MES Integration with the OSIsoft PI System · represent the logical components in your process. •...

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© Copyright 2012 OSIsoft, LLC.

MES Integration with the OSIsoft PI System

Barry Higgins


Agenda •  Introduction

•  Why MES in API

•  Solution Architecture

•  PI System / MES Integration

•  Benefits and Next Steps

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Introduction – About Janssen

§  3 key business sectors: §  Consumer §  Medical Devices &

Diagnostics §  Prescription Products

§  JSC API Supply Chain §  Chemicals – 6 sites §  Biologics – 5 sites

§  Worldwide Pharmaceutical sales of $6.1 billion in Q1 2012

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Introduction – JSC API Supply Chain

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CHEMICALS Athens, GA Cork, Ireland Geel, Belgium* Schaffhausen,Switz Wilmington, DE Westbury, Tasmania

BIOLOGICS Cork, Ireland Leiden, Netherlands Malvern, PA Manati, PR


Introduction – OSIsoft Products and Services

•  Janssen & OSIsoft Enterprise Agreement •  PI Server (High Availability) •  PI Asset Framework •  PI Interfaces

–  PI OPC interface –  PI UFL interface –  PI Batch interface –  PI RDBMS interface

•  RtReports •  PI WebParts •  PI Manual Logger

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PI System in Janssen API SC •  PI System in place in Cork, Ireland (2

sites) and Geel, Belgium. •  Deploying PI System as part of an

MES readiness projects to: –  Leiden, Malvern, Manati, Springhouse,

Schaffhausen •  Collecting all process data, alarms &

events and batch event data. •  This provides a common data

presentation layer for MES, independent of control system platform.

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Why MES in API – Expected Benefits 1)  Automate the manufacturing workflow

2)  Streamline the release process

3)  Replace existing bespoke legacy systems with a single standardised manufacturing system

4)  Eliminate the ‘hidden-factory’ related to the current paper based process, e.g. effort to generate, maintain, correct, distribute batch records, logbooks, etc.

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© Copyright 2012 OSIsoft, LLC. 10

Production order status Material consumptions Inventory update

Master material data Overall inventory

Material lot status Production orders

Sample IDs

Act

ual

val

ues

Process Control System(s)

ERP

PAS|X

Material Master Overall Inventory Overall Genealogy Master Batch Record Master Production Schedule Production Orders

Production Resource Management Detailed Master Batch Records Production Plan Execution Electronic Batch Recording Weigh & Dispense Review by Exception Material Management in Production

Training Management

Building Automation System(s)

DMS SOP’s / WI’s Drawings Instructions

IPC instruments

LIMS

J&J Users (LDAP / AD)

CAPA Set

val

ues

Tele

gram

s

Login verification

UserID & PW

Doc

ID

File

Manual Interface

Sync

hron

izat

ion

Proc

ess

data

Ala

rm &

Ev

ents

Manual Interface

Global

MES

Local

Proc

ess

data

, Bat

ch d

ata,

Ala

rm &

Ev

ents

OSIsoft PI System (Historian)

Scales &

Printers

System Architecture – System Overview


System Architecture – The New Trinity •  PAS|X Commands & setpoints to Process Control System •  Process Data collected in the PI System •  The PI System data referenced in the PAS|X EBR •  PAS|X EBR batch execution data referenced in the PI System

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Process Control System(s)

PI System

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System Architecture – PI Centric Architectural View

12

PI Server Collective PI AF

Collective

API nodes

Manufacturing Data Sources







13


•  A database of user configured “Process Object Models” called elements which represent the logical components in your process.

•  Allows data from multiple PI Servers to be combined in one common view.

•  Allows the user access to non PI System data sources, e.g. external databases.

•  Allows process specialists to build process relative models without the need for extensive PI System knowledge.

PI Asset Framework – What is PI AF?


Super Class concept. •  Class based templates – built in

conjunction with process and subject matter experts.

•  Only process critical information grouped together in a logical model.

•  Ensures that the entire organisation have a common taxonomy.

PAS|X \ PI AF •  Using Unit based templates allows us to

build unit based MBR elements that can be applied on other sites.

PI Asset Framework – PI AF in Janssen


Different Bio Reactors on various sites all classed under one common schema

PI Asset Framework – Similar Equipment all talking the same language


PI Asset Framework – From PI AF to eBR

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PI AF Element Templates • Class based template.

• Unit Elements created from template.

Upload from PI AF • Class based PCS MBR elements

• Building blocks for MBR modellers

MBR Generation • Class based MBR

EBR Execution • Unit resolved at run-time.

• Data retrieved from PI AF Unit Element


PI Asset Framework – Production Analysis using PAS|X to PI Batch •  OSIsoft and Werum collaborated to develop the Werum PAS-X

Batch Interface which will become standard OSIsoft product. •  This enables us to perform batch analysis at the EBR level from a

Basic Operation (BO) or Basic Function (BF) perspective.

•  The capability to store basic function activities as batch events is similar to current DCS batch events.

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•  Allows Janssen to track, compare and analyse MES batches using standard tools.

•  From Order creation in SAP to finished product delivered.

PI Asset Framework – PAS|X to PI Batch \ PI Event Frames


•  Allows Janssen to track, compare and analyse MES batches using standard tools.

•  From Order creation in SAP to finished product delivered.


Livepoint from Mirabo Systems



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•  Interface allows us to write to PI Event Frames.

•  Allows for data from any PI AF data source to be put into an configurable timeframe context


PI Asset Framework – PAS|X to PI Batch \ PI Event Frames •  Interface allows us to

write to PI Event Frames.

•  Allows for data from any PI AF data source to be put into an configurable timeframe context

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Livepoint from Mirabo Systems


PI Batch or PI Event Frames •  PI Batch and S88

constraints. •  Cannot leverage

PI AF.

•  Flexibility to build recipe templates.

•  Third party client tools.

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The PI System Effect •  pH testing before:

Result in batch record, printout and copy are reviewed before batch release.

Batch Record instructs technician to take pH sample.

Technician takes sample and performs test and prints out result.

Technician copies result and attaches it to Batch Record and records result.

Technician manually checks pH meter logbooks.


The PI System Effect •  pH testing after:

EBR prompts Technician to. Take pH sample.

Technician scans pH meter for status

Technician performs pH test and result is sent to the PI System

PAS|X requests result from PI AF

Result is evaluated, during EBR execution.


PI Asset Framework •  One Screen,

multiple sources of live data.

•  Visual Equipment status

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PI Asset Framework - Visual Equipment log

One location for multiple data sources: •  MES data •  SAP data •  OSIsoft PI System data •  QA information


PI Asset Framework – Visual Equipment Status







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Why MES in API – Expected Benefits 1)  Automate the manufacturing workflow

2)  Streamline the release process

3)  Replace existing bespoke legacy systems with a single standardised manufacturing system

4)  Eliminate the ‘hidden-factory’ related to the current paper based process, e.g. effort to generate, maintain, correct, distribute batch records, logbooks, etc.

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Benefits Realised Removal of 1002 paper

documents (to date) from Manufacturing

•  Interface of Scales to the PI System and PAS-X eliminates manual entries

•  Automated pH/Cond/Osmo/Filter integrity testing. Result retrieval directly from the instrument to the PI System

Greater Visibility on Status of Orders

•  Process is tracked from Warehouse to Manufacturing to Warehouse

Exception Free Manufacturing

•  Mistake proofing in area of GDP errors and partially completed ‘Paperwork’ eliminated

•  No more searching for Docs / SOPs; automatically linked to Master Batch Record

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Future Plans and Next Steps •  Complete roll out of PAS|X to remainder of site.

•  Display process relevant data from PAS|X on shop floor using standard PI System tools, PI ProcessBook, PI DataLink

•  Begin analysis of data gathered by the PI System from PAS|X to discover the next ‘hidden-factory’

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Barry Higgins

[email protected]

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4) Compliance –  Eliminating Good Documentation Practice errors. –  Enforced workflow.

5) Productivity

–  Interface with plant systems eliminates manual data entry steps. –  Process Data historian, LIMS, Balances etc. interfaced –  Interface with LIMS eliminates manual steps. –  System checks greatly reduce the number of operator verification steps (system acts as witness).

6) Continuous Improvement

–  Real-time data in batch context facilitates process improvement efforts. –  Real-time material transactions highlight scrap reduction opportunities.

Why MES in API – Expected Benefits cont. Barry – I think this slide is largely covered in the last side. Can we remove this one?


PI AF - PAS|X •  Class based templates –

built in conjunction with process and subject matter experts.

•  Ensures that only process critical information from a number of data sources can be grouped together in a logical model.


PAS|X to PI Batch •  Allows us to track, compare and analyse MES

batches using standard tools


System Architecture – PI System / PAS|X

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Where does the PI system fit in ?

Production Data

Collection

Production Execution

Management

Production Resource

Management

Production Dispatching

Production Tracking

Production performance

Detailed Production Scheduling

Production schedule

Product Definition

Management

Production level 1-2 functions

Production Performance

Analysis

Production capability

Product definition

Equipment and process specific production rules

Equipment and process specific data

Operational responses

Operational commands

MES

OSIsoft PI

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