XCell ATF Series Скачать руководство пользователя страница 3

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Contents

Description of XCell

ATF System and Process ...................................................................... 1

1.1

XCell

ATF System Pump Cycle .................................................................................... 2

1.2

XCell

ATF System Control Scope and Objectives: ....................................................... 4

1.3

XCell

ATF Pump Housing and Controller Pairings ...................................................... 4

1.4

XCell

System Interconnectivity Drawing .................................................................... 5

Utility Requirements ............................................................................................................. 6

Size and Weight .................................................................................................................... 7

XCell™ ATF Pump Housing Assemblies ................................................................................... 8

C410:V3 Controller Layout .................................................................................................. 17

5.1

General Layout ............................................................................................................. 17

5.1.1

Filtration Assembly ............................................................................................ 18

5.2

Primary Pneumatic Services......................................................................................... 19

5.3

Primary Electric Services .............................................................................................. 21

5.4

Signal ............................................................................................................................ 21

5.5

C410:V3 Ethernet set-up and Connectivity ................................................................. 21

C410:V3 Controller Process and Control .............................................................................. 22

6.1

Interface and screens ................................................................................................... 22

6.2

Control Overview ......................................................................................................... 45

6.3

Start-up ........................................................................................................................ 46

6.4

Examples ...................................................................................................................... 48

Hollow Fiber Module and Diaphragm Replacement ............................................................. 50

7.1

Separating the Filtration Assembly from the bioreactor: ............................................ 50

7.2

HFM removal: .............................................................................................................. 50

7.3

HFM insertion: ............................................................................................................. 51

7.4

Screen Module replacement: ...................................................................................... 52

7.5

Diaphragm replacement: ............................................................................................. 52

7.6

Assembly ...................................................................................................................... 53

7.7

Use ............................................................................................................................... 53

Sterilization ........................................................................................................................ 53

8.1

Preparation of Filtration Assembly for autoclaving ..................................................... 53

Содержание ATF Series

Страница 1: ...XCellTM ATF System With C410 V3 Controller USER GUIDE XCell ATF4 XCell ATF6 XCell ATF10...

Страница 2: ...in connection with the furnishing performance or use of this material No part of this document may be photocopied reproduced or translated to another language without the prior written consent of Rep...

Страница 3: ...tration Assembly 18 5 2 Primary Pneumatic Services 19 5 3 Primary Electric Services 21 5 4 Signal 21 5 5 C410 V3 Ethernet set up and Connectivity 21 6 C410 V3 Controller Process and Control 22 6 1 Int...

Страница 4: ...nce 57 10 1 Diaphragm 57 10 2 Pump Air Inlet Filter 57 10 3 O Rings gaskets and Quick Connects 57 10 4 Controller Maintenance 58 Appendix 1 XCellTM Cycle Time vs Flow Rate 59 Appendix 2 User Access 60...

Страница 5: ...rocess vessel Bioreactor Adaptor adaptor between the Connection Assembly and bioreactor port Typical ports connectors adaptors for stainless steel bioreactors include an Ingold type port or if a singl...

Страница 6: ...hrough the filtration device The second pump chamber the Pump Air PA chamber is connected to the pump flow control system Typically controlled addition of compressed air into the PA chamber increases...

Страница 7: ...ng the process vessel at atmospheric pressure On the other hand when using a vessel that can be pressurized vessel pressure can be used to drive the liquid from the vessel to the PL chamber When vesse...

Страница 8: ...s XCellTM ATF Pump Housing XCellTM Controller Description XCellTM ATF4 Stainless Steel C410 4V3 C410 V3 C410 controller for XCellTM ATF4 system with air tubing C410 4V3 GMP C410 V3 C410 controller for...

Страница 9: ...XCellTM ATF System with C410 V3 Controller User Guide 1 4 XCellTM System Interconnectivity Drawing Figure 3 C410 V3 controller with XCellTM ATF10 stainless steel pump housing and pressure relief valv...

Страница 10: ...5 psi 2 4bar Working regulated pressure VACUUM SERVICE 20 508 mm Hg at maximum flow use a service capable of sustaining 20 Hg at full flow EXHAUST Untreated discharge or user specified ELECTRICAL 100...

Страница 11: ...t and effective area XCell ATF 4MC System 44 10 8x12 XCell ATF 6 System 44 10 8x12 XCell ATF 10lgcy System 44 14 14x20 XCell ATF 10 System 44 14 14x20 XCell ATF 6 Single use Device 38 12 10 XCell ATF...

Страница 12: ...in Figure 3 Certain parts may vary depending on requirements and specifications Optional components for the XCell ATF housing include bioreactor connection kits pressure transducers vacuum pump and op...

Страница 13: ...XCell 50A P C Silicone 1 8 0 295 C S x 6 835 ID x 7 425 Silicone 2 9 90 Degree Elbow 1 5TC 316 SS 1 10 Sanitary Gasket 1 1 2 TC EPDM 5 11 Clamp Sanitary 1 1 2 TC 304 SS 5 12 Sanitary Gasket 3 4 TC EPD...

Страница 14: ...10 XCellTM ATF System with C410 V3 Controller User Guide Figure 4b Exploded View of XCell ATF 10 Single use Device with 0 2u PES Hollow Fiber Filter...

Страница 15: ...11 XCellTM ATF System with C410 V3 Controller User Guide Table 4b XCell ATF 10 Single use Device Components...

Страница 16: ...12 XCellTM ATF System with C410 V3 Controller User Guide Figure 4c Exploded View of XCell ATF 6 System Filtration Assembly P N ATF6 PH GMP...

Страница 17: ...13 XCellTM ATF System with C410 V3 Controller User Guide Table 4c XCell ATF 6 Pump Housing Parts List...

Страница 18: ...14 XCellTM ATF System with C410 V3 Controller User Guide Figure 4d Exploded View of XCell ATF 6 Single use Device with 0 2u PES Hollow Fiber Filter...

Страница 19: ...413 O Ring Class VI 70A Silicone 2 12 233 O Ring Class VI 70A Silicone 2 13 Air Inlet Filter w 1 4 NPT male ends gamma stable 1 14 Poly Tube 1 4 ID x 3 8 OD White 1 15 GE ReadyMate to 1 TC 3 16 GE Re...

Страница 20: ...16 XCellTM ATF System with C410 V3 Controller User Guide Figure 4e Exploded View of XCell ATF 4 System Filtration Assembly P N XCell ATF4 PH GMP...

Страница 21: ...re 5 and the P Box Figure 4 The two are interconnected with a cable that relays signal and power A general layout of the two boxes with the XCellTM ATF System is shown in Fig 1 The primary design obje...

Страница 22: ...Interconnect Cable Plug c Plugs for sensor inputs 4x4 20mA d Connection for Diaphragm Pump e Connection for compressed air f Connection for vacuum supply g Pressure regulator 0 to 60psi 0 to 4 1 bar h...

Страница 23: ...neumatic Services Air inlet e Located on the P Box and provides an inlet to house compressed air source Recommended minimum air pressure requirement is 50psi 3 4bar Somewhat higher inlet pressures may...

Страница 24: ...low of liquid from the Filtration Assembly to the P Box Air Pressure regulator Typical range of regulator is 0 60psi 4 1bar This is a second stage pressure regulator for regulating service air inlet p...

Страница 25: ...is an open Industrial Ethernet standard developed by the PROFIBUS Organization and is standard Ethernet IEEE802 3 The Profinet communication protocol sends and receives data using the open Ethernet T...

Страница 26: ...ed in Server Client pairs The OPC Server is a software application that bridges the communication of the PLC with the Windows environment and then with the OPC Client Software application Some common...

Страница 27: ...n the Primary Screens Screen Description LOG ON Initial System Log On which appears when the C410 V3 controller first powers up MAIN Main Diaphragm Pump Control Monitoring Displays Real Time Pump Stat...

Страница 28: ...User Guide Description of Screens and Buttons A LOGON Logon screen appears when the C410 V3 controller is powered up Click on LOGON to bring up User Password Dialog Box and Keyboard For first time us...

Страница 29: ...starting the Diaphragm Pump a dialog box will appear to enable the user to start with current settings start with default settings or cancel and return to the main screen b When stopping the Diaphragm...

Страница 30: ...e of last pump cycle Sec E FLOW SP Displays current E Flow Set Point SP LPM or Seconds E FLOW PV When running displays pump exhaust Flow rate Process Value PV of last pump cycle LPM E FLOW Calculated...

Страница 31: ...Up Administration When starting the pump the following dialog box will appear Yes setting is preferred when stopping the Diaphragm Pump and restarting with the same flow rate or process settings i e...

Страница 32: ...ance Set Up Screen Calibration Screen Help Guide Exit to Primary Screens Navigate to the following Secondary screens From the Basic Set Up Screen an Engineer Administrator can 1 Set initial Controller...

Страница 33: ...m Set Point Sets a low limit on P2 pressure during the E Flow Cycle If P2is LOL follow with WARNING Alarm Delay msec Delays response to HIHI and LOLO Set Point If the alarm parameter is set for 0 minu...

Страница 34: ...t enable this function unless you thoroughly understand its effects Button Description Advance Set Up Press to switch to Advanced Set Up Screen Help Guide Press to switch to Start up Help Guide Scree...

Страница 35: ...limit for EFLOW set point LPM Min E FLOW sec Minimum limit for EFLOW set point Seconds PV1 Max Maximum operating limit for PV1 PV1 Min Minimum operating limit for PV1 PV2 Max Maximum operating limit...

Страница 36: ...t Up Press to switch to Advanced Set Up Screen Calibration Instrument Calibration All Primary All Primary Screen Buttons are displayed to navigate to those screens Ethernet Configuration only accessib...

Страница 37: ...personal or Repligen Field Service Engineer The Calibration screen will display parameters in the following tables Field Description Engineering Units Enter the Engineering Units for the selected anal...

Страница 38: ...analog input Capture Second Calibration Point This button will capture the raw input value for the second point for the selected analog input Actual Value This button will finalize the two point calib...

Страница 39: ...Controller User Guide The Trending screen displays an Overview screen from where the following trends are selected This screen monitors in real time the Flow and Exhaust Set Points and Process Values...

Страница 40: ...mum value for the chart Y Axis Button Description Scrolls back to the beginning of the trend recording The start values with which the trend recording started are displayed Zooms into the displayed ti...

Страница 41: ...Min Enter minimum value for the chart Y Axis Button Description Scrolls back to the beginning of the trend recording The start values with which the trend recording started are displayed Zooms into th...

Страница 42: ...the Diaphragm Pump While the PLC records the output from the load cell in milliseconds the computer HMI is much slower and refresh rate is about once every 0 5 1 0 second therefore while one may not...

Страница 43: ...ON POWER ON RUNNING C ON ON POWER ON WARNING D ON OFF Two 2 Pump Interlock Relays are provided which energize per the following states HARVEST PUMP STATE RELAY 3 RELAY 4 ACTIVE ON ON NOT ACTIVE OFF O...

Страница 44: ...hed E Regulator PV2 below minimum operating setting The following is a list of C410 V3 controller Alarms that can occur during normal operation XCellTM ATF System Warning has not been acknowledged XCe...

Страница 45: ...istrator User ID and 1 predefined Engineer Level and 1 predefined Operator Level User ID s Only the administrator will have security access to add edit delete all other User ID s by touching the appro...

Страница 46: ...MIN Basic Screens Each level of security allows different levels of access to the C410 V3 controller control functionality please refer to Appendix 2 for details Note Software version numbers shown ab...

Страница 47: ...psed time of current batch run Time is reset by changing Batch Name Cycle Count Displays Diaphragm Pump Cycle count of current batch run User ID Displays Users ID Engineer or Administrator Batch Set U...

Страница 48: ...y parameters in the following tables Field Description Algorithm Performance Tracks cycle change mechanism Primary Method Shows cycle count triggered by Set point method tracks Pressure cycle and Exha...

Страница 49: ...calculate the Diaphragm Pump cycle time based on a user s flow rate selection according to the following relationship The pump displacement volumes with no pressure difference across the diaphragm ar...

Страница 50: ...rifice opening in combination with fine adjustments in the air flow stream pressure with the PRV Adjustments in flow are based on the error difference between Calculated CT and Actual CT The proportio...

Страница 51: ...psi LoLo Alarm Set Point 7 psi Alarm Delay x10 msec 50 for both Pump Parameters VALUE P Pressure Offset psi 0 5 E Pressure Offset psi 0 5 P Delay 70 E Delay 70 P Overtime 120 E Overtime 120 P PV Step...

Страница 52: ...essure Offset and P between PRV2 P2 should be less than E Pressure Offset If not manually lower PV in small increments b Flow is too rapid A flow that is too rapid during the Exhaust Cycle can be read...

Страница 53: ...t connect the Pump Line from the C410 V3 controller to the Diaphragm Pump at this point 6 Power ON the E Box Wait for system to boot up and display the XCellTM ATF System LOGON screen 7 LOGON the main...

Страница 54: ...placing a HFM in Filtration Assembly connected to a pressure rated vessel Prerequisites Steam is available and the HFM has to be replaced in mid run in a sterile manner Refer to Figure 1 7 1 Separatin...

Страница 55: ...odule Preparation Instructions that are included with every hollow fiber There are different preparation methods depending on the module type purchased Two types of HFMs are available for the XCellTM...

Страница 56: ...nto the housing 3 Insert one O ring into the groove formed between HFM and Filter Housing end ferrule wall 4 Place the reducer onto the end forcing the O ring into the groove 5 Clamp the reducer to th...

Страница 57: ...here 2 Clamp the two hemispheres with the C clamps use the three long clamps first and place 120 degrees to each other about the Diaphragm Pump periphery 3 Uniformly and sequentially tighten the clamp...

Страница 58: ...ully assemble Filtration Assembly as shown in Figure 9 8 1 3 Perform a pressure test 8 1 4 Vent all ports blocked with 0 2micron vent filters With both the filtrate and retentate sides vented formatio...

Страница 59: ...n autoclave The XCellTM ATF System Filter Preparation and Autoclave Guide provides detailed guidance on the entire procedure including the recommended filter integrity test procedures and specificatio...

Страница 60: ...5 60 min Ramp down slowly with wet cycle exhaust protocol or 0 5 10 C min to 1000 C Allow the system to cool to 50 oC before handling 8 2 3 Open autoclave door inspect the system re tighten all clamps...

Страница 61: ...the Steam inlet valve and immediately open the main valve into the Filtration Assembly to minimize a pressure drop in the connection Note that following SIP of the connection the cool down of the conn...

Страница 62: ...P box 6 Inspection of pneumatic fittings 7 Inspection of the pneumatic tube from the P box to the XCell ATF pump housing 8 Inspection of enclosure for damage locks and hinge performance external elect...

Страница 63: ...ystem PUMP VOLUME L ATF4 0 4 ATF6 1 3 ATF8 2 5 ATF10 lgcy 5 1 ATF10 6 0 Cycle time sec FLOW RATE L MIN 4 6 0 18 8 37 5 76 5 90 0 6 4 0 12 5 25 0 51 0 60 0 8 3 0 9 4 18 8 38 3 45 0 10 2 4 7 5 15 0 30 6...

Страница 64: ...ending PV1 Input Value Not Allowed PRV1 Input Value Not Allowed PV2 Input Value Not Allowed PRV2 Input Value Not Allowed P2 General View Only Alarms View Only General Allowed Silence Alarm General Not...

Страница 65: ...General Access View Not Allowed no access to Set Up Screens Admin Basic General Access Not Allowed Users General Access Not Allowed Engineer Main Screen General Access General Access Upon Login Start...

Страница 66: ...d to adjust Min and Max P4 Trend General View and allowed to adjust Min and Max P5 Trend General View and allowed to adjust Min and Max WI Trend General View and allowed to adjust Min and Max Batch In...

Страница 67: ...pressure and exhaust cycle fields PV Step Size Allowed to adjust pressure and exhaust cycle fields Alarm Set Points P2 Pressure Allowed to adjust HiHi and LoLo Fields Alarm Delay Allowed to adjust Hi...

Страница 68: ...lowed Default Gateway Not Allowed Remote TSAP Not Allowed Calibration 1 General Access General Allowed Analog Input P2 Select Allowed Eng Units Not Allowed 1st Point Not Allowed Eng Units Not Allowed...

Страница 69: ...h Point Not Allowed Eng Units Not Allowed 6th Point Not Allowed Actual Value Not Allowed Accept Allowed No changes occur Analog Input P5 Select Allowed Eng Units Not Allowed 6th Point Not Allowed Eng...

Страница 70: ...iew Only P2 Trend Enable View only change range in trending Alarms View Only General Allowed Silence Alarm General Allowed Clear Alarm General Allowed Trending Overview General View and allowed to adj...

Страница 71: ...ed Set Up Basic Controller Setup Pump Model Allowed to adjust Control Mode Allowed to adjust Alarm Delay Allowed to adjust Slope Function Enabled Allowed to adjust Bioreactor Pressure Allowed to adjus...

Страница 72: ...Max Allowed to Adjust LPM and Seconds field Exhaust Cycle Flow Min Allowed to Adjust LPM and Seconds field Accept Changes Allowed Discard Changes Allowed Admin Set Up Advanced Output CV Limits PV1 Al...

Страница 73: ...owed Analog Input PRV1 Select Allowed Eng Units Allowed 2nd Point Allowed Eng Units Allowed 3rd Point Allowed Actual Value View Only Accept Allowed Analog Input PRV2 Select Allowed Eng Units Allowed 3...

Страница 74: ...t W1 Select Allowed Eng Units Allowed 7th Point Allowed Eng Units Allowed 8th Point Allowed Actual Value View Only Accept Allowed Help General Access View only Allowed Admin Basic General Access Gener...

Страница 75: ...XCellTM ATF4 ATF6 and ATF10 pump falls under the article 3 3 of the Pressure Equipment Directive 97 23 EC and indicate the pumps are compliant with the SEP Sound Engineering Practice For XCellTM ATF p...

Страница 76: ...Controller software v3 has been marked legibly and indelibly with the following information Name and address of the manufacturer Rated voltage full load amperage and frequency Serial number Short circ...

Страница 77: ...lter between the XCellTM ATF System and the Controller o Inspect air and vacuum connections to the controller o Inspect that all components inside of the controller are secured and intact o Inspect en...

Страница 78: ...ordance with the ASME Boiler and Pressure Vessel Code XCell ATF Single use devices are designed and validated to withstand a pressure of 60 PSIG at 40 oC All device units are subjected to a pressure h...

Страница 79: ...and the device fields populate with the current configuration h From this interface the IP Address Subnet Mask and all other Ethernet Properties can be adjusted i Once the values have been entered sel...

Страница 80: ...Real 66 DB1 DBD66 Min Exhaust Flow Setpoint LPM PTIME Real 70 DB1 DBD70 Pressure Flow SEC PTIMESP Real 74 DB1 DBD74 Pressure Flow Setpoint SEC PTIMEMAXSP Real 78 DB1 DBD78 Max Pressure Flow Setpoint...

Страница 81: ...eal 574 DB1 DBD574 PRV2 Process Value P3_PV Real 582 DB1 DBD582 P3 Process Value P4_PV Real 586 DB1 DBD586 P4 Process Value P5_PV Real 590 DB1 DBD590 P5 Process Value W1_PV Real 594 DB1 DBD594 W1 Proc...

Страница 82: ...N A N A N A Spare N A N A N A N A N A N A Spare N A N A N A N A N A N A PL1 System Stop Indicator Q0 0 N A N A N A N A N A HN1 System Fault Warning Horn Q0 1 N A N A N A N A N A SOL1 Pump Inflate Def...

Страница 83: ..._1 Optional Pressure 4 IW106 Note 1 N A PSI N A Y RAW_P5_PV_1 Optional Pressure 5 IW108 Note 1 N A PSI N A Y RAW_W1_PV_1 Optional Weight IW110 Note 1 N A LBS N A Y RAW_PRV1_CV_ Inflation Pressure QW12...

Страница 84: ...stem Fault Warning Horn DB1 WARN_REG 0 Flow Set Point cannot be reached Air Supply Regulator PRV1 above maximum pressure setting DB1 DBX132 0 Pump is Running PRV1 PRV1 MAX N A Warning Activate System...

Страница 85: ...200 C2410 E AX CPU SIMATIC S7 200 CPU module XCell ATF 6 Pneumatics Spares C410 P6 RF PM Pressure Manifold for C410 6 C410 P6 RF EM Exhaust Manifold for C410 6 C410v2 P48 RF SOL1 ASSEMBLY 3 way valve...

Страница 86: ...Barb Fitting XCell ATF6 AIR ASSY Air Inlet Assembly XCell ATF6 P3 CPM1 5 TC3 4 Kit PT 1 5 CPM Fitting 3 4 TC XCell ATF6 PH AA AIR Air Hemisphere XCell ATF6 w XCell ATF6 AIR ASSY XCell ATF 10 Pump Hous...

Страница 87: ...TS Thumb Screw for XCell ATF10 XCell ATF8 Base XCell ATF10 AIR ASSY Air Inlet Assembly XCell ATF10 XCell ATF10 PH AA AIR Air Hemisphere XCell ATF10 w XCell ATF10 AIR ASSY P3 CPM1 5 TC3 4 Kit PT 1 5 CP...

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