Mass Serialization for Track & Trace and ePedigree … Serialization for Track & Trace and ePedigree based on 2D Matrix Code Christian Riediger, SCM Bayer Schering Pharma ... •Develop

Mass Serialization for Track &

Trace and ePedigree based on

2D Matrix Code

Christian Riediger, SCM Bayer Schering Pharma

Biotech Supply Chain Academy, San Francisco, 26th of October 2010

Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 2

• Background from Bayer Healthcare perspective

• The 2D Matrix Code

• Developments in other Countries

• Implementing a Mass Serialization System

• Project Challenges and Conclusion

Topics


Animal Health (2005):

IFAH (International Federation for Animal Health) has agreed on a

unique worldwide identification principle for animal health products.

Data Matrix ECC200 was selected because of it„s small size, error

correction, low contrast requirements and the amount of data that can

be encoded compared to one-dimension codes.

Background from Bayer Healthcare perspective


Background from Bayer HealthCare perspective

Pharma (2007):

*EFPIA = European Federation of Pharmaceutical Industries Associations

Under the presidency of A. Higgins (former CEO of Bayer HealthCare), the EFPIA*

working group “Distribution” has worked out an identification system for

prescription drugs composed of a standard serialized 2D Data Matrix Code on unit

pack level and a database system accessed by all relevant parties in the supply

chain to verify the integrated serial number.

With this system, the following goals shall be

achieved:

- Raise the hurdles for counterfeiting of

medicines

- Product verification on the point of dispense

- Limit reimbursement fraud

- Unify coding systems across the EU

Ultimately, the aim is to enhance security for

patients!







Topics


The 2D Matrix Code (ECC 200)

Technical Details

• Full ASCII character set

• Datacapacity: 1 to 2335 characters

• Variable, data-dependent size

• ECC200 - Reed Solomon Error Correction

(the code can be up to 25% defective)

• Defined boundary line as identifier


Why is the 2D Data Matrix Code Popular ?


I

Indica

tor

C10000NNNNNNN

CheckArticle number (1 to 99999)Marketing authorization owner’s number(fix)

I

Indica

tor

C10000NNNNNNN

CheckArticle number (1 to 99999)Marketing authorization owner’s number(fix)

Always 0 Id number (GS1) Product Code

GTINBatchExpiration dateSerial number

Product identification Global Trade Item Number (GTIN)

With Application Identifier (AI) 01

Example: (01)01234567890128

Batch Number


Example: (10)KP12345

Expiration Date


Example: (17)090800

Format: (17)YYMMDD

Serial number unique, fraud resistant


Example: (21)245673291386

Randomized serial number (up to 20 chars),

cryptographically secured

• Code version: 24x24 modules

• Size on product: appr. 9x9mm

The EPFIA proposed content of the 2D Matrix Code







Topics


Turkey

• It is obligatory for any product manufactured after 01/01/2010 to bear a 2DMC Code

- regulation regarding packaging & labeling of medicinal products for human use

• Target is to reduce counterfeits and reimbursement fraud

• Database owned and managed by Turkish health authorities

• Phase 1: corresponding to EFPIA coding proposal for unit packs

- readiness achieved in 2009, mass serialization started beginning of 2010

• Phase 2: additionally, full aggregation is required by 01/2011

- allow traceability over the whole supply chain

- postponement expected (no data interchange concept defined up to now)


France

• The French Agency for the Safety of Health (AFSSAPS) decided

- to extend the product code (CIP) from CIP 7 to CIP 13 characters

- to switch from Code 39 to DataMatrix (transition period until 2011 regulated)

• 2D Matrix Code mandatory from 31/12/2010 for all pharmaceutical products (Rx & CC)

- content of the code:

• batch number

• expiration date

• CIP 13 no. (product number)

no serial number required


Brazil

• Brazilian law calls for serialization with a 2D Matrix code on security labels

• Implementation timelines (06/2010) have been removed by health authorities

(ANVISA), evaluation of alternatives ongoing (inline printing vs. labelling)

• National Pharma association (INTERFARMA) strongly lobbying to avoid labels,

discussions ongoing

25 mm

19 mm


China

• Linear EAN/UCC-128 “Surveillance Code” 20 digit randomized number to identify each

package of the finished product. Aggregation (shipper, pallet) required.

• Currently only traditional Chinese medicine, but implementation timelines of max. 6 month

expected.

• Expected timelines (not declared and finalized by authority)

- 2010: antibiotic products and injections which are covered in national essential drug list

- 2011: the rest of products in the national essential drug list

- 2012: all locally produced products will be covered


Korea

• Introduction of Code 128 (linear Barcode or 2D Matrix Code) by Jan 2012

• Content of the code (similar to France):

- GTIN (Global Trade Item Number),

- Batch number

- Exp. date

• Timelines:

- Special Designations: Jan1, 2012

- All prescriptions except OTC and Orphan drugs, Jan1, 2013

• Ministry of Knowledge Economy (MOKE) explained that they plan to implement

RFID to 50% of the products by 2015, implications to be clarified


USA

• Californian ePedigree postponed for 50% of all pharmaceuticals to 2015 & to

2016 for remaining 50%

• FDA provided final guidance for product serialization on March 26, 2010

- no implementation timelines defined for a federal law

- no data carriers defined (e.g. 2D Matrix Code, RFID)

- SNI for most prescription drugs should be a serialized NDC code (sNDC)

Format:

• Variable data (batch number, expiry date) not officially requested


EFPIA Pilot Sweden - Overview and Key Figures

• Pilot project successfully completed

• Key figures

- 25 pharmacies in the greater Stockholm area (owned by

Apoteket AB) with a total of 180 dispensing points

- 25 products (SKUs) with total of 110.000 packs

- 14 manufacturers

• Operational phase

- 4 months: 17 Sept 2009– 29 Jan 2010

• Excellent technical results

- Response time 99,7% < 1 sec,

- Minor issues regarding work flow in pharmacies

- Positive feedback from pharmacists


EFPIA – Way Forward

• Continue discussions with stakeholders on European level

• Develop strategy for implementation of expected requirements

- conduct survey to understand different market conditions

- develop appropriate governance models for different markets

- develop strategy for communication with stakeholders in different markets







Topics


BHC Core System

• Due to the upcoming legal requirements for mass serialization with 2D Matrix

Code in different countries, a BHC core system has been developed with the

following components:

- A central database to generated and store unique serial numbers

- A middleware to connect the line equipment (printer/camera) to the

central system, enabling autonomous operation of the production sites

- A line controller system to handle mass serialization on each single

production line (SKU level)


Implementing a Mass Serialization System (spec.)

• Centrally generated serial numbers to avoid company internal duplicates and to

improve security by validating the incoming serial numbers (Contract

Manufacturer Interface)

• To prevent a serial number run-off, unused/free serial numbers should be stored

on all production plants by using a buffer of the central system on each plant

• The global system should be connected to the government databases

• The system should be fully integrated to the shop floor level

• Autonomous operation without continuous connection to higher layer system to

overcome network interruptions


• Decision criteria for the system selection

- Performance (max. 400 cycles / min)

- Print Quality (ISO Grade C at 400 cycles/min)

- The system components can be integrated in a production line or installed as

a separate fully equipped conveyor belt

- Compatibility with system architecture

BHC Core Solution – Standard Line Equipment

../../../../../../Temp/notes2D6091/Temp/notes2D6091/Temp/Local%20Settings/Temp/notesE6D35A/ENTW61786~00%202008-06-24.EASM


Bayer Core Solution – System Architecture

External DBs (e.g. ITS

Turkey)

Corporate Level

External Level

Local / Site Level

T&T ModuleMES System

Camera Camera

Company DB

Line Level

PrinterPrinter

Single Unit / Line Controller

ERP System

Warehouse Connection(Commissioning devices)

Central creation and storage

of unique randomized serial numbers

Handheld

Scanner

Contract Manufacturer(External serial number

management)







Topics


Project Challenges and Conclusion

• Harmonize all relevant parties in the overall project

- Artwork changes of packaging material

- Handling of imported products (pre-printing/printing in the relevant country)

- Integrate partner companies (Contract Manufacturer)

- Setup of the IT infrastructure for the equipment installations

- Timing of the line equipment installations to minimize production

downtimes

• Find position & space in legacy lines

• Optimize the inkjet printer in regard to a good printing contrast



• Selection of the right carton quality due to the printing on a lacquer

free area / raw area –> tapering of the ink

• Space problems on small folding boxes (Turkish requirements)

- exact positioning required

- it is not possible to print an OCR font for the human readable data on all

folding boxes



• Due to the ongoing moving target, this is a very challenging project.

- California ePedigree law (postponement 01/2009 ->01/2015)

- Turkey (postponement 01/2009 -> 06/2009->01/2010)

- Brazil (01/2012) ?

- Spain, China, Korea, … ?

• Bayer is prepared to install the system for all relevant countries and

supports/drives the idea of one harmonized coding solution worldwide.


Christian Riediger

_________________________________________

Bayer Schering Pharma AG

PS PH Supply Chain Management

Supply Strategy & Optimization

E-mail: [email protected]

Internet: http://www.bayerscheringpharma.de


Backup


Item

Case/Multi-Pack

(2DMC/RFID)

Aggregation with 2DMC/RFID (parent/child relationship)

Pallet

(2DMC/RFID)

Bundle


Qualification of the 2D Matrix Code ISO 15415 Evaluation Parameters

• Symbol contrast- Symbol Contrast is the value difference between light and dark symbol

elements, and between the quiet zone and perimeter elements.

• Fixed Pattern Damage

- Fixed Pattern Damage refers to finder pattern and clock pattern damage.

• Axial Non-Uniformity - Axial Non-Uniformity is the amount of deviation along the symbol‟s

major axes.

Source: Handbook of the Microscan Quadrus verifier


Qualification of the 2D Matrix Code ISO 15415 Evaluation Parameters

• Grid Non-Uniformity

- Grid Non-Uniformity refers to cell deviation from the theoretical or “ideal” grid

intersections as determined by the reference decode algorithm.

• Modulation- Modulation refers to the reflectance uniformity of a symbol‟s light and

dark elements.

• Unused Error Correction Capacity- Unused Error Correction Capacity indicates the amount of available

error correction in a symbol. 100% Unused Error Correction capacity is ideal.

Source: Handbook of the Microscan Quadrus verifier


EFPIA‟s Point of Dispense (PoD) verification concept helps to

improve patient safety

Verification

Dispensing

PatientPharma Manufacturer

Unique

Serialization

2D Data

Matrix on 2nd pack

Product and Data Flow End-to-End With the EFPIA concept: Centralized Design

Data Transfer

Product

Serialization

Database

Pharmacist/ HospitalWholesaler

Product Flow

Wholesaler

Verification


Governance model can be developed as well

based on distributed system design

Verification

Dispensing

PatientPharma Manufacturer

Unique

Serialization

2D Data

Matrix on 2nd pack

Product and Data Flow End-to-End With the EFPIA concept: Distributed Design

Manufacturer

Database

Pharmacist/ HospitalWholesaler

Product Flow

Wholesaler

Verification

Pharmacies

Database

Wholesaler

Database

Data Transfer

optional

Documents

Mass Serialization for Track & Trace and ePedigree … Serialization for Track & Trace and ePedigree based on 2D Matrix Code Christian Riediger, SCM Bayer Schering Pharma ... •Develop