Post on 23-Aug-2020
A sense of urgency......are you ready to meet the
Track & Trace deadline?
Laetus S-TTSSecure Track & Trace Solutions
Carlos Guidobono, Sindusfarma, Sao Paulo 2014.Area Sales Manager Laetus GmbH
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Source:
Secure Track & Trace SolutionsWhich systems for traceability do we focus on?
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Emerging Pharmaceutical LegislationWe start seeing “the wall”
20xx 2010 2011 2012 2013 2014 2015 2016 2017
Pharma Track & TraceUnderstand the Magnitude & Complexity
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Pharma Track & Trace
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Serialisation Aggregation
IT-Datamanagement
The complexity of a Track & Trace architecture is based on three main issues.
OEE!
Magnitude & ComplexityGet ready for some truly interdisciplinary project teams
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T&T
Corporate IT
ERP / MES
Devices / Machines
Documentation
ProcessesValidation
Project Engineer
Support
Production / OEE
Comprehensive T&T System SolutionsFully embedded, highly complex, customized with real-time IT needs
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T&T software architectureModular, flexible, scalable and GAMP-compliant
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ISA 95 StandardsThe international nomenclature
Level 3Plant & Warehousing
Level 2Line Management
Level 1Cell Management
Level 0Hardware Device Level
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3 Level Secure Track & TraceS-TTS´ 3 levels cover all ISA 95 needs
Level 4Interfaces
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CLevel 1 – Cell configurations on demandEasily adapted to different packaging levels
SerializationCM&V
AggregationC
I-M&V
CIC-M&V
InspectionCI
CM&V
CI - M&V
CIC - M&V
CI - M&V
CI - M&V
Configuration example for serialization & multi-level aggregation (to comply with: Anvisa Brazil, California e-Pedigree)
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LLevel 2 – Line autonomyConfigure and manage each line to meet production needs
Level 3
Level 4
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• Production order data, billof material, shipping orderdata
• Serial codes forcode poolhandling • SAP AII, SAP OER, Werum Pas-X,
IBM, Rockwell, Oracle, Kezzler,customized (e.g. EPICS based)
• Code requests• List of used codes • Productionstatistics andcounters
• Aggregation list
Level 3 – Plant controlMaintain a single point of DB management P
P
ERP / MES
Level 3
Level 3
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• Download of data fromrunning or finishedproduction order
• De-Aggregation and Re-Aggregation
• Upload of newaggregation tree toLevel 3 (PlantManagement)
Level 3 – Warehouse managementThe starting point for a secure supply chain management W
W
P
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Secure Track & Trace SolutionsLaetus turn-key solutions, OEM machines or retrofits
Flexibility to integrate S-TTS in any kind of packaging machines
Laetus MV-XX machinesNew machinesRetrofit of legacy machines
Multiple solutionsAt-Line (stand alone) In-Line (MV-XX module integration into line layout)On-Line (integration into packaging machines)
• Serialization at single packaging line:
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Secure Track & Trace SolutionsFrom easy to complex architecture
• See Laetus machinery portfolio• S-TTS Express SW package installed on
one machine:• S-TTS Plant Express License and
USC Generator• S-TTS Line License• S-TTS Cell License (Serialisation)• Additional S-TTS Cell License Aggregation
• Serialization & Aggregation at “n” packaging lines:
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Secure Track & Trace SolutionsFrom easy to complex architecture
• Just add the Serialization and Aggregation cells to the existing architecture!
• Manage the level of aggregation via numbers of aggregation cells along the packaging line.
1 2 3 n
Aggr Aggr Aggr Aggr
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Overview Laetus S-TTS portfolioMV-50 and MV-70 systems for carton marking
MV-50, the most compact T&T cellOnly 0.5 m line space neededSimple and secure operationFront or backside printing
MV-70, the most versatile T&T cellAll kinds of printing technologies (TIJ, DOD, Laser)Labeling and/or Tamper-evident modulesAll side printing (back, front and top)
Stand alone or inline operationAutomated reject integrated
Overview Laetus S-TTS portfolioCS-60 Manual Hand Packing module
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CS-60• COMMANDER Station • Desktop label printer • MMI • Hand Help Scanner
Overview Laetus S-TTS portfolioIM-410 Semi-Automatic Aggregation module
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IM-410 •Semi automatic aggregation for cases and bundles •Large work area•IHM•Printer•Hand Held Scanner
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Overview Laetus S-TTS portfolioIM-400 Hand Packing and Warehouse module
Movable all-in-one station for manual aggregation
Easy to use hand packing stationIn warehousesAt wholesalers
Multiple child codes reading via integrated camera system
Efficient operation due to dedicated HMI
• Pharma companies
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References of our Customer BaseLaetus is a trusted Partner worldwide
• OEM’s• Other industries
…and many others
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Secure Track & Trace SolutionsThe S-E-C-U-R-E way with Laetus as your partner
Strong and experienced partner with proven T&T solutionEasy expandable and configurable solution portfolio
from SAP interface to barcode reader
Competent and global project management team
User friendly and easy operating concept
Reliable service support – locally, all around the world
Embedded in financially strong group
www.securetrackandtrace.com
Thank you
Get started now……time is running out!
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Laetus: Your partner for T&T solutions