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    Manufacturing Execution Systems (MES) : Overview and Case Study

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    damodara9bille
    The document discusses Manufacturing Execution Systems (MES), with a case study on Novo Nordisk's implementation of an MES called PAS-X at their Clayton, North Carolina site. It provides an overview of MES characteristics and standards, along with details of PAS-X such as its product-focused design, integration with other systems, and goals of harmonizing processes across sites. The case study describes Novo Nordisk's motivation to implement a global MES, details of deploying PAS-X at Clayton, and lessons learned from the implementation process.

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    Manufacturing Execution Systems (MES) : Overview and Case Study

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    damodara9bille
    222 views21 pages
    The document discusses Manufacturing Execution Systems (MES), with a case study on Novo Nordisk's implementation of an MES called PAS-X at their Clayton, North Carolina site. It provides an overview of MES characteristics and standards, along with details of PAS-X such as its product-focused design, integration with other systems, and goals of harmonizing processes across sites. The case study describes Novo Nordisk's motivation to implement a global MES, details of deploying PAS-X at Clayton, and lessons learned from the implementation process.

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    The document discusses Manufacturing Execution Systems (MES), with a case study on Novo Nordisk's implementation of an MES called PAS-X at their Clayton, North Carolina site. It provides an overview of MES characteristics and standards, along with details of PAS-X such as its product-focused design, integration with other systems, and goals of harmonizing processes across sites. The case study describes Novo Nordisk's motivation to implement a global MES, details of deploying PAS-X at Clayton, and lessons learned from the implementation process.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    222 views21 pages

    Manufacturing Execution Systems (MES) : Overview and Case Study

    Uploaded by

    damodara9bille
    The document discusses Manufacturing Execution Systems (MES), with a case study on Novo Nordisk's implementation of an MES called PAS-X at their Clayton, North Carolina site. It provides an overview of MES characteristics and standards, along with details of PAS-X such as its product-focused design, integration with other systems, and goals of harmonizing processes across sites. The case study describes Novo Nordisk's motivation to implement a global MES, details of deploying PAS-X at Clayton, and lessons learned from the implementation process.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
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    The presentation discusses Manufacturing Execution Systems (MES), their characteristics, standards, and a case study of an MES implementation at Novo Nordisk.

    The document lists characteristics of an MES system as being component-based, having high integration capability, using state-of-the-art technologies, having simple parameterization, access security, compliance, and mobility/flexibility.

    The document discusses ANSI/ISA 95 and ANSI/ISA 88 as standards for MES systems.

    Manufacturing Execution Systems

    (MES): Overview and Case Study


    Gilad Langer, NNE Pharmaplan
    Ray Boshold, Novo Nordisk
    December 6, 2012
    Agenda

    • Manufacturing Execution Systems – Past,


    Present and Future
    • Gilad Langer, NNE Pharmaplan
    • An MES Implementation at Novo Nordisk
    – Clayton, NC
    • Ray Boshold, Novo Nordisk
    Characteristics

    • Component-based structure
    • High integration capability
    • State-of the-art technologies
    • Simple parameterization
    • Access security
    • Compliance
    • Mobility and flexibility
    ANSI/ISA 95 and ANSI/ISA 88 Standards
    Integration
    Benefits
    An MES Implementation at
    Novo Nordisk – Clayton, NC
    • PAS-X:
    • Background and Overview
    • Implementation
    • Infrastructure & Deployment
    • Lessons Learned
    Novo Nordisk

    Novo Nordisk
    • Global health care company with an 89-year history of innovation
    and achievement in diabetes care.
    • Leader in the industry, providing a complete product portfolio of
    insulin and GLP-1 products and offers easy-to-use insulin delivery
    systems.
    Novo Nordisk Pharmaceutical Industries, Inc (NNPII) - Clayton
    • Employs over 540 local members of the community on a 264 acre
    property in Johnston County.
    • Produces diabetes treatment products from formulation and aseptic
    filling to packaging and distribution.
    • Only production site for diabetes products in North America.
    Novo Nordisk Product Supply
    PAS-X: One Global Harmonized MES System
    For Discrete Production
    PDS290 – “FlexTouch”
    PDS290 at DFP Site Clayton

    • 1 packaging line • 2 final assembly lines

    The specific location of Packaging Line 4 is yet to be


    determined.
    Paperless Electronic Workflow
    Master Batch Record Electronic Batch Record Completed Batch Record
     Bill of Material + +
     Process Definition
     Work Instructions
     Version
    1  Order Number
     Batch Number
     Exact Work Center Routing
    2  Actual Values
     Exception Summary
     Review by Exception
    3
     Right Sequence & Right First Time  Signatures

    Order & EBR Creation Approve & Release EBR


    (ERP & MES) (MES & Operator)
    PAS-X Product Description
    V1.4
    Clayton
    PDS290 PAS-X
    Strategy
    • Goal is for PAS-X Core to become
    a global MES system including
    95% of the MES functionalities
    that are required by the sites
    • To achieve this, focus on
    • Functionality/processes
    • Technology.
    • Streamline the business and
    manufacturing processes with as
    few variants as possible
    Business Objectives

    • Harmonise MES and manufacturing processes


    through one central NN core – build on lessons
    learned from the current projects
    • Reduce infrastructure operation costs
    • Minimize licensing and maintenance cost on
    software
    • Reduced ambiguity in validation costs
    • Stabilize operation and maintenance costs
    • Governance of functionality implemented will
    support harmonisation
    Deployment

    • 3 integral parties
    • Werum
    • PSIT
    • Clayton Site
    • Consultants (NNE Pharmaplan, etc.)
    • Site Automation
    • Site IT
    Infrastructure
    • Developed and qualified centrally.
    • Local installations with local design (e.g. MBR) and settings validated by sites
    • DK sites will use the data centre for database and application services
    • Non-DK sites will use a locally placed server rack called “PAS-X in a box”.

    T, V and P Interface Software In VMP Scope


    Environment for PAS-X to:
    - Taurus
    NN PAS-X NN PAS-X - CMES Citrix Citrix
    DB Application - MCS Servers Clients
    - NNTZW
    - SAP
    - OPC Client (PCS
    integration)
    - Etc.

    In VMP Scope (*)


    Not in VMP Scope
    Network / Switches

    Other Systems Like Other System


    - Taurus Devices
    - CMES - Printers
    Werum - MCS - PDA
    remote - NNTZW - Barcode Scanners
    support - SAP - Label Printers
    - OPC (PCS integration) - Etc.
    - Etc.
    Architecture
    Clayton Interfaces

    Interfaces PRISM
    ERP

    DataStage
    NNIT Interface
    FP2PI
    Clayton Finished
    Production 2 Prism
    Interface
    LDBS
    Clayton Local
    Database

    PAS-X
    Recipe Mgmt /
    Electronic Batch
    Record

    OPC
    Process Optimization
    Information Technol

    POINT SCADA
    Process Optimization
    Process Controls
    Information Technol
    IT Work Pkg
    Lessons Learned

    • Planning
    • Gap analysis ~3 months
    • Involving stakeholders from LOB
    • Supply Chain
    • Quality
    • IT
    • Ownership of system
    • Customization
    • Programming
    • Validation
    • Associated costs
    • Organizational Change Management
    • New processes, technologies for the site
    • Expertise

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