1. DAu OMAC Make2Pac 2010 11 09 OMAC in new Plants ? OMAC Make2Pac 2010 Ernst Madsen Product Supply IT Machine automation / a User view on Standardization / OMAC & Make2Pack What are our drivers and needs? Process Coordinate Record & Analyze Ready Execute

2. DAu OMAC Make2PacSlide no 22010 11 09 Machine automation at Novo Nordisk Many applications From standard equipment/low cost e.g. simple packaging To very customized/high cost e.g. assembly lines Different architectures PLC (many vendors, many types) User interface (none, HMI, SCADA) MES/EBR integration (customized if any) Performance monitoring (none, simple, light, full OEE) Infrastructure integration Machine automation Interface layer Application Platform “Make2Pack”

3. DAu OMAC Make2PacSlide no 32010 11 09 Requirements Allow high automation levels with a minimum of cost and risk Not first movers but fast followers Fast to market Life cycle requirements: Operational Maintenance and support Analyze and implement Analyze and plan Implement Operate Maintain and review

4. DAu OMAC Make2PacSlide no 42010 11 09 Operational requirements Ease of use Standardization for operators Efficient workflows and quality reporting (MES/EBR) Recipes and order information QC sampling Alarms and warnings Reporting / electronic batch record Material control (quality and advanced transport control) Performance monitoring (OEE) Infrastructure Security Users Time Narrow close down windows

5. DAu OMAC Make2PacSlide no 52010 11 09 Maintenance requirements Disaster recovery Configuration management (Backup)

6. DAu OMAC Make2PacSlide no 62010 11 09 Analyze and implement Novo Nordisk need: Terminology Ability to communicate complex projects Standard building blocks Things should not be reinvented Standard interfaces Solutions should be plug-and-play

7. DAu OMAC Make2PacSlide no 72010 11 09 Standardization Novo Nordisk need and support industry groups: We don’t want to start from scratch every time We don’t want to reinvent the wheel

8. DAu OMAC Make2PacSlide no 82010 11 09 Processes and Systems MES (API) PCS ERP MES (Finished procuct) Utility PLC+HMI SCADA PLC/HMIPLC+HMI SCADA StandAlone PLC/SCADA PLC/MES PLC/HMI SCADA Functional and Interface Requirements

9. DAu OMAC Make2PacSlide no 92010 11 09 Types of unit Processes The types of equipment that this report focuses on are: Washers Sterilizers Autoclaves Filling lines Inspection machines Freeze driers Packaging lines Assembly lines Utility, WFI-distribution Formulation Weighing Granulators Facility Monitoring Systems Building Management Systems Black utilities and other auxiliary systems

10. DAu OMAC Make2PacSlide no 102010 11 09 Infrastructures in finished Products PLC with interface to a SCADAPLC with interface to a MESPLC Stand alone system

11. DAu OMAC Make2PacSlide no 112010 11 09 Strategy & standard goals SCADA MES Equipment Data (Batch data, OEE, etc.) Functions (Datalogging, alarm handling, etc.) Same interface for allvendors Same data for all vendors Samefunctionsfor allvendors (Production schedule, Master Recipe, OEE, etc.) Interface Change of paradigm Equipment suppliers can choose its preferred PLC platform Equipment suppliers must fulfil functional and interface requirements A global and agile support and maintenance organization must exist

12. DAu OMAC Make2PacSlide no 122010 11 09 Approach to standards 2. Implementation Approaches 1. System Standards 4. Risk Evaluations 3. System Strategies Technologies Life Cycle Management The Technology Standard covers: Description of relevant system configurations Relevant functionalities and interfaces Maintenance and support Generic functional and interface requirements In future development of Unit Process specific interface requirements

13. DAu OMAC Make2PacSlide no 132010 11 09 Recommendations Functional Development of unit process specific (“PLC”) requirements Make requirements suitable for central library storage to impose direct harmonization and reuse (testable) Gradual implementation of the Make2Pack standard as it matures and vendors start to comply with the standard Competences Development of support and maintenance organization supporting multiple PLC platforms Enable knowledge sharing across sites and countries Develop procedures for support and maintenance Enable remote service capability for use by equipment suppliers and supporters

14. DAu OMAC Make2PacSlide no 142010 11 09 Functions (Generic) Scan materials at the destinationsLog / Verify materials that have been received Download recipe to equipmentTransfer of process parameters to equipment Categorization of recipe parametersRecipe parameters must be split in Production / Machine recipes and individually version controlled Download batch informationTransfer of batch information to equipment Equipment control Batch executionSend execution commands on the unit level (must comply with S88). Also includes receiving of status changes

15. DAu OMAC Make2PacSlide no 152010 11 09 Functions cont. Equipment control Batch executionS88 OMAC Phase/operation/sequence control Equipment control -S88 OMAC em/cm module operation mode (AUTO, MANUAL...) Equipment control – S88 OMAC em/cm module control commands (OPEN, CLOSE…) Equipment control - S88 OMAC Module control - Control Values Time synchronizationSynchronize the system time on equipment Line clearance, before productionInclude in batch report

16. DAu OMAC Make2PacSlide no 162010 11 09 Functions cont. Operator assignment log(Electronic records) Log which operators was working on the machine Critical alarm log(Electronic records) List of critical equipment alarms Non-Critical alarm log(Electronic records) List of non-critical equipment alarms Log book (Electronic records)List of events occurring during a batch e.g. parameter change, etc. Process data (ER)Data that must be logged in order to approve a batch Manage IPC SamplingTake and record in-process samples as specified Line clearance, after prod.Include signatures for line clearance in batch report Reconciliation reportLog number of produced goods in categories e.g. Good, Rejects, Manually removed, etc.

17. DAu OMAC Make2PacSlide no 172010 11 09 Functions cont. Prepare batch report Generate production batch report (containing data specified above or by user) Evaluate equipment (Manual OEE data logging) Log manual OEE data to OEE database (stop causes). Compliant with MAKE2PACK and OMAC standards. Evaluate equipment (Automatic OEE data logging) Log automatic OEE data to OEE database (from e.g. critical alarms). Compliant with MAKE2PACK and OMAC standards. Data analysis (OEE data) Analyze OEE data and optimize production Data analysis (KPI data) Analyze KPI data and optimize production

18. DAu OMAC Make2PacSlide no 182010 11 09 Functions cont. Prepare OEE/KPI data report Generate OEE data report (containing data specified above or by user) Issue preventive maintenance jobSend notification when preventive maintenance is required. Scheduling or operation counters Change managementA well defined baseline of critical items must be supplied Disaster recoveryA disaster recovery plan and installation media must be supplied (incl. definition of critical data) Documentation standardsThe documentation supplied must fulfill e.g. standards for engineering Programming standardsAll programming must fulfill listed standards Data communication interfaceCommunication protocol used by PLC to communicate with external systems

19. DAu OMAC Make2PacSlide no 192010 11 09 Agreeing on Point of Sameness – The balance central versus local Specification Management Machine Logic Process Control Process Management Recipe / Work Order Execution Plant Operation Analysis Production Scheduling Capacity Planning Production Processes Production Throughput Production Orders, Plant Schedules Site Autonomy Corp Standards Supply Chain Management Enterprise Management Manufacturing Management Plant Management Production Unit Management Production Process Management Machine Management Machine, Material Execution, Procedures Demand, Capacity Planning, Customer Requirements

20. DAu OMAC Make2PacSlide no 202010 11 09 Questions - ? Functions, Data, Interfaces & Dataflow is production EndUser Domain – Input to std. Organisations Machine standards as OMAC & Make2Pac is supplier and integrator Domains (and of partial EndUser maintenance interest)