How to Establish a Future-Proof Serialization
Strategy to Comply with the DSCSA Regulation
Interphex New York, 27th April 2016
Michael Urso, Product Manager Pharma Packaging Solutions
Atlantic Zeiser GmbH, Germany
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World Map of Pharma Counterfeiting
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Reasons to Serialize Medication
Governments
Protect consumers
Protect tax paying industry
Secure tax collection
Reimbursement insurance fraud
Pharmaceutical Industry
Loss of turnover and revenue
Control of returns
Liability claims
Customer complaints
Reputational damage
Protection of patients
Easier recalls
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Status Quo Legislation Worldwide
Turkey – Since 01/2012 – Serialisation + Track & Trace
Data Matrix Code (GTIN, Serial No., Expiry Date, Lot No.)
China – 02/2015 – Governmental Serialisation + Track & Trace
Barcode (NDC 20 Digit Serial No.)
USA – 11/2017 – Serialization + Track & Trace (e-pedigree)
Data Matrix Code (GTIN, Serial No., Expiry Date, Lot No.)
EU – 02/2019 – Serialisation (6 years transition period for Italy, France, Belgium, Greece)
Data Matrix Code (GTIN, Serial No., Expiry Date, Lot No.)
Russia announced (from 2017 until 2019)
Brazil recently paused and postponed
(new date communicated in Spring 2016)
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Difference between Serialization and Track & Trace
Serialization (EU) Track & Trace (US, China, Brasil)
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Serialization – Pre-coding of Flat Folding Boxes
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Serialization – Pre-coding of Labels
Offline Label Printer
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Serialization – Inline Coding of Filled Boxes
Integration Kit
Track & Trace Unit
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Serialization – Inline Coding of Filled Bottles
Inline/Nearline Label Printer
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Which is the best Printing Technology for Label Serialization?
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Limitations of Thermal Transfer Technology
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Wrinkles in the ink ribbon
Solvents
Wear/Abrasion
Limitations of Thermal Transfer Technology
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Thermal Transfer Technology
Low investment, little need of space, not very complex (common technology)
Limited speed, high cost of consumables, frequent exchange of components,
limited resistance of printed information to wear, abrasion and solvents
Laser
No cost for consumables, high durability of printed information
High investment, speed depends on amount of data, pretreatment of substrates
partly required
UV-Inkjet
High printing speed, very durable, relatively low cost of consumables
Higher investment, more need of space and more complex than TT printers
Pro’s & Con’s of different Printing Technologies
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DoD UV-InkjetThermal Transfer
Technology
CO2-Laser Marking
Technology
Printing width (typical range) 12 mm - 210 mm 50 mm - 200 mm 12 mm - 50 mm
Maximal resolution 360 dpi - 720 dpi 200 dpi - 300 dpi Equals approx. 300 dpi
Average grading of a 1D barcode
(Barcode 128 - Module 0,2 mm)A B B
Printing complex graphics Yes Yes Yes but reduces speed
Max. speed 120 m/min 15 m/min 60 m/min
Influence resolution & data on speed None Low High
Durability of printed information on substrate HighLow
(Alcohol, Abrasion)High
Pre-treatment of substratesOnly required for
very smooth surfacesUsually not required
Pre-treatment if dark colour or high
contrast required
Distance printer to substrateShort
(approx. 2 mm)
Physical contact required
(frequent exchange of print bars)> 1 cm
Initial Investment High Moderate High
Cost of consumables
(Reference typical barcode)Aprox 0,60 $ per 1.000 codes Approx 1 $ per 1.000 codes No Consumables
Cost of substrates Low Low Moderate
High print quality, High production
speed, Low operating costsLarge print width, Fair print quality No Consumables
Higher investment
Requirement of space
High operating costs
Low durability of codes on
substrates
Accident-sensitive due to physical
contact with substrate
High investment
Lower speed for complex information
Pre-treatment of material party
required
Summary System Limitations
Performance
Process Relevant Aspects
Cost Aspects
Summary System Advantages
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Dedicated UV-Inkjet System for Serialization of Labels
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Track & Trace – Aggregation to Parent-Child Hierarchies
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Track & Trace – Automatic Aggregation of Filled Boxes
Vision System
Case Packer
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Track & Trace – Semi-Manual Aggregation of Filled Boxes
Manual Loading
Integrated camera
with automatic focus
for multiple layers
Printer for Case Labels
HMI Touchscreen
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Track & Trace – Aggregation of Bottles Approach 1
Reading the serialized label code of each single bottle before being
packed The amount of incoming bottles to fill one case is counted
Bottles need to be rotated during this process and special 360
degree cameras are required that allow reading of moving pictures
Installation and retrofit in existing lines moderately complex
Limited process safety Has the bottle really been packed?
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Track & Trace – Aggregation of Bottles Approach 2
Reading of one entire layer of bottles in the case packer
Additional ”helper codes” on the top or bottom are required
More complex Additional work step to apply the helper code is
necessary
Much higher process safety Each read code has been packed
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Track & Trace – Aggregation of Bottles Approach 2
To apply the required helper codes the serialized labels on the bottle
need to be read in a previous work step
Subsequently the helper code is applied and merged to the primary
code
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Track & Trace – Aggregation of Bottles Approach 2
All-in-One modules available that can print serialized labels, attach
labels and print a helper code (e.g. from Herma)
Integration of necessary components into existing lines possible
(cameras, printers, rejects)
Alternatively pre-printed caps
can also be used Merging
still necessary
Herma 132M HC - Courtesy of Herma GmbH
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Regardless of the chosen approach in most cases automatic case
packers need to be retrofit with the following equipment
Print case labels
Apply case labels
Verify case labels
Reject cases
Always consider a possibility to rework faulty cases
No automatic process is 100% failure proof
Booking out/in of single items and entire cases should be possible
Track & Trace – Aggregation of Bottles General
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The Base – Management of Serialization Data
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The Main “Concerns” of Pharma Companies
Source: IQPC Research
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Overview – DSCSA Regulation
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The Challenge – Simultaneous Production on Multiple Lines
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The Real Challenge – Exporting to Different Markets
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The Solution – Central Serialization Database on Level 3 & 4
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ISA95 Level
Level 1
Management of single machines/modules in a packaging line
“Machine Level”
Level 2
Entire packaging line “Line Level”
Level 3
Multiple lines “Plant Level”
Level 4
Multiple plants “Enterprise Level”
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Reasons to Implement a Central Solution on Level 3 & 4
Generation of unique codes for different products in different markets
with different regulations on multiple production lines or sites
Distribution and monitoring of serialisation jobs over one or more
lines or sites at the same time Production Management Platform
Management of external partners such as CMOs
Generation of aggregation hierarchies (e-pedigrees) for compliance
purposes or management of logistical processes (repacking, returns
of goods, callbacks etc.)
Forwarding of serialization data and pedigrees to hubs and supply
chain
Safe and reliable data repository of large data volumes for longer
periods
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Data Flow – Architecture and Links on Level 3 & 4
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Level 4
Controls and monitors all level 3 systems (sites/plants)
Controls and monitors CMOs
Exchanges data with the company ERP-System
Exchanges data with customers (wholesalers)
Central data repository for serial numbers & aggregation hierarchies
Exchanges data with country hubs and generation of e-pedigrees
Level 3
Controls and monitors packaging lines
Controls and monitors local CMOs
Receives order specific serial numbers form level 4
Reports production results to level 4
Data exchange with local ERP-System
Data Flow – Architecture and Links on Level 3 & 4
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Pool Management – Administration of Serial Numbers
Level 4
Level 3
ProductsHeadache123
500 mg
Headdache123
500 mg
Headdache123
500 mg
Headache123
1.000 mg Forte
Market Germany USA China UK
Product Definition GS1 with EXP. and LOTGS1 with EXP. and LOT
Aggregated / Pedigree
Barcode 20 digits
AggregatedGS1 with EXP. and LOT
Data Reporting EU Data Hub E-PedigreeData Broker
(Chinese Ministry of Health)EU Data Hub
Production Site No.1 Germany Production Site No.2 UK
Headquarter USA
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Site UK
Pool Management – Administration of Serial Numbers
Pool China
Pool USA Pool EU
Headquarter US
Result
Serial Numbers
Results
Ord
ers
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Example of a Process Workflow on Level 3
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Summary – How a suitable solution should look like
Possibility to interface existing machinery (Level 2)
Possibility to virtually administrate lines and machines (Level 3)
Central generation and recollection of serial numbers for subsequent
process steps (aggregation, rework or commissioning)
Free definition of products and workflows without programing (data,
aggregation levels, capabilities of machines)
Modular solution (extendable from a pilot line to “Enterprise Level”)
Generic interfaces with ERP-Systems (SAP etc.)
Interfaces with national and supranational hubs and possibility to
adapt them with minimal effort
High level security architecture and encryption of data
Easy and secure user management and generation of Audit-Trails
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Modular System Architecture of MEDTRACKER
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MEDTRACKER – Modules for Serialisation & Aggregation
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A Typical Schedule to equip a Pilot-line
Analyze
need
Select
a partner Supply phase
Installation
& training
Run up
incl. risk
buffer
4 Months 6 Months 6 Months 4 Months 5 Months
TIME IS SHORT!!!
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For more insight check the following websites
www.serializepharma.com
www.pack-and-trace.com
Atlantic Zeiser GmbH | Bogenstrasse 6-8 | 78576 Emmingen | Germany
www.atlanticzeiser.com
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