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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
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 3
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
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 4
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!
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 5
• Background from Bayer Healthcare perspective
• The 2D Matrix Code
• Developments in other Countries
• Implementing a Mass Serialization System
• Project Challenges and Conclusion
Topics
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 6
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
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 7
Why is the 2D Data Matrix Code Popular ?
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 8
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
With Application Identifier (AI) 10
Example: (10)KP12345
Expiration Date
With Application Identifier (AI) 17
Example: (17)090800
Format: (17)YYMMDD
Serial number unique, fraud resistant
With Application Identifier (AI) 21
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
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 9
• Background from Bayer Healthcare perspective
• The 2D Matrix Code
• Developments in other Countries
• Implementing a Mass Serialization System
• Project Challenges and Conclusion
Topics
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 10
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)
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 11
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
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 12
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
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 13
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
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 14
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
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 15
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
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 16
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
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 17
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
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 18
• Background from Bayer Healthcare perspective
• The 2D Matrix Code
• Developments in other Countries
• Implementing a Mass Serialization System
• Project Challenges and Conclusion
Topics
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 19
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)
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 20
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
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 21
• 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
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 22
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)
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 23
• Background from Bayer Healthcare perspective
• The 2D Matrix Code
• Developments in other Countries
• Implementing a Mass Serialization System
• Project Challenges and Conclusion
Topics
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 24
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
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 25
Project Challenges and Conclusion
• 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
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 26
Project Challenges and Conclusion
• 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.
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 27
Christian Riediger
_________________________________________
Bayer Schering Pharma AG
PS PH Supply Chain Management
Supply Strategy & Optimization
E-mail: christian.riediger@bayerhealthcare.com
Internet: http://www.bayerscheringpharma.de
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 28
Backup
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 29
Item
Case/Multi-Pack
(2DMC/RFID)
Aggregation with 2DMC/RFID (parent/child relationship)
Pallet
(2DMC/RFID)
Bundle
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 30
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
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 31
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
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 32
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
Biotech Supply Chain Academy, San Francisco, 26th of October 201012th to 14th of October / NGP Summit, AmsterdamPage # 33
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
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