Operating Instructions
(Original Operating Instructions)
BIOSTAT® B-DCU II with BioPAT® DCU Tower
85037-541-51
Vers. 01 | 2014
The enclosed CD contains the operating instructions
as a PDF file in varius international languages.
If the CD is missing, you can obtain a copy form us
by specifying the order number:
Order number: 85037-543-88
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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Use start.html to run the application
Contents
1. Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2. Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.1
General Safety Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.2
Informal Safety Measures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.3
Symbols Used on the Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.4
Intended Use and Foreseeable Misuse . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.5
Residual Risks from Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.6
Danger Due to Electrical Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.7
Danger Due to Components Under Pressure . . . . . . . . . . . . . . . . . . . . . . . .
2.8
Hazards Arising from Bursting Culture Vessels . . . . . . . . . . . . . . . . . . . . . .
2.9
Danger Due to Gases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.9.1 Danger Due to Oxygen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.9.2 Danger Due to Nitrogen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.9.3 Danger Due to Carbon Dioxide . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.10 Danger Due to Escaping Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.11 Danger Due to Hot Surfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.12 Danger Due to Rotating Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.13 Danger Due to Use of Incorrect Consumables. . . . . . . . . . . . . . . . . . . . . . .
2.14 Personal Protective Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.15 Safety and Protective Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.15.1 Switch-disconnector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.15.2 Safety Valves and Pressure Reducer . . . . . . . . . . . . . . . . . . . . . . .
2.15.3 Overheating Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.16 Emergency Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.17 Operator Responsibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.18 Personnel Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.18.1 Personnel Qualification Requirements . . . . . . . . . . . . . . . . . . . . .
2.18.2 Personnel Responsibilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.18.3 Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.18.4 Unauthorized Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.18.5 Instruction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12
12
13
13
14
15
15
16
16
17
17
17
18
18
18
19
19
20
21
21
21
22
22
23
24
24
24
24
25
25
3. Device Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.1
System Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.2
BioPAT® DCU Tower . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.3
Supply Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.4
Aeration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.4.1 “O2 Enrichment” and “Gasflow Ratio” Aeration Modules. . . . . . .
3.4.2 “Exclusive Flow” and “Advanced Additive Flow” Aeration Modules .
3.5
Pump Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.5.1 Performance Parameters and Features . . . . . . . . . . . . . . . . . . . . .
3.5.2 External Pumps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.6
Temperature Control Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.6.1 Temperature Control Module for Jacketed Culture Vessels. . . . .
3.6.2 Temperature Control Modules for Single Wall Culture Vessels . .
3.7
Culture Vessels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.7.1 UniVessel® Glass . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.7.2 UniVessel® SU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.8
Drive System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
26
27
28
29
32
34
35
38
38
39
39
39
40
41
41
42
43
4. Transportation and Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.1
Inspection Upon Acceptance by the Recipient . . . . . . . . . . . . . . . . . . . . . .
4.2
Instructions for Transport Within the Company . . . . . . . . . . . . . . . . . . . . .
4.2.1 Intermediate Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.2.2 Loads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
44
44
45
46
46
Contents
3
5. Installation and Start-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.1
Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.1.1 Ambient Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.1.2 Work Surfaces and Loads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.1.3 Laboratory Energy Sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.1.3.1
Electricity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.1.3.2
Tempering Media . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.1.3.3
Gas Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.2
Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.2.1 Installation Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.2.2 Connecting the Supply Unit to the Power Supply . . . . . . . . . . . .
5.2.3 Connecting the BioPAT® DCU Tower to the Power Supply. . . . . .
5.2.4 Connecting the Supply Unit to the BioPAT® DCU-Tower . . . . . . .
5.2.5 Connecting the Laboratory’s Water Supply to the Supply Unit .
5.2.6 Connecting the Laboratory’s Gas Supply to the Supply Unit . . .
5.2.7 Connecting the Stirrer Driver . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.2.8 Connecting the UniVessel® SU Holder . . . . . . . . . . . . . . . . . . . . . .
5.2.9 Connecting the Barcode Scanner . . . . . . . . . . . . . . . . . . . . . . . . .
5.2.10 Connecting the Sensor Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.2.11 Connecting the Tubes for Aeration . . . . . . . . . . . . . . . . . . . . . . . .
5.2.12 Connecting the Temperature Control . . . . . . . . . . . . . . . . . . . . . .
5.2.12.1 Jacketed Culture Vessels | Single-walled
Culture Vessels with Heating | Cooling Jacket . . . . . .
5.2.12.2 Heating Jacket . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.2.13 Connecting the Exhaust Cooling Hoses . . . . . . . . . . . . . . . . . . . . .
5.2.14 Switching on the Supply Unit(s) and BioPAT® DCU Tower . . . . . .
4
Contents
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50
51
54
56
56
57
58
59
60
61
62
63
63
64
64
65
65
68
69
70
6. Preparing and Running the Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.1
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.2
Preparing the Glass Culture Vessels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.3
Connecting Transfer Lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.4
Fill the Culture Vessel with Culture Medium . . . . . . . . . . . . . . . . . . . . . . . .
6.5
Sterilizing Glass Culture Vessels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.6
Preparing the Cultivation Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.6.1 Mounting the Agitator Drive . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.6.2 Heating | cooling Jacket Installation . . . . . . . . . . . . . . . . . . . . . . .
6.6.3 Installing the Heating Blanket . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.6.4 Connecting the Aeration Modules . . . . . . . . . . . . . . . . . . . . . . . . .
6.6.4.1
Conduct Preliminary Steps . . . . . . . . . . . . . . . . . . . . . .
6.6.4.2
UniVessel® SU Safety Valve Station . . . . . . . . . . . . . . .
6.6.4.3
Connecting the “O2 Enrichment” and
“Gasflow Ratio” Aeration System . . . . . . . . . . . . . . . .
6.6.4.4
Connect ing the “Exclusive Flow” and
“Advanced Additive Flow” Aeration System . . . . . . . .
6.6.5 Preparing the Corrective Solution Supply. . . . . . . . . . . . . . . . . . .
6.7
Performing a Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.7.1 Setting Up the Measurement and Control System. . . . . . . . . . . .
6.7.2 Guarantee Sterility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.7.3 Carry out the Cultivation Process . . . . . . . . . . . . . . . . . . . . . . . . .
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71
71
72
73
73
74
76
78
79
81
81
81
7. Maintenance and Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.1
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.1.1 Cleaning Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.1.2 Cleaning the Culture Vessels . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.1.3 Carrying out Cleaning and Maintenance Work on the
Heating Jacket . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.2
Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.2.1 Carrying out Maintenance Work on Function Elements . . . . . . .
7.2.2 Safety Component Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . .
7.2.3 Maintenance Intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
88
89
89
90
82
82
83
85
86
87
87
90
92
92
92
93
8. Faults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8.1
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8.1.1 Fault Table “Contamination" . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8.1.2 Fault Table “Contamination" . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8.1.3 Troubleshooting Table “Aeration and Ventilation". . . . . . . . . . . .
95
95
96
97
97
9. Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
9.1
General Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
9.2
Hazardous Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
9.3
Decontamination Declaration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
9.4
Decommissioning the Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
9.5
Disposing of the Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
10. User Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
11. Principles of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
11.1 User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
11.1.1 Header . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
11.2 Footer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
11.2.1 Work area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
11.3 Display of Function Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
11.4 Overview of the Main Function Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
11.5 Overview of Selection Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
11.6 Direct Function Keys for Selection of Submenus . . . . . . . . . . . . . . . . . . . 107
11.7 Selection Lists and Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
12. System Start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
12.1 System Behavior During Start. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
12.2 First System Start or System Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
12.2.1 Login . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
12.2.2 Changing the Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
12.3 User Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
12.3.1 Settings for Individual Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
12.3.2 Settings for All Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
12.3.3 Managing Group Rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
12.4 Password System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
13. “Main” Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
13.1 General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
13.2 Process Displays in the “Main” Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
13.3 Direct Access to Submenus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
14. “Trend” Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
14.1 Trend Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
14.2 Configuring the “Trend” Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
14.2.1 Setting the Trend Display for Parameters . . . . . . . . . . . . . . . . . . 135
14.2.2 Setting the Parameter Display Range . . . . . . . . . . . . . . . . . . . . . 135
14.2.3 Resetting the Display Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
14.2.4 Setting the Trend Display Color: . . . . . . . . . . . . . . . . . . . . . . . . . 136
14.2.5 Defining a New Time Range as “Time Range” . . . . . . . . . . . . . . . 137
15. “Calibration” Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
15.1 General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
15.2 pH Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
15.2.1 Group or Individual Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . 140
15.2.1.1 Calibration of a Single Sensor . . . . . . . . . . . . . . . . . . 141
15.2.1.2 Calibrating Multiple Sensors . . . . . . . . . . . . . . . . . . . 144
15.2.1.3 Calibration of Sub-groups of Sensors . . . . . . . . . . . . 147
15.2.2 Recalibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
Contents
5
15.3
15.4
15.5
15.6
15.7
15.8
UniVessel® SU pH Sensor Calibration for Optical Measurements. . . . . . . 153
15.3.1 Displays, Operating Panels and Entries . . . . . . . . . . . . . . . . . . . . 153
15.3.2 Initial Calibration of a pH Sensor. . . . . . . . . . . . . . . . . . . . . . . . . 154
15.3.3 Changing pH Measurement Cycles (UniVessel® SU) . . . . . . . . . . 157
15.3.4 Recalibrating pH Sensor (UniVessel® SU) . . . . . . . . . . . . . . . . . . . 158
DO Calibration (pO2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
15.4.1 Calibrating All Measuring Points . . . . . . . . . . . . . . . . . . . . . . . . . 162
15.4.2 Calibrating a Measurement Point . . . . . . . . . . . . . . . . . . . . . . . . 163
15.4.2.1 Zero Point Calibration . . . . . . . . . . . . . . . . . . . . . . . . 164
15.4.2.2 Slope Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
UniVessel® SU DO Sensor Calibration for Optical Measurements . . . . . . 170
15.5.1 Displays, Operating Panels and Entries . . . . . . . . . . . . . . . . . . . . 170
15.5.2 Initial Calibration of a DO Sensor . . . . . . . . . . . . . . . . . . . . . . . . 171
15.5.3 Changing the DO Measurement (UniVessel® SU)
Measurement Cycles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173
15.5.4 Recalibrating the DO Sensor (UniVessel® SU) . . . . . . . . . . . . . . . 175
Turbidity Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177
Redox Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179
Totalizer for Pumps and Scales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181
15.8.1 Pump Calibration Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182
15.8.2 Scale | Balance Calibration Sequence . . . . . . . . . . . . . . . . . . . . . 184
16. “Controller” Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186
16.1 Functional Principle and Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186
16.2 Controller Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187
16.3 General Controller Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188
16.4 Setpoint Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189
16.5 General Controller Parameterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190
16.5.1 Output Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191
16.5.2 Dead Zone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191
16.5.3 Controller Parameterization Menu Screen . . . . . . . . . . . . . . . . . 192
16.5.4 PID Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192
16.5.5 PID Controller Optimization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193
16.6 Temperature Controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193
16.7 Speed Controller Agitator Motor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196
16.8 pH Controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199
16.8.1 Configuration of the pH Sensor Process Value Source . . . . . . . 200
16.8.2 Operating Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201
16.8.3 CO2 Supply-driven pH Control . . . . . . . . . . . . . . . . . . . . . . . . . . 201
16.9 DO Control Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
16.9.1 Configuration of the DO Sensor Process Value Source . . . . . . . 203
16.9.2 DO Cascade Controller CASCADE . . . . . . . . . . . . . . . . . . . . . . . . . 205
16.9.3 Operation of the Multi-staged Cascaded Regulation . . . . . . . . 207
16.9.4 DO Cascade Controller ADVANCED . . . . . . . . . . . . . . . . . . . . . . . 208
16.9.5 Selection and Configuration of the Slave Controllers . . . . . . . . 212
16.9.6 Instructions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215
16.10 Gas Filling Controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220
16.11 Gas Flow Controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 222
16.12 Foam and Level Controllers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 224
16.12.1 Displays. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225
16.12.2 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226
16.13 Gravimetric Filling Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226
16.13.1 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 227
16.14 Filling Pump Controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 227
16.15 Pump Assignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228
16.15.1 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229
6
Contents
17. “Settings” Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230
17.1 General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230
17.1.1 “Settings” Main Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231
17.2 Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 232
17.3 Manual Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 233
17.3.1 Manual Operation for Digital Inputs . . . . . . . . . . . . . . . . . . . . . . 233
17.3.2 Manual Operation for Digital Outputs . . . . . . . . . . . . . . . . . . . . 234
17.3.3 Manual Operation for Analog Inputs . . . . . . . . . . . . . . . . . . . . . 236
17.3.4 Manual Operation for Analog Outputs . . . . . . . . . . . . . . . . . . . . 238
17.4 Measuring Range Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 239
17.5 Service and Diagnosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 240
17.6 Logbook. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 241
18. Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243
18.1 Alarm Triggering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243
18.2 “Alarm Overview” Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244
18.3 Process Value Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 245
18.3.1 Operating Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 246
18.4 Alarms for Digital Inputs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 247
18.4.1 Operating Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 248
18.5 Alarms, Meaning and Corrective Measures . . . . . . . . . . . . . . . . . . . . . . . . 248
18.5.1 Process Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 248
18.5.2 Process Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 249
18.5.3 System Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 249
18.6 Error Handling and Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250
18.7 Locking Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250
19. Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251
19.1 Technical Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251
19.2 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 252
19.3 Additional Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 254
19.4 EC Declaration of Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 254
19.5 Decontamination Declaration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 254
19.6 GNU Licensing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 254
Contents
7
Notes on Using these Instructions
All information and instructions in this operating instructions manual have been
compiled in consideration of applicable standards and guidelines, the state of the art,
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-DCU II (referred to as “device” in the following).
The operating instructions must be read, understood, and used by all personnel
entrusted with the operation, service, cleaning, and troubleshooting of the unit.
This applies particularly to the safety instructions listed.
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,
− or that caution should be exercised while working,
− or indicates useful information
8
Notes on Using these Instructions
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.
1. Texts that follow this mark describe activities that must be carried out in the
numbered 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.
Notes on Using these Instructions
9
1. Introduction
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-DCU II bioreactor (referred to as “device” in the
following).
The unit may only be used with the equipment and under the operating conditions
described in the Technical Data Sheet.
Users must be qualified to handle the device, media and cultures [´ Section “1.18
Personnel Requirements”] and be aware of the hazards potentially associated with
the process.
The process may make it necessary to equip the unit 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.
The operating manual applies to the BIOSTAT® B-DCU II in combination with the
following culture vessels:
− UniVessel® glass culture vessels
− UniVessel® SU single-use bioreactors
The model designation can be found on the model plate or signage.
The model plate is located on the unit.
The operating manual must be read, understood, and used by all personnel entrusted
with the operation, service, cleaning, and troubleshooting of the unit. This applies
particularly to the safety instructions listed.
10
Introduction
Service Center
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.
Repairs can be carried out on-site by authorized service personnel or by the
responsible Service representative of Sartorius Stedim Systems GmbH.
In the event of a service request or warranty claims, please notify your representative
of Sartorius Stedim Systems GmbH and | or Sartorius Stedim Biotech GmbH or
contact:
Sartorius Stedim Systems GmbH
Robert-Bosch-Str. 5–7
D-34302 Guxhagen, Deutschland
Phone +49 (0) 5665 407-0
E-mail: info@sartorius-stedim.com
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 of application.
The sender must prove compliance with the regulations. Use the Decontamination
Declaration in the Appendix for this purpose [´ Section “1.5 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.
Introduction
11
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 started and serviced after gaining familiarity with this
operating manual.
− Use the unit only for its intended purpose [´ Section "2.4 Intended Use and
Foreseeable Misuse"].
− The unit 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 unit 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.
12
Safety Instructions
2.2
Informal Safety Measures
− Always keep the operating manual in the location where the unit is in use.
− In addition to the operating manual, follow all general and local regulations for
accident prevention and environmental protection.
2.3
Symbols Used on the Unit
The following symbols are used on the device:
Especially hazardous area or hazardous use of the peristaltic pump!
The peristaltic pump may be used by qualified personnel only.
Access to conductive parts!
Only specially qualified and authorized persons may access and work on this
equipment, such as to perform maintenance and repairs.
Turn off the equipment power and unplug it from the power supply (mains).
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.
− Pumps with hand switches:
Adjust this switch to the “off” position (if not marked, “off” is the middle position
between “man” and “auto”).
− For pumps without a manual switch:
These pumps must be switched off in the measurement and control system (in the
main menu or associated controller operator screen).
Danger of becoming crushed by heavy parts or by the corners of the housing!
Take note of the equipment’s weight and dimensions [´ Chapter 3 “Device
Overview”] or find these in the installation plans, where available. Get help from
others before you attempt to perform this step.
Use appropriately rated auxiliary equipment for moving and setting up the system.
Danger of burns! Motor and culture vessel equipment becomes too hot to touch
when in operation!
− Avoid accidental, unintentional contact.
− Use protective gloves when operating the equipment.
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.
Please follow the instructions in this manual.
− Keep all safety precautions and danger descriptions at the device in legible
condition, and replace them as needed.
Safety Instructions
13
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 unit is used for the cultivation of prokaryotic and eukaryotic cells in aqueous
solution.
Only biological materials in Safety Classes 1 and 2 may be used in the unit.
The intended use also includes:
− The observation of all instructions from the operating manual.
− 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
− Overloading the unit
− Work with parts under voltage
− Operation outdoors
14
Safety Instructions
2.5
Residual Risks from Use
This unit is a state-of-the-art machine and is built in accordance with recognized
safety standards. Nevertheless, the use of the unit 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 unit must have read and understood the operating manual.
The unit 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 can be life-threatening. Damage to the insulation or individual components
can be fatally dangerous.
− Never open the unit. The unit may be opened only by authorized personnel of the
Sartorius Stedim Systems 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 electrical components and stationary electrical equipment checked by an
electrician at least every 4 years.
− Have non-stationary electric equipment, cables with plugs, and extension or
connector cables and their connectors, if any, checked at least every 6 months by
an electrician or, if using suitable testers, by a trained person.
Non-stationary equipment is any equipment that is designed to be continually moved
while still connected to power. This includes electrical floor cleaning systems, for
example.
Safety Instructions
15
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 use the culture vessel without a safety valve.
− Turn the unit off and secure it against reactivation when working on the unit.
− 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 Vessels
Danger of injury from shattered glass!
Damaged and bursting culture vessels can cause cuts and damage the eyes.
Therefore:
− Provide operating personnel with training regarding glass breakage due to external
influences. Ensure the culture vessel remains stable at all times.
− Wear personal 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.
16
Safety Instructions
2.9
Danger Due to Gases
2.9.1
Dangers Due to Oxygen
Danger of 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.
Reaction with other materials!
− Ensure that 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, and leading to suffocation.
− Check the gas lines and culture vessels for leaks.
− Provide good ventilation where the unit is installed.
− 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 on leakages regularly.
Safety Instructions
17
2.9.3
Danger Due to Carbon Dioxide
Danger of poisoning by escaping carbon dioxide.
− Check the gas lines and culture vessels for leaks.
− Provide good ventilation where the unit is installed.
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.
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 personal protective equipment.
− Wear safety glasses.
Danger of contamination from escaping feed and culture media!
− Empty the feed hoses before loosening the hose connection.
− Wear personal protective equipment.
− 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.
18
Safety Instructions
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 unit.
− Disconnect the unit from power when performing maintenance and cleaning tasks.
− Block the danger zone off.
− Wear personal 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 overall documentation.
Safety Instructions
19
2.14 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.
20
Safety Instructions
2.15 Safety and Protective Systems
2.15.1 Switch-disconnector
Supply Units
The “Mains” switch-disconnector is on the supply unit’s operator side and is the
physical “mains in” on | off switch for the power supply. The switch-disconnector is
simultaneously the main switch used to turn the units on and off.
BioPAT®DCU Tower
The power cable and jack on the rear of the BioPAT® DCU Tower are the physical
“mains in” on | off switch for the power supply. Turn the LED-illuminated “Mains”
switch on the operator side to startup or switch off the DCU system.
2.15.2 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 Sartorius
Stedim Service.
− Follow the information in the overall documentation.
Overpressure Valve Aeration Segment
Overpressure valves for the sparger and overlay aeration are installed in 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 segment of the BIOSTAT® B-DCU Supply Tower. The pressure is limited to
0.5 barg (7.25 psig) with the help of the UniVessel® SU safety valve station.
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.
Safety Instructions
21
2.15.3 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.
− Follow the information in the overall documentation.
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
2.16 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 switch disconnector.
− Keep personnel out of 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.
22
Safety Instructions
2.17 Operator Responsibilities
The unit is used in the commercial sphere. The operator of the unit 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 unit must also be observed.
In particular, the following apply:
− 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 [ Section "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.
− The operator must also ensure that all employess 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.
Safety Instructions
23
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 people are permitted as personnel 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.
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.
The electrician is trained for the special place of use where he or she works and knows
the relevant standards and regulations.
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 are understood.
− Follow all safety and operation instructions in this operating manual.
2.18.3 Responsibilities
The responsibilities of personnel for the operation, maintenance, and cleaning must
be clearly defined.
24
Safety Instructions
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.
2.18.5 Instruction
Personnel must regularly receive instruction from the operator.
Log the performance of this training for better tracking.
Date
Name
Type of
training
Training
given by
Signature
Safety Instructions
25
3. Device Overview
The device is designed for cultivating microorganisms and cells in discontinuous and
continuous processes.
It was designed for cultivating microorganisms and cells at various reactor volumes.
The device 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 DO values) online, independent
monitoring of the progress of fermentation or cultivation in each culture vessel.
1 to 6 Supply Tower | culture vessel combinations can be connected per BioPAT® DCU
Tower.
3
2
1
Fig. 3-1: Example of BIOSTAT® B-DCU II MO “Tripple”
(1) BioPAT® DCU Tower with DCU4 system, operated using the touch screen
(2) Supply unit, in the example, with the aeration system, 6 metering pumps and
temperature control module for jacketed culture vessels.
(3) Culture Vessels
26
Device Overview
3.1
System Setup
BIOSTAT® B-DCU II bioreactors can be comprised of the following basic units:
− 1 BioPAT® DCU Tower, with the DCU4 measurement and control system.
− 1 ... 6 supply units (“supply tower”)
− Every supply unit contains 1 aeration module, pump module and temperature
control module each, as well as the associated fittings.
− Each DCU system has connections for connecting 6 supply units.
− UniVessel type culture vessels:
− Available in operating volumes of 0.5 L, 1 L, 2 L, 5 L or 10 L
− jacketed culture vessels
− single-walled culture vessels
− With fittings for either microbial cultures (MO) or cell cultures (CC)
− Stirrers | drives:
− Top-mounted drive for culture vessels:
− Stirrer shaft in the vessel lid, direct drive with single mechanical seal, optional
magnetic coupling
− Attachable motor
− 6-blade disk impeller for microbial cultures and | or segment-shaped paddle
stirrer with adjustable blades for cell cultures
Device Overview
27
3.2
BioPAT® DCU Tower
1
3
2
4
4a
4b
Mains In
Com Alarm
Serial 2
2
1 8 3
4
7
6 5
2
1 8 3
4
7
6 5
2
5a 5b
5c
Serial 1
2
1 8 3
4
7
6 5
3
PE
1
4c
5
Serial 4
Serial 3
2
1 8 3
4
7
6 5
2
1 8 3
4
7
6 5
4
Fig. 3-2: BioPAT® DCU Tower front and rear side
1
The touch panel
2
USB port for peripheral devices
3
LED-illuminated “Mains” switch activates the measurement and control system
4a
Power connection “Mains in” (on | off switch for the power supply),
4b
Connection “Com Alarm”
4c-d Serial connections 1-4 for external devices, e.g. scales | balances, printers
5a
Connection “Host” for an external host system e.g. MFCS SCADA
5b
Connection “Fieldbus” for integration into a network
5c-f Connections “Tower A-F” to the supply units
28
Device Overview
3.3
Supply Units
1
3
4
5
6
2
3
4
5
6
7
8
Fig. 3-3: BIOSTAT® B-DCU II supply units
1
Version “O2 Enrichment”, 2 gases, up to 6 pumps
2
Version “Advanced Additive Flow”, up to 6 gases, up to 6 pumps
3
Headspace aeration “Overlay”
4
Medium aeration “Sparger” hose nozzle | d 6 mm
5
Main switch | switch disconnector “Main I/O”
6
Connection cable [´ Section “3.3 Supply Units”]
7
Flow meter
8
6 peristaltic pumps with control button
Device Overview
29
1
2a
2a
3a
3b
4
5
6
7
8
9a
9b
10
11
12
13a
13b
14a
14b
Fig. 3-4: Supply unit connection panel, front
30
Device Overview
1
“Temp” temperature sensor Pt-100, 9a
M12 plug connection
“Ext.Sig-A” External signal input,
M12 plug connection
2a
“pH-A” pH sensor A, VP8 plug
9b
“Ext.Sig-B” External signal input,
M12 plug connection
2b
“pH-B” pH sensor B, VP8 plug
10
“Press in” hose connector, d 6 mm
3a
“pO2-A” DO sensor A, VP8 plug
11
“Heating blanket”, Amphenol plug
3b
“pO2-B” DO sensor B, VP8 plug
12
“Fill thermostat”, switch
4
Redox | VP8 plug
13a
“Exhaust Cooler” exhaust cooling
inlet, Serto gland
d 10 mm
5
“Foam” antifoam sensor,
M12 plug connection
13b
“Exhaust Cooler” exhaust cooling
return, Serto gland
d 10 mm
6
“Level” level sensor,
M12 plug connection
14a
“Thermostat” temperature control
inlet, Serto gland d 10 mm
7
“Turb” sensor for turbidity
measurement, Lemo plug
14b
“Thermostat” temperature control
return, Serto gland d 10 mm
8
“Press” pressure sensor,
M12 plug connection
1
2
2a
2b
2c
2d
2e
3
4a
4b
4c
4d
5
6
17
8
16
7
9
15
14
10
11a
13
11b
11c
11d
(In
le
t
)
12a
2
4b
a
r
g
12b
C
o
o
lin
g
w
a
t
e
r
Fig. 3-5: Supply unit connection panel, rear
1
“Ethernet DCU Tower” connection
BioPAT® DCU Tower, M12 plug
connection
8
Potential equalization
2
“Fieldbus” fieldbus connection,
M12 plug connection
9
Potential equalization
2a
“Serial-A” scales, serial RS232 |
M12 plug connection
10
Mains connection
2b
“Serial-B” scales, serial RS232 |
M12 plug connection
11a
“AIR” laboratory connection,
hose nozzle d 6 mm
2c
“Serial-C” scales, serial RS232 |
M12 plug connection
11b
“O2” laboratory connection,
hose nozzle d 6 mm
2d
“Serial-D” scales, serial RS232 |
M12 plug connection
11c
“N2” laboratory connection,
hose nozzle d 6 mm
2e
“Serial-E” scales, serial RS232 |
M12 plug connection
11d
“CO2” laboratory connection,
hose nozzle d 6 mm
3
“Serial-F” opt. pH | DO UniVessel® SU 11d
optical holder connection
serial RS-485 M12 plug connection
“CO2” laboratory connection,
hose nozzle d 6 mm
4a
“Pump-A” external pump,
M12 plug connection
12a
“Inlet” tempering medium supply,
hose nozzle d 10 mm
4b
“Pump-B” external pump,
M12 plug connection
12b
“Cooling water” tempering medium
return, hose nozzle d 10 mm
4c
“Pump-C” external pump,
M12 plug connection
13
Motor drive “Stirrer” for stirrer
driver
4d
“Pump-D” external pump,
M12 plug connection
14
Voltage sign
5
“Press Out” gas outlet, culture
vessel pressure regulation
15
Manufacturer’s ID label
6
“Ext. Drive” external agitator,
M12 plug connection
16
Supply tower ident. sign
7
“Lamp | T-Trap” power out,
M12 plug connection
17
NRTL sign
Device Overview
31
3.4
Aeration
The supply units of the BIOSTAT® B-DCU II can be equipped with a range of different
aeration modules. Every supply unit can only be equipped with one of the aeration
module models described below.
− For specifications on the aeration modules of the bioreactor supplied, please refer
to the P&I diagram [´ “Technical Documentation”].
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.
Flow Meter
All of the aeration modules are fitted with a flow meter. The ranges of the
measurement and control equipment supplied with the aeration modules will match
the culture vessel they are intended for or will be as agreed in the order confirmation.
On request, aeration module measurement and control equipment can also be
changed after delivery.
Mass flow controllers must be ordered separately. They will be included in the
standard equipment supplied for the bioreactor only if you specified these on your
order.
If fitted retrospectively, they must only be fitted by an authorized service technician.
− Mass flow controllers must be regularly recalibrated as specified by the
manufacturer [´ Manufacturer’s documentation].
− Recalibration work must only be performed by authorized service technicians or
the manufacturer. Please refer to the appendix for more information on sending
items to Sartorius Stedim Systems GmbH.
− If the gas flow of a gas or the total aeration rate is controlled via built-in mass
flow controllers, completely open the flow meter when no gas flow restriction is
required.
Designations on the Flow Meter
To identify the flow meters, these are labeled with a sticker. The following
nomenclature is used:
32
Device Overview
Description
Meaning
Air
Air
O2
Oxygen
N2
Nitrogen
CO2
Carbon dioxide
“Gas” OV
Gas to “Overlay” outlet
“Gas” SP
Gas to “Sparger” outlet
FI “XYZ”
Designation, flow meters according to P&I diagram
Supplemental Information
The built-in 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
1.293
Oxygen (O2)
1.429
Nitrogen (N2)
1.251
Device Overview
33
3.4.1 “O2 Enrichment” and “Gasflow Ratio” Aeration Modules
The “O2 Enrichment” and “Gasflow Ratio” aeration module supplies air and enriches it
with oxygen, e.g. for microbial cultures.
Fig. 3-6: “O2 Enrichment” and “Gas Flow Ratio” aeration module with output “Sparger”
“O2 Enrichment” Aeration
In the “O2 Enrichment” aeration module, aeration is carried out with “Air” as the
carrier stream, which can be enriched with oxygen via a solenoid valve.
The total aeration rate is set on the flow meter; optionally it can be controlled via a
mass flow controller.
− Oxygenation takes place via a 3 | 2-way solenoid valve, the solenoid valve is
controlled via the DCU system’s gas filling controller | DO controller.
− The mass flow controller is controlled via the DCU system’s gas flow controller |
DO controller.
− Output “Sparger” for culture vessel total aeration rate.
“Gasflow Ratio” Aeration
In the “Gas Flow Ratio” aeration module, aeration is carried out with air and | or
oxygen, each with a mass flow controller.
− The mass flow controller is controlled via the DCU system’s gas flow controller |
DO controller.
34
Device Overview
3.4.2 “Exclusive Flow” and “Advanced Additive Flow” Aeration Modules
These aeration modules can supply up to 4 gases and are suitable for cultures with
special requirements for the supply of gas (e.g. CO2):
− for pH control (e.g., in mammalian cell cultures)
− as a carbon source (for example, in anaerobic bacteria or algae cultures).
“Exclusive Flow” Aeration
Fig. 3-7: “Exclusive Flow” aeration module
In the “Exclusive Flow” aeration module, aeration takes place with up to 4 gases via
a “Sparger” and “Overlay” output. These are by default:
− Air supply for “Overlay”
− Carrier stream for air “Sparger”
− N2 for decreasing the O2 content, or O2 for increasing the oxygen content for the
“Sparger”
− Supply of CO2 for pH control or as a carbon source for “Sparger” or “Overlay”,
toggling takes place via a solenoid valve and soft key in the DCU system.
The total aeration rates are set on flow meters for “Sparger” and “Overlay”; optionally,
this can be controlled via a mass flow controller.
− Oxygen enrichment | reduction is carried out via a 3 | 2-way solenoid valve,
the solenoid valve is controlled via the DCU system’s gas filling controller |
DO controller.
− CO2 is added via a 3 | 2-way solenoid valve, the solenoid valve is controlled via the
DCU system’s gas filling controller | DO controller.
− The mass flow controller is controlled via the DCU system’s gas flow controller |
DO controller.
Device Overview
35
“Advanced Additive Flow - 2 out” Aeration
Fig. 3-8: “Advanced Additive Flow - 2 out” Aeration
In the “Advanced Additive Flow - 2 out” aeration module, aeration takes place with
up to 4 gases via a “Sparger” and “Overlay” output. These are by default:
− Air supply for “Sparger” and “Overlay”
− N2 for decreasing the O2 content, or O2 for increasing the oxygen content for the
“Sparger”
− Supply of CO2 for pH control or as a carbon source for “Sparger” and | or “Overlay”
− Toggling takes place via a solenoid valve and soft key in the DCU system.
The gassing rates are set at flow meters.
Optionally, this can be controlled via mass flow controllers.
− Oxygen enrichment | reduction is carried out via 2 | 2-way solenoid valves or mass
flow controllers. The solenoid valve | mass flow controller is controlled using the
gas filling controller | gas flow controller or via the DCU system’s DO controller.
− CO2 is added via a 2 | 2-way solenoid valve controlled by mass flow controllers.
The solenoid valve | mass flow controller is controlled using the gas filling
controller | gas flow controller or via the DCU system’s pH controller.
− Optional 3 | 2-way solenoid valves and soft keys in the DCU system allow toggling
of gases from “Sparger” to “Overlay”.
36
Device Overview
“Advanced Additive Flow - 6 out” Aeration
Fig. 3-9: “Advanced Additive Flow - 6 out” Aeration
In the “Advanced Additive Flow - 6 out” aeration module, aeration takes place with
up to 4 gases and up to 6 individual gas outputs. These are by default:
− Supply of air
− N2 for decreasing the O2 content, or O2 for increasing the oxygen content
− CO2 for adjusting the pH or use as a carbon (C) source
The gassing rates are set at flow meters.
Optionally, this can be controlled via mass flow controllers.
− Oxygen enrichment | reduction is carried out via 2 | 2-way solenoid valves or mass
flow controllers. The solenoid valve | mass flow controller is controlled using the
gas filling controller | gas flow controller or via the DCU system’s DO controller.
− CO2 is added via a 2 | 2-way solenoid valve controlled by mass flow controllers.
The solenoid valve | mass flow controller is controlled using the gas filling
controller | gas flow controller or via the DCU system’s pH controller.
Selection of possible equipment, actual equipment as per device or customer
specifications.
Device Overview
37
3.5
Pump Modules
The integrated hose pumps are designed for use with silicone hoses. Other tube
materials can significantly shorten the life of the hose pump.
The peristaltic pumps are located on the supply unit and convey the correction media
and nutrient media through hoses into the vessel.
Up to 6 peristaltic pumps can be installed per supply unit.
Using the keys on the supply unit, the pumps can, for example, be turned on to fill the
tubes; this is also possible using the soft keys in the DCU system. Additionally, in the
“Auto” operating mode, the pumps are automatically controlled in the corresponding
control loops.
The pumps are labeled with stickers according to their standard function.
Fig. 3-10: Integrated peristaltic pumps
3.5.1 Performance Parameters and Features
The peristaltic pumps can be installed in 4 different specifications in the supply unit:
38
Device Overview
Type
Speed (rpms)
WM 102 set speed
2
WM 102 set speed
20
WM 102 controlled speed
1 – 10
WM 102 controlled speed
5 – 50
The following overview shows the possible silicone hoses with their feed rate per
revolution:
Tubing Wall Thickness 1.6 mm
Hose internal diameter (mm)
0.5
0.8
1.6*
3.2
4.8
Flow rate (ml/revolution)
0.02
0.05
0.22
0.81
1.66
* = tubing sizes delivered by default
3.5.2 External Pumps
External pumps can be connected to the supply unit.
The connections for external pumps on the supply unit [´ Section “3.3 Supply
Units”].
3.6
Temperature Control Modules
3.6.1 Temperature Control Module for Jacketed Culture Vessels
The temperature control module is designed for connection to jacketed vessels.
Cooling water is only fed into the temperature control circuit if necessary in order to
cool the vessel.
Structure and Components
The temperature control module forms a temperature control circuit on each culture
vessel together with the double wall. The piping contains an open overflow routed to
the laboratory outlet for excess cooling media, which ensures that the loop operates
at ambient pressure.
− Temperature control circuit with circulation pump
− Electrical heater and cooling water valve controlled by the temperature controller
in the DCU system.
− “Thermostat” input | output for the connection to | from the double wall of the
culture vessels.
The cooling water supply for the exhaust coolers is supplied from a branch of the
cooling water supply pipe. The cooling water supply pipe does not form part of the
culture vessel circuit. The cooling water will flow into the system at a constant rate
as soon as an exhaust cooler has been connected and the supply point inside the
laboratory has been opened.
− “Exhaust cooler” input | output
Specifications
The thermostat systems are designed for and are installed with:
− 230 VAC, 50 Hz | 120 VAC, 60 Hz electrical connection
− Thermostat with 800 W electric heater
− Operating temperature range inside the culture vessels: 8°C above the cooling
water temperature to max. 90 °C
Device Overview
39
The bioreactor can only be operated at temperatures that are lower than those stated
above if used with an external cooling system. Sartorius Stedim Systems GmbH can
optionally supply cooling thermostats, i.e. “Frigomix®”.
3.6.2 Temperature control modules for single wall culture vessels
The temperature control modules contain the power supply for the electrical heating
jackets of the single wall culture vessels. The internal cooling water circuit supplies
and drains away the cooling water for the exhaust cooler and, if fitted inside the
culture vessel, operates the temperature control finger.
Structure and Components
The temperature control modules contain the power supplies for the heating blankets
of the culture vessels. The temperature controls for single wall culture vessels
comprise:
− 230 VAC, 50 Hz | 120 VAC, 60 Hz electrical connection
− Heating jacket
− Temperature control finger for cooling water supply (controlled flow)
− Exhaust cooler cooling water inlet and outlet
Operating Principle:
− The temperature controller of the BioPAT® DCU Tower activates the power supply
for the heating blanket on the culture vessel.
− The heating jacket must be connected to the female connector on the
connection panel on the side.
− The heating blanket must not be connected to any other power supply.
− The cooling water supply pipe from the laboratory and the return pipe must be
connected to the adapters on the rear on the connection panel on the side.
The cooling finger and exhaust cooler must be connected to the front panel.
− The cooling finger will be supplied with cooling water as regulated by the
temperature controller. The cooling water for the exhaust cooler will flow into the
system as soon as the exhaust cooler has been connected and the supply point
inside the laboratory has been opened.
− “Exhaust cooler” input for connecting the exhaust cooler;
− Outlet for returning the water to the laboratory system.
40
Device Overview
3.7
Culture Vessels
In the following figures, the functional elements will be displayed using the examples
of UniVessel® 1 l (made of glass) and UniVessel® 2 l Single Use (made of pre-sterilized
polycarbonate). More information about the culture vessels (single-walled, jacketed,
volumes) can be found in the [UniVessel® Operating Manual] and the included
operating and installation instructions of the UniVessel® SU components.
3.7.1
UniVessel® Glass
5
1
4
3
2
Fig. 3-11: UniVessel® 1 l, Glass
1
Cover plate with ports | retainers for sensors, supply media, sampling, aeration
2
Supply bottle with holding ring
3
Glass vessel, temperature control by double wall or heating jacket and cooling
finger
4
Culture vessel support column
5
Exhaust cooling
Device Overview
41
3.7.2
UniVessel® SU
7
6
1
5
2
4
3
Fig. 3-12: UniVessel® SU
42
Device Overview
1
Connection Box
2
Barcode scanner (to scan calibration data)
3
Holder
4
Adapter ring
5
UniVessel® SU culture vessel with calibration data sticker
6
Motor adapter
7
Heater for exhaust filter
3.8
1
2
Drive System
1
Power supply
2
Stirrer driver for culture vessel coupling
3
Sleeve
The drive includes a direct drive for the stirrer shaft and a magnetic coupling
[´ “UniVessel®” Operating Manual].
Available drive motors:
− Motor 75 W for 0.5 L culture vessel
− Motor 200 W for 1-10 L culture vessels
− Motor 400 W for 10 L culture vessel
The standard stirrer shaft is sealed with a rotating mechanical seal. The optional
magnetic coupling has two enclosed coupling components that ensure that the
medium space and ambient air are safely kept separate.
3
Fig. 3-13: Stirrer Driver
Operating the stirrer at impermissible high speeds can affect the culture vessel’s
stability and cause damage to their fittings. The max. permissible rpms can be found
in the technical data.
Depending on the size and equipment of the culture vessels, the permissible speed
may be limited, e.g. to max. 300 1/min in vessels with aeration rigs for bubble-free
aeration.
Device Overview
43
4. Transportation and Storage
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.
4.1
Inspection Upon Acceptance by the Recipient
Transport Damage
Upon acceptance of the device by the customer, the device must be inspected for
visible transport damage.
t Report transport damage immediately to the delivering office.
Completeness
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.
Packaging
The packaging used for transport and protection of the unit 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.
44
Transportation and Storage
4.2
Instructions for Transport Within the Company
When moving the unit, 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 unit may only be moved by technical personnel.
− This equipment requires two or more people to transport and set up, or the use of
appropriately rated lifting equipment.
− The load capacity of the lifting system (forklift) must be at least the weight of the
unit [´ Section “4.2.2 Loads”].
− Make sure that the transport routes, such as elevators, are sufficiently large and
have adequate load bearing capacity.
− 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 unit slowly and carefully, to ensure stability and safety.
− Secure the unit from falling during internal transport.
− During transport of the unit, ensure that no personnel is in the path.
Protect the unit 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.
Transportation and Storage
45
4.2.1 Intermediate Storage
If the unit is not set up immediately after delivery, or will not be used temporarily,
the following conditions of storage must be noted:
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.
4.2.2
Loads
Supply units, BioPAT® DCU Tower, culture vessels
The exact weight of a specific supply unit depends on the internal fittings, e.g.
whether and how many mass flow controllers it contains.
The exact weight of a UniVessel® culture vessel depends on the vessel equipment and
size (see following table) [´ Section “19.2 Specifications”].
46
Transportation and Storage
5. Installation and Start-up
5.1
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
[´ Section “5.1.1 Ambient Conditions”].
− Ensuring that there is sufficient and suitable work space
[´ Section “5.1.2 Work Surfaces and Loads”].
− Ensuring that the laboratory energy sources correspond to the specifications
[´ Section “5.1.3 Laboratory Energy Sources”].
− Setting up the supply units and the BioPAT® DCU Tower, as well as devices and
equipment 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 equipment 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.
Installation and Start-up
47
5.1.1 Ambient Conditions
The device may only be operated under the following ambient conditions:
Criterion
Ambient conditions
Installation Location
Conventional laboratory rooms, max. 2,000 m
above sea level
Ambient temperatures in the
operating temperature range
5 – 40 °C
Relative humidity
<80 % for temperatures up to 31 °C (87.8°F),
decreasing linearly < 50 % at 40 °C (104°F).
Contamination
Pollution degree 2 (normally only non-conductive pollution occurs. Occasionally, however,
temporary conductivity caused by condensation
must be expected.)
Acoustic Emission
max. sound pressure level < 70 db (A)
5.1.2 Work Surfaces and Loads
The culture vessels are designed to be setup 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.
− All of the equipment should be set up at a distance of at least between 100 mm to
around 300 mm from any walls to ensure adequate ventilation and convenient
access to the connections on the rear.
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 unit 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 [´ Section “19.2
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.
48
Installation and Start-up
Setup Example
This example set up shows a BIOSTAT® B-DCU II with a BioPAT® DCU Tower and
6 supply units as well as the associated culture vessels and the dimensions of other
configurations. The actual required space depends on the additional equipment used
for the process.
315 40
768
250
800
1650
1200
2100
2550
3000
>
_ 100
Fig. 5-1: Setup example with 6 supply units and BioPAT® DCU Tower
Fig. 5-2: Set up example, viewed from above
Installation and Start-up
49
5.1.3 Laboratory Energy Sources
The connections for energy and supply systems must be prepared before installation
of the device in the work area, 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 [´ Manufacturer’s type plates] and in the
[´ Section “19.2 Specifications”].
The connections for the supply media are located at the back of the supply units
[´ “Fig. 3-5: Supply unit connection panel, rear”] and a voltage connection on the
BioPAT® DCU Tower [´ “Fig. 3-2: BioPAT® DCU Tower front and rear side”]
The following supply media are connected to the supply unit:
− Power supply, potential equalization
− Tempering media
− Gases:
− Compressed air (AIR)
− Oxygen (O2)
− Nitrogen (N2)
− Carbon dioxide (CO2)
Make sure that the inlets for electricity, water, compressed air and gases comply with
the specifications of the device.
Ensure that the intakes are equipped with suitable valves for blocking
and emergency shutoff.
5.1.3.1
Electricity
Risk of death from electrical shock!
The power supply (mains) in your laboratory must meet the equipment specifications.
− Check whether the equipment ratings match your voltage supply rating
[´ Manufacturer’s type plates].
− Do not switch on any devices if the laboratory’s mains voltage is incorrect.
− Your laboratory must have grounded, interference-free power outlets that are
protected from splashes of water.
− The safety equipment for emergency shutoff (residual current circuit breaker,
emergency shutoff switch) must be fully functional.
− 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).
− 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 the
technical customer service at Sartorius Stedim Systems GmbH.
50
Installation and Start-up
Risk of damage to the equipment 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
equipment’s power connections clear.
If the bioreactor needs to be switched off in an emergency, first press the emergency
stop switch in the laboratory, then shut off the laboratory’s energy supply lines and
then disconnect the equipment’s mains cables.
To clean and perform user maintenance, be sure to shut off the power on all
equipment and to unplug all power cables from the outlets.
Manufacturer’s type plates
All information concerning the correct power supply can be found on the
manufacturer’s ID label on the supply unit and the BioPAT® DCU Tower.
The manufacturer’s ID label are located near the power connection of the devices
[´ “Fig. 3-5: Supply unit connection panel, rear”, “Fig. 3-2: BioPAT® DCU Tower front
and rear side”].
Type
BB-8840152
Type
BB-8840151
No./
Year
06800 / 12
No./
Year
06800 / 12
V
230
V
120
A
10
A
10
Hz
50
Hz
60
Fig. 5-4: Manufacturer’s ID label on the
supply unit | 230 V version
Type
BB-8841212
No./
Year
06500 / 12
V
120 / 230
A
4
Hz
60 / 50
Fig. 5-5: Manufacturer’s ID label on the
supply unit | 120 V version
Fig. 5-3: BioPAT® DCU Tower,
manufacturer’s ID label
5.1.3.2 Tempering Media
Water is used as tempering medium for the supply unit and applies to the following
functions:
− Temperature of a jacketed culture vessel or a UniVessel® SU with heating | cooling
jacket
− Cooling liquid of the exhaust cooler and the cooling finger (for single-walled glass
vessels)
Installation and Start-up
51
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 Systems.
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 max. 2-4 barg (29 – 58 psig)
− Flow rate quantity max. 5 l/min
− Depressurized outlet
t Check whether the water is clean before connecting it to the supply unit.
t Flush the laboratory supply pipes.
t If necessary, install a suitable prefilter in the laboratory or feed line routed to the
supply units.
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.
52
Installation and Start-up
The information of the local water supplier regarding water hardness can be
converted by using the following table.
Alkaline earth ions
Alkaline earth ions
German hardness
CaCO3
UK hardness
French hardness
[mmol/l] [mval/l] [°d]
[ppm] [°e]
[°f]
1 mmol/l
alkaline
earth ions
1.00
2.00
5.50
100.00 7.02
10.00
1 mval/l
alkaline
earth ions
0.50
1.00
2.80
50.00
3.51
5
1° hardness [°d], 0.18
Germany
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° hardness [°e], 0.14
UK
0.285
0.798 14.30
1.00
1.43
1° French
hardness [°f]
0.200
0.560 10.00
0.702
1.00
0.10
Installation and Start-up
53
5.1.3.3 Gas Supply
Gas supply comprises the following gases (depending on the integrated aeration
module):
Aeration Modules
’O2 Enrichment’
’Gasflow Ratio’
’Exclusive Flow’
’Advanced Additive Flow’
Air
Air
Oxygen (O2)
Oxygen (O2)
Nitrogen (N2)
Carbon dioxide (CO2)
Danger of explosions and fire due to escaping oxygen!
There is danger of 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.
− Provide good ventilation where the unit is installed.
− 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.
54
Installation and Start-up
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.
ammoniac can cause corrosion to gas-carrying components made of brass).
− Make sure that the supply gases are dry and free of dirt, oil and ammoniac.
− Install suitable filters, if necessary.
− Malfunctions and damages arising from contaminated gas media are excluded
from the warranty granted by Sartorius Stedim Systems.
Installation and Start-up
55
5.2
Getting Started
Starting up the bioreactor involves the following main steps:
− Connecting the supply unit(s) and the BioPAT® DCU Tower to the power supply
[´ “5.2.2 Connecting the Supply Unit to the Power Supply”,
“5.2.3 Connecting the BioPAT® DCU Tower to the Power Supply”]
− Connecting the supply unit(s) to the BioPAT® DCU Tower
[´ “5.2.4 Connecting the Supply Unit to the BioPAT® DCU-Tower”].
− Connecting the laboratory’s water supply
[´ “5.2.5 Connecting the Laboratory’s Water Supply to the Supply Unit”]
− Connecting the laboratory’s gas supply
[´ “5.2.6 Connecting the Laboratory’s Gas Supply to the Supply Unit”]
− Connecting the stirrer motor to the supply unit
[´ “5.2.7 Connecting the Stirrer Driver”]
− Connecting the holder (UniVessel® SU)
[´ “5.2.8 Connecting the UniVessel® SU Holder”]
− Connecting the barcode scanner
[´ “5.2.9 Connecting the Barcode Scanner”]
− Connecting the sensor cable
[´”5.2.10 Connecting the Sensor Cable”]
− Connecting the tubes for aeration
[´”5.2.11 Connecting the Tubes for Aeration”]
− Connecting the temperature control system
(´ “5.2.12 Connecting the Temperature Control”]
− Connecting the exhaust cooling
[´ “5.2.13 Connecting the Exhaust Cooling Hoses”]
− Connecting the supply unit(s) and the BioPAT® DCU Tower
[´ “5.2.14 Switching on the Supply Unit(s) and BioPAT® DCU Tower”]
5.2.1 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 Systemsapproved 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, nor any secondary damage arising from this.
56
Installation and Start-up
5.2.2 Connecting the Supply Unit to the Power Supply
The “mains in” On | Off switch and interface to the BioPAT® DCU Tower are located at
the back of the supply unit.
Ethernet DCU-Tower
Serial-A
Serial-B
Serial-C
Serial-D
Serial-E
Serial-F Exhaust
Pump-C
Pump-D
Pump-E
Pump-F
External Drive
Press Out
Common Alarm
Lamp/T-Trap
PA
PA
1
Mains
15
GAS IN, 1,5 barg
AIR
O2
N2
157
CO2
Cooling Water
2-4 barg
Fig. 5-6: The rear of a supply unit
Mains connection
− Supply units can be supplied as either of the two voltage versions below:
− 230 V (± 10%), 50Hz at a power consumption of 10 A or
− 120 V (± 10%), 60 Hz at a power consumption of 10 A
t Use the power cables supplied with the device in accordance with the power
specifications of your country.
t Only use the supplied or equivalent and matching hoses, fittings and fastening
equipment for connecting the equipment inside the laboratory.
t The supply unit must only be switched on by pressing the main mains switch on
the front when all of the other supply connections (cooling water “Cooling Water”
and gas supplies) as well as the communications cable for the BioPAT® DCU Tower
and the culture vessels have been connected.
The mains switch on the front of the supply units is the “Mains” on | off switch for
the power supply:
t First, plug the mains cable “Mains” (1) into the mains socket and then into a mains
wall outlet with a protective grounding conductor in the laboratory.
t If you wish to stop operating the device, especially if you need to clean the supply
units or perform user maintenance on them, switch off this equipment using the
LED-illuminated “Mains” switch first, then disconnect the power cable from the
AC power outlet (mains outlet).
Installation and Start-up
57
5.2.3 Connecting the BioPAT® DCU Tower to the Power Supply
The “mains in” On | Off switch and interface to the supply units are located at the
back of the tower.
kg
BioPAT® DCU TOWER
1
2
30
Fig. 5-7: BioPAT® DCU Tower, rear view
Mains In
2
Serial 2
2
1 8 3
4
7
6 5
2
1 8 3
4
7
6 5
Serial 1
2
1 8 3
4
7
6 5
3
PE
1
Com Alarm
Serial 4
Serial 3
2
1 8 3
4
7
6 5
2
1 8 3
4
7
6 5
4
Fig. 5-8: Connection panel with the “mains in”
Mains connection
The connection voltage of the BioPAT® DCU Tower is designed for the following
bandwidth:
− 120 V | 230 V (+- 10%) 60Hz | 50 Hz
− The device has a power consumption of 4 A
t Use the supplied mains cable in accordance with your national mains connection
regulations and specifications.
The mains in connection on the rear of the BioPAT® DCU Tower is the ’mains in’ on |
off switch for the power supply. The DCU system can be activated and deactivated by
pressing the mains LED switch on the front:
t First, plug the mains cable into the ’mains in’ (2) socket and then into a mains wall
outlet with a protective grounding conductor in the laboratory.
t Switch on the BioPAT® DCU Tower with the mains LED switch (1) when you are
ready to start up the bioreactor.
t If you want to stop the unit or want to clean or maintain it, switch off the BioPAT®
DCU Tower at the LED switch first and then disconnect the mains cable from the
laboratory mains wall outlet.
The power cable and jack on the rear of the BioPAT® DCU Tower are the physical
“mains in” on | off switch for the power supply. Turn the LED-illuminated “Mains”
switch on the front panel to startup or switch off the DCU system.
58
Installation and Start-up
5.2.4 Connecting the Supply Unit to the BioPAT® DCU-Tower
The front of the BioPAT® DCU Tower is optionally fitted with a USB port for
connecting peripheral devices.
The following connections can be found on the rear side:
− “Serial” connections for external devices, e.g. scales | balances, printers
− “Tower” connections for “supply tower” supply units
− “Host” and “Fieldbus” ports, e.g., for MFCS SCADA.
Fig. 5-9: Connecting the supply units to the
BioPAT® DCU Tower.
t Connect the supply units to the “Tower” connections.
Depending on the scope of delivery, up to 6 supply units A-F can be connected to the
BIOSTAT® B-DCU II.
t Connect an external host system (e.g. MFCS SCADA) to the “Host” port.
The “Fieldbus” socket can be used to integrate the equipment into a network.
Information on operating the DCU system can be found starting in the Chapter
“11. Principles of Operation”
Installation and Start-up
59
5.2.5
Connecting the Laboratory’s Water Supply to the Supply Unit
Risk of injury due to bursting culture vessels!
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. 3-5: Supply unit connection panel, rear”].
− 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. 5-10: 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, the following specifications
apply:
− Water pressure max. 2-4 barg (29 – 58 psig)
− Flow rate quantity max. 5 l/min
− Temperature min. = 4 °C
− Depressurized outlet
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.
60
Installation and Start-up
5.2.6 Connecting the Laboratory’s Gas Supply to the Supply Unit
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. 3-5: Supply unit connection panel, rear”].
Please observe the following information and the P&I diagram:
Specifications of the Supply Units
− Compressed air, preset to 1.5 barg (21.76 psig)
− Gas required, e.g. O2, N2 or CO2, preset to, e.g. 1.5 barg (21.76 psig)
− Gas flow rate 0.02 – 2 vvm (depending on the size of the culture vessel)
− 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 “Gasflow Ratio”
are sealed with dummy plugs.
Dimensions of Flow Meters
The flow meters must be sized to accommodate the types of gas to be used.
The measurement tubes of these meters are calibrated to 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 other gases with a different pressure or temperature, the flow meters
may deliver flow rates that are too high or too low. To determine the actual gas flow
volumes, you will need to convert the flow rates measured.
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 supply unit using the appropriate
adapters [´ “Fig. 5-11: Gas supply on the supply unit’s connection panel”].
Fig. 5-11: Gas supply on the supply unit’s connection
panel
Installation and Start-up
61
5.2.7
Connecting the Stirrer Driver
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.
Danger of Damage to the Stirrer Drive!
The supply unit 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.
2a
1a
3
1b
1a
2a
3
2b
2b
1b
Fig. 5-12: Cap nuts, connection plugs
t Stick the connecting cable plug into the respective female connector on the
motor.
t Carefully tighten the plug connection cap nuts (3) finger-tight.
62
Installation and Start-up
5.2.8 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 BioPAT® DCU Tower via
the interface.
Sensor Plate Behind
Serial-F
opt. pH | DO
Conn.Cable UniVessel® SU
RS485, M12-8 | M12-8, 2m
UniVessel® SU Holder
Side View Front
Serial
®
B
IO
S
T
A
T B
-D
C
UII
Fig. 5-13: Connecting the UniVessel® SU Holder to the Supply Unit
t Connect the holder’s data cable to the “Serial” port and to the “Serial-F” port at
the rear of the supply unit [´ Section “3.3 Supply Units”].
5.2.9 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. 5-14: Barcode scanner (optional equipment)
The calibration data can either be entered manually or with the barcode scanner and
then transmitted to the BioPAT® DCU Tower via the USB port.
t Connect the barcode scanner to the USB port on the front side of the BioPAT® DCU
Tower [´ Section “3.2 BioPAT® DCU Tower”].
t Before the process, carry out the pH and DO calibration
[´ Chapter “15. “Calibration” Menu”].
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”
Installation and Start-up
63
5.2.10 Connecting the Sensor Cable
t Connect the sensor cable to the front side of the supply unit
[´ Section “3.3 Supply Units”].
The temperature sensor Pt-100 is firmly attached with the connection cable.
5.2.11 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 supply unit is fitted with aeration systems which have independently controllable
spargers, depending on the specifications of the device.
− The versions “O2-Enrichment” and “Gasflow Ratio” only have one adjustable
“Sparger” outlet for medium aeration.
− The versions “Advanced Additive Flow 2-out” and “Exclusive Flow” have an
adjustable “Sparger” outlet for medium aeration and an “Overlay” outlet for
headspace aeration.
t Connect the hoses for aeration to the front side of the supply unit. The version
“Advanced Additive Flow 6-out” has up to 6 individual gas outlets for medium
aeration. Depending on the process requirements, hoses can be connected to these.
64
Installation and Start-up
5.2.12 Connecting the Temperature Control
5.2.12.1 Jacketed Culture Vessels | Single-walled Culture Vessels with Heating |
Cooling Jacket
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 supply unit.
Installation and Start-up
65
1
2
9
3
4
5
8
7
6
Fig. 5-15: Hose kit | temperature control for jacketed culture vessels
1
2
3
4
5
9
8
7
6
Fig. 5-16: Hose kit | temperature control for single-walled culture vessels with heating | cooling jacket
10
5
6
66
Installation and Start-up
1
Jacketed culture vessel, heating | cooling jacket
2
Hose with plug-in sleeve
3
Sealing coupling
4
Hose with sealing coupling for return (length 600 mm)
5
Supply unit connection (return)
6
Supply unit connection (inlet)
7
Hose with sealing clip for inlet (length 600 mm)
8
Plug-in sleeve
9
Hose with sealing coupling
Filling with Tempering Medium
The supply unit and the BioPAT® DCU Tower are switched on [´ Section “5.2.14
Switching on the Supply Unit(s) and BioPAT® DCU Tower”].
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 Press the switch (10) on the front of the supply unit for approx. 1-2 min. to fill the
double wall or heating | cooling jacket.
t The filling process can be stopped as soon as the water exits from the laboratory’s
outlet.
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 an external cooling circuit in the laboratory
or a cooling thermostat, the temperature control circuit must be operated at zero
pressure (at ambient pressure).
Installation and Start-up
67
5.2.12.2 Heating Jacket
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. 5-17: Heating jacket
1
Power cord
2
1a
Cable connection with
overheating protection
Protective film of heating coil
(vessel side)
3
Heating coil
1b
6-pin Amphenol power cord
4
Silicone foam sleeve
2
Protective film of heating coil
5
Velcro fastener
Connecting the Heating Jacket to the Supply Unit
t Ensure that the supply unit has been switched off at the main switch “Mains I/O”.
t Stick the heating jacket’s connecting cable plug into the connection “Heating
Blanket” on the front of the supply unit [´ Section “3.3 Supply Units”].
68
Installation and Start-up
5.2.13 Connecting the Exhaust Cooling Hoses
1
2
3
5
4
Fig. 5-18: Hose kit, exhaust cooling for culture vessels
1
Exhaust cooling
2
Hose with sealing coupling for return
3
Supply unit connection (return)
4
Supply unit connection (supply line)
5
Hose with sealing clip for inlet
Connect the hoses to the supply unit
Connect the inlet hose (5) to supply unit connection (4).
t Connect the return hose (2) to supply unit connection (3).
3
4
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.
Installation and Start-up
69
5.2.14 Switching on the Supply Unit(s) and BioPAT® DCU Tower
Requirements
The system must be properly installed and connected in accordance with the
specifications. You must also have gained familiarity with the safety instructions in
[´ Chapter “2. Safety Instructions”].
t Ensure that all required supply energies are connected to the supply unit(s).
Fig. 5-19: Supply unit main switch
t Switch on the supply unit(s) at the main switch “Mains I/O”
[´ Chapter “3.3 Supply Units”].
Switching On the BioPAT® DCU Tower
Fig. 5-20: Supply unit main switch
t Switch on the BioPAT® DCU Tower’s control unit at the main switch “Mains”
[´ Chapter “5 Setup”].
70
Installation and Start-up
6. Preparing and Running the Process
Read the operating manual carefully before carrying out processes on the unit.
This particularly applies for the safety instructions
[´ Chapter 2 “Safety Instructions”].
6.1
Overview
Process preparation of the bioreactor during the relevant process involves the
following main steps:
− Equipping and changing the equipment of the culture vessels [´ UniVessel®
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 culture vessels and setting 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® Operating Manual]
− Performing a Process
6.2
Preparing the Glass Culture Vessels
Risk of injury when handling heavy culture vessels!
Fully equipped and filled culture vessels are heavy, e.g. a UniVessel® with an operating
volume of 5 liters weight > 18 kg.
− The culture vessels must be handled with care.
− Always use suitable transport 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® 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.
Preparing and Running the Process
71
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.
− DO sensor (see operating instructions of the manufacturer):
− Test the sensor as recommended by the manufacturer and service it if required.
Replace the membrane and the measuring electrolyte solution.
− 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.
6.3
Connecting Transfer Lines
The transfer lines are connected between the correction medium bottle(s) and the
culture vessel.
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® Operating Manual.
Attaching 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-DCU II, each of the culture vessels can be supplied with correction
media from up to 3 different bottles.
t Stick the end of a length of silicone tubing onto the hose nipple of the correction
medium bottle to which the riser tube is attached.
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.
72
Preparing and Running the Process
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.
Please refer to the [´ UniVessel® Operating Manual] for detailed information on
connecting the STT quick release couplings.
6.4
Filling the Culture Vessel with Culture Medium
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 cable must not be autoclaved.
The culture vessel must be filled with sterile medium.
6.5
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, 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.
Preparing and Running the Process
73
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].
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.
6.6
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. a UniVessel® with an operating
volume of 5 liters weight > 18 kg.
− Always use suitable transport 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.
[´ Section “6.6.1 Mounting the Agitator Drive”]
Temperature control system – UniVessel® double-walled:
t Connect the supply and drain tubing of the temperature control system with the
ports on the culture vessel.
Temperature control system – UniVessel® 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.
[´ Section “6.6.2 Heating | cooling Jacket Installation”]
or (depending on the equipment)
t Fit the heating jacket to the culture vessel.
[´ Section “6.6.3 Installing the Heating Blanket”]
Exhaust Cooling
t Connect the supply and return tubing of the exhaust cooling to the ports of the
exhaust cooler at the culture vessel.
74
Preparing and Running the Process
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.
[´ Section “6.6.4 Connecting the Aeration Modules”]
Corrective solution supply
t Place the transfer hoses in the peristaltic pumps on the device.
[´ Section “6.6.5 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.
Preparing and Running the Process
75
6.6.1
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.
Danger of injury if motor falls!
If the motor falls, it can cause bodily injury.
− After dismantling from the culture vessel, place the motor on a suitable surface
and secure it against falling.
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 a silent force transmission of the drive.
The stirrer drive motor can be fitted to the following stirrer shafts:
− UniVessel® (single-walled | jacketed)
− UniVessel® SU (with corresponding adapter)
Assembly of UniVessel®Culture Vessels
Fig. 6-1: Motor coupling
1
2
3
4
Fig. 6-2: Stirrer coupling UniVessel®
76
Preparing and Running the Process
t Take the motor (1) off of the device rack 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.
Installation in UniVessel® SU culture vessels
In UniVessel® SU culture vessels, the motor for the stirrer shaft cannot be directly
installed on the coupling. You need an adapter to install 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 Systems.
3
1
4
5
2
Fig. 6-3: Stirrer coupling UniVessel® SU
t Fit the adapter (1) to the coupling of the stirrer shaft (2)
[´ “Motor adapter installation instructions”].
t Prior to placing the supply unit, 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 (3) 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.
Preparing and Running the Process
77
6.6.2
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. 6-4: Heating | cooling jacket on the UniVessel® SU
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
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 [´ Section “5.2.12.2 Heating Jacket”].
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”.
78
Preparing and Running the Process
6.6.3 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.
tt
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 jacket on the power cord. This can damage to the cable
attachment.
−− Do not roll the blanket together more tightly than the shape of the culture vessel
allows.
−− Do not bend or fold the heating blanket.
−− 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.
tt
Wrap the heating blanket around the culture vessel with the foil-shielded side
touching the vessel.
yy
The side insulated with silicone foam should face outwards. The isolated layer
prevents burns when touching the device.
tt
Secure the Velcro fasteners so that the blanket is lying flat on the culture vessel
without folds, warping or dents.
Fig. 6-5: Heating jacket at culture vessel
Preparing and Running the Process
79
Operating the Heating Jacket
Danger of burns from 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.
− If you have to handle the culture vessel, use safety gloves.
t Turn the device on.
t Set the temperature measurement on the BioPAT® DCU Tower control unit 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® Operating Manual].
t During 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 and clean and dry it
thoroughly.
80
Preparing and Running the Process
6.6.4
Connecting the Aeration Modules
6.6.4.1 Conduct Preliminary Steps
The culture vessels must be fitted with the equipment needed for supplying the media
with gas [´ UniVessel® 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 Advanced Flow”
aeration module.
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 “15. “Calibration” Menu”].
After autoclaving and before aeration with air and oxygen, you can carry out the zero
point calibration of the DO sensor with nitrogen.
Observe the instructions for zero point calibration of the DO sensor with nitrogen in
vessels with “O2 Enrichment” and “Gasflow Ratio” aeration modules [´ Section
“6.6.4.3 Connect aeration system “O2 Enrichment” and “Gasflow Ratio””].
6.6.4.2 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.
2
3
1
4
5
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.
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 UniVessel® SU culture vessel [´ UniVessel® SU operating
instructions].
When laying and connecting the hoses, make sure not to bend or stretch them.
Preparing and Running the Process
81
6.6.4.3
1
2
3
Connecting the “O2 Enrichment” and “Gasflow Ratio” 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” (2) to the supply air filter of the
culture vessel.
t Open the laboratory nitrogen supply and the flow meter at the outlet
“Sparger” (1).
t Aerate the culture medium with nitrogen and calibrate the zero point
[´ Section “15.4 DO Calibration (pO2)”].
t After zero point calibration, remove the laboratory’s nitrogen supply tubing from
the “AIR” (3) connection.
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
[´ Section “15.4 DO Calibration (pO2)”].
t Set the gas flow rate that you want to use at the start of the process using the
“Sparger” 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 flow meter for the
“Sparger” outlet to the maximum gas flow rate.
6.6.4.4
1
2
3
Connect ing the “Exclusive Flow” and “Advanced Additive Flow”
Aeration System
t Connect the tubing from the outlet “Sparger” (3) to the supply air filter of the
culture vessel.
t Aerate the culture medium with nitrogen and calibrate the zero point
[´ Section “15.4 DO Calibration (pO2)”].
t Aerate the culture medium with air and calibrate the slope
[´ Section“15.4 DO Calibration (pO2)”].
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 flow meters (1).
If the supply unit is fitted with mass flow controllers for the gas supply, set the
flow meter for the “Sparger” and “Overlay” outlets to the maximum gas flow rate.
82
Preparing and Running the Process
6.6.5 Preparing the Corrective Solution Supply
The supply unit can contain up to 6 WM102 peristaltic pumps for supplying
correction media (acid, base, anti-foam agent or nutrient solution).
Preliminary steps:
The culture vessels must be fitted with the following equipment needed for supplying
correction media or media removal [UniVessel® 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 [´ Section “6.3 Connecting Transfer Lines”].
Danger of crushing limbs by being pulled into the rotation pump!
− Allow only qualified technical personnel to work on the device.
− Keep the associated DCU controller function switched off or switch this controller
function off, e.g. antifoam, pH or level controller [´ Operating Instructions Part B].
− Only turn the pump head by hand when installing the hose.
Place the hoses in the pump head
5
2
1
1
3
3
4a
5
4b
Fig. 6-6: Pump head, vertical view
1
Pressure rollers, tubing guide
4a
Input clamp
2
Rotor pump head
4b
Output clamp
3
Tube clamps
5
Contact pressure adjusting screws
Preparing and Running the Process
83
Unsuitable tubing material may damage the peristaltic pump!
Using hoses not made of silicone can damage the peristaltic pump.
− Only use silicone hoses.
In the peristaltic pumps, the silicone hoses can be installed with different wall
thicknesses.
The contact pressure is pre-configured for silicone hoses with a wall thickness of
1.6 mm.
Silicone hose example:
DI
WS
Version 3.2 + 1.6
DI
Hose internal diameter 3.2 mm
WS
Wall thickness 1.6 mm
To install silicone hoses in the peristaltic pump, perform the following steps:
t Open the cover on the pump head, press open the hose clamp at the “Input clamp”
(4a) and insert the hose.
t Thread the hose into the 1st rotor guide. Turn the rotor (2) clockwise and insert the
hose into the 2nd rotor guide.
t Continue turning the rotor until you are able to insert the hose into the output
clamp (4b). The tubing must be uniformly threaded inside the pump head.
t Close the cover on the pump head.
t Test the contact pressure of the rollers. These must clamp off the hose to prevent
medium from flowing back.
The silicone hose must not be pressed too tightly, as this may damage the hose.
t To adjust the contact pressure, turn the rotor (3) until you can see the setting
screws (5).
t To increase the contact pressure, turn the setting screws clockwise, to decrease it,
anticlockwise.
Adjust the same contact pressure for both rollers.
Configurations
Before starting the automatic correction media supply system, the hoses must be
filled with correction media. To fill them, start up the hose pumps manually:
t Activate the pump using the touch screen or the pump key.
t Let the pump run until the hose leading to the culture vessel is filled with
correction media right up to where it joins the vessel.
84
Preparing and Running the Process
6.7
Performing a Process
Danger of injury from shattered glass when using glass culture vessels!
The culture vessel can burst due to unallowed overpressurization, resulting in cuts
and damages 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® Operating Manual).
− Make sure that the culture vessel is positioned stably.
− Wear personal 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 companies’ 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 personal protective equipment.
− 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® 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® to >65 °C for approx. 1 hour. This will
kill off any viable cells, but not spores or thermophilic microorganisms.
− When using non-hazardous cultures and media, the UniVessel® only needs to be
carefully rinsed with water.
Preparing and Running the Process
85
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 motors!
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 their fittings.
Depending on the size and equipment of the culture vessels, the
permissible speed may be limited, e.g. to max. 300 1/min in vessels with
aeration rigs for bubble-free aeration.
6.7.1 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 “18. Alarms”].
t Select the measurement and control functions and set the parameters required for
your process:
86
Preparing and Running the Process
6.7.2
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. To perform a sterility test:
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.:
− a changed 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 Dismantle all of the vessel equipment and connections and check all of the seals
and lines for damage.
6.7.3 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 further processes are running on a supply unit, use the relevant mains switch
to shut of the supply units and the BioPAT® DCU Tower after the process has ended.
Preparing and Running the Process
87
7. Maintenance and Cleaning
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 can be life-threatening.
− Never open the unit. The unit may be opened only by authorized personnel of the
Sartorius Stedim Systems Company.
− Work on the electrical equipment of the device may only be carried out by
Sartorius Stedim Service or authorized technicians.
− During maintenance 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 unit 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 crushing limbs by being pulled in and direct contact!
− Do not remove the safety mechanisms.
− Allow only qualified and authorized personnel to work on the unit.
− Disconnect the unit from power when performing maintenance and cleaning tasks.
− Block the danger zone off.
− Wear personal 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.
88
Maintenance and Cleaning
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.
7.1
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.
7.1.1
Cleaning Devices
Supply unit and BioPAT® DCU Tower
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.
Maintenance and Cleaning
89
7.1.2 Cleaning the Culture Vessels
In some cases, it may be sufficient to carefully rinse the culture vessels (UniVessel®)
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 to remove them.
− Inorganic deposits must be removed using diluted hydrochloric acid. Once these
contaminants have been removed, carefully rinse the culture vessel with water.
− The metallic parts (cover plate, etc.) can be cleaned mechanically with a mild
cleaning agent or alcohol.
− Mechanically clean seals and other O-rings. 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® Operating Manual].
7.1.3
Carrying out Cleaning and Maintenance Work on the Heating Jacket
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 blankets 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 jackets 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
90
Maintenance and Cleaning
Possible Damage
Risk of electric shock if heating blanket is damaged!
No parts should be porous or have cracks, kinks, folds or chipped areas.
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 jacket and discontinue its use.
4
2
2
1a
1b
3
Fig. 7-1: Damage
1a
Cracks, porosity of the cable
connection
1b
Cracks, porosity of the power cord
2
Cracks, porosity of the silicone foil
above the heating coils
3
Short circuiting of the heating
coils, evidenced by discoloration
on the silicone foil
4
Cracks, porosity of the Velcro
straps
After using the heating blanket, only store it in a clean, dry location.
Do not expose it to sunlight for extended periods.
In flawless condition, the heating blankets allow safe heating of the culture vessels.
Malfunctions and dangerous operating states may occur if damage is overseen during
the pre-use inspection.
Spare and Wearing Parts
Heating blankets do not contain spare and wearing parts. If worn or defective, they
must be replaced.
Maintenance and Cleaning
91
7.2
Maintenance
7.2.1 Carrying out Maintenance Work on Function Elements
Maintenance performed by the user is restricted to the following tasks:
− Maintaining the pH, pO2 or Redox sensors 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. inoculum
membranes.
Detailed information on maintaining culture vessels, vessel equipment and sensors
can be found in the [´ UniVessel® Operating Manual].
The internal modules of the device, and the safety equipment, pump modules, drive
motors and stirrer shaft couplings, should 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.
7.2.2
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. 7-2: 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.
92
Maintenance and Cleaning
7.2.3 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
Tightness test
x
Visual inspection
x
Leak test
Visual inspection
Temperature control system
x
Leak test
x
Control Unit
Connections to the culture
vessel, air and water
Gas leak test
Tapping septa
­
Replace
x
O-rings
­
Visual inspection, replace if needed x
­
Replace
x x
Air inlet and exhaust filters
Filter elements
Integrity testing
x
­
Replace
x x
­
Replace
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
Peristaltic pumps
Pump hoses
Visual inspection, replace if needed x
Probes
pH probe
Calibration, visual inspection for
damage
x
pO2 probe
Calibration, visual inspection for
damage
x
Membrane body, electrolyte
Visual inspection, replace if needed x
(Clark probes)
Maintenance and Cleaning
93
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 Sartorius
Maintenance and functional experts.
test according to maintePlease contact the Sartorius Stedim
nance report
Service.
94
Maintenance and Cleaning
x
8. Faults
Danger to life caused by electrical voltage!
Electrical switching elements are installed in the device. Contact with parts under
voltage can be life-threatening.
− Work on the electrical equipment of the unit may only be carried out by a
competent electrician.
− Before any work, turn the unit off and disconnect it from power.
− Always make sure any electrical equipment is disconnected from AC power before
performing any maintenance, cleaning or repair work.
Danger of crushing limbs by being pulled in and direct contact!
− Do not remove the safety mechanisms.
− Allow only qualified and authorized personnel to work on the unit.
− Disconnect the unit from power when performing maintenance and cleaning tasks.
− Block the danger zone off.
− Wear personal 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 culture vessel cool before troubleshooting.
− Block the danger zone off.
8.1
Troubleshooting
Always proceed according to the following steps when faults occur on the unit.
− Turn the unit off if the fault represents a direct danger to personnel or property.
− Inform management on site about the fault.
− Determine the cause of the fault and remedy it before switching the device back
on. [´ Section “5.2.14 Switching on the Supply Unit(s) and BioPAT® DCU Tower”].
Faults, possible causes and remedies are listed in the following Troubleshooting
Tables.
Faults
95
8.1.1
Fault Table “Contamination"
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
filter defective.
Replace the tubing.
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
inoculum 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
connection has become
non-sterile or defective
Check the filter and replace
if necessary.
Replace the connection line.
Supply air filter or
connection has become
non-sterile or defective
Check the filter and replace
if necessary.
Replace the connection line.
Accidental or unauthorized manipulation of
equipment
Take organizational measures at
your work area to prevent
tampering with the equipment.
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.
During the process,
rapid
During the process,
gradually
96
Faults
We recommend that you perform a sterility test before each process.
Duration: 24 – 48 hours
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).
8.1.2 Fault Table “Contamination"
The counter cooling system does not work or does not provide sufficient cooling
power.
Problem
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).
Check the non-return valve.
Feed clean cooling water into
the system (if necessary, install
a pre-filter).
Flow rate too low
Cooling water
temperature too high
The minimum operating
temperature is around 8° C
above the cooling water
temperature.
If necessary, install an upstream
cooling device.
Insufficient cooling
power
8.1.3 Troubleshooting Table “Aeration and Ventilation"
Aeration or ventilation system does not work or does not provide sufficient gas/
ventilation.
Problem
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
blocked or decreases
suddenly
Hose kinked or disconnected.
Exhaust air filter blocked
(e.g. as a result of moist
air and the formation of
condensate, or foam).
Check the hose and filter and, if
necessary, fit new sterile filters.
Faults
97
9. Disposal
9.1
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
37079 Goettingen, Germany
Telephone +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.
9.2
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.
98
Disposal
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.
9.3
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
[´ Section “19.5 Decontamination Declaration”].
To create additional copies, simply copy the attached form or request additional
forms from Sartorius Stedim Systems GmbH.
Danger of severe 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.
9.4
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 Carry out a cleaning of the entire unit.
t Carry out sterilization of 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
99
9.5
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 unit may only be disassembled by technical personnel.
− Disassemble the unit carefully and in a safety-conscious manner.
− Wear the following personal protective gear during work
[´ Section “2.14 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 unit in an environmentally friendly manner. Follow the regulations
applicable in the local region.
100
Disposal
10. User Information
Introduction
DCU systems are digital measurement and control systems for controlling BIOSTAT®
bioreactors and fermenter systems, SARTOFLOW® crossflow systems from Sartorius
Stedim Systems GmbH and laboratory equipment, e.g. CERTOMAT® incubation shakers
from Sartorius Stedim Biotech GmbH.
The current version of DCU4 is an upgrade of the DCU system for controlling
bioreactors.
These operating instructions constitute “original” documentation and show 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 as “technical documentation” or in the “function specifications”.
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 digital measurement and control system supplied by Sartorius Stedim
Systems GmbH controls the terminal units it was specifically designed for.
The hardware can be integrated into the assigned device’s control towers or separate
benchtop housings or be contained as a rack version in measuring and controller
cabinets for pilot and production systems.
All measurement and control functions are localized in the software. The functionality is adapted to the terminal unit and depends on the configuration. The software is
stored on a PC board that can be exchanged whenever the system is extended or
updated with new versions.
Standard functions include the collection of measured data, calibration of sensors
and filling counters, controlling operating parameters and monitoring alarm criteria.
Additional software modules can be added to control process sequences by making
time- or status-dependent changes to parameters (phases). These include target value
profiles for controllers or timer functions for control elements among others.
Moreover, process parameter sets can be predefined in the form of formulations or
phases, thus allowing reproducible process control.
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.
Only system administrators or authorized, trained, and experienced users may change
the system configuration.
User Information
101
11. Principles of Operation
11.1 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, MFCs), 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
− Footer
− Work area
11.1.1 Header
Fig. 12-1: Header examples: “Main Overview All” and “Main Supply Tower 1”
Date, time
Example: 5/13/2009 2:55:09 PM
Date in format [yyyy-mm-dd]; time in format [hh:mm:ss]
Access to the time entry submenu (reference time for the process start).
Alarm display
− Bell white: no alarm
− Bell red: alarm triggered, information in alarm identifier
[´ List of alarm identifiers in the Appendix] and in the menu “Alarm”
Alarm messages can be displayed in the main function “Alarm”.
11.2 Footer
Fig. 12-2: Selecting “Main” using the main function key
The footer includes the main function keys for switching between main functions:
Display:
− Selected main function: Button light gray, activated
− Function not selected: Buttons dark gray, deactivated
102
Principles of Operation
11.2.1 Work area
The measuring range shows the function elements and submenus of the active main
function:
− Preselected process values with current measured or setpoint
− 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 set values
− Probes, e.g. for pH, pO2, antifoam, etc., with measured values
− Peripheral devices, e.g. weighing system, with measured values or current set
values
Fig. 12-3: Example: “Controller” main monitor for all units
Fig. 12-4: Example: “Controller” main monitor for Unit 1
− 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 keys. By pressing them, you can activate
the associated submenus, such as for the input of data and setpoints or the
selection of modes.
− Available functions, tag names, parameters, and submenus depend on the
controlled device for which the DCU system is intended and on the configuration.
Principles of Operation
103
11.3 Display of Function Elements
The display of the function elements in the working area shows the current status and
the intended use.
Symbol
[Tag PV]
MV [Unit]
Display
Meaning, use
Function element
Button with gray
underline
Field for short name (“tag”) for the
function element, e.g. TEMP, STIRR, pH,
pO2, ACID, SUBST_A, VWEIGH
Field for measured or set values in their
physical units
− Submenu or function can be selected
with a light touch
[Tag PV]
MV [Unit]
Button with green
underline
Measured value collection or output of
functional element is active, with
measured value or set value as shown
[Tag PV]
MV [Unit]
Button with yellow
underline
Display of function if in “Manual” mode;
(switched on or off); automatic control
not possible
[PV tag]
MV [Unit]
No underline
No submenu assigned (function cannot
be selected)
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
­
“off” ­ manual
Submenu to select mode: [­ Example
“on”
in Section (Main Function “Main”)]
Line displayed in
yellow, pump gray ­
green
­
Valve “off” ­ auto
“on”
Line gray ­ green
* Direct access to submenu to select
mode, example for 2 | 3-way valve
­
“off” ­ manual
“on”
Line displayed in
yellow, flow direction
green
Valve symbol also shows (changed) flow
direction
* Submenu to select mode: [´ Example
in Section (Main Function “Main”)]
“[r]” , “[s]”
“[v]” , “[w]”
* Examples for function elements, short descriptions, measured values, working
values, and submenus that can be called up by selecting touch keys are contained in
[´ Section “Main function “Main” menus”].
104
Principles of Operation
11.4 Overview of the Main Function Keys
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.
Button, symbol
Meaning, use
Main Function “Main”
Start screen with graphical overview of the controlled
unit:
− Display of components of the current configuration
− Overview of measured values and process parameters
− Direct access to important menus for operating
input
Main Function “Trend”
Display of process sequences, selection of 6 parameters
from:
− Process values
− Setpoints from control loops
− Outputs of controllers
Main Function “Calibration” Menus for calibration functions, for example for:
− Measurement electrodes for pH, pO2
− Totalizer for all pumps (ACID, etc.)
− Totalizer for aeration rates for valves
− Scales (optional, in development)
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, SUBSx
− Aeration rate regulation (valves, or mass flow
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 (passwordprotected, only for authorized service technicians)
Main Function “Remote”
Operation with external computer systems (central
computer)
− Pressing the menu button switches to remote
operation; instructions on configuration [´ Section
“Settings”]
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.
Principles of Operation
105
11.5 Overview of Selection Keys
Button, symbol
Meaning, use
Cancel
Changes are not saved
Confirmation of input
Additional controller functions
Cancel
Changes are not saved
Deleting characters
Selection of sign when entering a value
Selection list of process values
106
Principles of Operation
11.6 Direct Function Keys for Selection of Submenus
The function elements in the work area of the “Main” menu can contain direct
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.
The section “Main Displays” shows examples of the screens and submenus that can
be accessed via the direct function keys. Detailed instructions for the associated
functions and possible inputs can be found in the sections “Calibration” and
“Controller”.
Example: Inputting the temperature setpoint:
t In the work area of the main menu, press the TEMP function key or select the
“Controller” main function and then the “TEMP” controller.
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.
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 by pressing the “C”
key.
t Confirm with “OK”. The submenu window closes. The setpoint is active and is
displayed.
Fig. 12-5: Setpoint input and selection of the “TEMP”
controller mode from the “Main” menu
Principles of Operation
107
Example for selecting the controller mode “mode”:
t In the work area of the main menu, press the TEMP function key or select the
“Controller” main function and then the “TEMP” controller.
t Press the function key for the desired operating mode “Mode” on the right side.
t Confirm with “OK”. The function (of the controller) is activated and displayed.
You can access the full operator screen of the controller using the
button.
This is the same as activating the main function “Controller” and selecting the TEMP
controller on the overview screen.
11.7 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. 12-6: 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,
perform the following steps:
t Press the arrow key “s” (down) or “r” (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.
108
Principles of Operation
12. System Start
Activate the DCU system by switching it on at the main switch “Mains” on the basic
unit, the controlled terminal unit’s control unit or the measuring cabinet [´ Section
“5.2.14 Switching on the Supply Unit(s) and BioPAT® DCU Tower”].
12.1 System Behavior During Start
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 batterybuffered memory and can be used for the next process:
− Setpoints
− Calibration parameters
− Profiles (if there are any)
− All regulators are turned off, and actuators (pumps, valves) are in the rest position.
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 “Failtime”
12.2 First System Start or System Reset
During initial startup or after a reset of the DCU system, e.g. after installing a new
software version, the Administrator designated by the operator must log in and
perform the following tasks:
− Set system date and time
− Set up user accounts [´ Section “12.3 User Management”]
In order not to interfere with pre-defined tasks, such as control functions or phases,
the date and system time can only be set
within 5 minutes after starting up the system. After that,
the function keys are no longer selectable and the function is disabled.
System Start
109
Managing User Accounts
The management of user accounts is described in the chapter “12.3 User
Management”. The Administrator can perform the following user management tasks:
− assign existing user accounts (users) a password.
− assign a name “Real Name” to user accounts.
− delete or disable unnecessary factory-set user accounts.
− set up new user accounts and assign them to groups in the delivered configuration
with their respective access rights.
− set up new groups, specify the access permissions for these groups and assign users
to these groups.
After setup, the users must be informed about the accounts they will be working with
and which tasks and permissions they have.
Permissions
Description
Hierarchy
Permissions
Admin
Administrator − Changing system settings
− Creating and deleting user accounts
− Assigning a “Real Name”
− Assigning passwords
− Creating and deleting groups
− Adding users to a group
− Granting access rights
− for user accounts
− for groups
− Configuring parameters for processes
− Performing processes
− Confirming and deleting messages
User
User
− Configuring parameters for processes
− Performing processes
− Confirming and deleting messages
Guest
Guest
− Viewing measured values and operating
parameters
Settings cannot be performed
Password System and User Administration
In configurations with a password system and user administration, the “Main” menu
for the user “Guest” appears first after booting the system.
The user “Guest” usually only has rights to view measured values and operating
parameters, they may not make changes to the settings.
To operate the DCU system, an authorized user must log in
[´ Section “12.2.1 Login”].
110
System Start
12.2.1 Login
The administrator creates and configures the “User” accounts after logging in for the
first time.
Authorized “Users” can log in directly, given that this has been preset at the factory.
These authorized users will need the “User” name and password.
1. In the footer, press the touch key [User] to start the login process.
y The input screen “Login” is displayed.
2. Touch the input field next to “User”.
y The input screen “User Name” is displayed.
3. Enter the user name (logical user number or “Real Name”) in the input field and
confirm your entry with
.
y The input screen “Password” will appear.
4. Enter the password in the input field and confirm your entry with
.
Fig. 13-1: Input Screen “Password”
System Start
111
When the correct password is entered, the adjacent “Login” window will appear.
5. Press the touch key
to complete the login process.
y You can now use the DCU system in the context of your assigned access rights.
Input error: “Password failed”
If an incorrect password is entered, “failed” will be displayed in the display field
[Password].
1. You can cancel the login process by pressing the touch key [Logout].
To successfully login, make sure that you enter the correct password.
2. To do this, touch the input field next to “Password”.
y The input screen “Password” will appear [´ Step 4.].
3. Perform the following steps again.
12.2.2 Changing the password
The users can log in to the system using the login information provided by the
administrator. Users should change their password to prevent access to their account
by third parties and unauthorized operation of the DCU system.
The password must meet the following requirements:
− a minimum of 6, maximum of 20 characters, consisting of:
− at least 1 number
− at least one lower case letter
− at least one capital letter
Carry out the following steps:
1. Carry out the login process until the input screen “Login” appears [´ Section
“12.2.1 Login”.
2. Press the touch key [Change PW] to change the password.
112
System Start
y The input screen “Password” will appear.
3. Enter the new password in the input field and confirm your entry with
.
y The input screen “Password” will appear again.
4. Enter the new password in the input field again and confirm your entry with
.
Input error: “Bad Password”
If the password entered does not meet the requirements, the error message
“Bad Password” will appear.
t Confirm the error message with
.
t Enter a password that meets the requirements [´ Step 3.].
Input error: “Mismatch”
The re-entered password does not match the password entered initially.
t Confirm the error message with
.
t Perform the steps necessary to change the password again [´ Step 2.]
System Start
113
12.3 User Management
The user management function regulates the access of users to the DCU system.
The function makes it possible to grant or restrict access permissions, for example,
to prevent incorrect operation of the DCU system.
The operator or the party responsible for the use of the equipment must name an
Administrator who is given the login documents [´ user ID, administrator code] and
thereby access to User Management.
After the initial system startup, the Administrator logs in and activates the pre-loaded
accounts or sets up the intended user accounts and groups.
The users are assigned access rights via the groups they are assigned to. The DCU
system groups with graded rights are pre-configured in the factory, as intended for
the controlled terminal unit and | or for the customer [´ “Configuration
documentation”].
The Administrator can modify user accounts and set up groups with special
permissions [´ “Administration of user groups”].
User accounts are assigned to one of these groups at the factory:
− Group with rights “Level1” for user-no. 1-4
− Group with rights “Level2” for user-no. 5-8
− Group with rights “Level3” for user no. 9-34.
The pre-configured guest account “Guest” has minimal access rights, for example,
it allows you to view measured and set values. The administrator account “Admin” has
all the required permissions for user management.
The account “Service” is reserved for authorized service technicians.
12.3.1 Settings for Individual Users
The Administrator can use the user management function to:
− add new users
− enter the user’s “Real Name“
− assign or change user passwords
− assign a user to a group to grant permissions
− change or delete (factory-set) groups, or create new groups
− temporarily disable user accounts
− set an expiration date after which accounts are invalid
− delete user and group accounts
114
System Start
Settings Overview
Field
Value
Function, display, entry required
User
1 ... 34
Logical user number
Real Name
[ Name ]
User name with at least 6 characters:
− consisting of at least 1 number, 1 uppercase
letter, 1 lowercase letter
Change PW
[ nnXXyy ]
Password with at least 6 characters:
− as “User Name”
Group
Level1, etc.
Assigning users to a group with set permissions:
− Level1 - level3 (default)
− Admin(istrator)
− Guest
− Group with defined permissions
Dis | Enable
[ Enabled ]
[ Disabled ]
User access:
− “disable” to block if the user should not be
deleted
Expire
[ yyyy-mm-dd ]
Expiration date for user access
Delete
For deleting user accounts
Fig. 13-2: Main function “Settings” and access to user management
System Start
115
Adding Users
1. In the footer, press the touch key
.
2. In the main screen “Settings”, press the touch key
y A window with the list of existing users is displayed.
3. Press the touch key
.
to add a new user.
y The input screen “User Name” is displayed.
4. Enter a logical user number for the new user in the input screen and confirm the
entry with
.
116
System Start
y The “Edit User #” window will appear.
Fig. 13-3: User settings selection window
Input error “User Exists”
The logical user number is assigned.
t Confirm the error message with
.
t Select an unassigned logical user number.
Changing User Settings
The settings can be changed for existing users.
1. In the footer, press the touch key
.
2. In the main screen “Settings”, press the touch key
y A window with the list of existing users is displayed.
.
Select the user for whom you want to change the settings.
3. To do this, press the corresponding number in the column “Edit” (e.g. “4”)
You can move around in the table of registered users using the scroll bar or the arrow
keys [ U ], [ V ].
y The “Edit User 4” window is displayed [´ Fig. 1-3].
In the section “Configuring User Settings”, the steps for the user settings are
described.
System Start
117
Configuring User Settings
Setting | changing the user name [Real Name]
to specify or change the user name.
1. Press the touch key
y The input screen “Real Name” is displayed.
2. Enter the user name in the input field and confirm your entry
with
.
y The logical user number is associated with the specified user name.
Setting | changing the password [Change PW]
1. Press the touch key
to specify or change the password.
Fig. 13-4: Logical user number | real name
118
System Start
y The input screen “Password” will appear.
2. Enter the password in the input field and confirm your entry
.
with
3. Enter the password in the input field again and confirm your entry
with
.
The password can be changed by both the administrator and the user.
Assigning users to a group [Group]
1. Press the touch key
to assign the user to a group.
y The selection list for the groups appears.
Specify the access rights for the user by assigning him or her to a group.
You can move around in the table of registered groups using the scroll bar or the
arrow keys [ U ], [ V ].
2. To do this, press the corresponding touch key with the number in the column “No”.
(e.g. “3” for “level1”).
System Start
119
Enabling | disabling user access [Dis | Enable]
1. Press the touch key
to block user access.
y The entry “disable” changes to “enabled”
The user entry is not deleted.
Setting an expiration date [Expire] for user access
1. Press the touch key
to set the expiration date for the user access.
y The input screen “Expire Date” is displayed.
2. Enter the expiration date in the input field and confirm your entry with
120
System Start
.
Deleting a user account [Delete]
1. Press the touch key
to delete the user account.
y The confirmation window “Really delete #?” is displayed.
2. Confirm the deletion of the user account with
.
System Start
121
12.3.2 Settings for All Users
The user management submenu “Parameter” allows global settings that apply to all
users (groups):
− Term of validity for the password
− Warning that prompts the user to change his password after the designated time
has elapsed
− Time-out, after this time expiries the system logs off the active account and
re-activates the guest account.
Settings Overview
Field
Value
Function, display, entry required
Ch. PW after [ d ]
Term of validity for the user password
Warn
[d]
Warning that password will expire
Timeout
[ hh:mm ]
Automatic logoff (active user):
− [12:00] log off function inactive
Calling Up the List of Users
1. In the footer, press the touch key
.
2. In the main screen “Settings”, press the touch key
y A window with the list of existing users is displayed.
.
You can move around in the table of available functions using the scroll bar or the
arrow keys [ U ], [ V ].
3. Press the touch key
to specify settings for all users.
y The window “User Password Parameters” is displayed.
Fig. 13-5: Term of validity for the password
122
System Start
Setting the Term of Validity for the Password
1. Touch the box next to “Ch. PW after” to set the term of validity (in days).
y The input screen “Change PW after” is displayed.
2. Enter the number of days after which the password will become invalid and
confirm the entry with
.
The term of validity for the passwords is displayed.
y The term of validity for the passwords is displayed.
Fig. 13-6: Warning period
Setting the Time Period after which the User is Warned
Users are prompted to change their password after the designated time has elapsed.
1. Touch the field next to “Warn” to set the time period (in days).
y The input screen “Change PW after” is displayed.
2. Enter the number of days after which the user will be prompted to change the
.
password and confirm the entry with
System Start
123
y The time period is displayed.
Fig. 13-7: “Timeout” time
Setting the “timeout” Time
After the “timeout” time has expired, the system logs out of the currently active
account and the guest account is activated.
1. Touch the box next to “timeout” to set the “timeout” time (in hours and minutes).
y The input screen “Login timeout” is displayed.
2. Enter the hours and minutes after which the system logs out of the currently
active account and enables the guest account and confirm the entry with
.
y The “timeout” time is displayed.
3. Confirm the entries with
to complete the parameter settings.
124
System Start
12.3.3 Managing Group Rights
The rights defined using the user management function enable the user to select only
those functions activated (or released) for his group. Deactivated functions are either
not selectable or are not displayed on the screen.
Settings Overview
Field
Value
Function, display, entry required
Edit
[1-n]
Logical group number:
− Default “1 - 5”
− others as desired
Group
[ Name ]
Group names:
− Default: admin, guest, level1 - level3
− others as desired, e.g. “Supervisor”
Permissions
[ ON ] [ OFF ]
Granting or revoking permissions:
− “ON”: Users in this group may use the function
− “OFF”: Users in this group may not use the
function
NEW GROUP [ Name ]
Setting up a new user group
Delete
Deleting user groups with query to prevent
unwanted deletions:
− “YES”: Confirm deletion
− “NO”: Ignore deletion, group remains
[ ok ]
[ YES ] [ NO ]
Confirming the selection or setting
Fig. 13-8: Main function “Settings” and access to user and group management
System Start
125
Adding Groups | Setting Permissions
1. In the footer, press the touch key
.
2. Press the touch key
on the main screen “Settings”.
y A window with the list of existing users is displayed.
3. Press the touch key
to display the list of groups.
y A window with the list of existing groups is displayed.
4. Press the touch key
to add a new group.
y The input screen “Group Name” is displayed.
5. Enter the name for the new group in the input screen and confirm the entry with
.
126
System Start
y The list of selectable functions is displayed.
6. Press the touch key
of the respective function to release the access rights.
y The function is enabled and the touch key
changes to
.
You can move around in the table of available functions using the scroll bar or the
arrow keys [ U ], [ V ].
7. Perform step 6 for any additional features that you want to activate, and confirm
your entries with
.
y The list with the updated list of groups is displayed.
Deleting a Group
1. Press the touch key
to display the list of groups.
System Start
127
y A window with the list of existing groups is displayed.
2. Select the group you want to delete.
3. To do this, press the corresponding touch key with the number in the column
“Edit”. (e.g. “1” for “Supervisor”).
y The list of selectable functions for the group “Supervisor” is displayed.
4. Press the touch key
to delete the group.
y The confirmation window appears.
5. Confirm the deletion of the account and press the touch key
.
If you want to cancel the deletion,
press the touch key
.
Special Information:
Type and number of features are defined in the configuration
[´ Screen examples], [´ Configuration documentation].
[ Delete ] deletes the entire group; it does not allow the range of functions to be
modified for the group. A new configuration must be created and implemented to
modify the range of functions.
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System Start
12.4 Password System
Only make this information available to the designated administrator and users you
authorize to access password-protected features, as well as service personnel.
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 the password system.
This includes the following, for example:
− controller parameter settings in controller menus (e.g. PID),
− In the “Settings” main function:
− the process value setting “PV”,
− on the manual operation level (“Manual Operation”), the interface parameter
setting for digital and analog process in- and outputs or for simulation
controllers.
Furthermore, the “Service” submenu of the main function “Settings” is only accessible
with a special service password. This may only be 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 ]’.
− Standard password, customized for the customer: ’[ ___________________ ]’ 1).
− Specific user or user group passwords 2).
− Admin(istrator) password: ’[ ____________________ ]’ 2)
− Service password: ’[ ____________________ ]’ 3)
1)
The information is made available to you in the [´ Technical documentation],
e.g. in the [´ configuration documentation] or separately by post.
2)
If you grant access to certain functions for user groups or individual users
[´ Section “12.3 User Management”], create a suitable form. Keep it somewhere
that only authorized individuals have access to.
3)
Only for specially qualified and authorized service personnel
System Start
129
13. “Main” Menu
13.1 General Information
The “Main” menu opens after the control unit has been switched on.
This is the central starting point for in-process operations.
Fig. 14-1: “Main Overview All” main screens in a 4-way BIOSTAT® B-DCU II system
Fig. 14-2: “Main Supply Tower” main screens in a 4-way BIOSTAT® B-DCU II system
The graphical display of the system structure simplifies the overview of the system
components and uses function elements implemented as touch keys 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.
130
“Main” Menu
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.
13.2 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.
13.3 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:
Set value specifications and mode selection for headspace aeration (overlay) for air
and CO2 and media aeration (sparger) for all gases; example menu “AIR-OV1”
Settings for alarm limits and activation of alarm monitoring for totalizer; example
“ACIDT_#”
Mode selection for correction medium pumps, example “FEED_A#”
“Main” Menu
131
Target value configuration and mode selection for pumps, example “FLOW-A#”
Fig. 14-3: Menu screens for functions
accessible directly from the “Main”
menu
Agitator speed “STIRR_#”
Pressure measurement, where necessary pressure regulations (if used) PRESS_#
Mode selection for foam monitoring “FOAM_#” and level control “LEVEL_#”
132
“Main” Menu
Target value configuration and mode selection for the culture vessel temperature
“TEMP_#”
analogous to the temperature in the temperature control circulation “JTEMP_#”
Target value configuration and mode selection for pH Control “pH_#”
Target value configuration and mode selection for pO2control “pO2_#”
Weight measurement, e.g. “VWEIGH_#”
For menus pertaining to the culture vessel:
− BWEIGH_#”: Holding bottles for
nutrient solution or samples
− FWEIGH_#”: Media containers,
e.g. for perfusion operation
“Main” Menu
133
14. “Trend” Menu
14.1 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 1, 12, 24, 36 and 72 hours
− Zoom factor 1, 2 and 5
Operator Screen
Fig. 15-1: Trend function overview menu (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)
Top
Upper limits of the selected display ranges for each
channel
Center
Colored line chart
Bottom
Lower limits of the selected display ranges for each
channel
HH:MM:SS
Time scale
Subtitle
134
“Trend” Menu
14.2 Configuring the “Trend” Display
14.2.1 Setting the Trend Display for Parameters
t Select the “[ Trend ]” main function key.
t In the header, press the key of the channel that you want to set:
The “Channel # Settings” window opens.
Fig. 15-2: Menu for
parameter selection and
setting
t To change the parameter for the channel, press [ PV ] . 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 and confirm with [ ok ] .
t To deselect a parameter without having to re-assign the channel, press [ ..... ] .
Fig. 15-3: Overview table of default
parameters
14.2.2 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.
y The display limit values for the parameter are shown underneath the data window.
t Confirm the entry with [ ok ] .
Fig. 15-4: Example for setting the upper temperature
limit
“Trend” Menu
135
14.2.3 Resetting the Display Range
t Press [ Reset Range ] in the “Channel # Settings” window to reset a changed
display range back to the factory settings for “Max.” and “Min.”.
Fig. 15-5: Resetting a running trend recording
14.2.4 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. 15-6: Assigning a color to the selected parameter
136
“Trend” Menu
14.2.5 Defining a New Time Range as “Time Range”
Selecting a new time range deletes the current trend recording and restarts logging
the time curve.
t Press the [ h ] key in the header.
t Enter the desired time range on the keyboard.
y The time scale below in the working environment changes automatically.
y The parameter trend will be displayed over the new time range.
Fig. 15-7: Selecting the display range
“Trend” Menu
137
15. “Calibration” Menu
15.1 General Information
In the “Calibration” menu, all calibration actions required for routine operation can
be activated.
− Calibration routines for probes: e.g. pH, DO, turbidity
− Probe function test: e.g. REDOX
− Calibration of pump filling counter: e.g. acid, base, substrate
− Calibration of gas filling counter: e.g. N2, O2, CO2
Fig. 16-1: Overview menu in multiple systems (overview “All” shows the most important calibration
functions for all systems)
138
“Calibration” Menu
Fig. 16-2: Overview menu for the individual subunit (shows all calibration functions included in the
configuration)
After you press the “Calibration” main function key, the calibration screen opens.
Selectable function keys 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 DCU system continuously corrects the process
parameters affected (by the entries) during operation using the parameters
determined during the calibration routine.
The calibration parameters remain stored when the DCU system is switched off.
After the unit is switched back on, the DCU system uses the stored indicator values
for calculating the process parameters until an additional calibration routine is
performed.
15.2 pH Calibration
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.
During calibration you can enter the reference temperature manually; during pH
measurement temperature compensation is carried out automatically based on the
temperature measurement value in the bioreactor.
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.
“Calibration” Menu
139
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.
15.2.1 Group or Individual Calibration
Fig. 16-3: “Single or group calibration” selection menu
Field
Function, entry required
Single Calibrate
Calibration of one pH electrode
Group Calibrate
Calibration of several pH electrodes simultaneously
When using multiple pH and DO probes for parallel measurements, the calibration
of the probes can be carried out as a single or a group calibration. For example, in
configurations of the BIOSTAT®B-DCU-II, the group calibration of 1 … 3 probes of a
unit is possible if group calibration is selected in detail view “A”. If the selection is
made in the “All” view, calibration of 1…6 probes is possible. The number of probes
that can be simultaneously calibrated differs and depends on the configuration and
the unit controlled.
140
“Calibration” Menu
15.2.1.1 Calibration of a Single Sensor
Sequence of steps for single calibration:
t Press the touch key “Calibration” in the footer to carry out the calibration.
t Press the touch key of the sensor to be calibrated.
t Press the “[ Single Calibrate ]” touch key.
t Press the “[ Measure ]” touch key and select the desired calibration.
t Select the desired calibration function.
− “Calibrate”:
Complete calibration cycle with zero point calibration “Zero” and slope calibration
“Slope”.
− “Recalibrate”:
Recalibration
[´ Section “15.2.2 Recalibration”]
− “Calibrate Zero”:
Zero Point Calibration
− “Calibrate Slope”:
Slope Calibration
t Select the type of temperature compensation.
− If “Auto” is selected, the input field for the pH value will automatically appear
(“pH-1: Zero Buffer”).
“Calibration” Menu
141
If “Manual” is selected, the following input window opens for the temperature.
t Enter the value for the temperature compensation and confirm the entry with
“OK”.
If “Auto” is selected, the input field for the pH value will automatically appear (“pH-1:
Zero Value”).
t In the “Zero Buffer” submenu, enter the pH value to calibrate.
t Observe the measured value display in the “Zero Value” submenu.
t Once the display is stable, confirm the measurement with “OK”:
142
“Calibration” Menu
t In the “Slope Buffer” submenu, enter the pH value to calibrate.
t Observe the measured value display in the “Slope Value” submenu.
t Once the display is stable, confirm the measurement with “OK”:
Field
Fig. 16-4: Process and submenus
of the pH calibration routine
Value
Function, entry required
Mode
Measuring, Calibrating, Recalibrating
Measure
Switch to pH measurement after calibration routine is
completed
Calibrate
Starting the calibration routine
Recalibrate
Starting the recalibration
Calibrate Zero
Zero point calibration as a single step
Calibrate Slope
Slope calibration as a single step
pH
pH value and | or entering the pH of the external
sample during recalibration
Electrode
Combination electrode voltage (raw signal)
TEMP
Temperature for temperature compensation
Zero
Display the zero offset
Slope
Display the zero offset
manual
Manual temperature compensation
auto
Automatic temperature compensation with the value
measured inside the culture vessel
“Calibration” Menu
143
15.2.1.2 Calibrating Multiple Sensors
Group calibration is possible whenever several pH electrodes are to be used
simultaneously (in bioreactors with several subunits, e.g. several measuring points
in one culture vessel and | or several culture vessels).
t Press the touch key “Calibration” in the footer to carry out the calibration.
t For group calibration of the pH electrodes, select [Group Calibrate] from the
“Calibration” menu in the overview “All”:
t Press the “[ Group Calibrate ]” touch key to calibrate all pH sensors simultaneously.
t Press the function key next to “Mode”:
y It says “[ Inactive ]” during the initial calibration and “[ Measure ]” during a
running process.
t Select the desired calibration function.
− “Calibrate”:
Complete calibration cycle with zero point calibration “Zero” and slope calibration
“Slope”.
− “Calibrate Zero”:
Zero Point Calibration
− “Calibrate Slope”:
Slope Calibration
t Select the type of temperature compensation.
− If “Auto” is selected, the input field for the pH value will automatically appear
(“pH-1: Zero Buffer”).
144
“Calibration” Menu
If “Manual” is selected, the following input window opens for the temperature.
t Enter the value for the temperature compensation and confirm the entry with
“OK”.
If “Auto” is selected, the input field for the pH value will automatically appear
(“pH-1: Zero Value”)
t In the “Zero Buffer” submenu, enter the pH value to calibrate.
t Observe the measured value display in the “Zero Value” submenu.
t Once the display is stable, confirm the measurement with “OK”:
“Calibration” Menu
145
t In the “Slope Buffer” submenu, enter the pH value to calibrate.
t Observe the measured value display in the “Slope Value” submenu.
t Once the display is stable, confirm the measurement with “OK”:
Fig. 16-5: Group calibration process for all pH electrodes
Field
146
“Calibration” Menu
Value
Function, entry required
Mode
Measuring, Calibrating, Recalibrating
Measure
Switch to pH measurement after calibration routine is
completed
Calibrate
Starting the calibration routine
Recalibrate
Starting the recalibration
Calibrate Zero
Zero point calibration as a single step
Calibrate Slope
Slope calibration as a single step
ph
pH
pH value and | or entering the pH of the external
sample during recalibration
Electrode
mV
Combination electrode voltage (raw signal)
TEMP
°C
Temperature for temperature compensation
Zero
mV
Display the zero offset
Slope
mV | pH
Display the zero offset
manual
manual temperature compensation
auto
Automatic temperature compensation with the value
measured inside the culture vessel
15.2.1.3 Calibration of Sub-groups of Sensors
The individual calibration in the calibration menu overview “All” allows you to
calibrate subgroups of electrodes. The port identifications determine which electrodes
are combined to form a group.
t Press the touch key “Calibration” in the footer to carry out the calibration.
t Select the electrode group “pH_mn” and press the “[ Single Calibrate ]” touch key
t Press the function key next to “Mode”:
y It says “[ Inactive ]” during the initial calibration and “[ Measure ]” during a
running process.
t Select the desired calibration function.
− “Calibrate”:
Complete calibration cycle with zero point calibration “Zero” and slope calibration
“Slope”.
− “Calibrate Zero”:
Zero Point Calibration
− “Calibrate Slope”:
Slope Calibration
t Select the type of temperature compensation.
If “Auto” is selected, the input field for the pH value will automatically appear (“pH-1:
Zero Buffer”).
“Calibration” Menu
147
If “Manual” is selected, the following input window opens for the temperature.
t Enter the value for the temperature compensation and confirm the entry with “OK”.
If “Auto” is selected, the input field for the pH value will automatically appear (“pH-1:
Zero Value”):
t In the “Zero Buffer” submenu, enter the pH value to calibrate.
t Observe the measured value display in the “Zero Value” submenu.
t Once the display is stable, confirm the measurement with “OK”:
148
“Calibration” Menu
t In the “Slope Buffer” submenu, enter the pH value to calibrate.
t Observe the measured value display in the “Slope Value” submenu.
t Once the display is stable, confirm the measurement with “OK”:
Fig. 16-6: Group calibration process for subgroups.
“Calibration” Menu
149
15.2.2 Recalibration
To recalibrate a pH electrode, select the “[ Single Calibrate ]” function in the
“Calibration” selection menu.
By following the operating steps described below, you can adapt the calibration of a
pH electrode to changed measuring conditions after a sterilization cycle or during the
process as needed:
t Measure the pH value of a current sample in-process. Use a precise and carefully
calibrated measurement device.
t Press the touch key of the pH probe to be calibrated.
Group Recalibration
If multiple probes have been combined into a “measuring point”, you can recalibrate
them simultaneously.
t Press the “[ Group Calibrate ]” touch key.
150
“Calibration” Menu
Recalibrating Individual Sensors
t To recalibrate a single pH electrode, press the “[ Single Calibrate ]” touch key.
t Press the “[ Measure ]” touch key and select the desired calibration.
t For recalibration, press the “[ Recalibrate ]” touch key and enter the pH value
measured externally in a sample:
Fig. 16-7: Entry of the externally measured pH value
y The DCU system calculates the zero offset and displays the corrected pH value.
“Calibration” Menu
151
Special Notes
Whenever possible, use buffer solutions manufactured by the electrode manufacturer
as contained in the equipment supplied with the pH electrode. 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 electrode’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 electrode should be serviced and replaced as needed.
The pH electrode must be serviced or replaced when these values are outside the
specified range1):
− Zero point offset (“zero”) outside -30 to +30 mV or
− Slope is outside the range of 56 ... 59 mV | pH.
Depending on the type and design of the electrode 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.
1)
Limit values may differ depending on the construction and manufacturer of the
pH sensors; consult the manufacturer’s documentation.
152
“Calibration” Menu
15.3 UniVessel® SU pH Sensor Calibration for Optical
Measurements
15.3.1 Displays, Operating Panels and Entries
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-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
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 [´ Section “15.3.3
Changing pH Measurement Cycles (UniVessel®
SU)”].
Lot No.
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
“Calibration” Menu
153
15.3.2 Initial Calibration of a pH Sensor
t Choose the corresponding sensor pH-C “unit #” in the main menu.
t Press the key [Inactive] to start initial calibration of the pH sensor selected.
− [Parameter]:
After successful initialization, you can view the parameters to check them.
Entering the parameters
t Press the key [Enter init. Parameters] to enter the parameter.
Parameters can be entered in two ways:
− Scanning of the parameters with the barcode scanner (if available)
− Manual entry of the parameters
t Scan the parameters from the culture vessel label.
y Wait until [ok] is active.
t [Manual]:
Check the scanned parameters or input them manually in the following dialog
boxes.
t [ok]: Confirm the scanned parameters.
154
“Calibration” Menu
Manual entry of the parameters
t Enter the ’Lot- No.’
t Confirm the input with [Enter].
t Enter the parameters for temperature compensation.
t Confirm the input with [ok].
t Enter the parameter “pH f (max)”.
t Confirm the input with [ok].
t Enter the parameter “pH f (min)”.
t Confirm the input with [ok].
“Calibration” Menu
155
t Enter the parameter “pH dpH”.
t Confirm the input with [ok].
t Enter the parameter “pH pHO”.
t Confirm the input with [ok].
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].
156
“Calibration” Menu
Transferring the parameters
y The data are transferred.
t Wait until the parameters have been transferred.
The initial calibration of the pH sensor is now complete.
15.3.3 Changing pH Measurement Cycles (UniVessel® SU)
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).
Calculation of the measurement cycles
The measurement cycles can be configured so that a maximum number of
measurements is possible for the entire process time.
Calculation example:
− A measurement cycle of 120 s per measurement (1 measurement every 2 minutes)
comes to 30 measurements per hour or 740 per day.
20,000 measurements thus allow a process time (measuring time) of 666 hours,
or about 28 days.
Modifying the measurement cycle
t Choose the corresponding sensor pH-C “unit #” in the main menu.
t Press the key [Samp. Rate].
“Calibration” Menu
157
t Enter the standard password “19”.
t Confirm the input with [ok].
t Change the value for the pH measurement cycle according to the above
calculation.
t Confirm the input with [ok].
15.3.4 Recalibrating pH Sensor (UniVessel® SU)
t Choose the corresponding sensor pH-C “unit #” in the main menu.
The key next to “Mode”: It shows the current status of the function, i.e. [Inactive],
[Measure] or [Hold]:
− [Inactive] means no initial calibration has been performed.
− [Measure] means the initial calibration was performed and measurement is in
progress.
− [Hold] means the initial calibration was performed but the measurement was
stopped.
t Press the key [Measure].
158
“Calibration” Menu
t Press the key [Re-Calibration].
t Press the key [Act. Sample].
t Measure the pH value of a reference sample with precise pH measuring equipment.
t Enter the measured pH value.
t Confirm the input with [ok].
“Calibration” Menu
159
t Exit the dialog box without saving by pressing the button [X].
or
t Confirm the input with [ok].
y The system calculates the correction factor and uses it on the pH measurement.
y The data are transferred.
t Wait until the data transfer is complete.
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 [Inactive] must be switched
to manually.
160
“Calibration” Menu
15.4 DO Calibration (pO2)
Calibration of the DO electrode is based on a two-point calibration. Calibration is
performed in “% oxygen saturation”. The “zero” and “slope” electrode parameters
are determined during calibration. The reference value for “zero” is the oxygen-free
medium in the culture vessel. Air-saturated medium can be defined as “100 %
saturated” and can be used as a basis for determining the “slope”. Since you will be
calibrating the electrode after sterilization, take changes in the measuring properties
that can result from heat exposure or effects of the medium during sterilization into
consideration.
− If the culture vessels are autoclaved, the culture medium degasses due to heat
exposure and is almost free of oxygen. If the potential accuracy is sufficient, you
can use the electrode current measurable after autoclaving as the zero point
reference value. If you want to calibrate under reproducible conditions, you can
aerate the medium with oxygen-free nitrogen to eliminate the remains of any
dissolved oxygen and then measure the zero current.
− Measure the “Slope” electrode slope in the saturated condition, after aeration of
the medium with air (and | or an oxygen-containing technical gas mixture) under
the process’s operating conditions.
The operator screen for calibrating the DO electrode corresponds to that of the
pH calibration. Follow the description for pH calibration (see Section “15.2 pH
Calibration”) of this manual or the operator screen for DO calibration on your DCU
system. The operator screen shows the “DO saturation” along with the current
electrode current, the “zero” and “slope” and their calibration conditions. This allows
easy regulation of the electrode’s functions.
Group and Individual Calibration
As with pH calibration, you can perform group and individual calibrations for the
DO electrode
Field
Function, entry required
Single Calibrate
Calibrating the DO electrode
Group Calibrate
Calibration of several DO electrodes simultaneously
“Calibration” Menu
161
15.4.1 Calibrating All Measuring Points
Fig. 16-8: Selecting single or group calibration, “All” view
Group Calibration
t Press the touch key “[ All ] + [ Calibration ]”.
t Press the touch key [ pO2 Measure ] and select [ Group Calibration ].
Individual Calibration
t Press the touch key “[ All ] + [ Calibration ]”.
t Press the touch key [ pO2 Measure ] and select [ Single Calibration ].
162
“Calibration” Menu
15.4.2 Calibrating a Measurement Point
Fig. 16-9: Selection for individual calibration, “Unit_#”
Individual Calibration
t Press the touch key “[ Unit_# ] + [ Calibration ]”.
t Press the touch key [ pO2 Measure ].
“Calibration” Menu
163
15.4.2.1 Zero Point Calibration
After removal from the autoclave, do not yet aerate the culture medium with air or
the intended oxygen-containing gas.
Before starting the zero point calibration
t Leave the supply unit’s gas supply disconnected.
t When connecting the gas supply, do not yet aerate with air or oxygenic gas.
t For an exact zero point calibration, aerate with nitrogen until the oxygen
dissolved in the medium is displaced.
t Start the calibration function. With multiple bioreactors, you can select
“[ Single Calibrate ]” or “[ Group Calibrate ]”.
Fig. 16-10: Group calibration in the menu [ All ] + [ Calibration ]
Fig. 16-11: Group calibration in the menu [ Unit_# ] + [ Calibration ]
164
“Calibration” Menu
Fig. 16-12: Single calibration [ All ] and [ Unit_# ] + [ Calibration ]
t Select the desired calibration function:
− Calibrate:
Complete calibration cycle with zero point calibration “Zero” and slope calibration
“Slope”.
− Calibrate Zero:
Zero Point Calibration
− Calibrate Slope:
Slope Calibration
t Select the type of temperature compensation.
− If “Manual” is selected, the following input window opens for the temperature.
− If “Auto” is selected, the menus below open immediately:
“Calibration” Menu
165
t Monitor the values displayed. Once the display for the DO value near 0 % is stable
and shows a zero current in the range from 0 to 10 nA, confirm the measurement
with [ok].
Fig. 16-13: Group [ All ] values displayed
Fig. 16-14: Group [ Unit ] values displayed
Fig. 16-15: Single [ All ] und [ Unit ] values displayed
t Confirm that the measured zero current should be the reference value for the
electrode zero point.
166
“Calibration” Menu
15.4.2.2 Slope Calibration
t Set the stirrer’s rpm, temperature and, if needed, the pressure for the process.
Aerate the culture medium with the planned gas mixture or e. g. air until oxygen
saturation has been achieved.
t Continue the calibration or start the slope calibration [ Calibrate Slope ].
t Select the type of temperature compensation:
− If “Manual” is selected, the following input window opens for the temperature.
− If “Auto” is selected, the menus below open immediately:
Fig. 16-16: Group [ All ] values displayed
“Calibration” Menu
167
Fig. 16-17: Group [ Unit ] values displayed
Fig. 16-18: Single [ All ] und [ Unit ] values displayed
t As soon as the reading for the electrode current near 60 nA is stable, calibrate the
“Slope”.
Special Notes
Prior to first use or whenever the DO sensor has been disconnected from mains
power (from the measurement amplifier) for longer than 5 to 10 min., it has to be
polarized. Polarization takes up to 6 h (or less if the electrode has been disconnected
from the measurement amplifier for just a few minutes). This does not apply to
optical DO sensors e.g. VISIFERM, made by Hamilton). Follow the electrode
manufacturer’s instructions.
If necessary, you can enter the zero offset and slope directly into the relevant
submenus (see menus below):
168
“Calibration” Menu
Fig. 16-19: Direct input and verification of electrode parameters
The DO sensor must be serviced if:
− the zero point (“Zero Value”) is not within the range of 0 to +10 nA,
− the electrode current at maximum aeration with air is lower than 30 nA.
“Calibration” Menu
169
15.5 UniVessel® SU DO Sensor Calibration for Optical
Measurements
15.5.1 Displays, Operating Panels and Entries
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
%
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 [´ Section “15.5.3 Changing the
DO Measurement (UniVessel® SU) Measurement
Cycles”].
Lot No.
170
“Calibration” Menu
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
15.5.2 Initial Calibration of a DO Sensor
t Choose the corresponding sensor pO2-C “unit #” in the main menu.
t Press the key [Inactive] to start initial calibration of the DO sensor selected.
− [Parameter]:
After successful initialization, you can view the parameters to check them.
Entering the parameters
t Press the key [Enter init. Parameters] to enter the parameter.
Parameters can be entered in two ways:
− Scanning of the parameters with the barcode scanner (if available)
− Manual entry of the parameters
t Scan the parameters from the culture vessel label.
y Wait until [ok] is active.
t [Manual]:
Check the scanned parameters or input them manually in the following dialog
boxes.
t [ok]: Confirm the scanned parameters.
“Calibration” Menu
171
Manual entry of the parameters
t Enter the ’Lot- No.’
t Confirm the input with [Enter].
t Enter the parameters for temperature compensation.
t Confirm the input with [ok].
t Enter the parameter “pO2 0 %”.
t Confirm the input with [ok].
t Enter the parameter “pO2 100 %”.
t Confirm the input with [ok].
172
“Calibration” Menu
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].
Transferring the parameters
y The data are transferred.
t Wait until the parameters have been transferred.
The initial calibration of the DO sensor is now complete.
15.5.3 Changing the DO Measurement (UniVessel® SU) Measurement Cycles
Optical DO sensors show decay of the indicator dyes, e.g. photo bleaching.
Calculation of the measurement cycles
The measurement cycles can be configured so that a maximum number of
measurements is possible for the entire process time.
Calculation example:
− A measurement cycle of 30 s per measurement (2 measurements every minute)
comes to 120 measurements per hour or 2880 per day.
200,000 measurements thus allow a process time (measuring time) of 1,600 hours,
or about 66 days.
“Calibration” Menu
173
Modifying the measurement cycle
t Choose the corresponding sensor pO2-C “unit #” in the main menu.
t Press the key [Samp. Rate].
t Enter the standard password “19”.
t Confirm the input with [ok].
t Change the value for the pO2 measurement cycle according to the above
calculation.
t Confirm the input with [ok].
174
“Calibration” Menu
15.5.4 Recalibrating the DO Sensor (UniVessel® SU)
t Choose the corresponding sensor pO2-C “unit #” in the main menu.
The key next to “Mode”: It shows the current status of the function, i.e. [Inactive],
[Measure] or [Hold]:
− [Inactive] means no initial calibration has been performed.
− [Measure] means the initial calibration was performed and measurement is in
progress.
− [Hold] means the initial calibration was performed but the measurement was
stopped.
t Press the key [Measure].
t Press the key [Re-Calibration].
t Press the key [Act. Sample].
t Measure the DO value of a reference sample with precise DO measuring
equipment.
“Calibration” Menu
175
t Enter the measured DO value.
t Confirm the input with [ok].
t Exit the dialog box without saving by pressing the button [ok].
or
t Confirm the input with [ok].
y The system calculates the correction factor and uses it on the DO measurement.
y The data are transferred.
t Wait until the data transfer is complete.
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.
176
“Calibration” Menu
15.6 Turbidity Calibration
Calibrating the turbidity measuring probe determines the electrode parameter “zero
offset” by means of a one-point calibration.
Taking the zero point deviation into account, the system calculates the turbidity value
as a mean over a defined measuring time in absorption units (AU) and as a function
of the damping factor. To obtain stable process values, you can select DAMP in 4
setting ranges.
The operator screen for the turbidity electrode displays the absorption units (AU) and
the direct electrode raw signal in [%] at the same time, along with the “zero offset”
for “0 AU”. This allows you to easily check the turbidity electrode’s functional
capacity.
Operator Screen
Fig. 16-20: Menu screen for calibration of the turbidity sensor
Field
Function, entry required
Turbidity
Display of the process value in [AU]
Electrode
Display of the electrode raw signal in [%]
Zero
Display of the zero point after calibration in [%]
Damp
Set and display signal damping: 6 s, 12 s, 30 s, 60 s
“Calibration” Menu
177
t Place the electrode in the “zero point solution”
t Select the main function “Calibration” and press the turbidity measurement
“[Measure]” function key.
t In the “Calibration TURB_Unit#” menu, press the “[ Measure ]” mode key.
t Select the “[ Calibrate ]” key in the submenu.
Fig. 16-21: “Calibrate” key
(after being pressed, automatically switches
back to the operating state “not pressed”)
Depending on the process requirements, you can calibrate the light absorption before
inoculation and aeration as a reference parameter. This is possible in particulate- and
bubble-free water, deionized water, in a suitable buffer or in the culture medium
directly in the culture vessel.
178
“Calibration” Menu
15.7 Redox Calibration
The redox calibration covers a function test of the redox electrode (measurement of
the redox value of a reference buffer).
During sterilization, thermal effects and interactions with the culture medium can
impair the metrological properties of the Redox electrode.
You should therefore always check the electrode prior to use.
Operator Screen
Fig. 16-22: Menu screen for calibration of the Redox electrode
Field
Value
Function, entry required
REDOX
mV
Display the combination electrode voltage measured in the
reference buffer
Electrode
mV
Combination electrode voltage of the last calibration
Check Buffer
mV
Enter: Reference current of the reference buffer for the
current temperature of the reference buffer (information on
the buffer bottle)
“Calibration” Menu
179
Functional Test
The function test of the Redox electrode is carried out prior to installation in the
culture vessel, i.e., before sterilization.
t Fill the reference buffer into a graduated beaker and place the Redox electrode
in it.
t Select the main function “Calibration” and press the “[ Measure ]” function key.
t Press “[ Check Buffer ]” and enter the reference value of the buffer in [mV],
as indicated for the current temperature on the buffer bottle.
Fig. 16-23: Entry of the current
reference voltage of the buffer
When there are deviations of more than 6 mV (approx. 3%), the Redox electrode must
be serviced. Follow the manufacturer’s instructions on the documents supplied with
the electrode.
180
“Calibration” Menu
15.8 Totalizer for Pumps and Scales
For documenting 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 and you can enter known specific feed rates directly into the
calibration menus.
The calibration and filling counter functions are the same for all pumps and
proportioning valves. Therefore, this section only describes the calibration for one
of the “AcidT” acid pumps.
Operator Screens
Fig. 16-24: Access from the overview screen [ All ]+[ Calibration ] in systems with multiple bioreactors.
Fig. 16-25: Access from the menu screen [ Unit_# ]+[ Calibration ], corresponds to the menu screen in
systems with a bioreactor.
“Calibration” Menu
181
Field
Value
Function, entry required
ACID_A1
ml
Display the volume of liquid being pumped:
− BASET_# etc., for the alkaline pump
− AFOAMT_# for antifoam pump
− LEVELT_# for level pump
Mode
Calibrate
Totalize
Reset
Start the “Calibrate” or “Reset” routine:
− After completion of “Calibrate”, the system
automatically switches to “Totalize”
− Reset sets the filling counters back to zero
Flow
ml/min
Enter the specific feed rate of the pump or the flow
rate of the proportioning valve, if known
15.8.1 Pump Calibration Sequence
Always use the same type of tubing with the same dimensions for calibrating and
pumping the media.
t Place the tubing end of the pump inlet in a beaker filled with water and the tubing
end of the pump output in a measuring beaker to measure the feed volume in
liters.
t First, fill the tubing completely with the medium. For this purpose, you can switch
on the pump manually.
t Press the touch key of the acid pump to be calibrated.
t Select the touch key for the operating mode. Prior to the first calibration,
it displays the “off” operating mode. After running a calibration route, it switches
to “Totalize”.
t Press the touch key “[ Calibrate ]” in the “Mode” window.
182
“Calibration” Menu
t Start the pump calibration with “[ ok ]”. The “STOP calibration with OK” menu is
displayed. The pump pumps the medium.
t Once a sufficient volume has been transferred, press “[ ok ]”.
t On the graduated beaker, read off the feed volume and enter it in the “ACIDx_T:
Volume” submenu.
The DCU system automatically calculates the feed rate from the internally registered
pump running time and the determined feed volume and displays them in the
“Flow : x /min” field.
Activating the Filling Counter
The filling counter is activated after the calibration routine is completed and the
related controller is automatically switched on.
Fig. 16-26: Entry of the measured volume
If you know the feed rate of the pump, you can directly enter this rate after pressing
the “[ Flow ]” touch key.
“Calibration” Menu
183
t Press the “[ Flow ]” touch key.
Fig. 16-27: Direct input if feed rate known
t Enter the appropriate values on the keyboard.
t Start the pump calibration with “[ ok ]”.
You can set the filling counters to zero using the calibration function
[´ “Reset” mode].
15.8.2 Scale | Balance Calibration Sequence
The weight of bioreactors (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.
184
“Calibration” Menu
Operator Screen
Fig. 16-28: Menu screens of the different scale calibration menus
Field
Value
Function, entry required
xWEIGHT
g
Display net weight (WEIGH = GROSS TARE):
− VWEIGHT: weight of culture vessel
− BWEIGHT: Correction medium bottle
− FWEIGHT: Substrate or harvest container
Tare
g
Display tare weight
Gross
g
Display gross weight
t Select the “Tare” field to “zero” the scale | balance.
t Start the “Hold” mode to determine any weight changes.
t Enter the weight change in the “Tare” field.
t Confirm with “[ ok ]”.
“Calibration” Menu
185
16. “Controller” Menu
16.1 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 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” jacketed temperature controller
Slave controller for temperature control
− with TEMP controller “off”, possible as setpoint generator for heating
Speed regulation “STIRR”
Setpoint sensor for external motor controller controlling the agitator motor
pH controller “pH”
PID controller with pulse-duration 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 Controllers
− Controller for substrate supply
Gas Filling Controller:
− AirOv, AirSp
− O2
− N2
− CO2
Slave controller or setpoint generator for gas proportioning valves, pulsed feed:
− Air for headspace (overlay) and medium aeration (sparger)
− O2 for medium aeration
− N2 for medium aeration
− CO2 for headspace (overlay) and medium aeration (sparger)
Gas Flow Controller
Slave controller or setpoint generator for mass flow controller
− Each of the gases listed in each segment
“FOAM” antifoam controller
Impulse-pause controller for supplying “AFoam” antifoaming agent
“LEVEL” level controller
Impulse-pause controller for “Level” control
“SUBSA | B” substrate controller
Target value generator for filling pumps
Weight controller
PID controller with pulse-width modulated output for harvesting pump;
works with the weight of the culture vessel “VWEIGHT” 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:
“PRESS” pressure controller
PID controller with constant output for pressure control valve:
− Only controlled units with pressure regulation
186
“Controller” Menu
Any DCU system pre-installed at the customer’s facilities can be additionally
retrofitted with control functions by changing the configuration. Moreover, special
controllers are also configurable with the control blocks provided by the software.
Toggling the controllers between operating modes is mostly shock-proof:
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.
In the controller-operator screen, you can enter nominal value, operating mode and
controller output. The control ranges depend on the configuration. With a password,
you have access to the parameterization image to set PID parameters, output limits
and, if applicable, a dead zone. In “Remote” operation, the host PC defines the
setpoints and operating modes.
16.2 Controller Selection
You can access the operator screens on the controllers of a configuration in various
ways:
− The most frequently operated controllers can be accessed through the “Main” and
“Controller” main screens, both in the “All” view.
− Other frequently operated controllers can be accessed through the “Main” main
monitor, in the detail views of the units “Unit 1” ....
− All controllers can be accessed through the “Controller” main monitor, in the detail
views of the units “Unit 1” ....
“Controller” Menu
187
16.3 General Controller Operation
For the most part, operation of the controller is uniform. It comprises setting the
target values 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.
Operator Screen
Fig. 17-1: Selecting a temperature controller from the “All” overview menu
Field
Function key
Display
[ Mode ]
off
Controller and slave controller switched off
auto
Controller switched on, slave controller in “Cascade”
operating mode
manual
Manual access to control output
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.
Setpoint
Setpoint of process value in the physical unit, e.g. [°C]
for temperature
Out
Display controller output
Alarm
param.
Function key
Function key
“Controller” Menu
Enter controller operating mode
TEMP
Alarms Param.
188
Function, entry required
Enter alarm limits (high, low) and alarm status
(enabled, disabled)
Access to controller parameters (with password) for
cascade controllers: Selection of slave controller
[ ok ]
Confirm entries with “Ok”
16.4 Setpoint Profile
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.
Accessing Operator Screens
t Select the appropriate controller in the “Controller” menu.
t Call up the operator screen via the field “Profile Param.”.
Operator Screen
Fig. 17-2: Operator screen using the example of the AIRSP Profile
Field
Value
Add
Mode
Function, entry required
Adding a profile spike
off
Setpoint profile not active
profile
Setpoint profile has been started and is being processed
Setpoint
[PV]
Display of the current controller setpoint in the
physical units of the process value, e.g. °C for
temperature
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
“Controller” Menu
189
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.
16.5 General Controller Parameterization
For optimum adaptation of the controller to each control segment, the controller
parameters can be changed using the parameterization screens:
Fig. 17-3: Controller parameterization using the example of a TEMP controller
190
“Controller” Menu
Field
Display
Function, entry required
MIN, MAX
[ Day ]
Value %
Minimum and maximum output limit for the
controller output
DEADB
[ Day ]
Value PV
Dead zone setting (PID controller only)
XP, TI, TD
[ Day ]
Value %, s 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.
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.
16.5.1 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 setpoint 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:
− Unilateral controller output: MIN = 0 %, MAX = 100 %
− Split range controller output: MIN = -100 %, MAX = 100 %
16.5.2 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:
configured dead zone ± 0.1 pH
configured target value 6.0 pH
− In that case, the control loop is inactivated at nominal values between 5.9 pH and
6.1 pH.
“Controller” Menu
191
16.5.3 Controller Parameterization Menu Screen
Fig. 17-4: Submenu for controller parameterization (Example “pH controller”)
Field
Value
Function, entry required
MIN
%
Minimum output limit, limit value for switch to upstream slave
controller
(0 - 100 % = measuring range process value)
MAX
%
Maximum output limit, limit value for switch to downstream
slave controller
(0 - 100 % = measuring range process value)
DEADB
PV
Dead zone in the unit of the process value
XP
%
Proportional range in [%] of the measuring range (100 % = max.
measuring range process value)
TI
sec
Enter reset time
TD
sec
Enter reset time
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)
16.5.4 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.
192
“Controller” Menu
XP
Proportional range in [%] of the measuring range (P portion)
TI
Reset time in seconds (I portion)
TD
Hold time in seconds (D portion)
The control structure can be set by zeroing individual PID parameters:
P controller
´ TI = 0, TD = 0
PI controller
´ TD = 0
PD controller
´ TI = 0
PID controller
All PID parameters defined
16.5.5 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. If the
nominal values fluctuate stochastically, the controller output changes fast and
dramatically through the D portion, which can lead to 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 target value jumps and | or in the case of
nominal value drift, you can lower Xp and | or TI | TD.
16.6 Temperature Controller
The temperature control works like a cascaded regulation. The TEMP controller uses
the temperature measured in the culture vessel as a guiding variable and works on
the slave controller JTEMP. 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:
− Electrical heaters in the temperature control circuit;
Electrical heating jackets or heating mats;
Valves on the steam supply of steam-heated heat exchanger
− Valves of the cooling water supply(ies)
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.
“Controller” Menu
193
Master Controller TEMP Operator Screens
Fig. 17-5: Operator screen when called from “Calibration – All” main screen.
Fig. 17-6: Operator screen when called from “Calibration–Unit_#”.
194
“Controller” Menu
Slave Controller JTEMP Operator Screen
Fig. 17-7: Slave controller JTEMP operator screen
Refer to Section “16.3 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 jacketed) 60 °C
UniVessel® SU (heating | cooling jacket)
80 °C
The temperature cascade controller is operated from the master controller. You can
only change target values 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).
− For test purposes, the cascaded regulation can be disconnected and a target value
for the control element preset on the slave controller (JTEMP) in the “auto”
operating mode.
“Controller” Menu
195
Special Notes
In “auto” mode of the TEMP master controller, the JTEMP slave controller
automatically switches to “cascade” mode. When master controller is “off”, 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: max. out = 60% for max. temperature = 90 °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.
16.7 Speed Controller Agitator Motor
The DCU speed controller function works like a setpoint generator for an external
motor controller, which controls the speed of the stirrer motor controls. Operator
entries, output of the analog target value signal for the motor controller and the
display of the speed signal from the controller are all done on the DCU system.
When the speed controller function is switched off, an additional digital output also
modulates the drive protection. If the system has a DO controller, the speed controller
function can be modulated as a slave controller in the DO cascade control loop.
Operator Screens
Fig. 17-8: Operator screen when calling up the main menu “Controller-All”
196
“Controller” Menu
Fig. 17-9: Operator screen when called from “Controller–Unit_#”.
Refer to Section “16.3 General Controller Operation” for notes on the fields, entered
values and entries.
Special Notes
High speeds can damage vessel attachments!
Sometimes, only a certain maximum speed is allowed depending on the vessel type,
volume and equipment. Higher 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 speed for your bioreactor [´ configuration
documentation of the DCU system].
If the MIN | MAX setting is changed after a system reset, you must reset them new
limits to the range permissible for the bioreactor!
“Controller” Menu
197
When inputting MIN | MAX output limits or making direct entries into the OUT field,
the permissible speed controller range must be considered.
Example
When selecting the speed control MIN | MAX 0 ... 100% for speed range 0 ... 2000 rpm
and 1200 rpm as a permissible max. speed, a value of [“OUT”: MAX: 60%] must be
configured.
Fig. 17-10: Parameterizing the speed controller
For operation as a slave controller in DO cascade control, use the MIN | MAX output
limits to enter the speeds which, when exceeded or not reached, serve as a switch
condition:
Fig. 17-11: Speed controller in the parameterization screen of the DO controller for setting the switch
conditions of the cascaded regulation.
198
“Controller” Menu
16.8 pH Controller
The pH control normally works with PID control characteristics. It controls correction
medium pumps for acids and bases and | or proportioning valves for CO2 in splitrange mode using pulse-width modulated outputs. This enables bilateral control.
− The negative controller output acts on the acid pump (or the CO2 valve) 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.
Operator Screens
Fig. 17-12: pH controller menu on the “Controller – All” operator screen
Fig. 17-13: pH controller menu on the “Controller – Unit_#” operator screen
“Controller” Menu
199
Refer to section “16.3 General Controller Operation” for notes on the fields, entered
values and entries.
16.8.1 Configuration of the pH Sensor Process Value Source
The pH control must be set to the process value to be used for control with reference
to the pH sensor used.
Types of pH sensors
Description
Type
pH-A “Unit #”
classic pH sensor
pH-B “Unit #”
classic pH sensor (dual measurement)
pH-C “Unit #”
UniVessel® SU optical pH sensor
t Choose the corresponding sensor pH “unit #” in the main menu.
t Press the key [pH-A ’unit #’] or [pH-C ’unit #’].
t Enter the password (standard password: “19”).
200
“Controller” Menu
t Select the process value source by pressing the key [pH-A ’unit #’] or
[pH-C ’unit #’].
t Confirm the input in the pH controller menu with [ok].
y The process value actively being used for control is marked with a green point in
the pH controller menu on the “Controller – Unit_#” operator screen.
Fig. 17-14: pH-A “Unit #” selected and active
Fig. 17-15: pH-C “Unit #” selected and active
16.8.2 Operating Instructions
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.
Set dead zone
± 0.1 pH
Set target value
6.0 pH
In that case, the control loop is inactivated at nominal values between 5.95 pH and
6.05 pH.
16.8.3 CO2 Supply-driven pH 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.
Special Notes
− The pH controller output “–Out” normally controls the acid pump with a negative
output signal (0 ... –100%). Correspondingly, the controller output “+Out” controls
the base pump “BASE_2” with a positive output signal (0 ... +100%) and adds base.
− 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.
− 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”.
− When activating the modes “auto” or “manual”, the filling counters “ACID_T” |
“CO2_T” and “BASE” are automatically connected in mode “Totalize”.
“Controller” Menu
201
16.9 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.
− Aerate with air and either reduce the oxygen portion by adding nitrogen or
enriching the air with oxygen.
− Control the total gas flow with a flow controller [´ PI diagram].
− The mixture can be influenced e.g. by controlling the agitator speed.
− Effects cell growth by supplying the substrate.
The DO control works as a cascaded control. 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 MFC for N2 or O2 or the stirrer).
The following control strategies are possible:
− 1-stage control cascade, i.e. the DO control only affects one of the available
setting variables
− Up to 4-stage control cascade, during which the DO 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 DO controller acts on the slave controller with the priority 1 (Cascade 1) and
defines its target value. The slave controller 2 receives the target value defined in
the DO controller as “MIN”.
− When the setpoint entry for the 1st slave controller reaches its maximum, the
output of the DO controller switches to an adjustable delay time “Hyst.” on the
target value input of the 2nd slave controller (Cascade 2) and defines the following
setpoints:
− 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.
202
“Controller” Menu
16.9.1 Configuration of the DO Sensor Process Value Source
The DO controller must be set to the process value to be used for control with
reference to the DO sensor used.
Types of DO sensors
Description
Type
pO2-A “Unit #”
classic DO sensor (amperometric or optic
e.g. Visiferm, made by Hamilton)
pO2-B “Unit #”
classic DO sensor (dual measurement, amperometric or optic
e.g. Visiferm, made by Hamilton)
pO2-C “Unit #”
optical DO sensor UniVessel® SU
t Choose the corresponding sensor DO “unit #” in the main menu.
t Press the key [pO2-A ’unit #’] or [pO2-C ’unit #’].
t Enter the password (standard password: “19”).
“Controller” Menu
203
t Select the process value source by pressing the key [pO2-A “unit #”] or
[pO2-C “unit #”].
t Confirm the input in the pH controller menu with [ok].
y The process value actively being used for control is marked with a green point in
the DO controller menu on the “Controller – Unit_#” operator screen.
Fig. 17-16: pO2-A “Unit #” selected and active
204
“Controller” Menu
Fig. 17-17: pO2-C “Unit #” selected and active
16.9.2 DO Cascade Controller CASCADE
DO Cascade Controller Operator Screens
Fig. 17-18: DO level controller menu on the “Controller – All” operator screen
Fig. 17-19: DO level controller menu on the “Controller – Unit_#” operator screen
Refer to Section “16.3 General Controller Operation” for notes on the fields, entered
values and entries. The operator screen also includes the following input fields:
“Controller” Menu
205
Field
Value
Function, entry required
Setpoint
% sat
Preset Target Value in the Master Controller
Cascaded
controller
setpoint
OUT
Preset setpoint for the slave controller in the cascaded
regulation, in the sequence of the priority predefined in the
parameterization screen:
N2_xy
GASFL
O2_xy
N2 supply controller (proportioning valve)
Controller for massflow controller
O2 supply controller (proportioning valve)
STIRR
%
Speed Controllers
Status of the slave controller for cascade control with actual
value of controller output
DO Cascade Controller Parameterization Screen
Fig. 17-20: DO cascade controller parameterization screen
206
“Controller” Menu
Field
Value
Function, entry required
DEADB
%
Dead Zone Entry
Cascade
[Controllers] Slave controller with the relevant parameters.
Minimum
%
Minimum output limit, corresponding to the minimum
target value for the slave controller.
Maximum
%
Maximum output limit, corresponding to the maximum
target value for the slave controller.
XP
%
Proportional range for the slave controller (PARAM) in
relation to the measuring range.
TI
sec
Reset time for slave controller (PARAM).
TD
sec
Pre-holding time for slave controller (PARAM).
Hyst.
m:s
Lag time for switching between the slave controllers.
Mode
off | auto
Slave controller operating mode after switching off the
DO controller.
16.9.3 Operation of the Multi-staged Cascaded Regulation
t Select the slave controller according to the desired priority for CASCADE.
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 DO controller.
y When switching on the DO controller, the slave controller modulated by the DO
controller is displayed as “active”.
Special Information:
− In modes “auto” and “profile” of the DO controller, the selected slave controllers
are automatically switched to “cascade” mode.
− In mode “off” of the DO controller, the selected slave controllers are also
automatically switched to “off”.
− 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 image has been over- or undershot. After this time
has elapsed, check the switch conditions once again and only switch 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 and MAX must always be >2% of the relevant
measuring range.
“Controller” Menu
207
16.9.4 DO Cascade Controller ADVANCED
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 controller acts as the master controller in the DO control cascade. 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 connected in cascade. 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 control cascade. 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 control cascades, the advanced DO 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 easyto-understand and convenient to operate DO cascade control.
Operator Screen
Fig. 17-21: DO controller menu on the “Controller – All” operator screen
208
“Controller” Menu
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
[Æ configuration]
auto
Controller active, controls the actuator if necessary
Manual
Manual access to controller output
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 via standard
password
[Æ Appendix in operating manual for the DCU system]
[ 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 (order in the
cascade)
N2, O2, AIR etc.
tag
Media feed (gas, substrate) or function (e.g. 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”)
“Controller” Menu
209
Example: Input (modification) of the DO setpoint:
Since the selection of slave controller can be changed according to process
requirements, the setpoint of the DO controller output is set (in %) relative to the
control range. The slave controllers control their actuators with setpoints in their
physical units.
t Press “DO” in the “Controller” menu.
t Press “Setpoint” and enter the password.
Access is password-protected in order to prevent unauthorized changes
[Æ “Appendix” in the DCU system manual].
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”.
210
“Controller” Menu
Parameterizing the Master Controller
Fig. 17-22: 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)
Parameterization of the DO Master Controller
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
[´ “Appendix” in the DCU system manual].
t Select the parameter to be set (“MIN”, “MAX”, or “DEADB”), enter the value and
confirm with “OK”.
“Controller” Menu
211
t 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.
16.9.5 Selection and Configuration of the Slave Controllers
Fig. 17-23: Selecting the slave controller
212
“Controller” Menu
Fig. 17-24: Configuring the slave controller
Elements of the Operator Screens for Selection and Configuration
Field
Value
Function, display, entry required
Cascade #
Slave controller to be assigned to the “Cascade #”
position;
up to 6 slave controllers are possible [à configuration,
specification]
up to 5 slave controllers can form a control cascade
N2, O2, AIR etc. tag
Feed of media (gases, substrate) or actuators
(e.g. drives)
SP, OV, FL etc. tag
Introduction to control segment (e.g. sparger “SP”,
headspace aeration “OV” in the culture vessel or
container, massflow controller “FL”)
1, 2 etc.
#
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 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”)
“Controller” Menu
213
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 [Æ “Appendix” in the DCU system manual].
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.
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 [à“Appendix” in the DCU system manual].
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 control cascade, in the physical unit of the actuator.
t Enter the setpoint for the other “Out” segments. 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 [Æ “Settings” menu in the DCU system manual] restores
the factory settings. You must therefore store process- or user-specific settings
before the reset if you want to use them again later.
214
“Controller” Menu
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.
16.9.6 Instructions for Use
With an appropriate setup of setpoints for the slave controllers, they can work in a
conventional sequential control cascade. Example:
t Give “N2” a setpoint in the range “Out” = 0 to 20%, with the maximum at 0 %.
t Give “AIR” a setpoint in the range “Out” = 0 to 20%, with the maximum at 20 %.
Leave “Out” constant for 20 to 100%.
t Set “O2” between “Out” = 20 to 40%, with the maximum at 40%.
Leave “Out” constant for 40 to 100%.
t Set “STIRR” between “Out” = 0 to 40% and increase to a maximum at 60 %.
Leave “Out” constant for 60 to 100%.
t Leave “Substrate” constant in the range “Out” = 0 to 60% and increase to a
maximum at 80%.
− 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.
Examples of Applied Control Strategies
The examples are based on the control of mass flow controllers in the gas feeds.
Control strategies, e.g. O2 enrichment and additive flow, can be implemented by the
selection and configuration of control cascades:
O2 Enrichment
t Select “AIR” and “O2” as slave controllers.
t For “AIR”, set up a constant setpoint over the entire control range “Out” = 0 to
100%.
t For “O2”, set up the lower (minimum) setpoint up to “Out” = 40% and the upper
(maximum) setpoint starting at “Out” = 60%.
− This yields enrichment with oxygen starting at “Out” = 40%.
“Controller” Menu
215
Aeration rate (%)
Setting
DO controller output (%)
Touch panel
DO Out (%)
Fig. 17-25: Configuring cascade control for O2 enrichment
Exclusive Flow
t Select “N2FL”, “AIRFL” und “O2FL” as slave controllers.
t For “N2FL”, set the maximum setpoint at “Out” = 0% and the minimum at “Out” =
20%.
t For “AIRFL”, set the minimum setpoint at “Out” = 20%, the maximum at “Out” =
40%, and all other “Out” up to 100%.
t For “O2FL”, set the minimum setpoint at “Out” = 40%, the maximum at “Out” =
60% and all other “Out”.
− This configuration dispenses N2 at a controller “Out” below 20%.
Air is added for a controller “Out” of 20% or more, and the oxygen contribution
rises starting at “Out” = 40% by the introduction of O2.
216
“Controller” Menu
Aeration rate (%)
Setting
DO controller output (%)
Touch panel
DO Out (%)
Aeration rate (%)
Setting
DO controller output (%)
Touch panel
DO Out (%)
Aeration rate (%)
Setting
DO controller output (%)
Touch panel
DO Out (%)
Fig. 17-26: Settings for the cascade control for “Exclusive flow”
Gasflow Ratio Air | O2 (Total)
The “Gasflow Ratio (Total)” aeration strategy is only possible with “AIRFL” and
“O2FL” as slave controllers and if the gas feeds have massflow controllers as
actuators [à configuration, PI diagram].
t Select “AIRFL” and “O2FL” as slave controllers.
t Set the minimum “AIRFL” setpoint for “Out” = 0 to 40% and a setpoint (not the
maximum) starting at “Out” = 60%. This gives the DO that should be achieved by
adding air.
t Set the minimum “O2FL” setpoint for “Out” = 0 … 40% and increase the setpoint by
a certain amount starting at “Out” = 60%. The increase yields the DO content that
proportionally should be achieved by the addition of oxygen.
“Controller” Menu
217
− The added air is enriched with oxygen in the range “Out” = 40 to 60% of the DO
setpoint, with a maximum oxygen feed in the range “Out” = 60 to 100% of DO.
Air and oxygen portions add up to a relative maximum “Total” = 100%.
Aeration rate (%)
Setting
DO controller output (%)
Touch panel
DO Out (%)
Aeration rate (%)
Setting
DO controller output (%)
Touch panel
Total Flow (%)
DO Out (%)
Total
Fig. 17-27: Configuring the control cascade for Gasflow Ratio Air | O2 (Total)
218
“Controller” Menu
Gasflow Ratio Air | O2 (Ratio)
The “Gasflow Ratio (Ratio)” aeration strategy is only possible with “AIRFL” and
“O2FL” as slave controllers and if the gas feeds have massflow controllers as
actuators [à configuration, PI diagram].
t Select “AIRFL” and “O2FL” as slave controllers.
t For “AIRFL”, set up the maximum set value up to DO of “Out” = 40% and the
minimum set value starting at “Out” = 60%.
t For “O2FL”, set up the minimum set value up to DO of “Out” = 40% and the
maximum set value starting at “Out” = 60%.
− This means that in the DO setpoint range “Out” = 0 to 40%, only air is added,
that is, only the air feed regulates DO. In the range “Out” = 40 to 60%, the
portion of air reduces to a minimum and the oxygen portion increases to its
maximum. In the range “Out” = 60 to 100%, only the oxygen feed regulates DO.
Aeration rate (%)
Setting
DO controller output (%)
Touch panel
DO Out (%)
Aeration rate (%)
Setting
DO controller output (%)
Touch panel
Total Flow (%)
DO Out (%)
Total
Fig. 17-28: Configuring the control cascade for Gasflow Ratio Air | O2 (Ratio)
“Controller” Menu
219
16.10
Gas Filling Controller
Gas filling controllers control valves for the corresponding gas feeds, e.g. “AirOV_#”,
“AirSp_#”, “O2SP_#”, “N2SP_#”, “CO2OV_#”, or “CO2Sp_#” and introduce gases into
the aeration segments “Overlay” or “Sparger”. 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.
Depending on how the system is configured, gas filling controllers are available as
slave controller and | or setpoint generator.
Operating Menus
Fig. 17-29: Gas filling controller menu on the “Controller – All” operator screen
Fig. 17-30: Gas filling controller menu on the “Controller – Unit_#” operator screen
220
“Controller” Menu
Refer to Section “16.3 General Controller Operation”for notes on the fields, entered
values and entries.
Operating Instructions
To operate the gas filling controller as a target value generator, the master controller
must be switched off.
t Check its operating mode in the “Main” or “Controller” main screen and,
if activated, switch the “mode” of the master controller to “off”.
t Select the view “Main” or “Controller” in the detail view “A”… in which you want
to configure the gas filling controller.
t Select the function key with the current display of the target value [0.0 %].
Enter the target value in the window via the numerical keypad.
y The target value in [%] indicates the switch-on ratio of the valve per switch cycle.
At 100 %, the valve remains constantly open.
t Set the alarm limits, if needed, and activate alarm monitoring.
t Select the function key for the operating mode and select the “Auto” operating
mode.
t Activate the controller by pressing [ ok ].
Special Information:
− Select the target value of 100 % to set the flow rate on the flowmeter and to
calibrate the filling counter (if the calibration function is included in
configuration). Oxygen then flows continuously in the air supply.
− For manual gas supply, select the desired setpoint in the range 0..100 %.
− When the “auto” operating mode of the master controller is activated, the gas
filling controller is automatically switched in “cascade” operating mode. In that
event, settings in the gas filling controller are not possible or will be ignored.
− When switching the master controller to the “off” operating mode, the gas filling
controller is initially always switched to “off”.
“Controller” Menu
221
16.11
Gas Flow Controller
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.
Gas flow controllers control the massflow controllers of the assigned gas segment
(“GAsSP” or “GAsOV”) [´ PI diagram]. This makes it possible to aerate the reactor
vessel with a continually changing gas flow.
The gas flow controller normally operates as a slave controller in the DO cascade
control circuit. The master controller (DO controller) controls the massflow controller
in accordance with the sequence in the control cascade, using a continuous output
signal.
The gas flow controller can be deselected in the master controller. It is then available
as a setpoint generator. It controls the massflow controller using an analog setpoint
signal.
Operating Menu A
Fig. 17-31: Operating menu for the GASFL flow controller
Parameterization Menu B
Fig. 17-32: Parameterization screen for the GASFL flow controller
222
“Controller” Menu
Operating menu [´ A]
Field
Value
Function, display, entry required
Function key
[ Mode ]
Enter controller operating mode:
[ manual ] Manual access to control output
[ auto ]
automatic operation, control with a predefined target
value
[ off ]
Controller switched off, output on stand-by
[´ configuration]
XYZ_FL
ccm / lpm
Current total gas flow
Setpoint
ccm / lpm
Target value for the flow controller
Access the parameterization menu with standard
password [´ Appendix]
OUT
%
Current controller output
Alarm GASFL
Alarm monitoring settings:
− HiLim
%
Upper alarm limit
− LoLim
%
Lower alarm limit
− Alarm
state
Status: Alarm monitoring activated (enabled) or
deactivated (disabled)
Parameterization menu [´ B]
Field
Value
Function, display, entry required
Min.
%
Lower output limit,
setting range 0 to 100% of the control range
Max.
%
Upper output limit,
setting range 0 to 100% of the control range
OUT
The controller output is assigned to the control
element (if implemented)
Special Information:
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, e.g.:
− 2 L culture vessel: 0 - 100 % = 0 - 3 l / min (1.5 vvm)
− 10 L vessel: 0 - 100 % = 0 - 20 l / min (2 vvm)
− 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 “Mode: off” and after an
emergency shut off due to overpressure) closes the control valve in the mass flow
controller.
“Controller” Menu
223
16.12
Foam and Level Controllers
The input signal to the controller is a limit value signal generated by the
measurement amplifier to which the antifoam and | or level probe is connected.
This is activated, as long as foam or medium is on the probe. The response sensitivity
of the measurement amplifier can be configured on the operator screen of the
controller.
The output of the controller modulates a correction medium pump and switches it on
and off periodically when a probe signal is emitted. You can enter the pump run and
cycle time for repeated switching on and off on the controller operator screen.
This segment shows an example antifoam controller. Specifications in menus and
settings apply accordingly for the level controller.
Operator Screens
Fig. 17-33: Level controller menu on the “Controller – All” operator screen
Fig. 17-34: AFOAM controller menu on the “Controller – Unit_#” operator screen
224
“Controller” Menu
Field
Value
Function, display, entry required
Function key
[ Mode ]
Enter controller operating mode:
[ manual ] Manual operation of controller output
[ auto ]
Controller switched on
[ off ]
Controller switched off
Cycle
[h:m:s]
On | off time of the control element output
Cycle time in [minutes : seconds]
Pulse
[h:m:s]
On time of the control element output
Filling time in [minutes : seconds]
Sensitivity
Low .. high Response sensitivity of the probe
Access the parameterization menu with standard
password [´ Appendix]
Alarms Param.
Alarm monitoring settings:
− HiLim
%
Upper alarm limit
− LoLim
%
Lower alarm limit
− Alarm
state
Status: Alarm monitoring activated (enabled) or
deactivated (disabled)
16.12.1 Displays
OFF
ON
Probe signal off
ON
Signal on, output auto-off
Output manual-on
ON
Signal on, output auto-on
Fig. 17-35: Switches and submenus for the AFOAM controller
“Controller” Menu
225
16.12.2 Operation
t Set the cycle time (CYCLE) and the dispensing time (PULSE) according to process
requirements.
t Select the trigger sensitivity “Sensitivity” of the probe:
“[Low]”, “[Medium Low]”, “[Medium High]”, or “[High]”.
To prevent proportioning errors resulting from leakage currents and probe growth,
you should set the response sensitivity as low as possible.
t Switch the “Mode” operating mode to “auto”.
In “manual” mode, the pump for long-term operation can be switched on or off.
Special Information:
− 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 “AFOAMT_#” and | or “LEVELT_#”.
16.13
Gravimetric Filling Control
The “Flow Controller” is an accurate gravimetric filling control. It is used with 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.
Operator and Parameterization Screens
Fig. 17-36: Operator screen for the controller
Fig. 17-37: Parameterization screen
Refer to Section “16.3 General Controller Operation” for notes on the fields, entered
values and entries.
226
“Controller” Menu
16.13.1 Operation
Operation with feed tank and flow controller:
t Fill the vessel, sterilize if necessary and place on the scale | balance. Tare scale |
balance to zero.
t Preset the target value for the flow controller in the DCU system.
t Switch the “Mode” operating mode on the flow controller to “Auto”.
y A negative weight readout on the scale | balance or on the DCU indicates the feed
volume.
Special Information:
− The feed volume of the filling pump has an important influence on the controlled
loop path.
That is why the pump throughput must be adapted to the required flow.
− For accurate proportioning, the working range of the controller output (“Out”)
must lie in the range from 15 to 90 [%]. For that purpose, you can adapt the feed
range of the pump to the working range of the controller. You can use tubing with
a different diameter or a pump membrane that yields the desired feed range.
16.14
Filling Pump Controller
To introduce nutrient solution, the filling pump controller can control an internal or
external pump. The controller function works as a setpoint generator and emits an
analog setpoint signal for the pump. In external pumps, the controller function
displays the measurement signal for flow rates, as long as the pump is equipped with
a measurement signal output.
Operator Screen
Fig. 17-38: Operator screen for the controller
Fig. 17-39: Parameterization screen
Refer to Section “16.3 General Controller Operation” for notes on the fields, entered
values and entries.
Special Information:
− Matching connecting cables are available for certain pumps, like WM 101, WM
323. Ordering information is available on request.
− Pumps from other manufacturers can be connected if they have an external target
value input 0 ... 10 V, 0/4 ... 20 mA.
“Controller” Menu
227
16.15
Pump Assignment
This function is intended for custom configurations and not normally included in
standard configurations.
All controllers that can control pumps are assigned a pump. If the configuration so
specifies, the controller outputs can be connected to other pumps. However, only one
controller at the time can be connected to the corresponding pump.
If there are no external substrate pumps available, you can switch the substrate
controller to one of the internal pumps not in use.
Operator Screens
Fig. 17-40: Selecting and enabling the output of the pH controller from ACID to BASE
228
“Controller” Menu
Fig. 17-41: Switching the output for substrate pumps
16.15.1 Operation
To switch the assignment of a controller output to a pump, proceed as follows:
t Release the pump not in use by the other controller at its output OUT.
Example:
− Set the output OUT in the pH controller to [ None ].
t Assign the now free pump under “OUT” in the substrate controller.
− Set the output OUT in the SUBSxy controller to [ Acid.... ].
Special Information:
The configuration of the DCU4 system must permit the desired assignment and switch
the pumps to the controller outputs. If not,
− Either no “OUT” switch is visible or selectable
− Or the pump is hidden and cannot be selected, e.g. “ACID.... ].
If not, the pump switch is dimmed and cannot be selected although the configuration
allow switching, the assignment was not cancelled in the previous controller.
“Controller” Menu
229
17. “Settings” Menu
Danger of malfunctions and unsafe operating states due to impermissible
settings.
The “Settings” main function 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 [Chapter “12. System Start”] may only be disclosed to
authorized users; the service password [separate notice] only to authorized service
technicians and administrators.
17.1 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.
230
“Settings” Menu
17.1.1 “Settings” Main Screen
Fig. 18-1: “Settings” main screen (system settings)
Field
Value
Function, display, entry required
Hardware
Microbox
Version of the DCU hardware
Firmware
X.YY
Version of the system’s firmware
Configuration
XX YY_ZZ
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.
“Settings” Menu
231
17.2 Settings
In “System Parameters” (Settings), you can change general system settings, like
setting the real-time clock on the DCU system.
Operator Screen
Fig. 18-2: “System Parameters” submenu
Field
Value
Function, display, entry required
Date
dd.mm.yyyy
Enter current date in the format “Day.Month.Year”
Time
hh:mm:ss
Enter the current time in “hour:minute:second”
Fail time
h:m
Enter power outage time to tell system how to
behave when switched back on:
− Power outage time < FAIL TIME: The system
continues to run on the previous settings
− Power outage time > FAIL TIME: System switches
to default mode
Internet Config 32-digit binary The DCU system’s address in the IP network
number
Screen saver
hh:mm:ss
Screen saver 00:00:00 = switched off
Changes to the date and time will only take effect in the first 5 minutes after the
DCU4 system is turned on.
232
“Settings” Menu
17.3 Manual Operation
When starting up operations and troubleshooting, all analog and digital process
inputs and outputs as well as DCU internal inputs and outputs can be switched to
manual operation (“Manual Operation”).
− To switch to manual operation, the “system password” needs to be entered.
− 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.
17.3.1 Manual Operation for Digital Inputs
t For manual operation, disconnect the digital input from the external sensor,
e.g. limit value sensors, and simulate the input signal by entering “ON” or “OFF”.
Operator Screen
Fig. 18-3: Manual configuration of digital inputs, example “HEATC” (simulation for signal of the power-on
status of the heating)
Field
Value
Function, display, entry required
Day
Description
Displaying the digital input, entering the “AUTO” or
“MANUAL ON | OFF” operating mode
Port
Hardware address
VALUE
Switch status of the digital input
off = turned off
on = turned on
AL
Alarm state
A = activated
- = not activated
“Settings” Menu
233
Field
Value
Function, display, entry required
PV
Process value
MODE
auto
manual
Process value
Special Notes:
− The following signal levels apply to the switch status (status):
OFF
:
0V
ON
:
5 V for DCU int. inputs (DIM); 24 V for process inputs (DIP)
− When the selected digital input is in the “Auto Mode” status, the display in the
“VALUE” column is backlit green.
− When the selected digital input is in the “Manual Mode” status, the display in the
“VALUE” column is backlit yellow.
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.
17.3.2 Manual Operation for Digital Outputs
t 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.
Internally, several functions can have an effect on a digital output; the respectively
active function is displayed in “Mode”. If several functions are activated (e.g. on
controller outputs that interact with sterilization), the following priority applies:
Highest priority
Shut down
Manual operation (manual level)
Locking
Sterilization (only reactors capable of in situ sterilization)
Pump calibration
Controllers, timers, sensors, scales | balances
Lowest priority
234
“Settings” Menu
Operating state (OPS)
Operator Screens
Fig. 18-4: Manual configuration of digital outputs, example “COOL-1” (simulation for signal controlling the
cooling water valve)
Field
Value
Function, display, entry required
Day
Description
Displaying the digital input, entering the “AUTO”
or “MANUAL ON | OFF” operating mode
Port
Hardware address
VALUE
Switch status of the digital input
off = turned off
on = turned on
Ty
Upstream function
CL = controller
- = without
SRC
Upstream controller output
MODE
auto
manual
Normal operation, external input affects DCU
manual operation, manual presetting digital input
VALUE
Off
on
nn%
Digital output switched off Digital output
switched on Switch-on ratio (0 ...100%) for
pulse-duration modulated digital outputs
“Settings” Menu
235
Special Notes:
− The following signal levels apply to the switch status (status):
OFF
:
0V
ON
:
24 V for process outputs (DOP, DO)
− On pulse-duration 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, pulse-duration modulated 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.
17.3.3 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. 18-5: Manual configuration of digital inputs, example “JTEMP-1” (simulation for input signal for
temperature measurement in heating circuit)
236
“Settings” Menu
Field
Value
Function, display, entry required
Day
Display the analog input; entry to switch to the
“AUTO” or “MANUAL ON/OFF” operating mode
Port
Hardware address
VALUE
0 ... 100%
equivalent to 0 ... 10 V or 0/4 ... 20 mA
PV
Process value
Unit
Physical variable
Special Notes:
− For internal analog inputs (AIM), the physical signal level is always 0...10 V
(0...100%).
− For external analog inputs (AIP), the signal level can be configured between:
− 0 ... 10 V (0 ... 100%)
− 0 ... 20 mA (0 ... 100%)
− 4 ... 20 mA (0 ... 100%)
− During manual operation, only the relative signal level (0 ...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.
BAdDCU4-
“Settings” Menu
237
17.3.4 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...100%). Output signals have the
following priorities:
Highest priority
Shut down
Manual operation (manual level)
Locking
Highest priority
Controllers, etc.
Operator Screen
Fig. 18-6: Manual configuration of digital inputs, example “STIRR-1” (simulation of control signal for the
speed regulation of the motor drive)
Field
“Settings” Menu
Function, display, entry required
Day
Display of analog output, selection of the “AUTO”
or “MANUAL” operating mode
Port
Hardware address
VALUE
238
Value
PV
Output signal 0 ... 10 V or 0/4 ... 20 mA
Ty
Upstream function
CL = controller
– = without
SRC
Upstream controller output
MODE
auto
manual
Normal operation, external input affects DCU
manual operation, manual presetting digital input
1AO01
Tag name
Tag no. and description of the analog output
STIRR-1
Tag name
Example: Channel assigned output STIRR-1
Special Notes:
− The physical signal level of the analog outputs (AO) can be configured between:
− 0 ... 10 V (0 ... 100%)
− 0 ... 20 mA (0 ... 100%)
− 4 ... 20 mA (0 ... 100%)
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.
17.4 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, a “system password” needs to be entered.
Operator Screens
Fig. 18-7: Table of process values (or ranges) configured
“Settings” Menu
239
Fig. 18-8: Manual configuration of process values using example “TEMP-A1”
Field
Value
Ch.
Process value
Function, display, entry required
Channel
0 ... 100%
% or physical unit
Min
Minimum value
Max
Maximum value
Decimal point
Decimal point display
Alarm Lowlim
°C
Lower alarm limit in the physical Unit
Alarm Highlim
°C
Upper alarm limit in the physical units
Alarm
disable
Alarm monitoring deactivated
Alarm
enable
Alarm monitoring alarms active
Delay
s
Alarm lag time
17.5 Service and Diagnosis
This operating level is only accessible for interventions by authorized service
technicians or associates of Sartorius Stedim Systems GmbH.
240
“Settings” Menu
17.6 Logbook
The Logbook function (“Logbook”) is an optional function of the DCU system and only
available in accordingly equipped configurations.
After starting the DCU system, it records all event messages, e.g. those triggered by
alarms and any actions performed.
The “Logbook” function key can only be activated by authorized users.
Only system administrators and users from groups specifically authorized to use the
function have access to it. Information as to which of these are in the as-delivered
state can be found in the [´ Configuration Documentation]. The administrator can
grant access rights to additional users [´ Section “12.3 User Management”].
Fig. 18-9: The “Settings” main function with blocked function keys is only accessible by authorized users
after they log in.
Fig. 18-10: The “Settings” main function with activated function keys.
“Settings” Menu
241
Screen Display
Fig. 18-11: Overview of the messages recorded in the logbook.
Field
Value
Message
Function, display, entry required
Recorded message
[ yyyy-mm-dd ]
− Date
[ hh:mm:ss ]
− Time
[ Day ]
Origin of the message, e.g.:
− PANEL: Entry using the touch screen
− DI DCU: Digital input signal
− SYS: System message | event
[ Name ]
Type of event:
− Alarm, e.g. “Motor failure”
− User action, e.g. “Login”
− Confirmation, e.g. “Alarm reset”
Special Notes:
Logbook messages cannot be changed, supplemented or deleted.
Turning the DCU system off will delete all recorded messages.
Should you need the recording at a later point in time, e.g. to determine whether
events, settings or action have influenced the process, the data must be transferred
to a host system, e.g. MFCS/Win.
242
“Settings” Menu
18. Alarms
The DCU system makes a distinction between alarms and messages. Alarms have
higher priority and are displayed first ahead of the messages.
18.1 Alarm Triggering
− When alarms are triggered, they automatically are displayed in a window that
superimposes all other windows. Additionally, the color of the alarm bell (alarm
touch) turns red.
− The color of the alarm bell in the alarm touch stays red as long as at least one
unconfirmed alarm remains in memory.
Operator Screen
Fig. 19-1: Alarm message: “New Alert” pop-up screen (new alarm)
Closing the window:
− After pressing [ X ] , 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 color of the alarm symbol (alarm bell) turns white.
Alarms
243
18.2 “Alarm Overview” Menu
The alarm overview can be selected as follows:
− Press the [ ALARM ] direct function key.
Operator Screens
Fig. 19-2: Alarm table, accessible through the [ Alarms
Field
244
Alarms
Value
] function key.
Function, display, entry required
ACK ALL
Acknowledges all activated alarms
ACK
Acknowledges the selected alarm
RST
Resets and deletes the selected alarm
18.3 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).
High | Low alarm limits must be within the limits of the measuring range. After
entering the alarm limits, you can release or lock the limit value monitoring
individually for every process parameter.
In the event of process value alarms, the DCU system can switch specific process
outputs into the “Shut down” mode via locking functions.
Operator Screen
Fig. 19-3: Submenu for configuring alarm monitoring, example “TEMP-1”, called from the “Controller”
menu, overview “ALL”.
Field
Value
Function, display, 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
disable
Alarm monitoring, High | Low alarms locked
enable
Alarm monitoring, High | Low alarms activated
Alarms
245
18.3.1 Operating Notes
This way, alarms can be displayed and reacted to:
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 menu “Main Overview …”. The process value display contains a red triangle,
e.g. ” V ”, ” W “:
Fig. 19-4: Alarm message, below the alarm limit for ACIDT-1.
− The alarm window closes after acknowledgement of the alarm with
[ Acknowledge ] or after pressing [ X ] .
− After the alarm is confirmed, the alarm symbol
disappears.
− After pressing [ X ] , the alarm is stored as an “unacknowledged alarm” in the
alarms list and the alarm symbol remains activated
.
− 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.
246
Alarms
18.4 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.
Digital alarms can switch specific process outputs into the “Shut down” mode via
locking functions.
Operator Screen
Fig. 19-5: Activating and deactivating alarm monitoring
Field
Value
Alarms param.
Function, display, entry required
Alarm monitoring operating mode
disabled
Alarm monitoring locked for the input
enabled
Alarm monitoring activated for the input
Alarms
247
18.4.1 Operating Notes
A triggered 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.
is displayed in the header line of the menu “Main”.
− The alarm symbol
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 The alarm window closes after acknowledgement of the alarm with
[ Acknowledge ] or after pressing [ X ] .
− After the alarm is confirmed, the alarm symbol
disappears.
− The alarm appears in the alarms list as a “confirmed” alarm (“ACK”).
− After pressing [ X ] , the alarm is stored as an “unacknowledged alarm” in the
alarms list and the alarm symbol remains activated
.
Special Notes:
For an overview of alarms that have occurred, you can open the alarm table with the
[ Alarm
] menu button.
18.5 Alarms, Meaning and Corrective Measures
18.5.1 Process Alarms
The user can switch on and off the individual alarms listed in the following table:
248
Alarms
Text in the alarm line Meaning
Remedy
“Name State alarm ...”
Digital input alarm with
(name)
Confirm alarm with
’ACK’nowledge
“Name low alarm ...”
The process value with the
(name) has undershot its
lower alarm limit
Confirm alarm with
’ACK’nowledge
“Name high alarm ...”
The process value with the
Confirm alarm with
(name) has overshot its upper ’ACK’nowledge
alarm limit
“Heater failure ...”
Overheating protection from The tempering system
the temperature circulation must be refilled
responded
“Heater failure ...”
Overheating protection of
the motor responded
Allow the motor to cool
down
“TEMP Sens. failure”
Pt-100 not inserted in the
culture vessels or defective
Check Pt-100 and
connection,
change sensor if necessary
“JTEMP Sens. failure”
Internal Pt-100 of the
temperature circulation is
defective
Inform the Service
Department
“TURB Sens. failure ...”
Turbidity measurement sensor Check and change sensor
not connected or defective
if necessary
18.5.2 Process Messages
Text in the alarm line
Meaning
Remedy
“Steriliz. Finished …”
Sterilization is finished
The fermentation process
can be started by
confirming with
’ACK’nowledge
“Shut down DCU ...”
The “SHUT DOWN” key was
pressed
End “SHUT DOWN” status
by pressing the key once
more
“Shut down fermenter”
“Emergency-off” was
confirmed on the bioreactor
Switch the bioreactor
back on with “Emergency
off”
18.5.3 System Alarms
The alarms of the following table are system-generated messages that the user
cannot switch off:
Text in the alarm line
Meaning
“DCU Reset HH:MM ...”
Confirmation message for a Confirm alarm with
system reset, triggered in the ’ACK’nowledge
“Settings” menu, indicating
the time (before HH hours
and MM minutes)
“(Taskname)
Watchdog Reset”
Confirmation message for a
watchdog reset, 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’nowledge
“Power failure HH:MM ...”
Power outage before HH
hours and MM minutes
[´ Chapter: “Operating
Behavior”]
Confirm alarm with
’ACK’nowledge
“Pwf stop ferm HH:MM ...” Power outage before HH
hours and MM minutes;
max. power failure exceeded
[´ Chapter: “Operating
Behavior”]
Remedy
Confirm alarm with
’ACK’nowledge.
Alarms
249
18.6 Error Handling and Troubleshooting
If the DCU system should encounter technical problems, contact Sartorius Stedim
Service.
18.7 Locking Function
Locking functions are permanently configured; the user cannot change them.
The system displays all outputs that are influenced by a locking function on the
manual level with the “lock” status. 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.
250
Alarms
19. Appendix
19.1 Technical Documentation
The operating manuals describe how to operate the devices along with the standard
equipment intended for this purpose.
The operating manuals may contain additional documentation such as a P&I
diagrams, lists with fittings, floor plans, technical drawings, etc. All of these
documents will either be provided in the Technical Documentation folder or
separately.
The equipment supplied will not necessarily contain all equipment described.
Customer-specific equipment may contain modified or additional components.
Please refer to the order or delivery documents for detailed information on the device
specifications and the scope of the delivery as contractually agreed or as supplied
with the device.
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 directly with Sartorius Stedim Systems.
Appendix
251
19.2 Specifications
BIOSTAT® B-DCU II
Value
Name:
BIOSTAT B-DCU II
Laboratory Energy Sources
Power connection for
a supply unit:
230 V (± 10%), 50Hz, power consumption 10 A
120 V (± 10%), 60 Hz, power consumption 10 A
Protection class: IP 20
Power connection
BioPAT® DCU II Tower:
120/230 V (± 10%), 50/60Hz at a power consumption
of 4 A
Protection class: IP 20
Cooling water supply:
Supply rate: max. 5 l/min
Supply pressure: 2–4 barg (29–58 psig)
Water hardness: max. hardness 12° dH
Water quality: clean water, free of particles
Process gas supply:
Supply pressure [barg | psig]:
− Compressed air [AIR]: with 1.5 barg (21.76 psig),
Class 2 (ISO 8573-1)
− 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: 10 l/min
− N2: 20 l/min
− CO2: 5 l/min
Compressed air: Class 2 (ISO 8573-1)
Other gases: Dry and free of particles
Culture Vessels
Operating volume | total volume [ L ] | [ L ]
− UniVessel® 0.5 L: 0.5 | 0.75
− UniVessel® 1 L: 1 | 1.5
− UniVessel® 2 L: 2 | 3
− UniVessel® 5 L: 5 | 6.6
− UniVessel® 10 L: 10 | 13
Material: Steel | glass
UniVessel® SU 2 L: 2 | 2.7
Material: Polycarbonate
Size [mm]
Supply unit
length | width | height
BioPAT® DCU II Tower
length/width/height
Work surface for 6 supply
units:
252
Appendix
402 | 345 | 768
512 | 378 | 768
approx. 3000 mm = 800 mm
BIOSTAT® B-DCU II
Value
Weights [kg]
Supply unit:
BioPAT® DCU II Tower
Culture Vessels:
UniVessel® 0.5 L DW-SW
UniVessel® 1 L DW-SW
UniVessel® 2 L DW-SW
UniVessel® 5 L DW-SW
UniVessel® 10 L DW-SW
UniVessel® 2 L SU without
vessel holder
UniVessel® 2 L SU with
vessel holder
approx. 45 (depending on the equipment)
approx. 30
approx. 8
approx. 10
approx. 14
approx. 20
approx. 34
approx. 1.5
approx. 15
Temperatures [°C]
maximum operating
temperatures
minimum operating
temperatures
(cooling water)
+ 80
+8
Stirrer Driver
Motor 75 W,
− 0.5 L bioreactor
Motor 200 W:
− 1 L, 2 L culture vessel
− 5 L bioreactor
− 10 L bioreactor
Motor 400 W:
− 10 L bioreactor
rpm range 20 … 2000 1/min
rpm range 20 … 2000 1/min
rpm range 20 … 1500 1/min
rpm range 20 … 800 1/min
rpm range 20 … 1200 1/min
Ambient Conditions
Installation location:
Ambient temperatures of
between [°C]:
Relative humidity [%]:
Impurities:
Acoustic emission [dB (A)]:
Conventional laboratory rooms,
max. 2,000 m above sea level
5 – 40
<80% for temperatures up to 31 °C (87.8°F), decreasing
linearly < 50% at 40 °C (104°F)
Pollution degree 2 (Normally only non-conductive
pollution occurs. Occasionally, however, temporary
conductivity caused by condensation must be
expected.)
max. sound pressure level < 70
Appendix
253
19.3 Additional Documentation
− In addition to this operating manual, you can find all necessary technical
documentation about the bioreactors in the folder “Overall documentation”.
− You can find the spare parts list in the “Overall documentation” folder.
− If customer-specific modifications were implemented, the appropriate documents
can either be integrated into the “Overall documentation” folder or they can be
delivered together with the bioreactor as separate documents.
19.4 EC Declaration of Conformity
− With the attached declaration of conformity, Sartorius Stedim Systems GmbH
confirms the compliance of the BIOSTAT® B-DCU II bioreactor with the directives
cited.
19.5 Decontamination Declaration
− Observe the form in the “Overall documentation” folder for the “Declaration
concerning the Decontamination and Cleaning of Equipment and Components
(for Returning Parts)”.
− When returning equipment, copy and carefully complete this pre-printed form as
required, and enclose it with the delivery documents.
The recipient must be able to inspect the completed declaration before removing the
device from the packaging.
19.6 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.
254
Appendix
Appendix
255
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 specify exactly the biological,
chemical, or radioactive contaminant
Attention: Please describe the cleaning and
decontamination procedure | method.
The equipment was contaminated with:
and it has been cleaned and decontaminated by
Legally binding declaration
I (we) certify that all information given in this form is correct and complete. The equipment and components have
been adequately decontaminated and cleaned according to the legal requirements. No chemical or biological or
radioactive risks remain that could endanger exposed persons’ safety or health.
Company | Institute:
Address | country:
Tel.:
Name of authorized person:
Position:
Date | Signature
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
256
Appendix
Fax:
Sartorius Stedim Systems GmbH
Service Department
Robert-Bosch-Str. 5–7
34302 Guxhagen
Germany
Sartorius Stedim Systems GmbH
Robert-Bosch-Str. 5–7
34302 Guxhagen, Germany
Phone +49.5665.407.0
Fax +49.5665.407.2200
www.sartorius-stedim.com
Copyright by
Sartorius Stedim Systems GmbH
Guxhagen, 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
Stedim Systems GmbH.
All rights reserved by Sartorius
Stedim Systems GmbH in accordance with copyright laws.
The information and figures
contained in these instructions
correspond to the version date
specified below. Sartorius Stedim
Systems GmbH reserves the right
to make changes to the technology,
features, specifications and design
of the equipment without notice.
Date:
Januar 2014
Sartorius Stedim Systems GmbH
Guxhagen, Germany
Printed in the EU on paper bleached
without chlorine. | W
Publication No.: SBT6026-e140101
Ver. 01 | 2014