Barcoding on pharmaceutical products: Getting it right

Siva Nagarajan

Today, healthcare and pharmaceutical industries globally, are actively investing in accurate traceability, as a deterrent against counterfeiting apart from benefits of tracking and supply chain automation.

This has grown in the last few years to become a legislative compliance requirement, and spreading fast across many countries. India has also clearly laid down steps for the legislation for all exports to begin with. The preferred data carrier to achieve this is two-dimensional 2D barcoding, chosen over other comparable technologies, like RFID for numerous reasons.

Datamatrix is a very efficient, 2D barcode symbology that uses a small area of square modules with a unique perimeter pattern, which helps the barcode scanner determine cell locations and decode the symbol. Characters, numbers, text and actual bytes of data may be encoded, including unicode characters and photos. The Datamatrix ECC 200 is the most suitable format given its very robust nature and small footprint. The ECC 200 provides redundancy through error checking and correction which is particularly relevant for scanning the symbol under challenging circumstances, particularly online.

Amongst the countries who have pioneered in adopting barcoding on pharma products for traceability, very successfully, is the French pharma industry. This has become a benchmark for other countries in the world to follow, given its success. The legislation in French, CIP-13, requires every pharma item to incorporate a 2D Data Matrix barcode consisting of product code, batch number and expiry date.

The gathering momentum globally requires all pharma manufacturers to gear up to the challenges of this upcoming legislative requirement and be able to print and verify this barcode symbols on their products, before supplying them into the supply chain network. The printing techniques to generate these 2D Datamatrix barcodes could cover thermal inkjet, thermal transfer, print-and-apply and, drop-on-demand systems depending on the particular application requirements.

In view of the criticality of the task on hand, and traceability upto the point of consumption of the drug, it is an obligation of pharma manufacturers to be able to assure reliable and correct data content and barcode print quality, since much depends on this, for any track and trace system to work. Maintaining acceptable barcode quality is an important task and basic requirement.

To check this, using a fixed-mount scanner or a hand-held reader to see if it reads, the code is very insufficient. The symbol’s reading quality cannot be established. The specialised testing equipment and assessment procedure are already laid down, to be adopted, in conformance to ISO/IEC standards, and GS1 general specifications, that have been created for assessing and defining barcode quality.

Barcode verifiers are therefore used to verify these 2D Datamatrix barcodes and they perform a detailed analysis of defined parameter as per ISO IEC 15415. The global standards body – GS1 which is also the issuing agency for the linear EAN/UPC family of barcodes, developed ‘Calibration Conformance Standards Text Chart’ for the Datamatrix barcodes as well. This makes it a very definitive parameter check of the data quality generated by the barcode verifiers.

The printer or the pharma company has to therefore use the data structure of GS1 general specifications in handling the Datamatrix barcodes for their products. The ISO/IEC 15415 standard specifies the methodologies for measuring, evaluating, and grading 2D symbol characteristics in order to indicate the quality of the mark. In addition, the standard identifies possible causes for symbol degradation. Users with less than optimal symbols due to problems with marking methods or substrate inconsistencies can use this information to correct and improve their marks and achieve better symbol quality

In printing of the Datamatrix 2D barcodes there are always potential areas of problems and challenges that need to be carefully considered.

Important among this is the structure of the symbol identified by a perimeter where scanners begin their attempt to read the encoded data. This finder pattern is ‘L’-shaped and the opposite two adjacent sides consist of a dark and light clock-pattern.

Some of the critical elements of ISO/IEC 15415 in assessing the quality of the printed Datamatrix code include:

• Axial non-uniformity
• Fixed pattern damage
• Grid non-uniformity
• Modulation
• Symbol contrast
• Decode
• Unused error correction
• Reflectance margin
• Quiet zones
• Transition ratios

Not to confuse scanning or camera-based reading with verification as this is a very critical link, within control and scope of the pharma manufacturer. No scanning system will be able to reliably assess and measure barcode quality as defined by ISO/IEC with repeatability and consistency, to be able to therefore assure scanability in any other scanning environment further down the supply chain. It is important that ‘verification’ has to be performed using the right optics and correct wave length of light source while reading the barcodes under test. Furthermore, during verification the symbol is also checked for encodation, right usage of the GS1 application identifiers (AI) mistakes of which, often go undetected otherwise.

It is very important to be able to measure this quality conformance, since simply put, we can’t control what we can’t measure. Drawing a parallel from the retail and FMCG industries, we have seen as a global phenomenon that even with linear barcodes more and more, larger retailers and distributors globally are imposing fines on suppliers when they deliver goods with poor or low quality barcodes. We have seen these include the likes of TESCO, Walmart, Woolworth, and more, in retail supply chain operations.

Logically, barcode quality and assured scanability assumes greater importance and criticality in a health and pharma environment.

The most effective method of supervising the Datamatrix barcode quality would be to use standalone verifiers which allow a comprehensive assessment on every single aspect of the Datamatrix quality. Any on-line scanning system would be motivated from a data collection perspective, and can never do the job to define the barcode quality.

In selection of a barcode verifier, care must be taken that it meets the standards of ISO/IEC 15415 and ISO/IEC 16022. Secondly, the verifier must be capable of consistent performance in any environment. The verifier’s camera pixel size apart from wave length of light should be in conformance to the symbology specification and the GS1 requirements respectively.

An important element of Datamatrix verification also includes operation training and calibration as per standards. Care and attention to these above parameters will ensure that manufacturers get the right product and knowledge to implement a successful Datamatrix printing operation for their facility.

This is going to stay and grow, and getting it right is critical for all.

Recently in the US, The Healthcare Distribution Management Association (HDMA) has just updated their guide for formatting, encoding, and placing bar codes on pharma products. Their aim is the safe and efficient distribution of healthcare products and services. Some significant changes now done include:

• The addition of a unique serial number in the GS1-128 product identification bar code to product case labels
• A recommendation to add an optional 2D GS1 Data-Matrix bar code symbol to drug packages and product cases
• A reduction in the bar code dimensions, thus freeing up space on labels for serial numbers
• New information on standardised numerical identifiers (SNIs)

The goal in adding the 2D GS1 Data-Matrix symbol—which duplicates exactly all of the primary GS1-128 symbol data (GTIN) plus the data encoded in the secondary GS1-128 bar code — is to populate the supply chain with efficiently scannable 2D symbols to complement and enhance scanning efficiency when camera-based (2D) scanning is implemented by distributors for case-level receiving, put-away, picking, and distribution.

These standards of barcode quality compliance are expected from most European, including Turkey, and American pharma markets as well.

So be it LINEAR barcodes or the 2D DATAMATRIX symbols, verifying the symbols as per clearly laid down global standards, is not only a serious obligation, but also necessary from an engineering and quality assurance perspective.

The proof of quality traceability being the verification report.