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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• Outdated technology, obsolete asset inventory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
Connecting Pharmaceutical Knowledge ispe.org
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