how to establish a future-proof serialization strategy to comply with the dscsa regulation

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

Atlantic Zeiser | Interphex – New York | April 2016 |

World Map of Pharma Counterfeiting


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


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)


EU – 02/2019 – Serialisation (6 years transition period for Italy, France, Belgium, Greece)


Russia announced (from 2017 until 2019)

Brazil recently paused and postponed

(new date communicated in Spring 2016)


Difference between Serialization and Track & Trace

Serialization (EU) Track & Trace (US, China, Brasil)


Serialization – Pre-coding of Flat Folding Boxes


Serialization – Pre-coding of Labels

Offline Label Printer


Serialization – Inline Coding of Filled Boxes

Integration Kit

Track & Trace Unit


Serialization – Inline Coding of Filled Bottles

Inline/Nearline Label Printer


Which is the best Printing Technology for Label Serialization?


Limitations of Thermal Transfer Technology


Wrinkles in the ink ribbon

Solvents

Wear/Abrasion

Limitations of Thermal Transfer Technology


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


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


Dedicated UV-Inkjet System for Serialization of Labels


Track & Trace – Aggregation to Parent-Child Hierarchies


Track & Trace – Automatic Aggregation of Filled Boxes

Vision System

Case Packer


Track & Trace – Semi-Manual Aggregation of Filled Boxes

Manual Loading

Integrated camera

with automatic focus

for multiple layers

Printer for Case Labels

HMI Touchscreen


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?



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



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



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


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


The Base – Management of Serialization Data


The Main “Concerns” of Pharma Companies

Source: IQPC Research


Overview – DSCSA Regulation


The Challenge – Simultaneous Production on Multiple Lines


The Real Challenge – Exporting to Different Markets


The Solution – Central Serialization Database on Level 3 & 4


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”


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


Data Flow – Architecture and Links on Level 3 & 4


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


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


Site UK

Pool Management – Administration of Serial Numbers

Pool China

Pool USA Pool EU

Headquarter US

Result

Serial Numbers

Results

Ord

ers


Example of a Process Workflow on Level 3


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


Modular System Architecture of MEDTRACKER


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!!!


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

© ATLANTIC ZEISER GmbH reserves all rights including industrial property rights and all rights of disposal such as copying and passing on to third parties.

how to establish a future-proof serialization strategy to comply with the dscsa regulation

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