Fake products can have fatal consequences for consumers. For manufacturers, counterfeits result in severe damage to their reputation and in high expenses. Growing volumes of Internet sales are one reason for the rise of fake products. Production outsourcing and longer supply chains also provide more opportunities for counterfeit products to enter the market. And still, many go undetected. To make the supply chain safer, worldwide laws regulating the serialization, aggregation and traceability of products have come – or will come – into force. While Pharma regulatory are already established in the most markets, Food is currently implemented in Russia for example. Fast delivery of machines and software in the shortest possible time as well as years of experience in Track & Trace are essential for critical products like vaccines, which in some cases have to be specially cooled during production and in the cold chain.
Track & Trace – What is it about?
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Serialization
Serialization means the assignment of a unique serial number to each saleable unit. Relevant information about the origin, batch number and expiration date of the product are linked and retrievable through the entire supply chain - from production to retail distribution to the final dispensation to the patient.
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Checkweighing
The cartons are checkweighed to avoid undesirable weight deviations within a batch. Cartons with discrepancies are rejected.
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Tamper Evident Labelling
Each product needs at least one indicator or barrier to entry which - if breached or missing - shows the consumer that tampering has occurred.
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Bundle Aggregation
Aggregation is about creating parent-child-relationships between single packs and bigger sales units. The serialized single packs are summarized to bigger sales units (e. g. bundles) which are then also serialized.
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Case Aggregation
Single units or bundles are packed in cases. Every case receives an unique identifier (serial number). Every single unit („child“) is linked to this case serial number („parent“)
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Pallet Aggregation
Cases are packed in pallets. Every pallet receives an unique identifier (serial number). Every case („child“) is linked to this pallet serial number („parent“)
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Connectivity
Track & Trace stands for linking machines with IT, and data exchange at all levels - Data have to be shared with other sites global and international, as well as with governmental institutions.
Regulations
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European Union
EUROPEAN UNION
SERIALIZATION
Deadline: February 09, 2019
Data carrier: Data Matrix ECC200
Data elements:
– Unique product identification number (e.g. GTIN/NTIN/PPN) (AI 01)
– Batch/Lot number (AI 10)
– Expiry date (AI 17)
– Serial number (AI 21 National reimbursement number (if applicable)AGGREGATION
– Not mandatory -
Russia
RUSSIA
SERIALIZATION
Deadline: July 2020
Data carrier: GS1 Data Matrix ECC200
Data elements:
– GTIN (AI 01)
– Serial number (AI 21)
– Batch/Lot number (AI 10)
– Expiry date (AI 17)
– Additional item identification (AI 240)
AGGREGATION
Deadline: July 2020
Data carrier: GS1 128
Data elements:
– Manufacturers and wholesalers (members of GS1 Russia): SSCC (AI 00)
– Manufacturers only: sGTIN: GTIN (AI 01) and serial number (AI 21) -
Brazil
BRAZIL
SERIALIZATION
Deadline: August 01, 2018 (3 batches); April 01, 2022 (all products)
Data carrier: Data Matrix ECC200
Data elements:
– GTIN (AI 01) or national number (NHRN) (AI 713)
– Expiry date (AI 17)
– Batch/Lot number (AI 10)
– Serial number (AI 21)
AGGREGATION
Deadline: August 01, 2018 (3 batches) April 01, 2022 (all products)
Data carrier: Possibly GS1 128
Data elements:
– Possibly SSCC (AI 00) -
USA
USA
SERIALIZATION
Deadline: November 27, 2017
Data carrier: Data Matrix ECC200
Data elements:
– GTIN (AI 01)
– Serial number (AI 21)
– Expiry date (AI 17)
– Batch/Lot number (AI 10)
AGGREGATION
Deadline: November 01, 2023 -
Middle East
EGYPT
Serialization
Deadline: June 01, 2018
Data carrier: GS1 Data Matrix ECC200
Data elements:
– GTIN (AI 01)
– Expiry date (AI 17)
– Batch/Lot number (AI 10)
AGGREGATION
Deadline: June 01,2018
Data carrier: GS1 128
Data elements: SSCC (AI 00)JORDAN
BATCH CODING
Deadline: July 01, 2018
Data carrier: GS1 Data Matrix
Data elements:
– GTIN (AI 01)
– Expiry date (AI 17),
– Batch/Lot number (AI 10)
SERIALIZATION
Deadline: January 01, 2020
Data carrier: GS1 Data Matrix
Data elements:
– GTIN (AI 01)
– Serial number (AI 21)
– Expiry date (AI 17)
– Batch/Lot number (AI 10)
AGGREGATION
– Not mandatoryLEBANON
Serialization
Deadline: December 2019
Data carrier: GS1 2D DataMatrix
Data elements:
– GTIN (AI 01)
– Expiry date (AI 17)
– Batch/Lot number (AI 10),SAUDI ARABIA
BATCH CODING
Deadline: March 21, 2017
Data carrier: GS1 Data Matrix ECC200
Data elements:
– GTIN (AI 01)
– Batch/Lot number (AI 10)
– Expiry Date (AI 17)
SERIALIZATION
Deadline: March 12, 2017
Data carrier: GS1 Data Matrix ECC200
Data elements:
– GTIN (AI 01)
– Serial number (AI 21)
– Batch/Lot number (AI 10)
– Expiry date (AI 17)
AGGREGATION
Deadline: March 31, 2020
Data carrier: GS1 128
Data elements: –SSCC (AI00) -
South Africa
SOUTH AFRICA
SECONDARY PACKAGING
BATCH CODING
Deadline: September 01, 2020
Data carrier: GS1 DataMatrix
Data elements:
– GTIN (AI 01)
– Batch/Lot Number (AI 10)
– Expiry date (AI 17)
SERIALIZATION
Deadline: June 30, 2022
Data carrier: GS1 DataMatrix
Data elements:
– GTIN (AI 01)
– Batch number (AI 10)
– Expiry date (AI 17)
– Serial number (AI 21)
TERTIARY PACKAGING
BATCH CODING
Deadline: December 30, 2018
Data carrier: GS1 128 Linear Barcode or GS1 Data Matrix
Data elements:
– GTIN (AI 01)
– Batch/Lot number (AI 10)
– Expiry date (AI 17),n
AGGREGATION
Deadline: June 30, 2022
Data carrier: GS1 128 or GS1 Data Matrix
Data elements:
– GTIN (AI 01)
– Batch number (AI 10)
– Expiry date (AI 17)
– Serial number (AI 21) -
South Korea
SOUTH KOREA
BATCH CODING
Deadline: January 01, 2013
Data carrier: GS1 Data Matrix ECC200 or GS1 128
Data elements:
– KDC (Korean Drug Code/NTIN) (AI 01)
– Expiry date (AI 17)
– Batch/Lot number (AI 10)
SERIALIZATION
Deadline: January 01, 2016
Data carrier: GS1 Data Matrix ECC200 or GS1 128 or RFID
Data elements:
– KDC (Korean Drug Code/NTIN) (AI 01)
– Serial number (AI 21)
– Batch/Lot number (AI 10)
– Expiry Date (AI 17)
AGGREGATION
– Not mandatory -
Japan
JAPAN
SERIALIZATION
Deadline: July 01, 2015
Data carrier: GS1 DataBar Limited Composite Symbol CC-A GS1 DataBar Stacked Composite Symbol CC-A GS1 DataBar Limited or GS1 DataBar Stacked
Data elements:
– Product Code (14-digit code consisting of the JAN – Japanese Article Number) (AI 01) = uniform commodity code [UCC]
– Expiry date (AI 17)
– Batch/Lot number (AI 10)
– Serial Number (AI 21),
AGGREGATION
Deadline: April, 2021
Data carrier: GS1-128-Barcode
Data elements:
– Product Code (14-digit code consisting of the JAN (Japanese Article Number))
– Expiry Date
– Quantity
– Batch / Lot or serial number -
Indonesia
INDONESIA
SERIALIZATION
Deadline: January 1, 2023 (Only drugs with secondary packaging and drugs packed in bottles > 5 ml volume
Data carrier: QR code issued by BPOM or own 2D data carrier which is published independently (can be however must not be DataMatrix)
Data elements:
– Product Edition Permission Number (AI 90)
– Batch number (AI 17)
– Expiry date (AI 10)
– Serial number (AI 21)
– ID of Production Facility (AI 91)
OUR SOLUTIONS
Serialization, Aggregation and Data Handling: From carton to pallet - flexible in-line and stand-alone solutions
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Serialization
- Aggregation
- Data Management System
CPI – Connected Packaging IT-Solutions
Track & Trace stands for linking machines with IT, and data exchange at all levels. To prevent lock-in effects, open platforms and the usage of standardized interfaces is very important. Beyond classical Track & Trace the data can be used for further benefits like shopfloor digitalization, data analysis, OEE improvements and Industry 4.0 This requires powerful software solutions – the Syntegon CPI portfolio is the answer.
CPI – Connected Packaging IT-Solutions
- CPI Level 3 Suit is a powerfull software suite located on Level 3 for conveniert handling of all lines in a site and to automatically connect the Level 2 systems with Level 4 systems like ERP and others
- Enhanced Master Data and Serial Number management
- Parallel communication with several systems and interfaces possible
- Modern Industry 4.0 applications to increase OEE and minimize TCO
CPI SODA – Single Objects Data Acquisition
- Today serialization starts with serialization of the smallest sales unit, often this sales units contains several single units (vials, containers, blister, syringes, etc.)
- All machines in different lines provide a large amount of data, e.g. IPC data, filling or inspection data, quality control data, other system data, etc. but today there is no link of machine data to single units in the production/processing, filling, inspection and packaging lines
- SODA (Single Objects Data Acquisition) is using and linking data to single units. The single units are already serialized from the beginning of production/processing and tracked till the end of line(s)
CPI Line Manager – Single Point Line Management and Automation
- The CPI line manager connects all machines in a line to a single point to reduce number of required operators and to eleminate causes of errors and costs by line automation
- An operator is able to controll the whole line from this single point
- Import/Export data from upper systems
- Transfer data to/from machines by OPC UA and other standardized interfaces
- Material verification and automatic quality samples reject
- Live line status overview and dashboard visualization
- Seamless line batch report afte production and many more functionalitites
CPI Machine Monitoring – Machine Data Acquisiton, Visualization and Analysis
- All machines provide a lot of data points. If the data are not monitored and collected, there´s a lack of transparency and no potential for improvements for example
- Real time monitoring of machine data like status, speed, operator, output, reject rate, temperature, etc.
- Storage of machine data in a database and analysis as well as alarm functionalities
We are very satisfied with the Syntegon solution. The machines not only have a compatible design but also run with minimum downtime and highest efficiency. Syntegon provided us with exactly the solution we needed for all serialization requirements.
Ayman Abusalem
MENA Technical Purchasing Manager at Hikma PharmaceuticalsWe provide solutions that excite!
- Flexible in-line and stand-alone equipment
- Standardized and customized solutions
- High usability, excellent user experience and low training requirements for operators
- Low TCO: reduced downtime and rejects, fast format changes, easy maintenance
Get in touch with us!
We´re looking forward to get in contact with you and provide you with further information about Track & Trace! Please contact:
Syntegon Technology GmbH
Stuttgarter Straße 130
71332 Waiblingen
Phone: +49 7151 14 0
E-mail - Aggregation
