2D-Mass Serialization For Track Trace and EPedigree Based On 2D Matrix Code RIEDIGER

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
12th to 14th of October / NGP Summit, Amsterdam
Page # 2
Background from Bayer Healthcare perspective
The 2D Matrix Code
Developments in other Countries
Implementing a Mass Serialization System
Project Challenges and Conclusion
Topics
Page # 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 its small size, error
correction, low contrast requirements and the amount of data that can
be encoded compared to one-dimension codes.
Page # 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!
Page # 5
The 2D Matrix Code
Topics
Page # 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
Page # 7
Why is the 2D Data Matrix Code Popular ?
Page # 8
I
Indica
tor
C 1 0 0 0 0 N N N N N N N
Check
Article number (1 to 99999) Marketing authorization owners number(fix)
I
Indica
tor
C 1 0 0 0 0 N N N N N N N
Check
Article number (1 to 99999) Marketing authorization owners number(fix)
Always 0
Id number (GS1) Product Code
GTIN Batch Expiration date Serial 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
Page # 9
The 2D Matrix Code
Topics
Page # 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)
Page # 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
Page # 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
Page # 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
Page # 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
Page # 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
Page # 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
Page # 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
Page # 18
The 2D Matrix Code
Topics
Page # 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)
Page # 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
Page # 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
Page # 22
Bayer Core Solution System Architecture
External DBs (e.g. ITS
Turkey)
Corporate Level
External Level
Local / Site Level
T&T Module MES System
Camera Camera
Company DB
Line Level
Printer
Printer
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)
Page # 23
The 2D Matrix Code
Topics
Page # 24
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
Page # 25
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
Page # 26
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.
Page # 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
Page # 28
Backup
Page # 29
Item
Case/Multi-Pack
(2DMC/RFID)
Aggregation with 2DMC/RFID (parent/child relationship)
Pallet
(2DMC/RFID)
Bundle
Page # 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 symbols
major axes.
Source: Handbook of the Microscan Quadrus verifier
Page # 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 symbols 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
Page # 32
EFPIAs Point of Dispense (PoD) verification concept helps to
improve patient safety
Verification
Dispensing
Patient
Pharma Manufacturer
Unique
Serialization
2D Data
Matrix on 2
nd
pack
Product and Data Flow End-to-End With the EFPIA concept: Centralized Design
Data Transfer
Product
Serialization
Database
Pharmacist/ Hospital
Wholesaler
Product Flow
Wholesaler
Verification
Page # 33
Governance model can be developed as well
based on distributed system design
Verification
Dispensing
Patient
Pharma Manufacturer
Unique
Serialization
2D Data
Matrix on 2
nd
pack
Product and Data Flow End-to-End With the EFPIA concept: Distributed Design
Manufacturer
Database
Pharmacist/ Hospital
Wholesaler
Product Flow
Wholesaler
Verification
Pharmacies
Database
Wholesaler
Database
Data Transfer
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