Human and machine readable 1D and 2D codes and their usage in packaging and traceability applications

Human and machine readable 1D and 2D codes and their usage in packaging and traceability applications SCOPE Changing legal requirements and increased demand by consumers and producers to provide more information on an individual product level, drive an increasing demand for the implementation of track & trace solutions in production and packaging lines in the Pharmaceutical, Medical Device, Tobacco, Cosmetics, Food and Beverage industry. This paper provides an introduction and overview on serialized machine readable code applications as an information source for technical, IT and engineering teams preparing to start with traceability/serialization implementation solutions in packaging. On the following pages, the key different code formats and relevant performance related aspects are evaluated and details and comparisons are provided. Omron has developed a whitepaper addressing the legal background, as well as a market review on solution concepts for track & trace solutions using serialization for these industries: CONTENT OVERVIEW 1. Situation and overview on machine readable code applications... 2 2. Machine inspected code usage in selected industries... 3 2.1 Pharmaceutical... 3 2.2 Food & Beverage... 4 2.3 Tobacco... 5 2.4 Medical devices... 5 3. Details on key 2D code formats, trends, current hot topics & challenges... 6 3.1 DataMatrix code... 6 3.2 QR code... 8 3.3 Dot code... 9 4. Evaluation... 9

1. Situation and overview on machine readable code applications Machine readable codes have become standard on packaging used in Food, Beverage, Pharmaceutical, Personal Care as well as additional industries. The below table provides examples on common applications where machine readable codes have become popular or standardized. Industry Application code format exemplary content format & issueing agency, users Logistic Parcel tracking alphanumeric, 1D ISO, e.g. DHL, UPS, TNT, etc. Publ. transp. Tickets, visa 2D Aztec ISO, e.g. Deutsche Bahn, US gov (US-VISIT program) General, gov Promotions, visa 2D QR code ISO, Marketing department defined, J-gov (visa) Tobacco Anti-counterfeit 2D Dot Code Codentify, patented but shared free-of-charge Pharma Anti-counterfeit (FMD) 2D DataMatrix ISO, GS1 Medical Anti-counterfeit alphanumeric, AIDC (1D, 2D, RFID, NFC) FDA, UDI Product ID 1D Barcode ISO, GS1 Food/Bev Best-before alphanumeric Manufacturer (e.g. required by EUregul. 1169/2011) Track&Trace (open) Various manufacturer or vendor driven initiatives Public transport ticket Meat label Promotion Serialized code on wine bottle Cigarette package with Dot Code Pharmaceutical package Human and machine readable 1D and 2D codes 2

2. Machine inspected code usage in selected industries 2.1. Pharmaceutical Many codes are already in use today for pharmaceutical packaging and new legislations are driving changes to add further codes. These codes are on the one hand intended for factory internal or logistic processes in the supply chain, on the other hand they are intended for use by pharmacies, medical staff or the consumer directly. Alphanumeric codes Various legal requirements are in place or in preparation around the world that require the addition of human readable (numeric or alphanumeric) codes for batch numbers, a product identifier e.g. the global or national trade item number (GTIN or NTIN), optionally a national reimbursement number, expiry date, shipment numbers etc. In some cases (e.g. Brazil) also national medical numbers and the manufacturing date are required. 1D barcodes Frequently a combination of machine and human readable codes are used for identifying products. Different contents are encoded e.g. a GTIN (replacing the still often used term EAN in Europe or JAN in Japan), the so called pharma code of the PZN number in Germany, CIP 13 (replacing CIP 7) in France, UPC-12 in North America or GS1 Databar/GS1-128. In logistic processes especially in bulk packaging an ITF-14 is also very common and for factory internal leaflet tracking a code also named pharma code is occasionally used. The content is encoded in barcode carrier types e.g. UPC-A, (EAN-8), EAN 13, EAN39, (EAN 93) or EAN128. Serialized codes on item level using 1D barcodes are required for China ( China code using ISO 128). In some countries (e.g. India) a serialized 1D barcode per shipping container is required (so called Serial Shipping Container Code (SSCC)). The SSCC contains the GTIN, batch number, expiry date and a unique serial number on shipment container level. The ISO 15416 provides information on the criteria for evaluating the print quality for 1D barcodes. Pharma code e.g. for leaflet tracking Pharma code (code 39 with PZN number) Human and machine readable 1D and 2D codes 3

2D DataMatrix codes In preparation for the implementation of the Falsified Medicine Directive 2011/62/EU with the need to apply a serialized (unique and non-predictive) code to each packaging, a standardization on machine readable DataMatrix codes with GS1 content format (ISO 15418:2009) is in preparation. While the final version of the delegated regulation on the safety features is expected for mid October 2015, a draft version is available from http://ec.europa.eu. Many other countries have also already standardized on DataMatrix codes with minor content variations. An overview summary of the global requirements can be downloaded from: http://www.domino-printing.com/global/en/your-market/packaging-coding/pharmanew/ Downloads/Map%20of%20Emerging%20Legislation%20and%20Adoption%20of%20Serialisation.pdf The hardware requirements to print and read the content thereby does not really change, but determining the correct content for the various countries and legal requirements can provide a challenge to the software management. For some pharmaceutical containers 2D datamatrix codes may also be applied during the filling and packaging processes ( helper codes ). In July 2015 the European Medicines Agency (EMA) announced that QR codes may be used in the labelling and package leaflet of centrally authorised medicinal products for communication purpose to patients. The announcement can be downloaded from: http://www.ema.europa.eu/docs/en_gb/document_library/regulatory_and_procedural_ guideline/2015/07/wc500190405.pdf Braille writing The EU directive 2004/27/EC Article 56 (a) clarifies the requirements for adding the name of pharmaceutical products using embossed braille writing for applicable products (e.g. for helping blind people to identify products). Detecting the presence of these embossed codes can be realized using appropriate lighting for optical inspection systems. 2.2. Food & Beverage Alphanumeric codes Human readable codes have become standard (e.g. required by 1169/2011 on provision of food information) for e.g. best-before dates, producer, country of origin, etc. The 1169/2011 implementation period ended Dec 2014 and has now become mandatory in the EU. 1D barcodes Barcodes with GS1 content format have become standard to identify many products using scanners and for many supermarkets this is a must requirement for products to be sold in their store. (compare 1D barcode section in pharmaceutical applications under 2.1 for more information on barcode variations). Human and machine readable 1D and 2D codes 4

2D codes For promotional purposes 2D codes are commonly used on labels and attached leaflets. For higher value products, serialized 2D codes are already in use to prevent counterfeiting (fakes) in several cases. Currently there are discussions ongoing on implementing 2D codes also on a wider base to track & trace products and for providing extended information on the origin of the products and enhancing consumer safety. The online shopping platform Alibaba offers a serialization possibility to suppliers using QR codes (compare: http://www.securingindustry.com/clothing-and-accessories/unilever-to-trial-alibaba-anticounterfeit-codes/s107/a2431/). General commercially available solutions are offered by various providers e.g. by GS1 - a database solution ftrace allows the usage of codes to provide extended information about the origin of products (meat, fish, etc) on batch level (e.g. compare https://www.gs1-germany.de/gs1- solutions/rueckverfolgbarkeit/ftrace/). Various other producer or supplier driven solutions are in place or in preparation. It is the expectation of the authors that eventually a standard or recommendation by associations may take place and it is expected that DataMatrix codes with GS1 content or Dot Codes with a similar content structure may be the most likely candidates for this standardization. 2.3. Tobacco Leading tobacco producers have decided to fight counterfeits (fakes) by implementing a serialized code printed on their tobacco packages. The high speed in the packaging lines in the tobacco industry gave preference to using a machine readable 2D code over an optical character recognition (OCR) of human readable print. The code is implemented as a Dot Code using a content coding (Codentify ) developed and patented by a tobacco company but shared free-of-charge within the tobacco industry. A content coding is available free of charge for the general use by AIM. A motivation to develop and use the Dot Code was to overcome issues with reliable printing of other 2D codes using ink jet technology. Currently most tobacco companies are working on implementing this printing + inspection solution globally throughout their production sites. 2.4. Medical devices The US Food and Drug Administration FDA has passed acts (FDA Amendments Act (2007) Section 519(f ), FDA Safety and Innovation Act (FDASIA)) requiring the addition of a unique device identifier (UDI) on labels and as a direct marking if applicable. The label content to be applied to packages is similar to the FDA requirements for pharmaceutical products but in addition the FDA requires the submission of data to a global UDI database (GUDID). Detailed information about the marking requirements and the timelines for the different device classes is available from: http://www.fda.gov/medicaldevices/deviceregulationandguidance/ UniqueDeviceIdentification/ The FDA medical device label application and central registration process is similar to the European requirements for pharmaceutical products requiring also the registration in a central hub. It is also expected that for Europe a similar legislation will be established in near future. Human and machine readable 1D and 2D codes 5

3. Details on key 2D code formats, trends, current hot topics & challenges In addition to 1-dimensional codes (barcodes), the use of 2-dimensional machine readable codes is becoming more and more popular. Though there are many different formats and content structures available, three main 2-dimensional code formats have become very popular in packaging applications: 3.1 DataMatrix code (ISO/IEC 16022:2006) 3.2 QR code (ISO/IEC 18004:2006) 3.3 Dot code (AIM specification) https://aimglobal.site-ym.com/store/ ViewProduct.aspx?nonssl=1&id=1343379 3.1. DataMatrix code (ISO/IEC 16022:2006) The DataMatrix code is one of the most commonly used codes in packaging used for identification and tracking of products. In logistic applications a barcode is still very common. With new legislations like 2011/62/EU (Falsified Medicine Directive), the use of DataMatrix codes with a content format defined by GS1 is mandatory or expected to become mandatory in most countries for prescription and some non-prescription pharmaceutical products (see summary paper on FMD). The DataMatrix code contains content and error correction methods. Most common today is a code with ECC200 error correction and GS1 data content format. Example of 2D DataMatrix code with GS1 content format. Human and machine readable 1D and 2D codes 6

Printing technology The serialized 2D code is usually printed on the package with: a. Thermal Ink Jet (TIJ) Seamless integration on complex packaging lines and leading connectivity options Lower initial capital outlay than laser technology High clarity, high contrast marking with lightfast inks (independently tested) b. High speed serialized coding with Laser Demonstrates highest Overall Equipment Effectiveness (OEE) levels of any printing equipment Higher capital cost but lower running cost through minimal consumable requirements, recommended for medium to high volume lines Permanent marking suitable for cold chain environments c. Coding with Thermal Transfer Overprinting (TTO) Demonstrates market leading performance for serialized high speed label and flexible package printing Needs to have comprehensive software suite for simple integration with existing technology Ideally the use of smart ribbon drives (such as i-tech from Domino) can reduce ribbon use by up to 30% A common technology especially for printing of alphanumeric codes is the continuous ink jet (CIJ) High speed item-level serialization up to 1,000ppm Small print head for easy integration Easy servicing and low TCO (total cost of ownership) Content area printing The DataMatrix code content is encoded using markers with high contrast to the background (ideally as high as possible e.g. black and white) within the matrix. The markers are either printed as: Squares Circular dots (also used for embossed codes (DPM)) Human and machine readable 1D and 2D codes 7

Quality grading The quality of printed codes may often need to be evaluated and graded. Non-legible codes (or even too many with low quality grading) may lead to shipment returns. The ISO 15415 describes the quality criteria for 2D DM codes and an offline special grading device is required to determine the quality. In practice an in-line grading following ISO 15415 as closely as possible may often be applied to obtain quality trend information. that can be used to obtain early-warning indicators about developing issues in the code application process. Note: though squares may be the target to be printed, in practice only 80% of the area may actually be filled during the printing. Circular dots in practice cover 70% of the target area. However the quality of the code and grading is more impacted by the poor handling and material changes than the slight disadvantage when using circular dots (both for DataMatrix as well as DotCode). A key aspect may also be the method applied to print the dark areas. For example the new Line Mode for Laser Printers by Domino reduce the amount of gas/dust created and therefore keep the marking area cleaner for longer. Comparison of print results using different modes for laser printers 3.2. QR code (ISO/IEC 18004:2006) Developed in Japan by Denso for the logistic processes within Toyota, the Quick-Response (QR) code is today widely used in promotion applications often encoding URLs. Many smartphones are able to scan this code. Though the name QR code is a registered trade mark by Denso Wave Inc., the code has become public domain and can be used license free. For serialization and traceability applications in most pharmaceutical, medical device and tobacco applications this code is not supported giving preference to GS1 compliant DataMatrix or Dot codes. However the GS1 compliant DataMatrix solution does not allow Chinese or Japanese characters to be encoded and thus preference may be given to QR codes in applications where a choice is available to producers. A potential downside to using QR codes on a widespread base is a higher risk of hidden attacks with viruses and malware as QR codes allow the hidden encoding of URLs which are often loaded by smartphones even when no action is taken and only the content is displayed first. In addition counterfeiters can encode fake websites together with fake codes thus making anti-counterfeit actions by manufacturers very difficult even when using additional security features. Hence for anti-counterfeit activities preference is often given to 2D DM codes while the extended language and URL encoding capabilities make the QR codes very popular for direct consumer interaction. The printing and reading aspects of the QR code are similar to the DataMatrix code. Human and machine readable 1D and 2D codes 8

3.3. Dot code The Dot code is a 2D code that uses circular shaped dots and blank areas in a matrix structure to encode the content. The dot code is not standardized by ISO/IEC but a standardized definition is available from the international trade association AIM: https://aimglobal.site-ym.com/store/viewproduct.aspx?nonssl=1&id=1343379 The content is encoded in tobacco applications using a patented process from a tobacco company. The definition from AIM also states that an encoding inspired by Code 128 with a subset definition to encode a GS1 content format is set aside, making the code usable independently of the patented content encryption for the tobacco industry. GS1 Germany has stated that the dot code may be considered as an alternative to the 2D DataMatrix for applications e.g. in food & beverage where no other guidelines or regulations apply. The decision will be left to the manufacturer. Where circular shaped dots in a DataMatrix code are considered lower code quality compared to square dots, in a Dot code the circular dots are the target. The benefit of using circular dots is that codes can also be applied by puncturing or drilling holes in the carrier material. Also in regular print processes a speed advantage may be present. There are also opinions that the additional space around a dot may also lead to an enhanced capability to distinguish dots even with badly printed dots. For the printing of Dot codes, the continuous ink jet technology (CIJ) is recommended unlike the situation when printing other 2D code formats. The quality grading of dot codes is done using five characteristics (FPD, UEC, PG, GN, AN) and definitions can be obtained from the authors. 4. Evaluation Various 2D code formats are available. Though there are systematic differences like square or round dots, in practice there are many other factors having a higher impact on printing speed, the obtained quality of the printed code and the overall performance of the machine. Therefore in principle all code formats can be used in suitable applications and decisions are recommended to be taken based on the legal situation, the packaging material, printing method and production environment. Outlook In areas with legal requirements for traceability / anti-counterfeiting (e.g. pharmaceutical, medical devices, food safety) there is a trend towards using standards as defined e.g. by GS1. These standards define the human readable parts, the codes on individual packages, the codes on aggregated bundles as well as on logistic level for shipments incl. transaction events (EPCIS). In applications where the direct interaction with consumers/patients is the primary target, there are two main trends. 1. On the one hand the ease-of-information-access using e.g. the widely accepted QR code scanning capability of smartphones drives this trend towards QR codes. Human and machine readable 1D and 2D codes 9

2. On the other hand marketing and branding departments are looking for new ways to attract attention and differentiate and may evaluate the usage of design elements in combination with codes e.g. logos&graphics integrated in codes, codes arranged in special shapes or using colored codes, e.g. the so called ULTRACODE. For more information: http://www.aimglobal.org/?page=review_ultracode&hhsearchterms=%22ultracode%22 Human and machine readable 1D and 2D codes 10

Omron Industrial Automation Headquartered in Kyoto, Japan, OMRON Corporation is a global leader in the field of automation. Established in 1933 and headed by President Hisao Sakuta, Omron has more than 35,000 employees in over 35 countries working to provide products and services to customers in a variety of fields including industrial automation, electronic components industries, and healthcare. The company is divided into five regions and head offices are in Japan (Kyoto), Asia Pacific (Singapore), China (Hong Kong), Europe (Amsterdam) and US (Chicago). The European organisation has its own development and manufacturing facilities, and provides local customer support in all European countries. For more information, visit Omron s Web site at industrial.omron.eu. Domino Printing Sciences Founded in 1978 and headquartered in Cambridge, UK, Domino has a global reputation for the development and manufacture of coding, marking and printing technologies that satisfy the requirements of manufacturers and commercial printers. Domino s year-on-year growth, both organic and through acquisition, is underpinned by an unrivalled commitment to product development, resulting in a portfolio that incorporates complete end to end coding solutions spanning primary, secondary and tertiary applications. Innovative ink jet, laser, print & apply and thermal transfer overprinting technologies are deployed for the application of variable data, bar codes and unique traceability codes onto product and packaging, across many industrial sectors, including pharmaceutical, food, beverage and industrial products. In 2013/14 the Domino Group (Domino Printing Sciences plc) achieved a turnover of 335 million. Domino was awarded the Queen s Award for Continuous Achievement in International Trade in 2012 and was named Company of the Year in the 2010 UK PLC awards. The Group employs 2,200 people worldwide and sells to more than 120 countries through a global network of 25 subsidiary offices and more than 200 distributors. Domino s manufacturing facilities are situated in China, Germany, India, Sweden, UK and USA. For further information on Domino, please visit www.domino-printing.com

AUTHORS Gunnar Bischoff Lucian Dold Jamie Steed Strategic Marketing Omron Industrial Automation Marketing Manager Omron Industrial Automation Tobacco Key Account Manager Omron Industrial Automation Omron Europe B.V. Wegalaan 67-69, 2132 JD Hoofddorp The Netherlands For information call: +49 (0)172 801 2228 www. Craig Stobie Head - Global Life Science Business Domino Printing Domino Printing Services Trafalgar Way, Bar Hill Cambridge, CB23 8TU United Kingdom www.domino-printing.com