PHARMA 4.0IOT IN PHARMACEUTICAL PRODUCTION

ENVIRONMENTS

Rolf Helge Traut

Global Lead Automation Engineer

Takeda Pharmaceutical International AG

Hannover Fair 2019 04.04.2019

Connecting Pharmaceutical Knowledge ispe.org

IIoT – A Data Driven Organization

Connecting Pharmaceutical Knowledge ispe.org

• Status Quo in the Industry

• Goal “Plug & Produce”

• Path forward

• Benefit

• Outlook

Agenda

Connecting Pharmaceutical Knowledge ispe.org

• “Weak, complex, aging” network infrastructure

• Many heterogenous island solutions

• Outdated technology, obsolete asset inventory

• Use of data is low, limited or inexistent

• Current GxP / Bio-Pharma requirementsnot considered

Status Quo in the Industry

Connecting Pharmaceutical Knowledge ispe.org

Status Quo in the Industry

Connecting Pharmaceutical Knowledge ispe.org

• Main goal: make data available, use data for optimizing production and end-to-end supply

• State of the art control and supervisory systems with message-based communication

• All production equipment connected through a powerful network infrastructure

• Data is available for all applications without work intensive configuration

• Pharma Data Integrity requirements fulfilled

Goal

Connecting Pharmaceutical Knowledge ispe.org

Goal “Plug & Produce”

Source: OPC UA server aggregation - The foundation for an internet of portals, Daniel Grossmann

et al, TH Ingolstadt, January 2015 https://www.researchgate.net/publication/283882805

ERP

SCADA

DCS PLC PAT

LIMS

Data Analytics

Track & Trace

BMS

EMS

Escalation Server

SCADA

Solu

tion

dep

ende

nt

Data Use

Data Acquisition

Data Supply

Direct ERP Feed

Process Control

SMSEmailVoice

Warehouse Management

Data Gateway

Historian

MES

IT Platform

AUT PlatformProduction Equipment (Packaging lines, tablet presses etc.)© Rolf Helge Traut, Takeda 2018 (Automation Guideline)

n/2 * (n+1) Schnittstellen

n Schnittstellen

Connecting Pharmaceutical Knowledge ispe.org

Path Forward

Data Model Audit TrailUser

ManagementBackup

Backup SystemCentralized User

Management

Production Network

Equipment

Infrastructure

Technology Standards

Governance

Time Synch

© Rolf Helge Traut 2016

Connecting Pharmaceutical Knowledge ispe.org

• Harmonized / Open Infrastructure to plug in any equipment at any time

• Separation of office and production network including Cyber Security

• Implementation of standard IT services analog to the Office world (SaaS)

• Easy Design / Upgrade or replacement of equipment together with vendors

• Centralized Message Gateway combined with Centralized Data Pool (Historian)

• Use & pilot new technologies / concepts like OPC UA, PackML, MQTT and MTP

• Be active in global communities (like ISPE) to drive standardization in the industry

Path Forward

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Path Forward – State Event Machine

State – Event Machine based on ISA-S88

Connecting Pharmaceutical Knowledge ispe.org

Path forward – Standard Data Structures<?xml version="1.0" encoding="utf-8" standalone="yes"?>

<EventList>

<Event>

<!-- Mandatory -->

<EventID>Unique Number angelehnt an OPC UA Standard </EventID>

<EventType>AuditTrail|Alarm</EventType>

<EventClass>GxP|EHS|Unclassified</EventClass>

<SequenceNumber>fortlaufende Nummer z.B.4711</SequenceNumber>

<Time>2018-07-22T11:23:19.958518</Time> <!-- UTC Time -->

<SourceName>UnitName z.B. DESIN321000</SourceName>

<Message>Message of the entry in human readable form</Message>

<!-- Alarm -->

<AlarmID>Alarmkurzbezeichnung / Number</AlarmID>

<AlarmCategory>10=Info / 20=Warning / 30=Fault / 40=Alarm</AlarmCategory>

<Severity>0-1000</Severity> <!-- Optional -->

<AckedState>true/false</AckedState>

<ActiveState>true/false</ActiveState>

<!-- AuditTrail -->

<OldValue>Old value</OldValue>

<NewValue>New value</NewValue>

<!-- Optional für Alarm & AuditTrail -->

<BatchId>Id of a batch</BatchId> 13 <Submessage>Submessage if available</Submessage>

<UserId>User id</UserId>

<Reason>Signierbegründung</Reason>

<SecondUserId>Second user id if available</SecondUserId>

</Message>

</Event>

</EventList>

Connecting Pharmaceutical Knowledge ispe.org

• Having the data real time available in any place – bidirectional exchange with stable and qualified communication paths – no USB or other «ancient» methods

• Efficiency increase through consistent, automated processes

• Process optimization online/offline through full data analysis

• Predictive Maintenance through automated identification of failure patterns

• Data Integrity – Single source of truth

Benefit – Real time Data

Connecting Pharmaceutical Knowledge ispe.org

• Each supplier will have to design its equipment in a way that it can communicate bi-directional

• New communication standards will simplify the data exchange between systems

• What TCP/IP is today, will be OPC UA tomorrow – a matter of course

• Plug and Produce will become reality through standardized configuration, e. g. MTP

• There will be an ISPE/Namur workshop in May 2019 with Pharma companies and suppliers for defining a showcase using MTP and a data integration layer – check the ISPE website

Outlook

Thank You

Questions?

Visit Namur and ISPE in Hall 11, Booth D44

Rolf Helge TrautGlobal Lead Automation Engineer / GMS – GE

M +41 79 794 92 40

Takeda Pharmaceutical International AGThurgauerstrasse 130, CH-8152 Glattpark-Opfikon (Zürich)

Switzerland