Dataopsamling. Stand-alone Dataopsamling i Pharma- og fødevarebranchen

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1 Dataopsamling Stand-alone Dataopsamling i Pharma- og fødevarebranchen

2 Reglerne Reglerne tager udgangspunkt i at de data man opsamler er troværdige og repræsentativt for den proces den skal dokumentere Pharma -> FDA CFR part 11, GAMP 4/5 Fødevarer -> EN12830_Foodlaw Man kan rimeligvis godt finde masser af sammenfaldende krav og fremgangsmåde i de to ovenstående standarder Begge tager udgangspunkt i sikring af menneskers helbredsmæssige sikkerhed. Begge produkter er til indtagelse i menneske kroppen. Kravene til sporbarhed i pharma normen overgår dog klart fødevare normen.

3 Fødevarer EN1280 Typisk fokusområde -> Temperatur Andre typiske krav fra standarden Maximal error på sensor Minimum krav til opsamlings intervals Respons tid ved event Særkrav under transport Særkrav til klimaovervågning ved opbevaring

4 Pharma CFR part 11 -> GAMP 4/5 som grundlag Risiko tilgang til krav Man kan ikke sige noget generelt om kravtyper, applikationsafhængigt Risikoafdækning -> Design -> Bevis

5 Pharma projektafvikling

6 Fødevare projektafvikling

7 Hvad skal du have styr på? Dataintegritet Tid og dato Bevis for hele datamængden Alle relevante data Hvilken tidstempling er relevant for sensor Opløsning af værdien Nøjagtigheder vs krav Events, alarmer Evt recept ændringer -> kvalitets kontrol Version styring

8 Typiske Produkter

9 Data Acquisition/Recorder Controller Production Management Asset Management and Operational Efficiency Data Acquisition and Monitoring Analytical Paperless Recorder Chart Recorder Single Loop & Temperature Controller Signal Conditioner Power Monitor Production Control and Safety Management Oxygen Analyzer ZR Pressure ph Transmitter PH202 Conductivity Transmitter SC202 Level Process Gas Chromatograph GC1000MKII Positioner Near-infrared Spectrometer NR800 Data Acquisition and Logic Control Analysis and Quality Control Pressure/Differential Pressure EJA/EJX Flow Remote Seal Differential Pressure EJA/EJX Advanced Valve Positioner YVP I/P Converter PK200 Temperature Sensing and Actuation Variable Area Rota Meter Coriolis Rota Mass Vortex DYF Differential Pressure EJA/EJX Magnetic AXF Ultrasonic US300 Temperature Transmitter YTA50/70 YTA100/300

10 New generation af papir løse skrivere compliant with FDA 21 CFR Part 11 for pharma markedet Login function Electronic Record and electronic signature Audit trail DX100P/DX200P 10

11 DXAdv R4 Advanced Security Function Login funktion Sign in funktion Audit trail funktion Data file beskyttelse Password management funktion via Active Directory Server Andet Uafhængig alarm ACK Extend alarm delay time 11

12 New Paperless Recorder GX/GP Yokogawa Europe January

13 SMARTDAC+ Concept Paperless Recorder (Panel mount type) Future model Modular Style DAQ + Control GX GM Now that s SMART. Paperless Recorder (Portable type) Data Logging Software GP GA

14 SMARTDAC Recording Station GX/GP Panel mount / Portable versions GX/GP10, 5.7, max 30 channels GX/GP20, 12.1, max 100 channels Superior Display Functionality Unique screen operation Easy to use standard display formats Modular expandable design Same modules for all platforms Large internal memory 500MB External memory up to 32GB Advanced mathematical capability Function blocks and freely programmable equations Seamless network integration and communications FTP/SNTP/SMTP/DHCP/MODBUS TCP

15 Smart User Interface Flexible display Pre-defined displays Trend, bar graph, numeric, overview, message list, alarm list Out of the box, ready to use Powerful search functions Search from a pop up calendar Move to trend from summary screens such as message/ alarm list Function description for digital inputs/ outputs Show real actions such as RUN/STOP, PUMP ON/ PUMP OFF Attach to an output allows physical switching to occur such as relay output Change the position of the digital information on the trend screen Click and swipe to move RUN

16 Smart User Interface Channel grouping Organize channels into groups Put channels into multiple groups 30 for GX/GP10 50 for GX/GP20 All channel display Shows all trends on one display rather than grouped information Jump to default display Display can return to a specific screen after a period of time

17 Smart Architecture Remote I/O Create a large scale monitoring system by adding up to 300 remote I/O channels Add monitoring or control devices Add any device communicating via MODBUS TCP GX/GP10 add 50 virtual channels GX/GP20 add 300 virtual channels

18 Smart Architecture - Security Computer style locking system Access to media device and power switch physically locked Multi-level user login access e.g Administrator/ Engineer/ Operator Simple password lockout User access selectable for both front panel and communications login

19 Smart Functionality Software Freely downloadable viewing and configuration software Search by tag/ channel/ batch/ date-time View all message types Convert to Excel/ ASCII file formats Offline configuration Excel friendly configuration data Copy to Excel for editing Import data from Excel into configuration data

20 Applikationer

21 INSATECH FLOW KALIBRERINGSRIG

22 INSATECH FLOW RIGS

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24 Flow control Pressure control Vegabar Reference UT35A UUT

25 Ethernet MW100 Modbus TCP SCPI Gateway Impuls Hz Modbus HCS Flow Density Temperature Diagnose Agilent 34411a Hart ma UUT

26 Software Ethernet HMI Pro-face AGP3750 Controller Flowregulator Yokogawa MW100 Yokogawa UT55A

27 MW100 Calculations MW100 CSV export Excel

28 UT55 Flowregulator Ladder Program Ladder Program to control the change of flowmeter and valve

29 Overvågning af sterilisationsprocessen i Fødevareproduktion : Ketchup

30 Ketchup produktion I produktionen af Ketchup skal man jf. fødevaresikkerheden sikre at holde en bestemt temperatur i en bestemt tid. GATEWAY Advance report software

31 Rapport Hver batch startes automatisk FTP server modtager færdig fil Rapport software tager fil Konverter til excel rapportskabelon Print til PDF Gem fil og print ud

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33 Overvågning af sterilisationsprocessen i Pharma applikation

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38 Novartis/jacobs projekt Novartis er Pharma >i Tuscany, Italien De laver vacciner De ledte efter en komplet styring af deres batch på hele fabrikken Dette her er det klart billigeste alternativ til et rigtig centralt DCS system

39 1 off Reporting Station Genzyme Architecture drawing PNC/ /001 rev 4 Central Engineering Station. Servers Servers AD Server Data Server L3 L3 L2 Security Alarm Panel. Hirschmann Eagle 20 Firewall L2 Hirschmann Eagle 20 Firewall (existing) Reporting Station Hirschmann RS20 Ethernet Switch 8 Port Reporting Station Hirschmann RS20 Ethernet Switch. (existing) Local operator station 1.2 nd Floor Local operator station 2. Ground floor UPS Panel UPS Panel Local operator station Building K22 Input marshalling stations. Input marshalling stations. UPS Panel Communication cable. Hard Wired. Building K31 Building K22

40 Novartis/jacobs project Schematic of their future system

41 Fjernovervågning af kølecontainer i europa

42 System lay out

43 MW100 Custom Webpage