Track and Trace Solutions

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.

OUR SOLUTIONS

Serialization, Aggregation and Data Handling: From carton to pallet - flexible in-line and stand-alone solutions

  • Serialization
  • Aggregation
  • IT Solutions

    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
  • Pharma

    Track & Trace solutions in the pharmaceutical industry for anti counterfeiting

    High safety standards apply to pharmaceuticals, and not only with regard to the substances used. In order to effectively eliminate health and economic threats posed by product piracy and counterfeiting, the legal requirements for serialization and aggregation of pharmaceutical packaging are becoming increasingly stringent.

    regulations for pharma

    Worldmap in shades of green
    • European Union
      Worldmap europe

      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
      Worldmap 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
      Worldmap 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
      Worldmap 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
      Worldmap 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 mandatory

      LEBANON

      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 (AI 00)

       

       

    • South Africa
      world map 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
      World map 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
      world map 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
      World map 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)

    Syntegon Track & Trace Pharma systems are not only made to meet the highest standard of quality, but are also flexible and modular. The portfolio covers hardware and software from Level 1 to Level 3 for Track & Trace as well as Industry 4.0 shopfloor digitalization and line packaging solutions for companies of all sizes. These systems can be easily integrated into third party Track & Trace environments. Setup and operating costs are reduced by the usage of standardized interfaces like OPC UA and Open-SCS. The benefits for customers are fast integration, interoperability of different systems and no lock-in to one supplier. Syntegon is part of the Open-SCS working group Steering Committee. Based on decades of experience, Syntegon can refer to numerous successful projects across the globe, not only in the Pharma but also in the Automotive Industry and others.

    Member of:

    Member of Open SCS and OPC foundation
  • Food

    Track & Trace solutions in the food industry – brand and consumer protection by anti counterfeiting

    In today's world, food fraud is a global problem that affects everyone. The World Health Organization estimates that 600 million people worldwide suffer from a disease transmitted through contaminated food. Regardless of the associated safety risk, food fraud incurs an estimated $50 billion in costs each year, paid directly or indirectly by food enterprises.

    With the alarming increase in food fraud, an ever-growing number of food manufacturers are adopting Track & Trace solutions for the traceability of their products, for example but not limited to dairy, baby and medical food or supplements. These solutions help protect their goods by enhancing supply chain visibility. In addition, an effective traceability system enables agile and efficient recall management, greater control over inventory, and optimized production management. It also increases loyalty to the company's brand as customers can identify and trace original products, which is a significant competitive advantage.

    Two people looking at milk in a supermarket

    Food traceability: preventing food fraud and inefficient product recalls

    Traceability has become the top subject in the food industry, especially in recent years. After catastrophic scandals, an increasing number of countries, such as Russia or South Korea, are now announcing strict regulations.

    In order to avoid time pressure when implementing new systems, it is advisable to deal with the requirements and possibilities of serialization early and carefully in order to be prepared for all future challenges.

    Food traceability illustration

    What is meant by food traceability?

    Traceability makes it possible to precisely locate each individual article in the supply chain at any point in time. Several actors are affected by traceability:

    • Manufacturers

      In addition, food traceability helps companies address numerous issues, such as necessary recalls, reducing external liability, and increasing consumer confidence in their brand. A system that provides accurate, consistent and complete product information reduces operating costs and increases productivity in equal measure.

    • Consumer

      Food traceability gives consumers trust in the brand. The consumer can now accurately determine the origin and content of the product. Correspondingly, this minimizes the risk of purchasing counterfeit items.

    • Supply Chain

      The entire process benefits from adequate food traceability, as it improves the efficiency of basic operations, increases cash flow and reduces waste.

    • Public safety

      Food traceability significantly minimizes the risk of counterfeit products and reduces food fraud, which poses a risk to public health. Recalls of harmful products are far more efficient, thereby significantly reducing the negative impact of contaminated food on public health.

  • Other Industries

    Together against counterfeited products

    Alongside the openness of our solutions, the focus is also on experience: we are familiar with strict regulations, as we have already installed more than 500+ Track & Trace solutions for customers worldwide, particularly in the highly regulation-driven pharmaceutical industry, but also in Food and Automotive.

    That expertise is also beneficial to customers in other industries, to whom we can also offer turnkey solutions for a wide variety of products. Accordingly, our portfolio ranges from cost-efficient entry-level solutions and high-speed lines to technically highly complex, fully validatable systems and complete turnkey solutions.

    Phone scanning an qr-code

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.

Icon of a person

Ayman Abusalem
MENA Technical Purchasing Manager at Hikma Pharmaceuticals

We 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
    Hands exchanging contact information via a business card

    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