MES in Biotech - MESA International

MES in Biotech
Liam O’Brien
Technical Director
www.mesa.org
2009 ISPE/MESA Seminar Merck Sharp & Dohme Biologics Ireland
The following Strategic Initiatives of
MESA International are associated with
this presentation:
Lean Manufacturing
Quality & Regulatory Compliance
Product Lifecycle Management (PLM)
Real-Time Enterprise
Asset Perfermance Management (APM)
Overview
General MES Implementation
Overview of typical MES implementation
Biotech Specific Challenges
More detail on specific Biotech challenges
Summary
Summary
Overview
General MES Implementation
Biotech Specific Challenges
Summary
MES Implementation
Paper
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1,000 of signatures
Attachments
No visibility
Poor RFT
Arduous Review Cycle
Wasted Effort
Does not improve quality
MES Implementation
Multitude of Systems
Enterprise Resource Planning
DMS
Regulatory
Reports
CMM
Downtime
CAPA
Disp. & Weigh
Finite
Scheduling
LIMS
SDMS
Manufacturing Systems Layer
MFC
EQM
Recipe Mgmt
EBR
Historian
Equipment/Process Automation Layer
Qualification
& Training
WMS
AGV
Material Flow &
Equipment Use
Blending
Coating
Compression
MES Implementation
MES Implementation
Scheduling & Visibility
MES IT Infrastructure
– High Availability
MES Implementation
Secondary Computer Room
Server Rack
Primary Computer Room
Server Rack
MES Database Server
MES Database Server
Print Server
Print Server
Dual Path
Dual Path
Peripheral / Edge
Computer Rooms
Citrix Farm Server
Dual Path
Citrix Farm Server
Core
Network Switch
Core
Network Switch
Dual Path
SAN Switches
SAN Switches
Peripheral Switches
&
Wireless AP’s
LTO Backup
Tape Library
Wireless
Wired
SAN
(central data storage)
SAN
(central data storage)
MES Implementation
Return On Investment
Labour
Materials
ROI
Equipment
MES Implementation
Cost
Level of Automation
Target?
Lights Out, Continuous Batch
Today
Paper Based, Manual Operation
Paperless Manual Operation
Degree of Automation
MES Implementation
Overall System Landscape
Enterprise Resource Planning System (ERP)
Variety of Reporting Systems
Laboratory Information Management System (LIMS)
Document Management System (DMS)
Global
Personnel Qualification & Training (PQ&T)
Corrective And Preventative Action tracking (CAPA)
Warehouse Management (WM)
Detailed Scheduling & Planning
Material Tracking (MT)
Plant
Equipment & Container Management
(ECM)
Recipe & Configuration Management
Weighing & Dispense (W&D)
Electronic Batch Record (EBR)
Data Historian (DH)
Process Automation
Best of Breed v
Integrated Approach
MES Implementation
Interfaces
ERP
PT&Q
CAPA
LIMS
MES
Process Automation Layer
Heading Towards
MES Implementation
Interfaces
ERP
PT&Q
CAPA
Change Mgt
Process Hist
Doc Mgt
CDMS
MES
LIMS
SDMS
Access Mgt
Recipe Mgt
Warehouse
Process Automation Layer
MES Implementation
Vendor Selection
•Corporate
•Quality
•Manufacturing
•Technical Services
MES Implementation
Vendor Selection
Some of the Vendors ….
Corporate
ERP Layer
Supply Chain
LIMS
CAPA
Doc. Mgmt
CMM
Downtime
Customers
BPCS
Recipe Mgmt
EBR
Disp. & Weigh
Historian
Regulatory
Reports
Equipment/Process Automation Layer
SQL*LIMS
LabWare
SampleManager
Thermo
MES
Camstar
Elan
POMS
Propack
Syncade
Werum
WMS
AGV
BAAN
LIMS
Smart CAPA
Trackwise
EQMLayer
Manufacturing
MFCSystems
Finite
Scheduling
JD Edwards
CAPA
SDMS
Qualification
& Training
SAP
Data Historian
Document
Management
Siemens
Honeywell Emerson
LiveLink
Documentum
OSI PI
Rapid
iHistorian
Rockwell
GE Fanuc
MES Implementation
Implementation - Phasing
Enterprise Resource Planning
ERP
Weigh & Dispense/Material handling
Packaging
Field Level
Cell Culture
Fill Finish
DCS / PLC
MES Implementation
Project Plan & Resourcing
Resources
Project Plan
Business
External
Steering Group
System Owner
Project Manager
Quality
Tech 1
Manufacturing
Tech 2
Validation
Training SOP
Technical
Proj Val
Report Develop
Overview
General MES Implementation
BiotechSpecific
SpecificChallenges
Challenges
Biotech
Summary
Challenges
A: Complexity of the Process
B: Automation Layer Integration
C: Peripherals and Equipment Interfaces
D: Cut Over in this complex environment
Challenge A
Typical Purification Step
SIP
A
C-4
C-6
V-A
C-1
C-2
V-1
V-2
SIP
B
SIP
C
V-B
C-11
C-13
C-14
Fill_Tank
Xfer Dilute w/WFI
A
PH & Mix
B
Eluate
Can
SIP
E
SIP
D
V-C
C-3
C-10
V-D
V-E
V-3
C-7
V-4
C-8
C-12
SIP
F
Column
Equil/Load
Wash/Elute
SP Kit
C-5
Regen
Store
In Line CIP
Final Docs
Finishing
Portable
Vessel
SIP
Portable
C-15
Reconcile
Complexity of
Process
Challenge A
How to Model This?
Complexity of
Process
One Process Step (part of MBR with 10 Steps)
– 8 Column prep Steps
– 10 Buffers and Solutions
– 7 SIP
– 14 CIP
Challenge A
Plant/Process Model
• Planning and Scheduling
• ERP interface
• One Big WO or many small ones.
– CIP/SIP
– Colum Prep and Filter Prep
– Filter Testing, Integration of FIT
– Buffer and solution prep
– Pooling and splitting
– Batch genealogy
Complexity of
Process
Challenge A
Plant/Process Model
• Management of room and equipment
status.
– Appropriate room/equipment model
Complexity of
Process
Automation Layer
Integration
• Automation Layer Integration
– Batch Structure
– Synchronisation
– Alarms and Events
– RBE
– ‘Light Touch’ or deep integration
– No Material Specific Information at DCS
layer?
– New plant or ‘cut over’
Challenge B
Automation
Layer
Integration
Challenge B
Basic DCS Interface
Active Ingr.
Bulk
Manuf.
Order
Automation
Layer
Integration
EBR Protocol
Mixing
DB
Granulation 1
Routing &
Equipment
Actual Values
Initiate Recipe via ID
Exchange Routing & Equip.-Information
Control DCS Recipe Execution
Tag 1: act. value
Tag 2: act. value
Tag 3: act. value
Alarms
&
Status
via status
tags in
DCS recipes
Paper
on Glass
Manufacturing
DCS with Existing &
Material Specific Recipes
23.11.2009 © Werum Software & Systems AG { 2-3-0-equipment-int-E }
DCS
SCADA
Challenge B
Flexible DCS Interface
MBR
Library
Procedure
Operation
1
1
ERP
Order
Data
Operation
2
Manuf. Order
Operation
1
Operation
2
Procedure
2
Procedure
3
+
Operation
3
Automation
Layer
Integration
EBR Protocol
DB
Batch
Record
Operation
3
MBR
Allocate
Library
Sync
Routing
& SFOs
Library
Procedure 1
Start
Element
1
Element
3
Element
2
End
Procedure n
Start
Element
1
Element
3
End
Element
2
• Actual Values
• Alarms
• Status
Paper on Glass
DCS / PLC
Parameter List
Tag List
Parameter 1.1
Tag 1.1
Parameter 1.n
Tag 1.n
Parameter List
Tag List
Parameter n.1
Tag n.1
Parameter n.n
Tag n.n
Material
independent
unit procedures
Procedure 1
Start
Execution
Element
1
Element
3
Element
2
End
23.11.2009 © Werum Software & Systems AG { 2-3-0-equipment-int-E }
DCS/SCADA
Integration of Batch
Functionality
ERP
MES
Challenge B
Automation
Layer
Integration
Product Definition
Production Definition
Management
Production
dispatching
Production Procedure
Production Database
Bill of Materials
Work-centers
Material Flow Control
Matl-related Data
Bill of Parameters
Storage-related Data
Routing
User-related Data
Equipment Model
Area
Unit
Equipment Module
Operations
Batch Recipe
Recipe Components
Procedures
Procedure Steps
Checklist/Trigger list
Procedure Model
Procedure
Equipment
Parameters
Unit Procedure
Operation
Phase
Materials
Manual Phase Logic
BES
Automated Phase Logic
Level 2 Process Control
Production
execution
Peripherals &
Equipment Interfaces
– HMI/Scanner in Sterile Area
– Sharing HMI with SCADA/DCS
– Printers
– Interface with Test Equipment
• FIT
• Analytical equipment
• Get interfaces from MES vendor or use
middleware?
Challenge C
Peripherals &
Equipment
Interfaces
Peripherals &
Equipment Interfaces
BGA
pH
ViCell
Conductivity
Osmometer
Refractive Index
Challenge C
Peripherals &
Equipment
Interfaces
Cut Over in Complex
Environment
• Cut Over in this complex environment
– Material and Equipment Management in
Hybrid State
– Operator Training
– Schedule disruption
Challenge D
Cut-Over
Overview
General MES Implementation
Biotech Specific Challenges
Summary
Summary
Any Questions?
Presented by
Liam O’Brien
Dermot O’Callaghan contact details:
Mobile:
+353 87 8328905
Email: [email protected]