is displayed
and | or preset. The cycle time is defined in the specific configuration.
Example:
Cycle time 10 sec, PWM*1 output 40%:
− Digital output 4 sec on and 6 sec off.
After working on the manual level, you have to switch all outputs back to the
“AUTO” operating mode. Otherwise, the function of the DCU system will be
limited.
1 PWM: Pulse-width modulation
164
Preparing and Running the Process
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8.12.4.2
Manual Operation for Analog Inputs
You can disconnect all analog inputs from the external circuitry during manual
operation, e.g., a measurement amplifier and simulate them by entering a relative
signal level (0...100%).
Operator Screen
Fig. 8-53: Manual configuration of analog inputs, example “JTEMP-1” (simulation for input signal for
temperature measurement in heating circuit)
Field
Value
Function, entry required
Day
Description
Display of analog input
Port
Description
Hardware address
Value
PV
Input signal 0 to 10 V or 0/4 to 20 mA
Input for “AUTO” operation or “MANUAL ON | OFF”
PV
Process value
Unit
Physical variable
Special notes
− For analog inputs (A), the signal level can be configured between
− 0 to 10 V
(0 to 100 %)
− 0 to 20 mA (0 to 100 %)
− 4 to 20 mA (0 to 100 %)
− During manual operation, only the relative signal level (0 to 100 %) of the analog
inputs is displayed or entered. The allocation to the physical value is a product of
the measuring range of the affected process value.
After working on the manual level, you have to switch all inputs back to the
“AUTO” operating mode. Otherwise, the function of the DCU system will be
limited.
Preparing and Running the Process
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165
8.12.4.3
Manual Operation of Analog Outputs
You can disconnect analog outputs from the internal DCU functions and influence
them directly using signals with a relative level (0 to 100 %).
Output signals have the following priorities:
Highest priority
Shutdown
Manual Operation (Manual Level)
Locking
Controllers, etc.
Lowest priority
Operator screen
Fig. 8-54: Manual configuration of analog outputs, example “STIRR-1” (simulation of control signal for the
speed regulation of the motor drive)
Field
Value
Function, entry required
Day
Description
Display of the analog output, e.g. STIRR-1
Port
Description
Hardware address, e.g. 1AO05
Value
PV
Output signal 0 to 10 V or 0|4 to 20 mA
Input for “AUTO” or “MANUAL ON | OFF”
operating modes:
“AUTO”: Normal operation, external input affects DCU
“MANUAL”: Manual operation, manual specification of
analog output
Ty
SRC
166
Upstream function
cl = controller
expr = logical function
– = without
nn % | off
Upstream controller output
Display of output value:
off
–100 % to +100 %
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Special notes
− The physical signal level of the analog outputs (AO) can be configured between:
− 0 to 10 V (0 to 100%)
− 0 to 20 mA (0 to 100%)
− 4 to 20 mA (0 to 100%)
After working on the manual level, you have to switch all outputs back to the
“AUTO” operating mode. Otherwise, the function of the DCU system will be
limited.
Preparing and Running the Process
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167
8.12.4.4
Manual Operation for Controllers (“Control Loops”)
You can simulate controllers in manual operation by entering a setpoint.
Operator Screen
Fig. 8-55: Manual configuration of controller, example “TEMP-1” (simulation of control signal of
temperature controller)
Field
Value
Function, entry required
Day
Description
Display of the controller, e.g. TEMP-1
PV
Process value
Setpt
Display of setpoint
Input for “OFF” or “AUTO” operating modes:
“OFF”: Controller is turned off
“AUTO”: Normal operation, setpoint for controller can
be configured
Unit
Physical variable
C
Display of active cascade
0 = no cascade
1 to n = specific cascade for cascade controller
Out
Calculated output value
Special notes
After working on the manual level, you have to switch all outputs back to the
“AUTO” operating mode. Otherwise, the function of the DCU system will be
limited.
168
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8.12.5 Manual Operation of Sequence Control (“Phases”)
You can simulate sequences in manual operation (e.g. during startup or in case of
problems in the sequence execution during sterilization) by starting a sequence.
Operator Screen
Fig. 8-56: Manual start of a sequence, example “FILL1” (simulation of control signal for double wall filling)
Field
Value
Function, entry required
Day
Description
Display of sequence, e.g. FILL-1
State
Display of sequence status | step
Start | stop of a sequence (“START” | “STOP”)
Continuation to next sequence step (“STEP”)
Step
Display of current sequence step
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169
Special Notes
Type and number of sequence steps of individual sequences depends on the
configuration of your system.
After working on the manual level, you must stop all sequences.
Otherwise, the function of the DCU system will be limited.
8.12.6 Externally Connected Devices
The “External” menu button can be used to view and set the status of externally
connected units (e.g. scales).
Only personnel authorized to do so may change the menu settings. To make
settings in the menu, the standard password needs to be entered [¨ Chapter
“19 Appendix”].
Operator Screen
After pressing the “External” touch buttons and entry of the standard password, the
“External System” submenu opens:
Fig. 8-57: Display of externally connected devices in the “External System” submenu (configuration
example)
170
Preparing and Running the Process
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Field
Value
Function, entry required
Day
Description
Display of the connection, e.g. SERIAL-A1
Interface
Description
Display of interface
Alarm
Display and configuration of alarm status:
enabled = activate alarm
disabled = deactivate alarm
Status
Display of status of connected device
(offline | online)
8.12.7 Service and Diagnosis
This operating level is only accessible for interventions by authorized service
technicians or associates of Sartorius Stedim GmbH.
Preparing and Running the Process
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171
9. Faults
9.1
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.
− Before any work, turn the unit off and disconnect it from power.
− During all work on the electrical equipment, disconnect it and check that voltage
is no longer applied.
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.
Danger of burns upon contact with hot surfaces!
− Avoid contact with hot surfaces like vessels, motor housings and pipelines
carrying steam.
− Let the vessels/culture vessels cool before troubleshooting.
− Block the danger zone off.
9.2
Troubleshooting
Always proceed according to the following steps when faults occur on the device.
1. Switch off the device and unplug it from the power supply (pull power plug) if the
fault (e.g. smoke or odors, abnormally high surface temperatures) represents a
direct danger to personnel or property.
2. Inform management on site about the fault.
3. Determine the cause of the fault and remedy it before switching the device back
on [¨ see Chapter “7.13 Turning the Device On and Off“].
If the fault cannot be remedied, please consult your Service Center [¨ Chapter
“15.1 Service Center“].
172
Faults
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9.3
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.
9.3.1
Fault Table “Contamination”
We recommend that you perform a sterility test before each process.
Duration 24 - 48 h.
Conditions for a Sterility Test:
− The culture vessels must be filled with the prescribed culture medium or a suitable
starter medium and autoclaved in accordance with the specifications.
− All of the components, peripheral devices, correction medium feed lines and
sampling systems to be tested must be connected to the culture vessels.
− The system must be set to the prescribed operating conditions (e.g., temperature,
stirrer speed, aeration).
Contamination
Possible causes
Corrective measures
Generalized and widespread, even without
having inoculated the
culture (during the
sterility test phase)
Insufficiently
autoclaved culture
vessel.
Check the autoclave settings.
Increase the autoclaving time.
Perform sterility tests using test
spores.
Air inlet line or air inlet Replace the tubing.
filter defective.
Check the filter and replace if
necessary.
Generalized and
gradual (even without
inoculating the
culture)
Seals on the culture
vessel or the integrated
components are
damaged (e.g. hairline
cracks)
Carefully check the integrated
parts.
If suspected to be damaged
(rough, porous surfaces or dents),
replace seals.
After inoculation,
wide-spread
Contaminated
inoculum culture
Non-sterile inoculation
equipment
Take control samples of the
inoculation culture and test
inoculated culture medium from
the vessels (e.g. on test nutrient
solutions).
Incorrect inoculation
Check the inoculation procedure.
Carefully practice the inoculation
process.
Supply air filter or
Check the filter and replace if
connection has become necessary.
non-sterile or defective Replace the connection line.
During the process,
rapid
Supply air filter or
Check the filter and replace if
connection has become necessary.
non-sterile or defective Replace the connection line.
Accidental or
unauthorized
manipulation of
equipment
Take organizational measures
at the work site to prevent the
equipment from being manipulated without authorization.
Faults
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173
Contamination
Possible causes
Corrective measures
During the process,
gradually
Seals on the culture
vessel or the integrated
components are
defective (e.g. hairline
cracks or porosity)
If possible, continue process to
the end. Once finished, dismantle
the vessel and carefully check the
integrated parts.
If suspected to be damaged
(rough, porous surfaces or dents),
replace seals.
Exhaust air filter(s) or
connection has become
unsterile or is defective
(contaminated from
the exhaust air line).
Check the filter (if possible,
perform a validity test) and
replace if necessary.
Replace the connection line.
9.3.2
Troubleshooting Table “Counter Cooling System”
The counter-cooling system does not work or does not provide sufficient cooling
power.
Fault
Possible causes
Corrective measures
The cooling water
is not fed into the
system
The laboratory’s supply
line is blocked or the
valves in the cooling
water supply are
defective.
If all other potential causes
can be excluded (see below),
contact customer service.
The cooling water supply
valve does not work or
the non-return valve has
become stuck because of
contaminated cooling
water or scale deposits.
Check the water hardness
(no more than 12 dH).
Flow rate too low
The minimum operating
temperature is around 8° C
above the cooling water
temperature.
Insufficient
cooling power
Cooling water
temperature too high
Check the non-return valve.
Feed clean cooling water into
the system (if necessary, install
a pre-filter).
If necessary, install an
upstream cooling device.
9.3.3
Troubleshooting Table “Aeration and Ventilation”
Aeration or ventilation system does not work or does not provide sufficient gas/
ventilation.
Fault
Possible causes
Corrective measures
Air inlet line blocked
Air inlet filter blocked
Check the air feed (dry and
free of oil and dust).
If necessary, install a pre-filter.
The gas or air supply is Hose kinked or
blocked or decreases
disconnected
suddenly
Exhaust air filter blocked
(e.g. as a result of moist
air and the formation of
condensate or foam)
174
Check the hose and filter and,
if necessary, fit new sterile
filters.
Faults
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9.4
Process-related Faults / Alarms
Faults in the operating sequence are displayed as alarms on the operator terminal.
To correct these process-related faults, read the following sections.
The DCU system makes a distinction between alarms and messages. Alarms have
higher priority and are displayed first ahead of the messages.
9.4.1
Alarm Triggering
When alarms are triggered, they automatically are displayed in a window that
superimposes all other windows. The color of the soft button alarm bell turns red.
The color of the alarm bell stays red as long as at least one unconfirmed alarm
remains in memory.
“New ALERT” operator screen
Fig. 9-1: Alarm message: “New ALERT” pop-up screen (new alarm)
− Closing the window:
− After pressing
, the alarm is stored as an “unacknowledged alarm” (UNACK)
in the alarms list and the alarm symbol remains activated.
− The alarm window closes after acknowledgement of the alarm with
“Acknowledge”. The alarm message disappears in the header.
Faults
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175
9.4.2
“Alarm Overview” Menu
The alarm overview can be selected as follows:
t Press the “Alarm” function key.
Operator screen “Alarm”
Fig. 9-2: Alarm table, accessible through the “Alarm” function key
Field
Function, entry required
ACK ALL
Acknowledges all activated alarms
ACK
Acknowledges the selected alarm
RST
Resets and deletes the selected alarm
9.4.3
Process Value Alarms
The DCU system has limit value monitoring routines that monitor all process variables
(measured data and calculated process values) to ensure that they are within the
alarm limits (High | Low).
The alarm limits must be within the measurement range limits. After entering the
alarm limits, you can release or lock the limit value monitoring individually for every
process parameter.
The DCU system can lock certain process outputs after process value alarms.
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Faults
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“Process value alarms” operator screen
Fig. 9-3: Submenu for configuring alarm monitoring, example “TEMP-1”, called from the “Controller” menu,
overview “All”
Field
Value
Function, entry required
High limit
°C
Upper alarm limit in the physical unit of the PV
Low limit
°C
Upper alarm limit in the physical unit of the PV
Alarm
Status for alarm monitoring
disabled
Alarm monitoring, high | low alarms locked
enabled
Alarm monitoring, high | low alarms activated
Faults
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177
Operating Instructions
Alarms are displayed on the operator screen and must be acknowledged:
− If the value falls outside the alarm limits, an alarm window opens above the active
screen. An acoustic signal sounds. The alarm display is displayed in the header line
of the operator screen.
The process value display also shows a small alarm symbol:
Operator screen example: exceeding the alarm limit
Fig. 9-4: Alarm message, exceeding the alarm limit for pH-1.
− The alarm window closes after acknowledgement of the alarm with “Acknowledge”
or after pressing
.
− After the alarm is confirmed with “Acknowledge”, the alarm symbol disappears.
”, the alarm is stored in the alarm list as an unacknowledged
− After pressing “
alarm and the alarm symbol remains active (the alarm bell stays red).
− If several alarms have been triggered, the next, still unconfirmed alarm will be
displayed after the active alarm window is closed.
Special notes
The DCU system continues to display limit value alarms as long as the process value
remains outside the alarm limits.
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Faults
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9.4.4
Alarms for Digital Inputs
Digital inputs can be prompted in response to alarm conditions as well.
These can be used to monitor components like limit contacts (antifoam | level
sensors), motor protection switches or circuit breakers.
When an alarm is triggered, an alarm message with the time of the alarm event and
an acoustic confirmation signal is emitted.
The DCU system can lock certain process outputs after process value alarms.
“Alarm monitoring” operator screen
Fig. 9-5: Activating and deactivating alarm monitoring
ÅÆ
Fig. 9-6: Fig. 19-6: Alarm deactivated, alarm activated
Field
Value
Alarms Param.
Function, entry required
Alarm monitoring operating mode
disabled
Alarm monitoring locked for the input
enabled
Alarm monitoring activated for the input
Faults
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179
Operating Instructions
A new alarm is indicated in two ways:
− When an alarm is triggered for the first time, a message appears in the display and
an acoustic signal is emitted.
− The alarm symbol is displayed in the header line of the operator screen.
t Eliminate the cause of the alarm. Check the function of the component that is
producing the input signal, the corresponding connections, and if necessary the
regulator settings.
t Confirm the alarm with “Acknowledge” or press “X”.
y The alarm window closes.
− After the alarm is confirmed with “Acknowledge”, the alarm symbol disappears
(the alarm bell turns white). The alarm is recorded in the alarm list as a
confirmed alarm (“ACK”).
− After pressing “X”, the alarm is stored in the alarm list as an unacknowledged
alarm and the alarm symbol remains active (the alarm bell stays red).
Special notes
For an overview of alarms that have occurred, you can open the alarm table with the
“Alarm” menu button.
9.4.5
9.4.5.1
Alarms, Meaning and Corrective Measures
Process Alarms
The user can switch on and off the individual alarms listed in the following table:
Text in the alarm line
Meaning
Remedy
[Name] State Alarm
Digital input alarm
Confirm alarm with “ACK”
[Name] Low Alarm
The corresponding process value has exceeded its
lower alarm limit
Confirm alarm with “ACK”
[Name] High Alarm
The corresponding process value has exceeded its
upper alarm limit
Confirm alarm with “ACK”
Jacket Heater Failure
Overheating protection in the temperature circulation
of the double wall has triggered
The tempering system must be refilled
Motor Failure
Overheating protection of the motor responded
Allow the motor to cool down
OVP
Overvoltage protection
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Faults
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9.4.5.2
System Alarms
The alarms in the following table are system-generated messages that the user
cannot switch off:
Text in the alarm line
Meaning
Remedy
Source: Factory Reset
Confirmation message for a system reset
started from the “Settings” menu
Confirm alarm with “ACK'
[Name] Watchdog Timeout
Confirmation message for a Watchdog Timeout, triggered by malfunctions in the DCU
including reference to the source of failure
Note down the alarm and report it to the
Service Department.
Confirm alarm with “ACK'
Power Failure
Power lost at
[yyyy-mm-dd hh:mm:ss]
Power failure with the date and time
Confirm alarm with “ACK'
Power Failure, Process Stopped
System in Standby
Power lost at
[yyyy-mm-dd hh:mm:ss]
Power failure with the date and time; maximum power outage time exceeded
Confirm alarm with “ACK”.
Shut down Unit #
“Shut down” was pressed on the bioreactor
Switch the bioreactor back on with “Shut down”
Faults
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181
10. Cleaning and Maintenance
Incorrect cleaning and maintenance can lead to erroneous process results, causing
high production costs. Regular cleaning and maintenance is thus essential. Among
other factors, the operational safety and effective performance of fermentation also
depend on proper cleaning and maintenance.
The cleaning and maintenance intervals largely depend on the stress placed on the
culture vessel and equipment by aggressive components contained in the media
(e.g. acids and bases used to regulate pH) and the level of contamination from culture
and metabolic product residues attached to this equipment.
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.
− 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.
− During repair work and cleaning, turn the power supply off and secure it against
reactivation.
− Keep moisture away from parts under voltage, as it can lead to short circuits.
− 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.
− Have the electrical components and stationary electrical equipment checked by an
electrician at least every 4 years.
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.
Danger of burns upon contact with hot surfaces!
− Avoid contact with hot surfaces like vessels, motor housings and pipelines carrying
steam.
− Block the danger zone off.
− Wear protective gloves when working with hot culture media.
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Cleaning and Maintenance
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Danger from projecting components!
− Ensure that danger points such as corners, edges and projecting components are
covered.
Preliminary Steps
Always take the following preliminary steps when performing cleaning and
maintenance:
t Turn the device off at the main switch.
t Remove the power supply from the laboratory connection.
t Turn off all supply media in the lab (water and gas supply).
t Ensure that the connections and hoses have been depressurized.
t If necessary, remove the supply media lines from the device.
10.1 Cleaning
Danger of corrosion and damage to the device and the culture vessel by
unsuitable cleaning agents.
− Avoid strongly caustic or alkaline and/or chloride-containing detergents.
− Avoid solvent-based cleaning agents.
− Ensure that the cleaning agents used are compliant materials.
Observe the safety instructions for the cleaning agents.
The use and disposal of cleaning agents, and water containing the same, may be
subject to legal or environmental protection regulations.
10.1.1 Cleaning the Device
t Clean the device housing with a slightly damp cleaning cloth; for more severe
contamination, use a mild soap.
t Clean the operator display with a slightly damp, lint-free cleaning cloth; for more
severe contamination, use a mild soap.
Be sure not to scratch the device or operating display. Future contamination is
otherwise more difficult to remove.
Cleaning and Maintenance
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183
10.1.2 Cleaning the Culture Vessels
In some cases, it may be sufficient to carefully rinse the culture vessels (UniVessel®
Glass) with water.
If the bioreactor is not used for a while, always fill the culture vessels with water,
as this will protect the integrated sensors from drying out.
Thorough cleaning is required if components of the culture or media adhere to the
inside surfaces of the culture
vessels and components installed.
− Culture vessels and glass containers can be cleaned in a dishwasher. Before
cleaning culture vessels inside a dishwasher, always remove the support frame,
the cover plate and the vessel fittings.
− Glass surfaces that are contaminated with organic substances can be cleaned with
conventional laboratory glass cleaners. To remove stubborn organic contaminants,
you may use mechanical means.
− Inorganic deposits must be removed using diluted hydrochloric acid. Once these
contaminants have been removed, carefully rinse the culture vessel with water.
− You can clean metallic parts (cover plate, etc.) mechanically, if needed with the
help of mild detergents or alcohol.
− The seals and O-rings must be cleaned mechanically. If deposits on the seals and
O-rings prove to be persistent, replace the seals and O-rings.
Detailed information on cleaning culture vessels, vessel equipment and sensors can be
found in the [¨ UniVessel® Glass Operating Manual].
10.1.3 Cleaning and Maintaining Heating Jackets
Danger of damage from unsuitable cleaning agents and cleaning procedures.
Do not use any cleaning agents or solvents that can corrode the power supply,
silicone foil or silicone foam and make them porous.
Do not use any hard and | or sharp objects to remove stubborn soiling.
The heating jackets are insensitive to water and the media used in conventional
culture procedures. Test the resistance to the laboratory acids, alkaline agents and
solvents used.
t Clean soiled heating jacket carefully using only a wet cloth and warm water or
mild soapy water.
t Before each use, make sure to check that the following parts are in perfect
condition:
− the power cord, especially where it connects to the heating jacket
− the silicone foil on the heating side,
− the silicone foam isolation
− the Velcro fasteners
184
Cleaning and Maintenance
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Possible Damage
Danger to life caused by electric shock if heating jackets are defective!
None of the parts should be porous, folded, kinked or chipped.
The silicone foil should not be discolored. This is a sign of short circuiting due to
broken heating coils or a defective power cord.
− In this case, switch out the heating and cooling jackets and discontinue its use.
4
2
2
1a
1b
3
Fig. 11-1: Picture of damage
1a Cracks, porosity of the cable
connection
3
Short circuiting of the heating coils,
evidenced by discoloration on the
silicone foil
1b Cracks, porosity of the power cord
4
Cracks, porosity of the Velcro straps
2
Cracks, porosity of the silicone foil
above the heating coils
After using the heating blanket, only store it in a clean, dry location.
Do not expose it to sunlight for extended periods.
When in perfect condition, the heating jackets allow for safe heating of the culture
vessels.
Malfunction and dangerous operating states can occur if damage was overlooked
during the pre-use check.
Spare and Wearing Parts
Heating jackets do not contain spare or wearing parts. If worn or defective, they must
be replaced.
Cleaning and Maintenance
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185
10.2 Maintenance
10.2.1 Carry out Maintenance Work on Function Elements
Maintenance performed by the user is restricted to the following tasks:
− Maintaining the pH, pO2 or Redox sensor as per the manufacturer's | supplier's
specifications.
− Checking and replacing parts subject to wear as well as disposables, e.g., glass
vessels, filters, tubing and seals with identical components with the same
specifications [¨ Spare parts list].
− Replacing O-rings, seals, filters, hoses and disposable items, e.g. inoculation
membranes.
Detailed instructions on the maintenance of culture vessels, vessel equipment and
sensors can be found in the [¨ UniVessel® Glass Operating Manual].
The internal modules of the device, and the safety equipment, pump modules,
drive motors and stirrer shaft couplings, must only be serviced by qualified and
correspondingly authorized service personnel.
Any servicing instructions for internal equipment, electrical modules and safety
equipment contained in this manual and the technical documentation must be
forwarded to the servicing personnel.
Please return the device to Sartorius Stedim Systems GmbH if it is defective.
Observe the Decontamination Declaration.
10.2.2 Safety Component Maintenance
Non-return Valve
The wastewater outlet in the temperature control module consists of a check valve
[¨ P&I Diagram]. This valve protects the system from excessive pressure buildup if
the water feed is accidentally connected to the outlet of the thermostat system,
if water dams up, or if water flows back into the supply unit from the outlet.
Non-return valves that are defective must be replaced.
Fig. 11-2: Non-return valve
If the pressure in the temperature control circuit is too high, the culture vessels
can burst.
In jacketed glass vessels, this can cause the wall to burst. Non-return valves are only
designed for assuring the direction of flow. They must not be used as safety valves.
If a sealed external cooling circuit has been connected to the system, it must be
ensured that this circuit operates at zero-pressure.
The non-return valve’s function must be checked before the bioreactor is
commissioned and thereafter checked once a year. The function test and replacement
of the non-return valve, where necessary, is carried out by Sartorius Stedim Service.
186
Cleaning and Maintenance
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10.2.3 Maintenance Intervals
The cyclical maintenance of the device depends on its service life.
The following table lists the maintenance intervals as they are assigned to the
components:
Before every process
After 10-20
autoclave cycles
Component
If unsterile
Activity
1 + yearly
Glass culture vessel
Pressure hold test
Leaktightness Test
x
Gas leak test
Visual inspection
x
Leak test Temperature
control system
Visual inspection
x
Replace
x
­
Visual inspection,
replace if needed
x
­
Replace
Leak test
x
Control Unit
Connections to the culture
vessel, air and water
Tapping septa
­
O-rings
x x
Air inlet and exhaust
filters
Filter elements
Integrity test
­
Replace
x
x x x
Holding bottles
Sampling bottles
­
Visual inspection,
replace if needed
Gaskets, ventilation filters
Replace
x
x x
Rotating mechanical seal
Check for contamination
and damage
Visual inspection
x
Visual inspection,
replace if needed
x
pH probe
Calibration, visual inspection
for damage
x
pO2 probe
Calibration, visual inspection
for damage
x
Peristaltic pumps
Pump hoses
Probes
Membrane body, electrolyte Visual inspection,
(Clark probes)
replace if needed
x
Cleaning and Maintenance
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187
Before every process
After 10-20
autoclave cycles
Component
If unsterile
Activity
1 + yearly
Sensor cap
(optical O2 probe)
x
Foam probe
Calibration, visual inspection
for damage
x
Level probe
Calibration, visual inspection
for damage
x
Temperature sensors
Calibration, visual inspection
for damage
x
Plugs, contacts, lines
x
­
Visual inspection
x
Maintenance according to
maintenance schedule
Only to be carried out by
Maintenance and
Sartorius experts.
functional test according to
Please contact Sartorius
maintenance report
Stedim Service.
188
x
Cleaning and Maintenance
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11. 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 “13.1 Ambient Conditions“.
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.
Storage
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189
12. Disposal
12.1 General Notes
If the packaging is no longer needed, it can be disposed of by local waste disposal
authorities. The packaging is made of environmentally friendly materials that can be
used as secondary raw materials.
The equipment, including accessories and batteries, should not be disposed of as
regular household waste.
EU legislation requires its Member States to collect electrical and electronic equipment and dispose of it separately from other unsorted municipal waste so that it may
be recycled.
In Germany and several other countries, Sartorius itself assumes responsibility for the
return and legally compliant disposal of its electronic and electrical products. These
products may not be placed with household waste or brought to collection centers
run by local public disposal operations – not even by small commercial operators. For
disposal in Germany and in the other member nations of the European Economic Area
(EEA), please contact our local service technicians or our Service Center in Goettingen,
Germany:
Sartorius Stedim Biotech GmbH
August-Spindler-Strasse 11
D-37079 Goettingen
Phone +49.551.308.0
Fax
+49.551.308.3289
In countries that are not members of the European Economic Area (EEA) or where no
Sartorius subsidiaries or dealerships are located, please contact your local authorities
or a commercial disposal operator.
Prior to disposal and/or scrapping of the equipment, any batteries should be removed
and disposed of at local collection points.
Devices contaminated with hazardous materials (NBC contamination) will not be
accepted for repair or disposal. Detailed information with service addresses for
returning your device for repair or disposal can be found on our website
(www.sartorius.com) or requested from a Sartorius Service Center.
12.2 Hazardous Materials
The device does not contain any hazardous materials that would necessitate special
disposal measures.
The cultures and media (e.g. acids, bases) used during the fermentation processes are
potentially hazardous materials that could cause biological or chemical hazards.
Note in accordance with European directive on hazardous substances!
According to the EU directives, the owners of devices that come into contact with
hazardous substances are responsible for properly disposing of these devices and to
declare such devices when transporting them.
190
Disposal
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Corrosion
When using corrosive gases, the fittings must be chosen accordingly, (e.g. made of
stainless steel instead of brass). To change such fittings, please contact Sartorius
Stedim Service.
We do not accept any responsibility for operating faults and defects resulting from
the use of unsuitable gases.
12.3 Decontamination Declaration
Sartorius Stedim Systems GmbH 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.
This declaration must detail the microorganisms, cells and media that the device has
come into contact with and the measures taken to disinfect and decontaminate it.
− The recipient (e.g. Sartorius Stedim Service) must be able to read this
decontamination declaration before opening the packaging.
− This document contains an attachment with a decontamination declaration form
in [¨ Chapter “15.2 Decontamination Declaration“].
To create additional copies, simply copy the attached form or request additional
forms from Sartorius Stedim Systems GmbH.
Danger of injury from improperly performed work!
The disassembly and disposal of the unit may only be carried out by technical
personnel.
Warning of dangerous electrical voltage!
Work on the electrical equipment may only be carried out by a competent electrician.
12.4 Decommissioning the Unit
Carry out the following work steps for the disassembly of the unit:
t Empty the culture vessel, pipelines and hoses of all culture media and additives.
t Clean the entire unit.
t Sterilize the entire unit.
t Turn the unit off via the unit’s main switch and secure the unit against being
turned back on.
t Disconnect the unit from power and the supply lines.
Disposal
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191
12.5 Disposing of the Unit
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.
− The device may only be disassembled by technical personnel.
− Disassemble the unit carefully and in a safety-conscious manner.
− Wear the following personal protective equipment during work [¨ see also
Chapter “2.15 Personal Protective Equipment“]:
− Safety gloves
− Protective work clothes
− Safety boots
− Safety glasses.
t Disassemble the unit until all unit parts have been assigned to a material group
and can be appropriately disposed of.
t Dispose of the device in an environmentally friendly manner. Follow the
regulations applicable in the local region.
192
Disposal
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13. Specifications
− BIOSTAT® B-MO (microbial)
Name:
− BIOSTAT® B-CC (cell culture = cell culture)
Laboratory Energy Sources
Power connection for a
supply unit:
230 V (± 10%), 50Hz, power consumption 10 A
120 V (± 10%), 60 Hz, power consumption 12 A
Protection class: IP 20
Cooling water supply:
Supply rate: min. 10 L/min
Supply pressure: 2...8 barg (29-116 psig)
Water hardness: max. hardness 12° dH
Water quality: clean water, free of particles
Process gas supply:
Supply pressure [barg | psig]:
− Compressed air, preset to 1.5 barg (29 psig)
− O2: with 1.5 barg (21.76 psig)
− N2: with 1.5 barg (21.76 psig)
− CO2: with 1.5 barg (21.76 psig)
Supply rate (max.):
− Compressed air [AIR]: 20 L/min
− O2: 20 L/min
− N2: 20 L/min
− CO2: 20 L/min
All gases: Dry and free of particles
Culture Vessels
Operating volume / total volume [ L ] / [ L ]
− UniVessel® Glass 1 L: 1 | 1.5
− UniVessel® Glass 2 L: 2 | 3
− UniVessel® Glass 5 L: 5 | 6.6
− UniVessel® Glass 10 L: 10 | 13
Material: Steel | glass
UniVessel® SU 2 L: 2 | 2.7
Material: Polycarbonate
RM Rocker 20 | 50
− CultiBag RM 20: 10 | 20
− CultiBag RM 50: 25 | 50
Size [mm]
Supply unit
length | width | height
402 / 345 / 768
Specifications
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193
Weights [kg]
Supply unit:
BIOSTAT® B
approx. 55 (depending on the equipment)
Culture vessels:
UniVessel® Glass 1 L DW/SW
UniVessel® Glass 2 L DW/SW
UniVessel® Glass 5 L DW/SW
UniVessel® Glass 10 L DW/SW
UniVessel® 2 L SU without vessel holder
UniVessel® 2 L SU with vessel holder
approx. 10
approx. 14
approx. 20
approx. 34
approx. 1.5
approx. 15
Temperatures [°C]
Maximum operating temperatures
+ 80
Minimum operating temperatures
(cooling water)
+8
Stirrer Driver [1/min]
Motor 200 W:
− 1 L, 2 L culture vessel
− 2 L culture vessel
UniVessel® SU
− 5 L bioreactor
− 10 L bioreactor
194
rpm range 20 … 2000
rpm range 20 … 400
rpm range 20 … 1500
rpm range 20 … 800
Specifications
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13.1 Ambient Conditions
Ambient Conditions
Installation location:
Conventional laboratory rooms, max. 2,000 m above
sea level
Ambient temperatures
of between [°C]:
5 – 40
Relative humidity [%]:
<80% for temperatures up to 31 °C (87.8°F),
decreasing linearly < 50% at 40 °C (104°F)
Impurities:
Pollution degree 2 (Normally only non-conductive
pollution occurs. Occasionally, however, temporary
conductivity caused by condensation must be
expected.)
Acoustic emission [dB (A)]:
max. sound pressure level < 70
13.2 Water Hardness Conversion Table
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 bioreactor as separate documents.
Alkaline
Alkaline
German CaCO3
earth ions earth ions hardness
English French
hardness hardness
[mmol/l]
[mval/l]
[°d]
[ppm]
[°e]
[°f]
1 mmol/l
1.00
alkaline earth ions
2.00
5.50
100.00
7.02
10.00
1 mval/l
0.50
alkaline earth ions
1.00
2.80
50.00
3.51
5
1° German hardness 0.18
[°d]
0.357
1.00
17.80
1.25
1.78
1 ppm CaCO3
0.01
0.020
0.056
1.00
0.0702
0.10
1° English hardness 0.14
[°e]
0.285
0.798
14.30
1.00
1.43
1° French hardness 0.10
[°f]
0.200
0.560
10.00
0.702
1.00
Specifications
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195
14. Conformity & Licenses
14.1 EC Declaration of Conformity
With the attached declaration of conformity [¨ Page 197], Sartorius Stedim
Systems GmbH confirms the compliance of the devices BIOSTAT® B-MO and BIOSTAT®
B-CC with the directives cited.
14.2 GNU Licensing
DCU systems contain software subject to the license terms of the “GNU General
Public License (GPL)” or the “GNU LESSER General Public License (LGPL)”.
If applicable, the terms of the GPL and LGPL as well as information about the options
for access to GPL code and LGPL code used in this product are available upon request.
The GPL code and LGPL code contained in this product are published without any
guarantee and subject to the copyright of one or more authors. You can find detailed
information in the documentation about the enclosed LGPL code and in the GPL and
LGPL terms and conditions.
196
Conformity & Licenses
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X
Conformity & Licenses
*** TeDIS Valid on Date Printed
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197
15. Appendix
15.1 Service Center
Repairs can be carried out on-site by authorized service personnel or by the
responsible Service representative of Sartorius Stedim Systems GmbH.
The model designation can be found on the model plate or signage [¨ see Chapter
“6.4.2 Manufacturer’s ID Label“].
For equipping and retrofitting as well as repairs, you may only use parts approved by
Sartorius Stedim Systems GmbH for the device.
Sartorius Stedim Systems GmbH shall not be liable for repairs made by the customer
or any resulting damage.
The warranty shall expire particularly in the case of:
− The use of unsuitable parts that deviate from the device’s specifications.
− Modification to parts without the approval of Sartorius Stedim Systems GmbH.
In the event of service requests or warranty claims, please notify your representative
of Sartorius Stedim Systems GmbH or contact:
Sartorius Stedim Systems GmbH
Robert-Bosch-Str. 5–7
D-34302 Guxhagen, Germany
Phone no. +49.5665.407.0
Fax. no. +49.5665.407.2200
E-Mail: info@sartorius-stedim.com
Website: http://www.sartorius-stedim.com
Returning Devices
Send defective devices or parts to Sartorius Stedim Systems GmbH.
Returned devices must be clean and in hygienically flawless condition and packed
carefully. Contaminated parts must be disinfected and | or sterilized in accordance
with the safety guidelines applicable to the area application.
The sender must prove compliance with the regulations. Use the Decontamination
Declaration [¨ Chapter “15.2 Decontamination Declaration“].
Transport damage, as well as measures for subsequent cleaning and disinfection of
the parts by Sartorius Stedim Systems GmbH, shall be charged to sender.
15.2 Decontamination Declaration
When returning equipment, copy the following form as required, carefully complete
it and enclose it with the delivery documents.
The recipient must be able to inspect the completed declaration before removing the
device from the packaging.
198
Appendix
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Decontamination Declaration
Declaration Concerning the Decontamination and Cleaning of Equipment and Components
To protect our personnel, we require that all equipment or components which come into contact with our personnel at
customers' facilities be free of biological, chemical or radioactive contaminants. We will only accept an order when:
– the equipment or components have been adequately CLEANED and DECONTAMINATED.
– this declaring document has been completed, signed and returned to us by an authorized person.
Please help us in assuring a safe, hazard-free work environment.
Description of the Equipment or Component(s)
Description | Cat. No.:
Serial No.:
No. of invoice | Delivery note:
Date of delivery:
Contamination | Cleaning
Attention: Please provide a precise description of the Attention: Please describe the cleaning and
biological, chemical or radioactive contamination
decontamination procedure | method.
The equipment was contaminated with:
and it has been cleaned and decontaminated by:
Legally Binding Declaration
I/We hereby certify that the information provided on this form are true and complete. The devices and components
have been decontaminated and cleaned properly and in accordance with legal specifications.
No chemical or biological or radioactive risks remain that could endanger exposed persons’ safety or health.
Company | Institute:
Address | Country:
Tel.:
Name of the authorized person:
Position:
Date | Signature:
Fax:
Please pack the equipment properly and send it ex recipient
to your local service representative or directly to
Sartorius Stedim Biotech GmbH.
© 2012 Sartorius Stedim Biotech GmbH
Sartorius Stedim Systems GmbH
Service Department
Robert-Bosch-Str. 5 – 7
D-34302 Guxhagen
Germany
Appendix
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199
15.3 Setup Drawings
On the following pages, you will find setup drawings for the following configurations:
− BIOSTAT® B, Single with UniVessel® Glass, DW
− BIOSTAT® B, Single with RM Rocker 20 | 50
− BIOSTAT® B, Single with UniVessel® SU, SW
− BIOSTAT® B, Twin with UniVessel® Glass, DW
− BIOSTAT® B, Twin with RM Rocker 20 | 50
− BIOSTAT® B, Twin with UniVessel® SU, SW
− BIOSTAT® B, Twin with UniVessel® SU, SW / UniVessel® Glass, DW
200
Appendix
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*** TeDIS Valid on Date Printed
Appendix
Printed on: 20-09-2023 11:08:41 ***
A
B
16
15
14
1L UniVessel DW
13
Supply Unit Twin
12
Wasseranschluß Rücklauf Ø10mm
Water return Connection Ø10mm
Wasseranschluß Zulauf Ø10mm
Water Supply Connection Ø10mm
Netzanschluß
Main Connection
PE-Anschluß
PE-Connection
12
11
11
507
9
10
9
Thermostat Rücklauf / Serto Verschraubung Ø10mm
Thermostate Return / Serto Connection Ø10mm
Thermostat Zulauf / Serto Verschraubung Ø10mm
Thermostate Supply / Serto Connection Ø10mm
Abluft Rücklauf / Serto Verschraubung Ø10mm
Exhaust Return / Serto Connection Ø10mm
Abluft Zulauf / Serto Verschraubung Ø10mm
Abluft Supply / Serto Connection Ø10mm
Serial / M12 Steckanschluß
Serial / M12 plug-in Connection
Pumpe / M12 Steckanschluß
Pump / M12 plug-in Connection°
Ext. Signal / M12 Steckanschluß
Ext. Signals / M12 plug-in Connection
Trübung / Lemo-Stecker
Turbidity / Lemo-Connection
LEVEL / M12 Steckanschluß
LEVEL / M12 plug-in Connection
FOAM / M12 Steckanschluß
FOAM / M12 plug-in Connection
Sparger Zulauf / Serto Verschraubung Ø6mm
Sparger Supply / Serto Connection Ø6mm
10
507
C
Gas Anschluß CO2 / Serto-Verschraubung Ø6mm
Gas Connection CO2 / Serto Connection Ø6mm
Gas Anschluß N2 / Serto-Verschraubung Ø6mm
Gas Connection N2 / Serto Connection Ø6mm
Gas Anschluß O2 / Serto-Verschraubung Ø6mm
Gas Connection O2 / Serto Connection Ø6mm
A(1:3)
13
8
Sensorfeld
Sensor panel
8
800
7
Heizmanschette / Amphenol Stecker
Heating Blanket / Amphenol Plug-In Connection
Serial / M12 Steckanschluß
Serial / M12 plug-in Connection
Pumpe / M12 Steckanschluß
Pump / M12 plug-in Connection
Ext. Signal / M12 Steckanschluß
Ext. Signals / M12 plug-in Connection
pO2 / VP8 Stecker
pO2 / VP8 Connection
pH / VP8 Stecker
pH / VP8 Connection
Temp / M12 Steckanschluß
Temp / M12 plug-in Connection
Overlay Zulauf / Serto Verschraubung Ø6mm
Overlay Supply / Serto Connection Ø6mm
7
800
D
Ethernet Host
Ethernet Host
14
Common Alarm Anschluß
Common Alarm Connection
Gas Anschluß AIR / Serto-Verschraubung Ø6mm
Gas Connection AIR / Serto Connection Ø6mm
15
1496
E
F
G
H
I
J
K
16
6
1496
1496
6
5
Ansicht A
5
1200
L
1200
1622
1882
201
1622
1882
4
Ablagebox
Utilitx Box
4
800
800
Index
3
Änderungen/Revision
Datum/Date
Name
Allowable tolerances unless otherwise
specified according to EN ISO 13920-A/-AE
Zul. Abweichungen für Maße ohne
Toleranzangaben nach EN ISO 13920-A/-AE
3
1
Datum/Date
Ursprung/Origin
28.03.2012
2
TKösters
Name
Ers. f./Repl. for
Artikel-Nr./Article-no.
Ers. d./Repl. by
DE-1028702
Dokument-Nr./Document-no.
1L Univessel MU
1
1 /1
Blatt/Sheet
Maßstab/Scale
Arrangemanet Plan BIOSTAT B, single, dw
Aufstellungsplan BIOSTAT B, Single, DW
Für diese Zeichnung behalten wir uns alle Rechte vor / This drawing is the property of Sartorius Stedim Systems GmbH
Oberfläche/Finish:
Bearbeiter
Drawn
Geprüft
Checked
2
A
B
C
D
E
F
G
H
I
J
K
L
202
*** TeDIS Valid on Date Printed
A
B
C
D
E
F
G
H
I
J
K
L
16
16
15
Thermostate return / Serto connection P10mm
Thermostat Rücklauf / Serto-Verschraubung P10mm
Thermostate supply / Serto connection P10mm
Thermostat Zulauf / Serto-Verschraubung P10mm
Ext. Signal / M12 Steckanschluss
Ext. signal / M12 plug-in connection
Serial / M12 Steckanschluss
Serial / M12 plug-in connection
Serial / M12 Steckanschluss
Serial / M12 plug-in connection
Serial / M12 Steckanschluss
Serial / M12 plug-in connection
Serial / M12 Steckanschluss
Serial / M12 plug-in connection
Overlay supply / Serto connection P6mm
Overlay Zulauf / Serto-Verschraubung P6mm
15
14
Sensorfeld für RM
Sensor panel for RM
14
13
Pumpe / M12 Steckanschluss
Pump / M12 plug-in connection
Pumpe / M12 Steckanschluss
Pump / M12 plug-in connection
Optischer Stecker PreSens
Visual connector PreSens
Optischer Stecker PreSens
Visual connector PreSens
13
12
12
11
11
RM 20/50
10
10
1344
1344
1600
1600
9
9
8
Supply Unit Single
8
7
810
810
7
1632
1504
800
1882
Appendix
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1632
800
1504
1882
6
6
Common Alarm Anschluss
Common alarm connection
Ablagebox
Utility box
5
4
Netzwerkanschluss
Ethernet hist
4
Gas connection CO2 / Serto Connection P6mm
Gas Anschluss CO2 / Serto-Verschraubung P6mm
Gas connection N2 / Serto Connection P6mm
Gas Anschluss N2 / Serto-Verschraubung P6mm
Gas connection O2 / Serto Connection P6mm
Gas Anschluss O2 / Serto-Verschraubung P6mm
Gas connection AIR / Serto Connection P6mm
Gas Anschluss AIR / Serto-Verschraubung P6mm
A
5
Index
Water supply connection P10mm
Wasseranschluss Zulauf P10mm
3
Datum/Date
Name
Ursprung/Origin
13.08.2013
Datum/Date
Oberfläche/Finish:
Bearbeiter
Drawn
Geprüft
Checked
1
2
ABernhard
Name
Ers. f./Repl. for
Artikel-Nr./Article-no.
Ers. d./Repl. by
DE-1033224
Dokument-Nr./Document-no.
RM 20/50
1
1 /1
Blatt/Sheet
Maßstab/Scale
Arrangement plan BIOSTAT B, Single
Aufstellungsplan BIOSTAT B, Single
Für diese Zeichnung behalten wir uns alle Rechte vor / This drawing is the property of Sartorius Stedim Systems GmbH
Water return connection P10mm
Allowable tolerances unless otherwise
specified according to ISO 2768-mH
Änderungen/Revision
Netzanschluss
Main connection
2
Wasseranschluss Rücklauf P10mm
Zul. Abweichungen für Maße ohne
Toleranzangaben nach ISO 2768-mH
PE-Anschluss
PE-Connection
A(1:3)
3
A
B
C
D
E
F
G
H
I
J
K
L
*** TeDIS Valid on Date Printed
16
15
14
13
12
11
10
10
604
9
9
Thermostat Rücklauf / Serto Verschraubung Ø10mm
Thermostate Return / Serto Connection Ø10mm
Thermostat Zulauf / Serto Verschraubung Ø10mm
Thermostate Supply / Serto Connection Ø10mm
Abluft Rücklauf / Serto Verschraubung Ø10mm
Exhaust Return / Serto Connection Ø10mm
Abluft Zulauf / Serto Verschraubung Ø10mm
Abluft Supply / Serto Connection Ø10mm
Serial / M12 Steckanschluß
Serial / M12 plug-in Connection
Pumpe / M12 Steckanschluß
Pump / M12 plug-in Connection°
Ext. Signal / M12 Steckanschluß
Ext. Signals / M12 plug-in Connection
Trübung / Lemo-Stecker
Turbidity / Lemo-Connection
LEVEL / M12 Steckanschluß
LEVEL / M12 plug-in Connection
FOAM / M12 Steckanschluß
FOAM / M12 plug-in Connection
Sparger Zulauf / Serto Verschraubung Ø6mm
Sparger Supply / Serto Connection Ø6mm
604
A
11
8
Sensorfeld
Sensor panel
8
1492
800
6
7
6
Heizmanschette / Amphenol Stecker
Heating Blanket / Amphenol Plug-In Connection
Serial / M12 Steckanschluß
Serial / M12 plug-in Connection
Pumpe / M12 Steckanschluß
Pump / M12 plug-in Connection
Ext. Signal / M12 Steckanschluß
Ext. Signals / M12 plug-in Connection
pO2 / VP8 Stecker
pO2 / VP8 Connection
pH / VP8 Stecker
pH / VP8 Connection
Temp / M12 Steckanschluß
Temp / M12 plug-in Connection
Overlay Zulauf / Serto Verschraubung Ø6mm
Overlay Supply / Serto Connection Ø6mm
7
1622
1622
B
Wasseranschluß Zulauf Ø10mm
Water Supply Connection Ø10mm
Wasseranschluß Zulauf Ø10mm
Water Supply Connection Ø10mm
12
Supply Unit Single
Netzanschluß
Main Connection
PE-Anschluß
PE-Connection
13
2L UniVessel single Use
A(1:3)
14
800
C
Gas Anschluß CO2 / Serto-Verschraubung Ø6mm
Gas Connection CO2 / Serto Connection Ø6mm
Gas Anschluß N2 / Serto-Verschraubung Ø6mm
Gas Connection N2 / Serto Connection Ø6mm
Gas Anschluß O2 / Serto-Verschraubung Ø6mm
Gas Connection O2 / Serto Connection Ø6mm
Gas Anschluß AIR / Serto-Verschraubung Ø6mm
Gas Connection AIR / Serto Connection Ø6mm
Common Alarm Anschluß
Common Alarm Connection
15
1492
D
E
F
G
H
I
J
K
16
5
5
Ansicht A
1200
L
1200
1882
Appendix
Printed on: 20-09-2023 11:08:41 ***
203
1882
4
Ablagebox
Utilitx Box
4
800
800
Index
3
Änderungen/Revision
Datum/Date
Name
Allowable tolerances unless otherwise
specified according to EN ISO 13920-A/-AE
Zul. Abweichungen für Maße ohne
Toleranzangaben nach EN ISO 13920-A/-AE
3
1
Datum/Date
Ursprung/Origin
28.03.2012
2
TKösters
Name
Ers. f./Repl. for
Artikel-Nr./Article-no.
Ers. d./Repl. by
DE-1028689
Dokument-Nr./Document-no.
2L UniVessel SU
1
1 /1
Blatt/Sheet
Maßstab/Scale
Arrangemanet Plan BIOSTAT B, single, sw
Aufstellungsplan BIOSTAT B, Single, SW
Für diese Zeichnung behalten wir uns alle Rechte vor / This drawing is the property of Sartorius Stedim Systems GmbH
Oberfläche/Finish:
Bearbeiter
Drawn
Geprüft
Checked
2
A
B
C
D
E
F
G
H
I
J
K
L
*** TeDIS Valid on Date Printed
A
B
C
15
Gas Anschluß CO2 / Serto-Verschraubung Ø6mm
Gas Connection CO2 / Serto Connection Ø6
Gas Anschluß N2 / Serto-Verschraubung Ø6mm
Gas Connection N2 / Serto Connection Ø6
Gas Anschluß O2 / Serto-Verschraubung Ø6mm
Gas Connection O2 / Serto Connection Ø6
16
Ethernet Host
Ethernet Host
14
14
2L UniVessel DW
Common Alarm Anschluß
Common Alarm Connection
Gas Anschluß AIR / Serto-Verschraubung Ø6mm
Gas Connection AIR / Serto Connection Ø6
15
13
Supply Unit Twin
A(1:3)
13
12
2L UniVessel DW
Wasseranschluß Rücklauf Ø10mm
Water return Connection Ø10mm
Wasseranschluß Zulauf Ø10mm
Water Supply Connection Ø10mm
Netzanschluß
Main Connection
PE-Anschluß
PE-Connection
12
11
11
9
10
9
Thermostat Rücklauf / Serto Verschraubung Ø10mm
Thermostate Return / Serto Connection Ø10mm
Thermostat Zulauf / Serto Verschraubung Ø10mm
Thermostate Supply / Serto Connection Ø10mm
Abluft Rücklauf / Serto Verschraubung Ø10mm
Exhaust Return / Serto Connection Ø10mm
Abluft Zulauf / Serto Verschraubung Ø10mm
Abluft Supply / Serto Connection Ø10mm
Serial / M12 Steckanschluß
Serial / M12 plug-in Connection
Pumpe / M12 Steckanschluß
Pump / M12 plug-in Connection°
Ext. Signal / M12 Steckanschluß
Ext. Signals / M12 plug-in Connection
Trübung / Lemo-Stecker
Turbidity / Lemo-Connection
LEVEL / M12 Steckanschluß
LEVEL / M12 plug-in Connection
FOAM / M12 Steckanschluß
FOAM / M12 plug-in Connection
Sparger Zulauf / Serto Verschraubung Ø6mm
Sparger Supply / Serto Connection Ø6mm
10
8
Sensorfeld
Sensor panel
8
7
Heizmanschette / Amphenol Stecker
Heating Blanket / Amphenol Plug-In Connection
Serial / M12 Steckanschluß
Serial / M12 plug-in Connection
Pumpe / M12 Steckanschluß
Pump / M12 plug-in Connection
Ext. Signal / M12 Steckanschluß
Ext. Signals / M12 plug-in Connection
pO2 / VP8 Stecker
pO2 / VP8 Connection
pH / VP8 Stecker
pH / VP8 Connection
Temp / M12 Steckanschluß
Temp / M12 plug-in Connection
Overlay Zulauf / Serto Verschraubung Ø6mm
Overlay Supply / Serto Connection Ø6mm
7
507
800
D
E
F
G
H
I
J
K
16
507
800
L
6
1496
1496
6
5
5
1200
204
1200
1622
1882
Appendix
Printed on: 20-09-2023 11:08:41 ***
1622
1882
Ablagebox
Utilitx Box
4
4
800
800
Index
3
Änderungen/Revision
Datum/Date
Name
Allowable tolerances unless otherwise
specified according to EN ISO 13920-A/-AE
Zul. Abweichungen für Maße ohne
Toleranzangaben nach EN ISO 13920-A/-AE
3
Ursprung/Origin
26.03.2012
Datum/Date
Oberfläche/Finish:
Bearbeiter
Drawn
Geprüft
Checked
1
2
TKösters
Name
Ers. f./Repl. for
Artikel-Nr./Article-no.
Ers. d./Repl. by
DE-1028603
Dokument-Nr./Document-no.
1L Univessel MU
1
1 /1
Blatt/Sheet
Maßstab/Scale
Arrangemanet Plan BIOSTAT B, twin
Aufstellungsplan BIOSTAT B, Twin
Für diese Zeichnung behalten wir uns alle Rechte vor / This drawing is the property of Sartorius Stedim Systems GmbH
2
A
B
C
D
E
F
G
H
I
J
K
L
*** TeDIS Valid on Date Printed
A
B
16
15
Thermostate return / Serto connection P10mm
Thermostat Rücklauf / Serto-Verschraubung P10mm
Thermostate supply / Serto connection P10mm
Thermostat Zulauf / Serto-Verschraubung P10mm
Ext. Signal / M12 Steckanschluss
Ext. signal / M12 plug-in connection
Serial / M12 Steckanschluss
Serial / M12 plug-in connection
Serial / M12 Steckanschluss
Serial / M12 plug-in connection
Serial / M12 Steckanschluss
Serial / M12 plug-in connection
Serial / M12 Steckanschluss
Serial / M12 plug-in connection
Overlay supply / Serto connection P6mm
Overlay Zulauf / Serto-Verschraubung P6mm
15
14
Sensorfeld für RM
Sensor panel for RM
14
1882
Pumpe / M12 Steckanschluss
Pump / M12 plug-in connection
Pumpe / M12 Steckanschluss
Pump / M12 plug-in connection
Optischer Stecker PreSens
Visual connector PreSens
Optischer Stecker PreSens
Visual connector PreSens
13
13
12
12
11
RM 20/50
11
10
10
9
2200
2335
2335
2200
Supply Unit Twin
9
8
8
7
7
RM 20/50
6
6
1506
C
D
E
16
1882
F
G
H
I
J
K
L
1632
800
1506
800
810
Appendix
Printed on: 20-09-2023 11:08:41 ***
205
1632
810
5
5
A
4
Index
Gas connection CO2 / Serto Connection P6mm
Gas Anschluss CO2 / Serto-Verschraubung P6mm
Gas connection N2 / Serto Connection P6mm
3
A ( 1:3 )
3
Änderungen/Revision
Datum/Date
Ursprung/Origin
14.08.2013
Datum/Date
Oberfläche/Finish:
Bearbeiter
Drawn
Geprüft
Checked
2
Water return connection P10mm
Wasseranschluss Rücklauf P10mm
Water supply connection P10mm
Wasseranschluss Zulauf P10mm
Netzanschluss
Main connection
1
2
ABernhard
Name
Ers. f./Repl. for
Artikel-Nr./Article-no.
Ers. d./Repl. by
DE-1033253
Dokument-Nr./Document-no.
1
1 /1
Blatt/Sheet
Maßstab/Scale
RM 20/50 - RM 20/50
Arrangement plan BIOSTAT B, Twin
Aufstellungsplan BIOSTAT B, Twin
Für diese Zeichnung behalten wir uns alle Rechte vor / This drawing is the property of Sartorius Stedim Systems GmbH
PE-Anschluss
PE-Connection
Name
Allowable tolerances unless otherwise
specified according to ISO 2768-mH
Zul. Abweichungen für Maße ohne
Toleranzangaben nach ISO 2768-mH
Netzwerkanschluss
Ethernet hist
Gas Anschluss N2 / Serto-Verschraubung P6mm
Gas connection O2 / Serto Connection P6mm
Gas Anschluss O2 / Serto-Verschraubung P6mm
Gas connection AIR / Serto Connection P6mm
Gas Anschluss AIR / Serto-Verschraubung P6mm
Common Alarm Anschluss
Common alarm connection
Ablagebox
Utility box
4
A
B
C
D
E
F
G
H
I
J
K
L
206
*** TeDIS Valid on Date Printed
A
B
16
15
Gas Anschluß CO2 / Serto-Verschraubung Ø6mm
Gas Connection CO2 / Serto Connection Ø6
Gas Anschluß N2 / Serto-Verschraubung Ø6mm
Gas Connection N2 / Serto Connection Ø6
Gas Anschluß O2 / Serto-Verschraubung Ø6mm
Gas Connection O2 / Serto Connection Ø6
Gas Anschluß AIR / Serto-Verschraubung Ø6mm
Gas Connection AIR / Serto Connection Ø6
A(1:3)
14
2L UniVessel single Use
14
13
12
12
2L UniVessel single Use
Wasseranschluß Rücklauf Ø10mm
Water return Connection Ø10mm
Wasseranschluß Zulauf Ø10mm
Water Supply Connection Ø10mm
Netzanschluß
Main Connection
Supply Unit Twin
PE-Anschluß
PE-Connection
13
11
11
10
10
9
Thermostat Rücklauf / Serto Verschraubung Ø10mm
Thermostate Return / Serto Connection Ø10mm
Thermostat Zulauf / Serto Verschraubung Ø10mm
Thermostate Supply / Serto Connection Ø10mm
Abluft Rücklauf / Serto Verschraubung Ø10mm
Exhaust Return / Serto Connection Ø10mm
Abluft Zulauf / Serto Verschraubung Ø10mm
Abluft Supply / Serto Connection Ø10mm
Serial / M12 Steckanschluß
Serial / M12 plug-in Connection
Pumpe / M12 Steckanschluß
Pump / M12 plug-in Connection°
Ext. Signal / M12 Steckanschluß
Ext. Signals / M12 plug-in Connection
Trübung / Lemo-Stecker
Turbidity / Lemo-Connection
LEVEL / M12 Steckanschluß
LEVEL / M12 plug-in Connection
FOAM / M12 Steckanschluß
FOAM / M12 plug-in Connection
Sparger Zulauf / Serto Verschraubung Ø6mm
Sparger Supply / Serto Connection Ø6mm
9
8
Sensorfeld
Sensor panel
8
1496
1622
6
7
6
Heizmanschette / Amphenol Stecker
Heating Blanket / Amphenol Plug-In Connection
Serial / M12 Steckanschluß
Serial / M12 plug-in Connection
Pumpe / M12 Steckanschluß
Pump / M12 plug-in Connection
Ext. Signal / M12 Steckanschluß
Ext. Signals / M12 plug-in Connection
pO2 / VP8 Stecker
pO2 / VP8 Connection
pH / VP8 Stecker
pH / VP8 Connection
Temp / M12 Steckanschluß
Temp / M12 plug-in Connection
Overlay Zulauf / Serto Verschraubung Ø6mm
Overlay Supply / Serto Connection Ø6mm
7
604
800
C
Ethernet Host
Ethernet Host
Common Alarm Anschluß
Common Alarm Connection
15
1622
1496
D
E
F
G
H
I
J
K
16
604
800
L
5
5
1200
1882
Appendix
Printed on: 20-09-2023 11:08:41 ***
1200
1882
Ablagebox
Utilitix Box
4
4
800
800
Index
3
Änderungen/Revision
Datum/Date
Name
Allowable tolerances unless otherwise
specified according to EN ISO 13920-A/-AE
Zul. Abweichungen für Maße ohne
Toleranzangaben nach EN ISO 13920-A/-AE
3
Ursprung/Origin
26.03.2012
Datum/Date
Oberfläche/Finish:
Bearbeiter
Drawn
Geprüft
Checked
1
2
TKösters
Name
Ers. f./Repl. for
Artikel-Nr./Article-no.
Ers. d./Repl. by
DE-1028579
Dokument-Nr./Document-no.
2L UniVessel SU
1
1 /1
Blatt/Sheet
Maßstab/Scale
Arrangemanet Plan BIOSTAT B, twin
Aufstellungsplan BIOSTAT B, Twin
Für diese Zeichnung behalten wir uns alle Rechte vor / This drawing is the property of Sartorius Stedim Systems GmbH
2
A
B
C
D
E
F
G
H
I
J
K
L
*** TeDIS Valid on Date Printed
A
16
15
14
13
12
1881
11
2L UniVessel single Use
11
507
9
Thermostat Zulauf / Serto Verschraubung Ø10mm
Thermostate Supply / Serto Connection Ø10mm
Abluft Rücklauf / Serto Verschraubung Ø10mm
Exhaust Return / Serto Connection Ø10mm
Abluft Zulauf / Serto Verschraubung Ø10mm
Abluft Supply / Serto Connection Ø10mm
Serial / M12 Steckanschluß
Serial / M12 plug-in Connection
Pumpe / M12 Steckanschluß
Pump / M12 plug-in Connection°
Ext. Signal / M12 Steckanschluß
Ext. Signals / M12 plug-in Connection
Trübung / Lemo-Stecker
Turbidity / Lemo-Connection
LEVEL / M12 Steckanschluß
LEVEL / M12 plug-in Connection
FOAM / M12 Steckanschluß
FOAM / M12 plug-in Connection
Sparger Zulauf / Serto Verschraubung Ø6mm
Sparger Supply / Serto Connection Ø6mm
10
10
9
Thermostat Rücklauf / Serto Verschraubung Ø10mm
Thermostate Return / Serto Connection Ø10mm
507
B
C
Supply Unit Twin
Wasseranschluß Rücklauf Ø10mm
Water return Connection Ø10mm
Wasseranschluß Zulauf Ø10mm
Water Supply Connection Ø10mm
Netzanschluß
Main Connection
12
1882
D
13
PE-Anschluß
PE-Connection
2L UniVessel DW
A(1:3)
14
8
Sensorfeld
Sensor panel
8
1496
1622
7
Heizmanschette / Amphenol Stecker
Heating Blanket / Amphenol Plug-In Connection
Serial / M12 Steckanschluß
Serial / M12 plug-in Connection
Pumpe / M12 Steckanschluß
Pump / M12 plug-in Connection
Ext. Signal / M12 Steckanschluß
Ext. Signals / M12 plug-in Connection
pO2 / VP8 Stecker
pO2 / VP8 Connection
pH / VP8 Stecker
pH / VP8 Connection
Temp / M12 Steckanschluß
Temp / M12 plug-in Connection
Overlay Zulauf / Serto Verschraubung Ø6mm
Overlay Supply / Serto Connection Ø6mm
7
604
800
E
Gas Anschluß CO2 / Serto-Verschraubung Ø6mm
Gas Connection CO2 / Serto Connection Ø6
Gas Anschluß N2 / Serto-Verschraubung Ø6mm
Gas Connection N2 / Serto Connection Ø6
Gas Anschluß O2 / Serto-Verschraubung Ø6mm
Gas Connection O2 / Serto Connection Ø6
Gas Anschluß AIR / Serto-Verschraubung Ø6mm
Gas Connection AIR / Serto Connection Ø6
Common Alarm Anschluß
Common Alarm Connection
Ethernet Host
Ethernet Host
15
1622
1496
F
G
H
I
J
K
16
604
800
L
6
6
1200
Appendix
Printed on: 20-09-2023 11:08:41 ***
207
1200
A
5
Ablagebox
Utilitx Box
5
800
800
4
4
Index
3
Änderungen/Revision
Datum/Date
Name
Allowable tolerances unless otherwise
specified according to EN ISO 13920-A/-AE
Zul. Abweichungen für Maße ohne
Toleranzangaben nach EN ISO 13920-A/-AE
3
1
Datum/Date
Ursprung/Origin
15.03.2012
2
AHalt
Name
Ers. f./Repl. for
Artikel-Nr./Article-no.
Ers. d./Repl. by
DE-1028439
Dokument-Nr./Document-no.
1
1 /1
Blatt/Sheet
Maßstab/Scale
2L UniVessel SU, 1L Univessel MU
Arrangemanet Plan BIOSTAT B, twin
Aufstellungsplan BIOSTAT B, Twin
Für diese Zeichnung behalten wir uns alle Rechte vor / This drawing is the property of Sartorius Stedim Systems GmbH
Oberfläche/Finish:
Bearbeiter
Drawn
Geprüft
Checked
2
A
B
C
D
E
F
G
H
I
J
K
L
Sartorius Stedim Biotech GmbH
August-Spindler-Str. 11
D-37079 Goettingen, Germany
Tel.: +49.551.308.0
Fax: +49.551.308.3289
Website: www.sartorius-stedim.com
Copyright by Sartorius, Goettingen,
Germany.
No part of this publication may be
reprinted or translated in any form or
by any means without the prior written
permission of Sartorius.
All rights reserved by Sartorius in
accordance with copyright law.
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.
Status:
May 2014
Sartorius Stedim Biotech GmbH,
Goettingen, Germany.
Printed in the EU on paper bleached
without chlorine.
Publication No.: SBT6034-e140501
*** TeDIS Valid on Date Printed
Printed on: 20-09-2023 11:08:41 ***