Track and Trace Solutions

Fake medicines which contain the wrong active ingredients or none at all can have fatal consequences for patients. For pharmaceutical manufacturers, counterfeits result in severe damage to their reputation and in high expenses. Growing sales volumes of Internet pharmacies are one reason for the rise of fake drugs. Production outsourcing and longer supply chains also provide more opportunities for counterfeit pharmaceuticals to enter the market. And still, many go undetected. To make the drug supply chain safer, worldwide laws regulating the serialization and traceability of pharmaceutical packages have come – or will come – into force.

Track & Trace – What is it about?

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.
Checkweighing

The cartons are checkweighed to avoid undesirable weight deviations within a batch. Cartons with discrepancies are rejected.
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.
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.
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“)
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“)
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

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: January 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: January 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

BATCH CODING

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

BATCH CODING

Deadline: January 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, 2015
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

– Not mandatory
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: 2020 (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

Serialization
CPS 0800 - Bottle serialization and verification

Carton printing system CPS 0800 system for printing and verification of folded cartons.

Output:

400 cartons/min

Speed:

up to 60 m/min

CPS 1400 - Module for printing, verifying and serialization of folded cartons, incl. checkweigher

Carton printing system CPS 1400 for printing, verification, serialization and optional checkweighing of folded cartons.

Output:

350 cartons/min

Speed:

up to 60 m/min

CPS 1900 - Code printing, verification and serialization of folded cartons

Carton printing system CPS 1900 system for printing, verification, check weighing, labeling or the application of Tamper Evident safety labels.

Output:

300 cartons/min

Speed:

up to 60 m/min

CPS 0600 - Bottle serialization and verification

CPS 0600 for bottle labeling, verification and serialization.

Optional: Helper code printing on the bottle for easy downstream bundling.

Output:

up to 150 bottles/min
Aggregation
CPA 0110 – Rework station for warehouses

CPA 0110 is connected to level 3 site management systems and used for rework at warehouses.

CPA 0320 – Aggregation system for integration into bundlers

Aggregation system for integration into bundlers

CPA 0410 - System for manual case aggregation

Aggregation system for manual case aggregation

CPA 0420 - Aggregation system for integration into case packers

Aggregation system for integration into case packers

CPA 0510 – Aggregation station for integration of cases into pallets

Aggregation system for integration of cases into pallets

CPA 0520 – Aggregation system for integration into palletizers

Aggregation system for the integration into palletizers. Aggregates cases into pallets.
Data Management System
Connectivity. Traceability. Our Software Solutions.

Track & Trace stands for linking machines with IT, and data exchange at all levels. This requires a powerful software suite – the Syntegon CPI. This data handling solution imports data, generates and manages serial numbers, and exports batch reports to superordinate systems. Syntegon offers multiple standard interface packages for easy and fast connection to the CPI.
- Generating serial numbers
- Bundling and sending serial numbers and production data
- Preparing records according to aggregation requirements
- Importing Exporting data related to specific requirements
- Ensuring secure and correct data and format transfer
- Linking individual components, complete packaging lines, and entire factories.

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 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
Telephone: +49 711 811-0
pharma.trackandtrace@syntegon.com

Track and Trace Solutions

Track & Trace – What is it about?

Serialization

Checkweighing

Tamper Evident Labelling

Bundle Aggregation

Case Aggregation

Pallet Aggregation

Connectivity

Regulations

EUROPEAN UNION

RUSSIA

BRAZIL

USA

EGYPT

JORDAN

LEBANON

SAUDI ARABIA

SOUTH AFRICA

SOUTH KOREA

JAPAN

INDONESIA

OUR SOLUTIONS

CPS 0800 - Bottle serialization and verification

CPS 1400 - Module for printing, verifying and serialization of folded cartons, incl. checkweigher

CPS 1900 - Code printing, verification and serialization of folded cartons

CPS 0600 - Bottle serialization and verification

CPA 0110 – Rework station for warehouses

CPA 0320 – Aggregation system for integration into bundlers

CPA 0410 - System for manual case aggregation

CPA 0420 - Aggregation system for integration into case packers

CPA 0510 – Aggregation station for integration of cases into pallets

CPA 0520 – Aggregation system for integration into palletizers

Connectivity. Traceability. Our Software Solutions.

We provide solutions that excite!

Get in touch with us!

Dear visitor, 6,100 employees, up to 150 years of experience, one thing is new: our name! From now on we are called: Syntegon

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Dear visitor,

6,100 employees, up to 150 years of experience, one thing is new: our name!
From now on we are called: Syntegon