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85037-552-79

Operating Manual

SARTOFLOW® SmartCrossflow Filtration System

Operating Manual SARTOFLOW® Smart 3

Contents

Contents

1 About this Document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61.2 Validity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61.3 Accompanying Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71.4 Target Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71.5 Symbols Used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

2 Safety Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92.1 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92.2 Personnel Qualification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92.3 Safety Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92.4 Electrical Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92.5 Energy Release . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102.6 Accessories, Consumables and Spare Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102.7 Media . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102.8 Pressurized Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112.9 Leaking Fluids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112.10 Heavy Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112.11 Unintentional or Unexpected Starting of the Device . . . . . . . . . . . . . . . . . . . . . . . 112.12 Rotating or Moving Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112.13 Conduct in an Emergency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122.14 Personal Protective Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

3 Device Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133.1 Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

3.1.1 Default Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133.1.2 Configuration 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143.1.3 Configuration 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153.1.4 Configuration 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

3.2 Device Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173.2.1 Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173.2.2 Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183.2.3 Filtration System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

3.3 Recirculation Tank . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203.3.1 Recirculation Tank. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203.3.2 Recirculation Bag. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

3.4 Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223.4.1 Sartocon® Slice 200. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223.4.2 Sartocon® Slice 50 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

3.5 Sartorius Permeate Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243.6 External Peristaltic Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 253.7 Functionality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 263.8 Safety Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

3.8.1 Main Switch and Power Disconnect. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283.9 Manufacturer’s ID Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

4 Operating Design. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 304.1 Software Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 304.2 User Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 304.3 System Start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 304.4 User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 314.5 Functional Areas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

4.5.1 Functional Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 334.5.2 Selection Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 334.5.3 Direct Function Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

4 Operating Manual SARTOFLOW® Smart

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4.6 Functional Area “Main” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 354.7 Functional Area “Calibration”. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 364.8 Functional Area “Phase” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 374.9 Functional Area “Trend” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 384.10 Functional Area “Settings”. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

4.10.1 System Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 404.10.2 Setting the Measuring Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 414.10.3 User Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 424.10.4 Manual Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

4.11 Alarm Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 434.12 User Login. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 444.13 Remote Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 444.14 Configuring a Process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

4.14.1 Setting Setpoints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 454.14.2 Setting the Controller Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 464.14.3 Setting the Alarm Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 474.14.4 Calibrate the Peristaltic Pump. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 484.14.5 Configure Phase Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 504.14.6 Starting and Stopping a Phase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

4.15 Password Protection of Individual Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 524.16 Error Handling and Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 524.17 Locking Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

5 Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 535.1 Monitor Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 535.2 Carrying out Internal Transport. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 535.3 Use Transportation Aids. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

6 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 556.1 Scope of Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 556.2 Prerequisites for Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

6.2.1 Installation Site. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 556.3 Unpacking the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 566.4 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

6.4.1 Setting Up the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 566.4.2 Mounting the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 576.4.3 Connect DCU-4 Control Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 576.4.4 Setting Up the Recirculation Tank . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 586.4.5 Setting Up the Recirculation Bag (Optional) . . . . . . . . . . . . . . . . . . . . . . . . 596.4.6 Setting Up the Filter System Sartocon® Slice 200 . . . . . . . . . . . . . . . . . . . 606.4.7 Setting Up Sartocon® Slice 50 (Optional) Filter System . . . . . . . . . . . . . 616.4.8 Mounting the Bag Holder on the Permeate Scale . . . . . . . . . . . . . . . . . . 626.4.9 Setting Up SARTOFLOW® Smart Tubing Set . . . . . . . . . . . . . . . . . . . . . . . . . 63

6.5 Setting Up Optional Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 666.5.1 Setting Up the Sensor Holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 666.5.2 Installing the Sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 676.5.3 Connect the Peristaltic Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

7 Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 707.1 Check Tubing Connections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 707.2 Insert Tubing into the Peristaltic Pump. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 707.3 Checking Filtration Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 707.4 Turning the Device On and Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

7.4.1 Switching On the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 717.4.2 Switching Off the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

7.5 Performing a Function Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72


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8 Cleaning and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 738.1 Preparing to Perform Cleaning and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . 738.2 Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

8.2.1 Environmental Protection Regulations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 738.2.2 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

8.3 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

9 Faults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 759.1 Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 759.2 Hardware-related Faults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 759.3 Process-related Faults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

10 Storage and Shipping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7710.1 Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7710.2 Shipping-related Tasks | Return . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

11 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7811.1 General Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7811.2 Hazardous Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7911.3 Decommissioning the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7911.4 Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7911.5 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

12 Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8012.1 Dimensions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8012.2 Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8012.3 Ambient Conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8112.4 DCU-4 Control Unit Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8112.5 Filtration System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8212.6 Filter Holders. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8212.7 ATEX. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8212.8 Lifespan of Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

13 Accessories, Consumables, Spare Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8313.1 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8313.2 Consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

13.2.1 Sterile Recirculation Bags for Liquids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8313.2.2 Permeate Bag. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8313.2.3 Sartocon® Slice 200 Filter Cassettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8313.2.4 Sartocon® Slice 50 Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8413.2.5 Hydrosart® Ultrafiltration Cassettes Sartocon®-ECO. . . . . . . . . . . . . . . . . 8413.2.6 Filter Cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84

13.3 Spare Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85

14 Conformity & Licenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8614.1 EC Declaration of Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8614.2 UL Approval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8614.3 Licensing Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

14.3.1 GNU Licensing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

15 Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8915.1 Sartorius Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8915.2 Decontamination Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

16 Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91


About this Document

1 About this Document

1.1 Introduction

This manual provides all the information necessary for operation of the SARTOFLOW® Smart (hereinafter referred to as the device).

The instructions must be read, understood and used by all personnel using the device.

t Before working with the device: Read the instructions carefully and completely. t Keep them in a safe and easily accessible place near the device's site of installation. These instructions are part of the device.

t If the instructions are lost: Request a replacement or download the latest instructions from our website.

Masculine or feminine forms are used to facilitate legibility in these instructions and always simultaneously denote the other gender as well.

1.2 Validity

This manual applies to the SARTOFLOW® in the following versions:

Device Type

SARTOFLOW® Smart

This manual applies to the SARTOFLOW® Smart in combination with the following components:

Component Type

Recirculation tank Recirculation tank, recirculation bag

FLEXBOY® 150 ml | 500 ml | 1000 ml

Filter holders Sartocon® Slice 200

Sartocon® Slice 50

Hydrosart® ultrafiltration cartridges Sartocon® Slice 50 | 200

PESU ultrafiltration cartridges Sartocon® Slice 50 | 200

Hydrosart® ultrafiltration cartridges Sartocon® ECO

Sartorius Permeate Scale

Permeate bag holder

Permeate bag FLEXBOY® 3000 ml


About this Document

1.3 Accompanying Documents

This manual contains the instructions for operating the device with the standard equipment intended for this purpose.

t In addition to this manual, observe the following documents: − Filter holder Sartocon® Slice 200 | Sartocon® Slice 50 − Bag holder for recirculation bags − Permeate bag holder for SARTOFLOW® Smart permeate bag − Filtration cartridges datasheets − Sensor data sheets (pH sensor, conductivity sensor, temperature sensor) − Peristaltic pump BF200-KZ15 − Sartorius Permeate Scale − Assembly instructions for SARTOFLOW® Smart tubing set − Importing | exporting parameters in DCU4 systems

1.4 Target Groups

These instructions are designed for the following target groups. The target groups must possess the knowledge listed.

Target group Knowledge | responsibilities

Operator The operator is familiar with the operation of the device and the associated work processes. He knows the dangers that can occur when working with the device and can avoid these dangers.The operator has been trained in the operation of the device. The training takes place within the scope of startup and is carried out by the operating engineer | laboratory manager or the operator of the device.

Operating engineer | laboratory manager

The operating engineer | laboratory manager makes decisions about the use and parameterization of the device. The operating engineer | laboratory manager is trained in the operation of the device. The training takes places within the scope of startup and is performed by Sartorius Service or the operator.

Administrator The administrator is responsible for integrating the device in the production process. He ensures the reliable functioning of the system and device software.The administrator is trained in the operation of the device. The training takes places within the scope of startup and is performed by Sartorius Service or the operator.

Electrician A qualified electrician who has the specialized training, knowledge and experience as well as familiarity with applicable standards to evaluate the work assigned to him or her and identify possible hazards.

Operator The operator of the device is responsible for compliance with safety requirements and workplace safety regulations. The operator must ensure that all persons who work with the device have access to the relevant information and have been instructed in work with the device.


About this Document

1.5 Symbols Used

As instruction and direct warning of danger, all text statements in these operating instructions to be particularly noted will be marked as follows:

WARNINGThis symbol denotes a possible danger with medium risk that death or (severe) injury may result if it is not avoided.

CAUTIONThis symbol denotes a possible danger with a low risk that moderate or minor injury may result if it is not avoided.

ATTENTIONThis symbol denotes a danger with low risk of damage to property if not avoided.

The following means of representation are also used:

t Required action: Describes activities that must be performed in the given order.

y Describes the result of the activities carried out.

– Item in a list.

[ ] Text inside brackets refers to control and display elements.

Figures on the Operating Display Depending on your device configuration, the figures on the operating display of your device may deviate from those in these instructions.


Safety Notes

2 Safety Notes

2.1 Intended Use

The device is a manually operated benchtop crossflow system that may only be used for industrial and commercial purposes as well as for teaching and research facilities.

The device is used to filter media. The device is designed to accommodate Sartorius Sartocon® Slice cassettes.

The device is not suitable for use in explosive environments.

The device may only be used indoors.

These instructions are part of the device. The device is intended exclusively for use in accordance with these instructions.

Foreseeable MisuseAny use beyond the intended use of the device can cause severe unforeseeable hazards and is the sole responsibility of the operator.

The following uses, for example, are deemed to be improper:

− Operation outside the permissible ambient conditions, e.g. extreme temperatures, chemical vapors, moisture, shock, vibration or strong electromagnetic fields

− Carrying out unauthorized modifications or other technical changes on the device

− Connecting unsuitable devices − Installation of unauthorized items on the device − Use of flammable or potentially explosive substances − Carrying out processes using biological materials in Safety Classes 3 and 4

2.2 Personnel Qualification

All persons working on the device must possess the necessary knowledge (see Chapter "1.4 Target Groups", page 7).

The activities described in these instructions are aimed at the target group of operators. If individual actions must be carried out by other target groups, this will be indicated.

2.3 Safety Equipment

The device’s safety equipment must not be dismantled or modified. The safety equipment is described in Chapter 3.8, page 28.

2.4 Electrical Power

Electrical switching elements are installed in the device. Damage to the insulation or individual components can be life-threatening. Contact with parts under voltage represents a direct danger of death.

Work on and modifications to the electrical equipment of the device may only be carried out by Sartorius Service personnel. The device may only be opened by Sartorius Service personnel.

t Check the device regularly for defects, such as loose connections or damage to the insulation. The device's housing, power cord and all connections must be undamaged.

t Note the device’s protection class (IP rating). The protection class specifies the


Safety Notes

suitability of equipment for various ambient conditions, e.g. moisture or foreign bodies (see Chapter "12 Technical Specifications", page 80).

t Make sure that the power connection is equipped with a ground lead. t Do not use inadequately sized power cords. t Keep live parts away from moisture. Moisture can cause short circuits. t If the electrical equipment is defective, immediately turn off the power supply and contact the Sartorius Service.

2.5 Energy Release

Energy supply lines may be incorrectly dimensioned and not protected against impermissible fluctuations and faults. This may cause an electric shock.

The power supplies used to operate the device must be designed in accordance with the technical data (see Chapter 12.4, page 81). The earth leakage circuit breaker for mains connections (ground fault circuit interrupter) must be present and functioning:

2.6 Accessories, Consumables and Spare Parts

The use of unsuitable accessories, consumables and spare parts can be hazardous and have the following consequences:

− Damage to the device − Malfunctions of the device − Device failure

t You should only use accessories, consumables and spare parts supplied by Sartorius. Information on operational quality is available upon request from Sartorius.

t Only use accessories, consumables and spare parts that are in technically perfect condition.

The use of accessories, consumables and spare parts not approved by Sartorius is the sole responsibility of the operator.

2.7 Media

The media used in the process can be dangerous and cause personal injury or damage the equipment.

t Observe the applicable safety and occupational health and safety information for the media, e.g. handling and storage and conduct in emergency situations.

t Wear personal protective equipment. t If required: Install additional safeguards, e.g. splashguards. t Only use media suitable for the device (see Chapter "2.1 Intended Use", page 9).

Using aggressive media may carry the danger of chemical burns.

t Wear personal protective equipment.


Safety Notes

2.8 Pressurized Components

Bursting of the Filtration CircuitIf the filtration circuit is subjected to too much pressure, the filtrate lines and hoses can burst, e.g. when hand-operated control valves are closed or filter cartridges blocked.

t Only personnel familiar with the crossflow system may carry out the filtration processes.

Bursting of the Recirculation TankWhen the recirculation tank is overfilled, the recirculation tank may burst if the system is closed, e.g. if the exhaust filter is blocked.

t Use the prescribed tubing. t Wear personal protective equipment.

Bursting of the Recirculation BagIf the recirculation bag is overfilled, it may burst in a closed system.

t Use the prescribed tubing. t Wear personal protective equipment.

2.9 Leaking Fluids

If the filtration circuit is leaking, liquid can spill on the floor and cause a slipping hazard.

t Wear personal protective equipment. t Check the connections of the filtration circuit for leaks.

2.10 Heavy Components

Components may fall down during maintenance, e.g. when replacing the filter cartridge of the filter holder.

t Only personnel familiar with the relevant procedures may carry out installation work.

2.11 Unintentional or Unexpected Starting of the Device

Depending on the DCU control unit settings, the device may start again automatically with the configured parameters after a power failure.

t Note the details on the behavior of the device after a power failure (see Chapter "4.3 System Start", page 30).

2.12 Rotating or Moving Parts

Crushing of Body PartsBody parts can be crushed when they come into contact with rotating or moving parts, e.g. the pump wheel of the peristaltic pump. This can lead to injuries.

t Only personnel familiar with the relevant procedures may carry out work on the peristaltic pump.


Safety Notes

t Turn off the peristaltic pump before opening the peristaltic pump cover.

2.13 Conduct in an Emergency

Malfunctions may result in injury or property damage. If there is immediate danger of personal injury or equipment damage, take the device out of operation immediately:

t Turn main switch | mains power disconnect I | O to the position [O]. t Have any malfunctions repaired immediately by the Sartorius Service.

2.14 Personal Protective Equipment

Personal protective equipment to protect against risks arising from the equipment or the material being processed.

Protective equipment designation

Explanation | Examples

Protective work clothing

Tight-fitting work clothing with low tear resistance, tight sleeves and without any projecting parts. | Protects against being caught by moving parts.

Head covering Protects hair from being pulled into moving parts.

Safety gloves Protect against chemicals, heat and injuries.

Safety glasses Protects against substances leaking under high pressure, splashing liquids.

Safety boots | non-slip shoes

Protect against injuries to the feet caused by mechanical effects. | Protect against slipping on wet surfaces.

t Wear appropriate personal protective equipment. t Also follow any instructions posted in the work area pertaining to personal protective equipment.

MainsI|O

MainsI|O


Device Description

3 Device Description

3.1 Configurations

Configuration Recirculation tank Filter

Default configuration Recirculation tank Sartocon® Slice 200

Configuration 1 (optional) Recirculation tank Sartocon® Slice 50

Configuration 2 (optional) Recirculation bag Sartocon® Slice 200

Configuration 3 (optional) Recirculation bag Sartocon® Slice 50

3.1.1 Default Configuration

1

5

34

7

6

2

Fig. 3-1: Default configuration

No. Description

1 Permeate bag (optional)

2 Filter holder with Sartocon® Slice 200 Crossflow cassette

3 Permeate bag holder (optional)

4 Sartorius Permeate Scale

5 Recirculation tank

6 DCU-4 control unit

7 Control panel


Device Description

3.1.2 Configuration 1

1

5

34

7

6

2

Fig. 3-2: Configuration recirculation tank, Sartocon® Slice 50 filter

No. Description


2 Filter holder with Sartocon® Slice 50 filter




6 Control panel



Device Description


1

534

8

7

2

6

Fig. 3-3: Configuration recirculation bag, Sartocon® Slice 200 filter

No. Description


2 Filter holder with Sartocon® Slice 200 Crossflow cassette



5 Bag holder for Crossflow bags

6 Recirculation bag

7 Control panel



Device Description


1

534

8

7

2

6

Fig. 3-4: Configuration recirculation bag, Sartocon® Slice 50 filter

No. Description


2 Filter holder Sartocon® Slice 50 filter



5 Bag holder for Crossflow bags

6 Recirculation bag

7 Control panel



Device Description

3.2 Device Overview

In the following sections, the device is shown in its default configuration.

3.2.1 Front View

3

4

5

7

9

1 2

8

6

Fig. 3-5: Front view

No. Description

1 USB port, import | export parameters and authentication data

2 Filter holder with filter cartridge

3 Permeate bag holder with permeate bag (optional)

4 System rail for filter holder


6 System rail for sensor holder


8 DCU control unit

9 Main switch and power disconnect


Device Description

3.2.2 Connections

1 3 4 5 6 8 9 1072 11

Fig. 3-6: Connections

No. Description Description

on the device

on the opera-tor screen

1 Sartorius permeate scale mains connection

2 Control signal to DCU control unit

3 Ext. In QIR2000 Control signal to Sartorius permeate scale

4 Serial A WIR2700 External signal port

5 Ethernet Network port

6 ComAl COM alarm terminal

7 Mains Power connection, fuses

8 Equipotential bonding terminal

9 pH/Cond QIR2101 pH sensor terminal

QIR2100 Conductivity sensor terminal

10 Temp TIR2100 Temperature sensor terminal

11 Ext. Pump P3000 Control signal to external peristaltic pump


Device Description

3.2.3 Filtration System

8

421

14 13 12 11 10

3

9

15

75 6

Fig. 3-7: Filtration system

No. Description

1 Retentate tubing

2 Feed hose

3 Supply media hand-operated control valve

4 Retentate hand-operated control valve

5 Retentate pressure sensor

6 Filter holder with filter cartridge

7 Permeate bag

8 Permeate hose

9 Permeate hand-operated control valve

10 Drain tubing

11 Permeate pressure sensor

12 Feed pressure sensor

13 4-piston diaphragm pump

14 Feed tubing



Device Description

3.3 Recirculation Tank

The recirculation tank is used to provide the medium for the filtration process and to receive the retentate.

3.3.1 Recirculation Tank

3

26

5

4

17

8

Fig. 3-8: Recirculation Tank

No. Description

1 Retentate inlet

2 Port for venting

3 Feed outlet

4 Device base with load cell and magnetic stirrer


6 Tank lid with ports

7 Port feed hose

8 Adapter for the pH sensor, temperature sensor or conductivity sensor


Device Description

3.3.2 Recirculation Bag

9

7

6

4

2

35

8 1

Fig. 3-9: Recirculation bag

No. Description

1 Bag holder fixture

2 Retentate inlet

3 Feed outlet

4 Device base with load cell and magnetic stirrer

5 Bag holder base plate

6 Diaphragm and reserve port

7 Recirculation bag

8 Bag holder locking lever

9 Bag holder system rail


Device Description

3.4 Filter

The filter is used for filtration of the medium in permeate and retentate.

3.4.1 Sartocon® Slice 200

8

1 2

5

7 6

3

4

Fig. 3-10: Filter holder with Sartocon® Slice 200 filter cartridge

No. Description

1 Retentate outlet

2 Product plate

3 Clamping nut

4 Filter cartridge

5 Clamping nut

6 Base plate

7 Permeate outlet

8 Feed input


Device Description

3.4.2 Sartocon® Slice 50

2

5

4

1

3

1

Fig. 3-11: Filter holder Sartocon® Slice 50 filter

No. Description

1 Permeate outlet

2 Filter

3 Retentate outlet

4 Filter holders

5 Feed input


Device Description

3.5 Sartorius Permeate Scale

The Sartorius permeate scale is used to weigh the permeate.

6

3

4

72

1

5

Fig. 3-12: Sartorius permeate scale

No. Description

1 Bag holder fixture

2 Retentate inlet

3 Permeate bag

4 Bag holder base plate


6 Permeate inlet

7 Bag holder locking lever


Device Description

3.6 External Peristaltic Pump

The external peristaltic pump is used for conveying the medium and the diafiltration buffer solution in the recirculation tank.

4 5

1 32

Fig. 3-13: External peristaltic pump

No. Description

1 Drive

2 Operation display

3 Peristaltic pump

4 Mains connection

5 Control signal


Device Description

3.7 Functionality

Media Flows

1

2

5

4

1

5

4

3

4

Fig. 3-14: Media flows

No. Symbol Filtration section Description

# Fluid direction of the medium

1 Retentate

2 Product supply

3 Product harvesting and purification

4 Permeate

5 Feed


Device Description

ConcentrationThe medium is pumped from the recirculation tank through the feed line to the filter. The substances passing through the filter are channeled through the permeate outlets of the filter into a collection vessel or a permeate bag.

The substances retained in the filter are pumped back through the retentate line into the recirculation tank. The medium is concentrated in the recirculation tank.

When the recirculation tank is used as a recirculation tank, a magnetic stirrer ensures the medium is mixed. The concentrate is located in the recirculation tank.

FiltrationThe medium is pumped from the recirculation tank through the feed line to the filter. The substances retained in the filter are pumped back through the retentate line into the recirculation tank.

If necessary, a diafiltration buffer is added to the medium in the recirculation tank. The diafiltration buffer is pumped through the addition tube into the recirculation tank with a peristaltic pump. The amount of the diafiltration buffer supplied and the fill level of recirculation tank is controlled by a load cell.

When the recirculation tank is used as a recirculation tank, a magnetic stirrer ensures the medium is mixed.

The substances passing through the filter are channeled through the permeate lines to the permeate outlets of the filter into a collection vessel or a permeate bag. The filtrate is located in the permeate bag.

Process Phase CombinationsThe concentration and filtration can be run in different phase combinations, if required:

− Concentration - diafiltration - concentration:In the 1st phase, the medium is concentrated to the predefined volume.In the 2nd phase, the medium in the diafiltration process is filtered.In the 3rd phase, the medium is concentrated to the final dimensions.

− Concentration:The medium is concentrated to the predefined final dimensions.

− Diafiltration - concentration:The medium is filtered in the diafiltration process in the 1st phase.In the 2nd phase, the medium is concentrated to the predefined final dimensions.

When the selected phase combination is complete, the concentrated medium is in the recirculation tank and can be harvested.

Monitoring of Process PhasesTo monitor the process phases of a pH sensor, a temperature sensor or a conductivity sensor can be used. The sensor measures the corresponding measured variables in the recirculation tank. The measurement data of the corresponding measured variables are transmitted to the DCU-4 control unit and are used to control the process.

The filling, harvesting and cleaning phase is started at the DCU-4 control unit.


Device Description

3.8 Safety Equipment

3.8.1 Main Switch and Power Disconnect

The main switch switches the device on and off. The main switch also serves as a power disconnect.

1

Fig. 3-15: Main switch | power disconnect


1 Mains I/O Main switch | power disconnect


Device Description

3.9 Manufacturer’s ID Label

The manufacturer’s ID label identifies the device and lists electrical performance data.

1

2

3

4

5

Fig. 3-16: Manufacturer’s ID Label


1 Type Device type

2 Year | No. Year of manufacture | serial number

3 V Connected voltage

4 A Bus load

5 Hz Voltage frequency


Operating Design

4 Operating Design

4.1 Software Description

The DCU system of the device is based on the digital measurement and control system DCU-4 for data acquisition and control of filtration processes. The control software is installed in the device. The device is operated using the 7" operating display. The phase control of filtration processes is carried out using the interactive user guidance on the control display.

4.2 User Information

ATTENTIONDanger of damage to the device due to incorrect handling! t Before switching on the device: Read through Chapter “7 Startup”, page 70. t Do not use sharp objects (e.g. pens) to operate the operator display. t System settings may only be configured by system administrators, authorized and trained users.

This operating manual shows operating values and settings that are default values and examples. Only if explicitly specified as such will they show settings for a specific filtration process.

Information about the settings that are permitted and the specifications for a customer system can be found in the configuration documentation.

4.3 System Start

The DCU system is switched on by flipping the main switch [Mains I / O] of the control unit.

After powering 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. − All controllers are turned [off], and actuators (pumps, valves) are in the rest

position.

Operating InterruptionsFor interruptions in operation, the startup behavior of outputs and system functions that have a direct effect on the associated end unit (controllers, timers, etc.) depends on the duration of the interruption (turning the device off | on at the main switch of the control unit).

A maximum duration for network interruptions - during which data are retained - can be set in the DCU system (see Chapter “4.10.1 System Settings”, page 40).


Operating Design

4.4 User Interface

The user interface is divided into 3 sections:

− Header − Working environment − Footer

Header

In addition to the device name, the following information is displayed in the header line:

− User logged in − Date, time:

− Date in format [yyyy-mm-dd] − Time in format [hh:mm:ss]

Working Environment

Fig. 4-1: Working environment

The working environment is a schematic representation of the functional elements of the controlled device. Functional elements are e.g. the recirculation tank, the filter, the product or filtrate lines, the controllers and sensors.

In the working environment, the following process values, setpoints and parameters of control cycles are displayed:

− Preselected process values with current measured values or setpoints − Pumps with process values, e.g. flow rates or metering volumes − Controllers, e.g. for temperature, pressure and agitator with current setpoints − Sensors for temperature and pH with measured values − Measuring instruments for pressure, weight and volume with measurement

values

Footer

The functional areas are selected in the footer.


Operating Design

4.5 Functional Areas

The DCU system is operated directly on the display by selecting a functional area. Pressing the functional element in the functional area activates assigned controller menus. In active controller menus, data and setpoints can be entered and operating modes can be selected.

Available functions, tag names, parameters and menus will depend on the configura-tion used.

Functional area Symbol Description

[Main] Configuration of the filtration system:

− Display of the current configuration

− Overview of the measured variables, process and alarm parameters

− Setting the controller parameters

[Calibration] Calibration of the following functional elements:

− Load cell

− Permeate scale

− Pressure sensors (feed, retentate, permeate section)

− pH sensor

− External peristaltic pump

[Phases] Process control of the preconfigured phases

[Trend] Trend display for chronological representation of the phases

[Settings] Configuring system parameters and system settings

[User] User login

[Remote] Activation and deactivation of remote control

[Alarm] Managing alarm messages

Functional areas can be selected at any time during a running process.

Functional area is selected and is displayed in the workspaceSettings can be made via the respective functional elements

Functional area is not selected and is not displayed in the workspace


Operating Design

4.5.1 Functional Elements

Functional element Symbol Description

Tag [PV] Field for short name “Tag” of the functional element (e.g. TIR2100, PIR2700)

MV [Unit] Field for measured or set value in its physical units (e.g. °C, bar)

Button with gray underline

Tag [PV]MV [Unit]

Measured value collection or output of the functional element is not active;Measured value or set value, as indicated;Menu or function selectable by pressing

Button with green underline

Tag [PV]MV [Unit]

Measured value collection or output of the functional element is active;Measured value or set value, as indicated;Menu or function selectable by pressing

Button with light green underline

Tag [PV]MV [Unit]

Measured value collection or output of the functional element is dependent on a configured setpoint and active; measured value or set value, as indicated;Menu or function selectable by pressing

Button with yellow underline

Tag [PV]MV [Unit]

Display of function if in “Manual” mode; (switched “on” or “off”);Automatic control not possible;Menu or function selectable by pressing

Button with a flashing triangle

Tag [PV]MV [Unit]

Display of the function when the set alarm value is reached;Alarm message is displayed;Menu or function selectable by pressing

Diaphragm pumpPeristaltic pump

MV [%]

Diaphragm pump | peristaltic pump off;Pump capacity is displayed as a percentage;Menu or function selectable by pressing

Diaphragm pumpPeristaltic pump

MV [%]

Diaphragm pump | peristaltic pump on;Pump capacity is displayed as a percentage;Menu or function selectable by pressing

4.5.2 Selection Keys

Selection key Symbol Description

Cancel Entry is canceledChanges are not savedEntry window is closed

Confirmationok

Input is confirmedInputs and changes take effectEntry window is closed

CancelC

Entry is canceledChanges are not savedInput window remains open

DeleteBS

Last entered character is deleted

Plus or minus sign+/-

Sign for the input value is selected


Operating Design

4.5.3 Direct Function Keys

Functional elements in the functional areas “Main” and “Phase” may contain direct function keys, which can be used to directly call up menus to important functions.

Direct function key Symbol Description

Alarm parameterAlarms

Param.

Setting the alarm parameters

Profile parametersProfile

Param

Setting the profile parameters

SetpointSetpoint

Entering the setpoint

Controller parameters%

Password-protected setting range of the PID controller

Controller optionsoff

Controller is disabled

auto

Controller is regulated by the setpoint

manual

Controller is manually regulated


Operating Design

4.6 Functional Area “Main”

Fig. 4-2: Functional Area “Main”

Module Description Description

Load cell WIRC2100 Setting the controller parameters and the alarm limits of the weight of the recirculation tank

Magnetic stirrer AG2100 Setting the controller parameters and alarm limits for magnetic stirrer speed

Configuration pH sensor

QIR2101 Setting the alarm limits of the pH value for the medium in the recirculation tank

Conductivity sensor configuration

QIR2100 Setting the alarm limits of the conductivity value for the medium in the recirculation tank

Temperature sensor TIR2100 Setting the alarm limits of the temperature for the medium in the recirculation tank

Peristaltic pump P3000_T Setting the alarm limits of the pumped supply mediumDisplay of pump capacity

4-piston diaphragm pump

P2500 Setting the controller parameters and alarm limitsDisplay of pump capacity

Pressure sensors

Feed section pressure sensor

PIRC2500 Setting the controller parameters and alarm limits of the pressure sensor

Retentate section pressure sensor

PIR2600 Setting the alarm limits of the pressure sensor

Permeate section pressure sensor

PIR2700 Setting the alarm limits of the pressure sensor

Differential pressure

DPRESS

Differential pressure

TMP

Taring Press Taring of pressure sensors

Permeate scale WIR2700 Setting the alarm limits of the weight of the permeate bag

F-PERM Permeate flow rate

Taring Weight Taring of the permeate scale


Operating Design

4.7 Functional Area “Calibration”

Fig. 4-3: Functional area “Calibration”

Module Description Description

Peristaltic pump P3000_T Calibrating the peristaltic pump

Configuration pH sensor

QIR2101 Calibrating the pH Sensor

Conductivity sensor configuration

QIR2100 Calibrating the conductivity sensor

Load cell WIRC2100 Taring the load cell

4-piston diaphragm pump

P2500 Display of pump capacity

Pressure sensors

Feed section pressure sensor

PIRC2500 Calibrating the pressure sensor

Retentate section pressure sensor

PIR2600 Calibrating the pressure sensor

Permeate section pressure sensor

PIR2700 Calibrating the pressure sensor

Permeate scale WIR2700 Taring of the permeate scale


Operating Design

4.8 Functional Area “Phase”

Fig. 4-4: Functional area “Phase”

Field Description Description

Actual values Setting alarm limits

Pressure PIRC2500 Feed section pressure sensor

PIR2600 Retentate section pressure sensor

PIR2700 Permeate section pressure sensor

DPRESS Differential pressure

TMP Differential pressure

Weight WIRC2100 Load cell

WIRC2700 Permeate scale

F-PERM Permeate flow rate

Ext. signal QIR2000 Magnetic stirrer

COND QIR2100 Conductivity (configuration with conductivity sensor)

pH QIR2101 pH value (pH sensor configuration)

Temp. TIR2100 Temperature sensor

Controllers Setting the controllers

Level controller WIRC2100 Load cell

P3000 Peristaltic pump capacity

P3000_T Peristaltic pump parameters

Stirrer AG2100 Magnetic stirrer

Feed pump controller PIRC2500 Feed section

P2500 Feed section pump capacity

DPRESS Differential pressure

Phases Preconfigured phase menu

Con-Di-Con Used for concentration of the product to a predefined degree and subsequent diafiltration of the product. Concentration to the final dimensions follows.

Conc Used to concentrate the product to a predefined final dimension.


Operating Design

Field Description Description

Diafi-Con Diafiltration of the product. At the end of this phase, the product is concentrated to a predefined volume.

Manual Con The product is concentrated to a pre-defined volume or diafiltered without the use of the peristaltic pump. The settings are made manually.

Flushing Used for cleaning the permeate line. During cleaning, the pipelines are rinsed with WFI, acidic or alkaline solutions.

Drain | harv Used for draining or harvesting of the product out of the system.

Filling Used for filling the tank or bag with the product.

Tare Taring

Weight Permeate scale

Press Pressure sensors

4.9 Functional Area “Trend”

Fig. 4-5: Functional area “Trend”

Field Value Description

Channels Configuring the channels

PIRC2500 -1 - 4 Feed section

PIRC2600 -1 - 4 Retentate section

PIR2700 -1 - 4 Permeate section

TIR2100 0 - 150 Temperature in the recirculation tank

QIR2100 2 - 12 Conductivity value in the recirculation tank

Diagram Line diagram of the selected channels (y-axis) over time (x-axis)

Upper 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


Operating Design

4.10 Functional Area “Settings”

Fig. 4-6: Functional area “Settings”

Field Description

System parameters General System settings1

PV ranges Settings of the measuring ranges for process values1

Users Settings for user management

Service Service and diagnostic interventions2

Manual operation Process inputs and outputs to manual operation1

User parameters Activate additional functions for importing | exporting parameters and user authentication data(see Chapter “1.3 Accompanying Documents”, page 7).

USB no media No USB stick inserted | detected.

USB eject Eject USB stick (only displayed if USB stickhas been inserted).

USB ejecting... USB stick is being ejected.

Hardware: Version of the DCU hardware

Firmware: Firmware of the software

Configuration: Version of the configuration

1 The default password must be entered to open the menu(see Chapter “4.15 Password Protection of Individual Functions”, page 52).

2 This operation level is only accessible by the Sartorius Service.


Operating Design

4.10.1 System Settings

Using the “System Parameters” function, general system settings such as setting the RTC be configured on the DCU system.


Time hh:mm:ss Display of the time (can only be changed immediately after startup)

Date dd.mm.yyyy Display of the date (can only be changed immediately after startup)

Fail time hh:mm:ss 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 is put in the default state

Standard password 19 See Chapter “4.15 Password Protection of Individual Functions”, page 52

Time synchronize on | off Time synchronization (if integrated in a network)

Beeper enabled | disabled

Alarm message acoustic signal

Screensaver hh:mm Enter the time of inactivity after which the screen saver will be turned on (format: 00:00:00 = disabled)

Internet config 12-digit binary number

The DCU system's address in theIP network

Domain 12-digit binary number

IP identifier of the network domain


Operating Design

4.10.2 Setting the Measuring Ranges

Only personnel authorized to do so may change the menu settings.

The beginning and end of the measuring range for all process values can be changed using the “PV Ranges” function. Measuring ranges configured specifically to devices or customer specifications are factory-set in the device [see Configuration Documentation].

Procedure t Press [PV Ranges] and enter the default password. y The “PV Ranges” menu is displayed.

Fig. 4-7: “PV Ranges” Menu

t Select process value: Touch numeric touch button in the column “Ch.”. y The input window for the selected process value is displayed. t Change settings. t Press to save the settings.


Operating Design

4.10.3 User Management

To operate the system, the user must log in.

Using the “Users” function, new user accounts can be created, existing user accounts deleted and permissions can be set for user accounts.

Fig. 4-8: “Users” menu


Edit “#” Editing user profiles

User “#” Numeric user ID (assigned by the system)

Name “User name” User name

Enable “YES” | “NO” Activated | inactivated user profile

Group “level#” Access rights of the user profile

NEW USER Create user profile

GROUPS Create rights profileEdit rights profile

PARAMETERS Set password parameters

Rights of User Groups

Group Rights Login

level3 All rights available. Login with Administrator password required.

level2 Modify parameters and profiles to a certain extent.The extent can be changed by the Administrator.

Login with username and password required.

level1 Only for displaying the parameters.Cannot change any parameters, profiles etc.

Login with username and password required.


Operating Design

4.10.4 Manual Operation

When starting up operations and troubleshooting, all analog and digital process inputs and outputs as well as DCU internal parameters can be switched to manual operation using the “Manual operation” function.

Settings during manual operation have the highest priority; their effects on the inputs and outputs of the DCU system supersede those of other functions.

− You can disconnect inputs from the external signal generators and preset input values to simulate measuring signals.

− You can separate outputs from internal DCU functions and directly influence them in the operator screen, for example to test the effect of certain settings.

4.11 Alarm Messages

The window with the alarm messages appears after pressing [Alarm]. All alarms that occur during the running process are listed in the window.

Alarm StatusWhen alarms are triggered, they automatically are displayed in a window that superimposes all other windows. Additionally, the color of the alarm bell turns red.

The color of the alarm bell is red as long as at least one unconfirmed alarm remains in memory.

Field Description

Time Alarm time (time at which the alarm was triggered)

Message Alarm text (description of the alarm)

State Alarm status (acknowledged | unacknowledged)

[ACK] Acknowledge alarm

[RST] Clear alarm message

[ACK ALL] Clear all alarm messages that occurred


Operating Design

4.12 User Login

Procedure t Press [User].

y The login window “Login” is displayed. t Press “User”. y The screen keyboard is displayed. t Enter the user name and confirm with [Enter]. y The screen keyboard is displayed. t Enter the password and confirm with [Enter]. y The login window “Login” is displayed. t Confirm the registration with [OK]. y The user is logged into the system.

4.13 Remote Control

If you are using MFCS / win or MFCS / DA, remote mode should be enabled for the DCU-4 control unit so that the bidirectional status can be determined. This is the only way to ensure that the remote control of the DCU-4 control unit is functioning properly.

Enable Remote Mode

Procedure t Press [Remote]. y Remote mode is enabled.There is communication between the external control unit and the DCU-4 control unit. Bi-directional control is enabled. The DCU-4 control unit can be remotely controlled.

Disable Remote Mode

Procedure t Press [Remote]. y Remote mode is disabled.There is no communication between the external control unit and the DCU-4 control unit. The operating staff has no access to the DCU-4 control unit from an external control unit (e.g. MFCS / win).


Operating Design

4.14 Configuring a Process

In the following chapters, examples of controller settings and a phase start are given.

4.14.1 Setting Setpoints

Procedure t In the functional area

t “Main”: Press functional element [WIRC2100] (see Fig. 4-2, page 35). t “Phases”: Press functional element [WIRC2100] (see Fig. 4-4, page 37).

y The menu is displayed. t Press [Setpoint] in the menu.

y The input menu is displayed. t Note the permissible value range below the entry field.

t Enter the setpoint using the onscreen keyboard and confirm with [ok].

y The menu is displayed again. In this example, the weight setpoint has been set at 900 g.

ExamplesThe following examples show the controller and alarm limit settings:

Example 1: Overview of the controller menu and alarm limit settingsExample 3: Select controller mode for the load cellExample 4: Enter weight setpoint for the recirculation tank


Operating Design

4.14.2 Setting the Controller Mode



y The menu is displayed. t Press [off] in the menu.

y The selection menu is displayed. t Controller mode

t Select “auto”: Press [auto]. t Select “manual”: Press [manual].

y The menu is displayed again. In this example, the controller mode “auto” has been selected.


Operating Design

4.14.3 Setting the Alarm Values



y The menu is displayed. t Press [Alarms Param.] in the menu.

y The input menu is displayed. t Enter the values for alarm limits “High Limit”, “LowLimit” and the delay times “Delay“.

t Switch on alarm function: Press [Alarm disabled].

y The alarm limits and delay times have been set. y The alarm function is switched on. t Close the input menu: Press .


Operating Design

4.14.4 Calibrate the Peristaltic Pump

Requirements − The container with liquid has been set up. − A glass cylinder with measuring scale is set up. − The tubing is inserted into the external peristaltic pump

(see Chapter “7.2 Insert Tubing into the Peristaltic Pump”, page 70).

Procedure t Select functional area “Calibration”: Press [Calibr.]. t Press functional element [P3000_T]. y The calibration menu is displayed. t Press [Totalize].

y The window for the calibration mode is displayed. t Press [Calibrate].

y The start window is displayed. t Start calibration: Press [ok].


Operating Design

y The peristaltic pump pumps the liquid from the container into the glass cylinder. t If the glass cylinder is filled: Press [ok].

y The Input window is displayed. t Read off the value of the volume in the glass cylinder. t Enter the value and confirm with [ok]. y The peristaltic pump is calibrated.


Operating Design

4.14.5 Configure Phase Parameters

Before starting a phase, the parameters must be checked and adjusted if necessary in the parameters menu. Settings in the parameters menu depend on the selected phase.

ProcedureExample: Phase parameter for the phase “Con-Di-CoP”

t Select functional area “Phases”: Press [Phase]. t In the field “Phases”, select the phase: Press the functional element [Con-Di-CoP]. y The phase menu is displayed. t Display parameter menu: Press [1].

y The input window for the default password is displayed. t Enter the default password “19” and confirm the entry with [ok].

y The parameter menu is displayed. t Check parameter values and adjust if necessary.

t Close the parameter menu: Press .

1


Operating Design

4.14.6 Starting and Stopping a Phase

Starting a Phase

Requirements − The setpoints of the controller and the controller operating modes are set. − The alarm values are set. − The load cell is tared. − The sensors and the peristaltic pump are calibrated. − The phase parameters are checked and adjusted if necessary.

ProcedureExample: Phase “Con-Di-CoP”

t Select functional area “Phases”: Press [Phase]. t In the field “Phases”, select the phase: Press the functional element [Con-Di-CoP]. y The phase menu is displayed. t Start Phase: Press [1].

t In the following window, press [start].

y The window for the phase progress is displayed. t Follow the instructions for the phase progress and confirm each with [ok].

Stopping a Phase

Procedure t Press [State Running] in the window for the phase progress. t In the following window, press [stop]. y The phase is stopped.

1


Operating Design

4.15 Password Protection of Individual Functions

Only disclose this information to authorized users or service staff. If required, remove this page from the manual and keep it in a special place.Certain system functions and settings that should only be accessible for authorized personnel are protected by a password. These include, in the controller menu, the settings for the controller parameters (e.g. PID), in the “Settings” menu:

− Process value setting “PV” − At the manual operation level (“Manual Operation”), the interface parameter

settings for digital and analog process inputs and outputs or for simulation controllers.

The “Service” menu of the “Settings” menu is only accessible via a special service password. This is only disclosed 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:

− Default password (factory-set: 19) − Customer-specific default password1

− Service password

4.16 Error Handling and Troubleshooting

If the DCU system should encounter technical problems, contact Sartorius Service.

4.17 Locking Functions

Locking functions are permanently configured. The user cannot change them. In the “Settings” menu, locked inputs and outputs are highlighted with a colored marking. The extent of the locking functionalities is system-specific and predefined during configuration. This is documented in the configuration lists enclosed with every system.

1 You will receive this information by post or together with the Technical Documentation


Transport

5 Transport

5.1 Monitor Delivery

The device will be delivered by Sartorius Service or by a transport company engaged by Sartorius.

ATTENTIONDamage to the equipment due to weather conditions and mechanical influences!Moisture from rain or snow can damage the device. t To protect against moisture, cover the device with foil. t Do not leave the device outdoors. t Additionally protect the device against bumping, dropping and damage.

Procedure t On acceptance, check the packaging for any visible damage during transport. t Report transport damage immediately to the delivering office and document it.

5.2 Carrying out Internal Transport

The internal transport of the device may only be carried out by technical personnel.

CAUTIONDanger of injury due to improper transport! t Carry out the transport with other people. t Personal protective equipment should be worn. t Transporting a packaged device:

t Use a suitable lifting device. The load capacity of the lifting system must be at least the weight of the device [see Chapter “12.2 Dimensions and Weights”, page 58].

t Once it is on the lifting system, secure the device against falling down. t Always lift the device slowly and carefully to ensure stability and safety. t When transporting, make sure that there are no persons in the transport path.

t Transporting an unpackaged device: t The device should only be transported using the designated carrying handles (see Chapter “5.3 Use Transportation Aids”, page 54).

t Always lift the device slowly and carefully to ensure stability and safety. t When transporting, make sure that there are no persons in the transport path.

ATTENTIONThe device could be damaged by improper transport! t Additionally protect the device against bumping, dropping and damage.


Transport

5.3 Use Transportation Aids

The system rails of the device can be used as transportation aids. The transport handles are located on both sides of the DCU-4 control unit.

1

1

Fig. 5-1: Transport handles

No. Description

1 Transport handles (system rails)


Installation

6 Installation

6.1 Scope of Delivery

The scope of delivery depends on the chosen configuration.

Information about the configurations can be found in Chapter “3.1 Configurations”, page 13.

The SARTOFLOW® Smart tubing set is included in the scope of delivery. In the following table, the assignments of the sections to the configurations are displayed (see also Chapter “6.4.9 Setting Up SARTOFLOW® Smart Tubing Set”, page 63):

Description Functional element Section Configuration

Basic DCU control unit, permeate bag B, C, E, F, I Standard, 1, 2, 3

Bag recirculation tank

Recirculation tank A, G Standard, 1

Bag recirculation bag

Recirculation bag A, G 2, 3

Filter holder Sartocon® Slice 200 D, H Standard, 2

Filter Sartocon® Slice 50 D, H 1, 3

6.2 Prerequisites for Installation

6.2.1 Installation Site

The installation site is suitable for the device and the optional equipment:

− The connections for energy and supply systems must be prepared before installation of the device in the work area. They must be easily accessible, correctly installed, set in accordance with the device's specifications and ready to operate.

− The environmental conditions for the installation site conform to the specifications in Chapter 12.3, page 81.

− The installation area of the device must be such that the device is easily available for operation in the process, for maintenance and service work and for emergencies (see Chapter “12.1 Dimensions”, page 80).

− The recommended wall distance is 300 mm. − When using the optional equipment, the installation area is increased by the

respective space requirements of additional modules. − The required minimum distance from the optional additional equipment or

other devices is 100 mm.

Procedure

WARNINGRisk of death due to electrical shock!Connecting the device to the wrong mains voltage at the installation site can be fatal. t Make sure that:

t The mains voltage specifications on the manufacturer’s ID label match those of the mains voltage at the installation site.

t The installation site is equipped with grounded and splash-protected mains connections.

t The power supply is equipped with a protective grounding conductor.


Installation

ATTENTIONDanger of damage to the device by unauthorized variation of the mains voltage!The variation of the mains voltage must not exceed the device specification values (see Chapter “12.4 DCU-4 Control Unit Power Supply”, page 81).

ATTENTIONDanger of damage to the device due to condensation on electrical components!When a cold device is taken into a warm environment, condensation can form on electrical components and damage the device.

t Acclimatize the device and the plug-ins for about 2 hours before the device and the add-on modules are connected to the network.

Personnel Electrician, administrator

t Check the following ports: − Supply voltage − Communication (Ethernet)

6.3 Unpacking the Equipment

Procedure t Unpack the device. t Dispose of the packaging material in accordance with local government regulations.

t Check that all parts of the device were delivered. t If any items are missing: Contact the Sartorius Service. t Check the order confirmation and delivery notes for accuracy. t Check all components of the device for damage. t If parts are damaged: Contact the Sartorius Service.

6.4 Installation

6.4.1 Setting Up the Device

CAUTIONDanger of injury when lifting and transporting!The device can slide out of your hands, fall down and crush limbs. t Only lift the device using the transport handles.

ATTENTIONThe device could be damaged by improper transport!Lifting and transporting the device without using the transport handles leads to cracks in the system and damages the device. t Only lift the device using the transport handles.

Procedure t Place the device on a suitable table and align.


Installation

6.4.2 Mounting the Device

Setting up the device involves the following main steps:

t Connect DCU-4 control unit (see) t Set up recirculation tank (see ) t Set up filter holder (see ) t Set up SARTOFLOW® Smart tubing set (see ) t Set up permeate scale (see ) t If available: Set up sensors (see ) t If available: Set up peristaltic pump (see )

6.4.3 Connect DCU-4 Control Unit

ATTENTIONFunctional and operational disturbances caused by improper installation material!Installation material that has not been released for the device may lead to functional and operational disturbances and damage it.Ensuing defects are not covered by the warranty from Sartorius. t Use the installation materials supplied in the scope of delivery.

Requirements − The main switch on the device is in the position [0].

Personnel Electrician

Material − Cable for potential equalization

− Power supply connection cable

Procedure t Connect the cable for the potential equalization to port (1) and to the potential equalization at the installation site.

t Plug the power cord into the connection socket (1) and connect the power cord to the power supply at the installation site.

Personnel Administrator

Material Network cable

1

1


Installation

Procedure t Plug the network plug into the connection socket (1) and connect the network cable to the network connection at the installation site.

6.4.4 Setting Up the Recirculation Tank

ATTENTIONDanger of damage to the load cell!When setting up the recirculation tank on the base plate, the load cell may be damaged. t Do not expose the load cell to torsion. t Do not exceed the maximum capacity of the load cell while setting up the recirculation tank.

Procedure t Align the recirculation tank so that the feed outlet of the recirculation tank is aligned to connect with the 4-piston diaphragm pump.

t Place the recirculation tank on the base plate.

1


Installation

6.4.5 Setting Up the Recirculation Bag (Optional)

ATTENTIONDanger of damage to the load cell!When setting up the recirculation tank on the base plate, the load cell may be damaged. t Do not expose the load cell to torsion. t Do not exceed the maximum capacity of the load cell while setting up the recirculation tank.

Procedure t Place the bag holder on the base plate.

t Hang the recirculation bag (2) on the bag holder fixture (1).

1

2


Installation

6.4.6 Setting Up the Filter System Sartocon® Slice 200

CAUTIONDanger of injury from heavy components!Components of the filter holder may fall during assembly work and crush limbs. t Wear personal protective equipment.

Material Filter holder, filter cassette

Documents Sartocon® Slice 200 filter system installation instructions

Requirements − The Sartocon® Slice filter cartridge is installed in the filter holder (see Sartocon®

Slice 200 installation instructions).

Procedure t Place the filter holder in the recess of the base plate.


Installation

6.4.7 Setting Up Sartocon® Slice 50 (Optional) Filter System

Material − Filter Holders − Filter

Procedure t Hang the filter holder (1) with the angled side into the system rail (2).

t Turn the locking lever (1) until the filter holder is locked into the system rail. y The filter holder is fixed to the system rail.

1

2

1


Installation

t Position the filter (1) in the filter recess (2) and fix the filter with the star grip screw (3).

6.4.8 Mounting the Bag Holder on the Permeate Scale

ATTENTIONDanger of damage to the load cell!When setting up the bag holder on the base plate, the load cell may be damaged. t Do not expose the load cell to torsion. t Do not exceed the maximum capacity of the load cell while setting up the bag holder.

Procedure t Place the bag holder on the base plate.

1

2

3


Installation

t Hang the permeate bag (2) on the bag holder fixture (1).

t Plug the power cord into the connection socket (1) and connect the power cord to the power supply at the installation site.

t Plug the control cable connector into the connection socket (1) and connect the control cable to the port on the rear of the device (for pin assignment, see Chapter “3.2.2 Connections”, page 18)

6.4.9 Setting Up SARTOFLOW® Smart Tubing Set

CAUTIONRisk of injury due to splashing supply media and product!The prefabricated fittings of SARTOFLOW® Smart tubing sets may loosen during transport and cause leaks at the connections. Supply media and product can spill during the process and cause burns. t Prior to mounting: Check prefabricated fittings of SARTOFLOW® Smart tubing set for tightness and tighten if necessary.

Documents SARTOFLOW® Smart tubing set parts list

Requirements − The recirculation tank has been set up. − The Sartorius permeate scale with bag holder and permeate bag has been set up. − The filter is mounted.

Procedure t Select tube sections for the appropriate configuration (see SARTOFLOW® Smart tubing set parts list).

The cap nuts have to be screwed firmly into the connections.

1

2

21


Installation

Default configuration t Set up the hoses B , C , E (“Ret” port on the filter), F and I of the Basic tubing set.

t Set up the hoses A and G of the recirculation tank tubing set. t Set up the hoses D (terminal “Feed” on the filter) and H (terminal “Perm” on the filter) of the filter holder tubing set.

A

G

FE

C

B

H

D

I

Fig. 6-1: Hoses installed in the standard configuration

Configuration 1 t Set up the hoses B , C , E (“Ret” port on the filter), F and I of the Basic tubing set.

t Set up the hoses A and G of the recirculation tank tubing set. t Set up the hoses D (terminal “Feed” on the filter) and H (“Perm” port on the filter) of the filter tubing set.

A

G

FE

C

BH

D

I

Fig. 6-2: Hoses installed in Configuration 1


Installation


t Set up the hoses A and G of the recirculation bag tubing set. t Set up the hoses D (terminal “Feed” on the filter) and H (terminal “Perm” on the filter) of the filter holder tubing set.

A

G

FE

C

B

H

D

I



t Set up the hoses A and G of the recirculation bag tubing set. t Set up the hoses D (terminal “Feed” on the filter) and H (“Perm” port on the filter) of the filter tubing set.

A

G

FE

C

B H

D

I



Installation

6.5 Setting Up Optional Components

ATTENTIONFunctional and operational disturbances caused by improper installation material!Installation material that has not been released for the components may lead to functional and operational disturbances and damage them.Ensuing defects are not covered by the warranty from Sartorius.

t Use the installation materials supplied in the scope of delivery.

6.5.1 Setting Up the Sensor Holder

Procedure t Position the sensor holder (1) on the system rail (2).

t Turn the locking lever (1) until the sensor holder is locked into the system rail. y The sensor holder is fixed to the system rail.

1

2

1


Installation

6.5.2 Installing the Sensor

The following sensors can be installed in the port of the recirculation tank lid:

− pH sensor − Conductivity sensor − Temperature sensor

Documents Technical data sheet of the corresponding sensor

Prerequisites − The recirculation tank has been set up.

Procedure t Remove the cap (1) from the connection port.

t Install the adapter (1) in the port of recirculation tank lid.

1

1


Installation

t Install the sensor (1) into the adapter (see Technical Data Sheet of the corresponding sensor).

t Connect the sensor cable to the sensor and to the connector on the rear of the device (for pin assignment, see Chapter “3.2.2 Connections”, page 18).

TipWhen the sensor is temporarily removed:

t Insert the sensor (1) in the sensor recess (2) of the sensor holder.

1

1

2


Installation

6.5.3 Connect the Peristaltic Pump

Requirements

− The main switch on the device is in the position [0]. − The peristaltic pump is installed next to the recirculation container.

Procedure t Plug the power cord into the connection socket (1) and connect the power cord to the power supply at the installation site.

t Plug the control cable connector into the connection socket (1) and connect the control cable to the connector on the rear of the device (for pin assignment, see Chapter “3.2.2 Connections”, page 18).

1 2


Startup

7 StartupStarting up the device involves the following measures:

− Check tubing connections for tightness − Insert tubing into the peristaltic pump − Switching on the device − Perform a function test − Calibrate sensors − Checking Filtration Unit

7.1 Check Tubing Connections

CAUTIONRisk of injury due to splashing supply media and product!The fittings of the tubes may become loosened, causing leaks. Supply media and product can spill during the process and cause burns. t Before starting the process: Check fittings of the tubes for tightness and tighten if necessary.

7.2 Insert Tubing into the Peristaltic Pump

Information on inserting the tubing into the peristaltic pump can be found in the operating instructions for the peristaltic pump.

7.3 Checking Filtration Unit

Before switching on the device, perform the following final actions:

t Check all valves of the filtration unit (valve matrix). t Check electric cable connectors on the measuring sensors (conductivity sensors, flowmeters, etc.).


Startup

7.4 Turning the Device On and Off

7.4.1 Switching On the Device

Requirements − You must also have gained familiarity with the safety instructions.

(see Chapter “2 Safety Notes”, page 9). − You must also have gained familiarity with the operating concept.

(see Chapter “4 Operating Design”, page 30). − The device has been properly installed and connected in accordance with the

specifications in Chapter “6 Installation”, page 55.

Procedure t Turn main switch | power disconnect to the position [I]. y System startup commences.

System StartAfter powering 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. − All controllers are switched “off”.

Startup Behavior after Interruptions in OperationFor interruptions in operation, the startup behavior of outputs and system functions that have a direct effect on the associated end unit (controllers, timers, etc.) depends on the duration of the interruption (turning the device off | on at the main switch of the control unit).

In the “System Parameters” menu of the “Settings” functional area, a maximum duration, during which data are retained, for power interruptions can be set as “Fail Time”.

In case of a power outage shorter than “Failtime”, the system continues as follows:

− A “Power failure” error message shows the outage time. − Controllers continue to work with the set target value and mode. − Timer and setpoint profiles continue to be processed.

If the power outage lasts longer than the configured “Failtime”, the DCU system acts as though the user had turned the unit off normally, that is, it starts in the defined basic state.

After the next restart, an alarm message appears, specifying the date and time at which the power failure occurred.

7.4.2 Switching Off the System

Procedure t Turn main switch | power disconnect to the position [0].


Startup

7.5 Performing a Function Test

A load cell is used to prevent the recirculation tank from overfilling. In the system, an adjustable alarm value is stored; when it is reached, the peristaltic pump is turned off. In this way, overfilling is not possible under normal conditions.

Possible malfunction due to incorrect data entry can be avoided by regular calibration and manual functional testing.

Procedure t Before starting the process:

t Set the alarm value for the recirculation tank (see Chapter 4.14.3, page 47).

t Calibrate peristaltic pump (see Chapter 4.14.4, page 48).


Cleaning and Maintenance

8 Cleaning and Maintenance

8.1 Preparing to Perform Cleaning and Maintenance

Procedure t Switch off device at main switch. t Remove the power supply from the laboratory connection. t Ensure that the connections and hoses have been depressurized.

8.2 Cleaning

Regular cleaning is essential. The operating safety of the device depends on the proper cleaning of the device, among other factors.

Cleaning intervals largely depend on the stress placed on the equipment by aggressive components contained in the media (e.g. acids and bases used to regulate pH) and the level of contamination from product residues attached to this equipment.

ATTENTIONDanger of corrosion and damage to the device!Unsuitable cleaning agents can cause damage to the device resulting from corrosion and mechanical loading. t Ensure that the cleaning agents used are compliant materials:

t Avoid highly caustic and | or chloride-containing detergents. t Avoid solvent-based cleaning agents. t Use soft cleaning sponges and towels.

8.2.1 Environmental Protection Regulations

The use and disposal of cleaning agents, and water containing such agents, may be subject to legal or environmental protection regulations in your country. t Note regulations for proper use and disposal.

8.2.2 Cleaning

Procedure t Measures before cleaning: Remove filter cartridge (see “Sartocon® Slice 200” Installation Instructions).

t Cleaning the device: t For moderate soiling: Clean the device with a slightly damp cloth. t For heavy soiling: Clean the device with a mild soap.


Cleaning and Maintenance

8.3 Maintenance

Maintenance work carried out by the user is limited to general testing and verification of the filtration unit and the recirculation tank.

Detailed instructions for maintenance of the optional extension modules (e.g. external peristaltic pump) can be found in the respective installation and operation instructions.

The internal modules of the device, particularly the safety equipment, must only be serviced by Sartorius Service.

Please return the device to Sartorius Stedim Biotech if it is defective. t Note the following conditions:

t Shipping: See Chapter “10 Storage and Shipping”, page 77 t Decontamination Declaration: see Chapter “15.2 Decontamination Declaration”, page 89).


Faults

9 Faults

9.1 Troubleshooting

Always proceed according to the following steps when faults occur on the unit.

t If you notice fumes and odors: Switch off the device and unplug it. t At high surface temperatures: Switch off the device and unplug it. t Inform responsible person on-site. t Before switching on the device: Determine cause of the fault and remedy it. t Fault cannot be corrected: Contact Sartorius Service(see Chapter “15.1 Sartorius Service”, page 89).

9.2 Hardware-related Faults

WARNINGDanger of injury if qualifications are insufficient!Improper use can lead to significant personal injury and property damage. t Only qualified personnel may perform service and repair work.

Fault Potential causes Corrective measures

Display remains black

Device is not switched on. t Check power supply. t Switch the device on.

Faulty system startup t Restart system.

Emergency shut-off is enabled.

t Disable emergency shut-off.

Device cannot be switched on

Incorrect power supply t Check power supply(see 12.4, page 81).



Pump P-2500 will not start



Readings are faulty or not displayed.

Connection error between measuring instrument and DCU control unit

t Check cable connections.

No communication between DCUcontrol unit and MFCS

The Ethernet cable has been connected incorrectly.

t Connect the Ethernet cable correctly (see 6.4.3, page 57).

Readings show the maximummeasured value.

Cable break t Replace the relevant cable.

Leakage at filter holder

Insufficientclamping torque

t Check clamping torque.

Filter cartridges damaged t Change the filter cartridges.

Leakage at the Luer lock connectors

Insufficient clamping torque

t Tighten Luer lock connections.


Faults

9.3 Process-related Faults

Fault Potential causes Corrective measures

Pump P-2500 will not start

No confirmation of alarms t Acknowledge alarms.

Other controllers are enabled.

t Check controller settings.

Peristaltic pump BF200S will not start

Incorrect controller settings

t Check controller settings.

Sequence cannot be started

Another sequence is active.

t Check active sequences and deactivate if necessary.

Alarms are active. t Acknowledge alarms.

No communication between DCU4-control unit and MFCS

Remote button has not been activated.

t Check remote settings.

Readings show the maximummeasured value

Measurement range has been exceeded.

t Check measurement range.

Incorrect pressure measurement results

Measuring instrument not calibrated.

t Calibrate the measuring instrument.

No zero point calibration t Perform zero point calibration.

Incorrect results for temperature measurement

Measuring instrument not calibrated


Incorrect results for tank level measurement

Weighing device not tared t Tare weighing device.

Measuring instrument not calibrated



Storage and Shipping

10 Storage and Shipping

10.1 Storage

ATTENTIONDamage to the device from incorrect storage!The device may be damaged if stored in a moist environment or outdoors. t Do not leave the device outdoors. t The device may only be stored indoors.

If the device is not set up immediately after delivery or temporarily not used, it must be stored under the conditions listed in Chapter “12.3 Ambient Conditions”, page 81.

In case of improper storage, no liability will be assumed for resulting damage.

10.2 Shipping-related Tasks | Return

Requirements − Device and optional equipment have been decontaminated. − Device is properly packaged for transport.

Procedure t Send device.(Delivery address: see www.sartorius.com)


Disposal

11 Disposal

11.1 General Instructions

PackagingThe packaging is made of environmentally friendly materials that can be used as secondary raw materials.

t When the package is no longer needed: Dispose of the packaging at the local waste disposal facility.

DeviceThe equipment, including accessories and empty non-rechargeable and rechargeable batteries, does not belong in your regular household waste; this equipment is manufactured from high-grade materials which can be recycled and reused.

t Remove the non-rechargeable and rechargeable batteries before disposal or scrapping and hand over to a collection point.

The European Directive 2002/96/EC on Waste Electrical and Electronic Equipment (WEEE) requires that electrical and electronic equipment be collected and disposed of separately from other unsorted municipal waste, with the aim of recycling it. The crossed-out waste bin symbol indicates that separate collection is required.

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.

PrerequisitesReturn of the device in Germany and in several other countries.

Procedure t Contact the Sartorius Service.

PrerequisitesReturn of the device in countries that are not members of the European Economic Area or in which there are no Sartorius subsidiaries:

Procedure t Contact local authorities and waste management companies.

Addresses for DisposalDetailed information with service addresses for the disposal of your device can be found on our website www.sartorius.com.

t Note the conditions for returning the device: t Shipping: See Chapter “10 Storage and Shipping”, page 77 t Decontamination Declaration: see Chapter “15.2 Decontamination Declaration”, page 89).


Disposal

11.2 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 process are potentially hazardous materials that could cause biological or chemical hazards.

According to the EU directives [European directive on hazardous substances], 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.

Devices contaminated with hazardous materials (NBC contamination) will not be accepted for disposal.

11.3 Decommissioning the Device

Procedure t Switch off device at main switch | power disconnect. t Disconnect the device from the supply voltage. t Empty recirculation tank and tubing.

11.4 Removal

CAUTIONDanger of injury from heavy components!Components can fall down and crush limbs during disassembly work. t Wear personal protective equipment. t Perform assembly work with 2 people.

Procedure t Measures before disassembling the device:

t Decommission the device. t Disassembly:

t Disassemble tubing. t Remove power cord. t Remove network cable. t Clean device and optional equipment. t Decontaminate device and optional equipment.

11.5 Disposal

t Dispose of the device in an environmentally friendly manner in accordance with local government regulations.


Technical Specifications

12 Technical Specifications

12.1 Dimensions

3

12

Fig. 12-1: Dimensions

No. Property Unit Value

1 Length mm 870

2 Width mm 500

3 Height mm 595

12.2 Weight

Specification Unit Value

Weight kg approx. 30



12.3 Ambient Conditions

Please also note the technical data for the optional equipment!


Installation site Conventional laboratory rooms max. 2000 m above sea level

Ambient temperatures in the operating temperature range

°C +5 to 40

Relative humidity % < 80% for temperatures up to 31 °C (87.8°F), decreasing linearly < 50% at 40 °C (104°F)

Impurities Pollution degree 2 (Normally only non-conductive pollution occurs. However, temporary conductivity caused by condensation must be expected)

12.4 DCU-4 Control Unit Power Supply


Mains connection (230 V~, 50-60 Hz)

Voltage V 230 ±10%

Frequency Hz 50

Bus load A 2.0

Fuses

2 + device fuses 6.3 + 32 mm, time lag, 230 V, 2.0 A/T (IEC)

Mains connection (120 V~ | 60 Hz)

Voltage VAC 120 ±10%

Frequency Hz 60

Bus load A 3.0

Fuses

2 + device fuses 6.3 + 32 mm, time lag, 230 V, 3.0 A/T (UL)

IP rating according to DIN EN 60529 IP 33

Protection class according to DIN EN 61140 I

Overvoltage class 2



12.5 Filtration System


Pump capacity of 4-piston diaphragm pump L / h 1-150

Maximum pressure of 4-piston diaphragm pump barg (psig) 3

Filter area cm2 50-1400

Minimum recirculation volume ml approx. 20

Maximum inlet pressure barg (psig) 3

Recirculation tank

Polysulfone tank with self-sealing lid L 1

Disposable recirculation bag L 0.15 - 1

Permeate bag L 3

Tubing connections Luer lock

Weighing range < 7000 g

12.6 Filter Holders

Specification

See “Sartocon® Slice 200” installation instructions

See “Sartocon® Slice 50” installation instructions

12.7 ATEX

WARNINGIgnition of explosive mixtures!The device is not ATEX (ATmosphère EXplosive)-certified. t Do not operate the device in potentially explosive atmospheres.

12.8 Lifespan of Device


Maximum lifespan Years 8


Conformity & Licenses

14 Conformity & Licenses

14.1 EC Declaration of Conformity

With the attached declaration of conformity, the compliance of the device SARTOFLOW® Smart with the directives cited is confirmed.

14.2 UL Approval

With the attached UL Listing Mark, the compliance of the device SARTOFLOW® Smart with the directives cited is confirmed.

14.3 Licensing Information

14.3.1 GNU Licensing

DCU systems contain software codes 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.


Accessories, Consumables, Spare Parts

13 Accessories, Consumables, Spare Parts

13.1 Accessories

Item

pH sensor

Conductivity sensor

Temperature sensor

Peristaltic pump

13.2 Consumables

The following consumables are available on request.

13.2.1 Sterile Recirculation Bags for Liquids

Item Value Order number

Flexboy® 150 ml, EVA 1 FFB 102643



13.2.2 Permeate Bag


Flexboy® 3000 ml, EVA 1

13.2.3 Sartocon® Slice 200 Filter Cassettes

Hydrosart® Ultrafiltration Cartridges

Cut off | pore size Value Order number

2 kD 200 cm2 3081441902E--SW*

5 kD 200 cm2 3081442902E--SW*

10 kD 200 cm2 3081443902E--SW*

30 kD 200 cm2 3081445902E--SW*

100 kD 200 cm2 3081446802E--SW*

0.2 μm 200 cm2 3081860702W--SW*

0.45 μm 200 cm2 3081860602W--SW*

* For gray silicone cassettes, the article number ends with '--SG'



PESU Ultrafiltration Cartridges


1 kD 200 cm2 3081460902E-SW*

5 kD 200 cm2 3081462902E-SW*

8 kD 200 cm2 3081463402E-SW*

10 kD 200 cm2 3081463902E-SW*

30 kD 200 cm2 3081465902E-SW*

50 kD 200 cm2 3081465002E-SW*

100 kD 200 cm2 3081466802E-SW*

300 kD 200 cm2 3081467902E-SW*

0.1 μm 200 cm2 3081545802E-SW*

* For gray silicone cassettes, the article number ends with '--SG'

13.2.4 Sartocon® Slice 50 Filter

Hydrosart® Ultrafiltration Filter


2 kD 50 cm2 3D91441950ELLPU

5 kD 50 cm2 3D91442950ELLPU

10 kD 50 cm2 3D91443950ELLPU

30 kD 50 cm2 3D91445950ELLPU

PESU Ultrafiltration Filter


1 kD 50 cm2 3D91460950ELLPU

5 kD 50 cm2 3D91462950ELLPU

8 kD 50 cm2 3D91463450ELLPU

10 kD 50 cm2 3D91463950ELLPU

13.2.5 Hydrosart® Ultrafiltration Cassettes Sartocon®-ECO

Cut off Value Order number

10 kD 0.14 m2 3M51443901E--SW

30 kD 0.14 m2 3M51445901E--SW

100 kD 0.14 m2 3M51446901E--SW

13.2.6 Filter Cartridge


Filter cartridge 0.375 m2 5182507T0----GA



13.3 Spare Parts


Bag holder recirculation bag 1 179SmartOp_BH1

Bag holder permeate bag 1 179SmartOp_BH2

Filter holder Sartocon® Slice 50 filter 179SmartOp_CH3

SARTOFLOW® Smart tubing set 1 179SmartOp_Tu


Appendix

15 Appendix

15.1 Sartorius Service

Repairs may be performed by authorized service personnel or by the responsible service representative.

Please contact Sartorius Service for all service needs, and in case of guarantee claims.

Service AddressesDetailed information with service addresses for returning your device for repair can be found on our website www.sartorius.com.

15.2 Decontamination Declaration

When returning equipment, copy the following form as required, carefully complete it and enclose it with the delivery documents. The recipient must be able to inspect the completed declaration before removing the device from the packaging.


Appendix

Decontamination Declaration

Declaration Concerning the Decontamination and Cleaning of Equipment and ComponentsTo 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 declarationI (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.: Fax:

Name of authorized person:

Position:

Date | Signature

Please pack the equipment properly and send it ex recipient to your Sartorius service.


Index

16 IndexC

Conformity & licensesEC Declaration of Conformity . . . . . 88GNU licensing . . . . . . . . . . . . . . . . . . 88

ControllersController mode . . . . . . . . . . . . . . . . 46Setting setpoints . . . . . . . . . . . . . . . . 45

D

Decontamination declaration . . . . . . . 91Device

Device return . . . . . . . . . . . . . . . . . . . 91Device return . . . . . . . . . . . . . . . . . . . . . 91Disposal

General instructions . . . . . . . . . . . . . 80

E

EC Declaration of Conformity . . . . . . . 88

F

FilterSartocon® Slice 50. . . . . . . . . . . . . . . 23Sartocon® Slice 200 . . . . . . . . . . . . . 22Setting up the Sartocon® Slice 50 . . 62Setting up the Sartocon® Slice 200 . 61

G

GNU licensing . . . . . . . . . . . . . . . . . . . . 88

P

Phase . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51Functional area “Phase” . . . . . . . . . . 37Phase parameters . . . . . . . . . . . . . . . 50Starting the phase . . . . . . . . . . . . . . 51

R

Recirculation tankOverview recirculation bag . . . . . . . 21Overview recirculation tank . . . . . . 20Setting up the recirculation bag . . . 60Setting up the recirculation tank . . 59

S

Service . . . . . . . . . . . . . . . . . . . . . . . . . . 91Service addresses . . . . . . . . . . . . . . . . . . 91

T

Tubing setEquipment supplied . . . . . . . . . . . . . 55Setting up the tubing set . . . . . . . . 65

06 | 2016

Printed in the EU on paper bleached without chlorine. | UBPublication No.: SPC6060-e160604

Last updated:

The information and figures contained in these instructions correspond to the version date specified below.Sartorius reserves the right to make changes to the technology, features, specifications and design of the equipment without notice.Masculine or feminine forms are used to facilitate legibility in these instructions and always simultaneously denote the other gender as well.

Copyright notice:This instruction manual, including all of its components, is protected by copyright.Any use beyond the limits of the copyright law is not permitted without our approval.This applies in particular to reprinting, translation and editing irrespective of the type of media used.

© Sartorius Germany

Sartorius Stedim Biotech GmbH August-Spindler-Strasse 11 37079 Goettingen, Germany

Phone: +49.551.308.0Fax: +49.551.308.3289www.sartorius.com