Sean Milmo, European Editor05.20.15
The European packaging sector is set to go through major changes in the next few years, as the result of the implementation of European Union legislation requiring individual items of medicines to carry unique identification codes.
The measure will not only radically alter printing processes in pharmaceuticals packaging, but will reverberate across packaging in other sectors in Europe.
The changes will require major improvements in the quality of the inks used in the coding of drugs on the European market. The inks will have to have a higher resolution, and above all, much greater stability than at present.
The new legislation – the Falsified Medicines Directive (FMD) introduced to combat counterfeiting of medicines – will result in a pan-European IT infrastructure being set up to enable pharmacists to authenticate a drug when dispensing it by checking information from barcode scanners against data held in central databases.
Much of the IT network will rely in cloud computing because it will cut costs and ultimately make the whole project more efficient. Since serialization is not only being introduced in the European medicines market but also the pharmaceuticals sectors of North America, parts of Latin America and China, the use of cloud computing systems will be the best option for international drug manufacturers.
The infrastructure could provide the basis for the pharmaceutical sector’s unique identification or serialization systems to be extended to other sectors with similar safety needs, such as the food industry. It could also be useful to sectors plagued by counterfeiting, like textiles, luxury goods and cosmetics.
In the longer term, serialization could become the main tool for brand protection across a wide range of markets. The role of inks in the serialization process will be crucial. Any deficiencies in the inks could be highly disruptive and expensive for drug manufacturers and distributors.
Currently, the main inks and coatings used in unique identification are thermal, continuous and drop-on-demand inkjet inks, thermal transfer overprint inks and laser marking coatings. One or two of these are likely to emerge with a dominant share of the serialization market because of superior qualities, flexibility and costs.
The main quality requirements of high levels of resolution and stability apply not just to the black or dark inks in the barcode but also the white or light color inks in the background on cartons or other drug containers.
“This legislation is going to have a massive impact on the quality of printing throughout the pharmaceutical packaging supply chain,” said Craig Stobie, global life sciences manager at Domino Printing Sciences, one of the leading players in global coding and printing technologies for pharmaceuticals and other sectors that develops and makes its own inks.
“If the black ink does not have sufficient stability and resolution, the barcode will fall below the required standard,” he explained. “If the background white or lighter ink on the carton has insufficient light, temperature or weatherfastness, the deficiency will be even greater.”
Combating Counterfeit Medicines
The FMD legislation was approved by the EU in 2011 in an effort to combat the increasing problem of counterfeiting of drugs. In 2011 alone, 30 million fake medicines were seized at EU borders.
The United Nations’ World Health Organization (WHO) estimates that 15% of all medicines on the global market are counterfeit, although the proportion is lower in developed regions like Europe and North America. Globally the numbers of seizures of falsified medicine soared by 92% between 2005-2011, according to the WHO.
Most of the controls introduced by the FMD, such as restrictions on imported active ingredients, regulation of internet supplies and tightening of requirements for wholesalers, have now been implemented.
However, because of the need to draw up additional packaging rules and guidelines, which has only recently been completed, the packaging measures on unique identification of individual medicine items will not come into full effect in the EU’s 28 member states until 2017/18.
Packaging specialists have been advising key players like the manufacturers and their packaging suppliers to start preparing for full implementation this year or, at the latest, in 2015. They believe it will take three years to plan, install and test new printing equipment, software and IT facilities. In particular, time is needed to test printing equipment, and above all, the inks.
The European Commission has stipulated under the legislation that the unique identification data will be placed in a 2D barcode and will comprise a manufacturer code, a serialization number, a national reimbursement number, if necessary, and the expiry date.
GSI Healthcare’s Standards
So far, many of the leading healthcare stakeholders in Europe have opted to use, for FMD compliance, the system of identification standards drawn up by the Brussels-based GSI Healthcare, a user group of manufacturers, distributors, healthcare providers, industry associations and regulatory authorities.
The GSI Data Matrix ECC 200, its most up-to-date standard, is based on a series of dark and light dots for encoding data of up to 2,335 alphanumeric characters and 3,116 numbers. The size of the Data Matrix is dictated by the amount of data to be encoded. The larger the amount, the smaller the dots.
In its GSI Data Matrix guide issued this year, the organization stresses the importance of sufficient contrast to enable the scanner to discriminate clearly between dark and light areas of the code.
Although a variety of colors can be used, it states that the “use of black and white is generally accepted to be the best color combination. Of critical importance for the final quality of the printed symbol is the ability of the printer to achieve the selected (dot size),” it added.
The GSI study lists thermal transfer, inkjet, laser etch and dot-peening or indentation as the processes “most suited” for printing GSI Data Matrix. But inkjet is the only one able to achieve the standard on all of the five main substrates of paper, corrugated board, glass, plastic and metal. Even with inkjet, it points out, edges tend to be printed in an irregular shape due to the absorbency of the substrate and the irregular shapes of single dots.
An increasing number of leading pharmaceutical manufacturers in Europe are opting to apply thermal inkjet for the Data Matrix code because of its speed and ease of use.
AstraZeneca has recently installed seven coding stations at Macclesfield, England, provided by Travec Ltd., to meet the requirements of 2D Data Matrix high-density codes. “From a coding perspective, this is one of the most challenging projects we have undertaken,” said John Currie, an AstraZeneca project manager.
The GSI Data Matrix ECC 200 allows some room for errors caused by printing problems, interference with reflection during scanning and degradation of the printed surface. However, the bigger the allowance for error corrections in the code, the less space will be available for actual data.
Some printing errors can be spotted and removed during a verification procedure with in-line monitoring equipment at the end of printing process. But some of the causes of these errors, particularly ink degradation, are likely to emerge between the packaging plant and the dispensing of the medicines.
“People forget that it can be as long as three years between the packaging of the medicines and their dispensing, “ said Stobie. “In that time the package will have gone through a variety of conditions during transportation and storage, including differences in temperature, moisture and light. That is why it is important that ink formulations are subjected to accelerated weather testing before they are applied, which is something that some producers of serialization coding inks do not do.”
The striving for quality in identification code printing will not just be confined to primary packaging, but will have to extend to tertiary and secondary packaging as well.
Amidst all these challenges, serialization may show itself to be prone to a disproportionate level of errors. As a result, ink producers are maintaining and expanding their portfolios of brand protection technologies as well as other traceability inks.
At the same time, they are ensuring that these remain consistent with the trend to even shorter runs and a greater variability of information on the label.
At the end of this year, another piece of EU legislation on consumer information – for food products – will be coming into force. Food labels will have to carry information on, for example, allergens, nanomaterials and origins of meat products, some of which will in certain cases have to be highlighted.
Sun Chemical has just launched an improved version of its SunLase laser marking coating, which enables a variety of barcodes, Quick Response (QR) codes, logos, text and serial numbers to be printed after the filling and closure of a pack.
Lasering has the advantage over inkjet of being cheaper while being able to deliver a higher quality image.
“(It) avoids the potential cost implications of more flexible, shorter-run package production and allows packaging to become more adaptable to what consumers demand,” said Eric Dejean, Sun Chemical’s product manager for water-based products in Europe.
Until it deals with the problem of costs and liability to scanning errors, inkjet could struggle to gain a predominant position in the printing of increasingly complex identification packaging codes.
European Editor Sean Milmo is an Essex, UK-based writer specializing in coverage of the chemical industry.
The measure will not only radically alter printing processes in pharmaceuticals packaging, but will reverberate across packaging in other sectors in Europe.
The changes will require major improvements in the quality of the inks used in the coding of drugs on the European market. The inks will have to have a higher resolution, and above all, much greater stability than at present.
The new legislation – the Falsified Medicines Directive (FMD) introduced to combat counterfeiting of medicines – will result in a pan-European IT infrastructure being set up to enable pharmacists to authenticate a drug when dispensing it by checking information from barcode scanners against data held in central databases.
Much of the IT network will rely in cloud computing because it will cut costs and ultimately make the whole project more efficient. Since serialization is not only being introduced in the European medicines market but also the pharmaceuticals sectors of North America, parts of Latin America and China, the use of cloud computing systems will be the best option for international drug manufacturers.
The infrastructure could provide the basis for the pharmaceutical sector’s unique identification or serialization systems to be extended to other sectors with similar safety needs, such as the food industry. It could also be useful to sectors plagued by counterfeiting, like textiles, luxury goods and cosmetics.
In the longer term, serialization could become the main tool for brand protection across a wide range of markets. The role of inks in the serialization process will be crucial. Any deficiencies in the inks could be highly disruptive and expensive for drug manufacturers and distributors.
Currently, the main inks and coatings used in unique identification are thermal, continuous and drop-on-demand inkjet inks, thermal transfer overprint inks and laser marking coatings. One or two of these are likely to emerge with a dominant share of the serialization market because of superior qualities, flexibility and costs.
The main quality requirements of high levels of resolution and stability apply not just to the black or dark inks in the barcode but also the white or light color inks in the background on cartons or other drug containers.
“This legislation is going to have a massive impact on the quality of printing throughout the pharmaceutical packaging supply chain,” said Craig Stobie, global life sciences manager at Domino Printing Sciences, one of the leading players in global coding and printing technologies for pharmaceuticals and other sectors that develops and makes its own inks.
“If the black ink does not have sufficient stability and resolution, the barcode will fall below the required standard,” he explained. “If the background white or lighter ink on the carton has insufficient light, temperature or weatherfastness, the deficiency will be even greater.”
Combating Counterfeit Medicines
The FMD legislation was approved by the EU in 2011 in an effort to combat the increasing problem of counterfeiting of drugs. In 2011 alone, 30 million fake medicines were seized at EU borders.
The United Nations’ World Health Organization (WHO) estimates that 15% of all medicines on the global market are counterfeit, although the proportion is lower in developed regions like Europe and North America. Globally the numbers of seizures of falsified medicine soared by 92% between 2005-2011, according to the WHO.
Most of the controls introduced by the FMD, such as restrictions on imported active ingredients, regulation of internet supplies and tightening of requirements for wholesalers, have now been implemented.
However, because of the need to draw up additional packaging rules and guidelines, which has only recently been completed, the packaging measures on unique identification of individual medicine items will not come into full effect in the EU’s 28 member states until 2017/18.
Packaging specialists have been advising key players like the manufacturers and their packaging suppliers to start preparing for full implementation this year or, at the latest, in 2015. They believe it will take three years to plan, install and test new printing equipment, software and IT facilities. In particular, time is needed to test printing equipment, and above all, the inks.
The European Commission has stipulated under the legislation that the unique identification data will be placed in a 2D barcode and will comprise a manufacturer code, a serialization number, a national reimbursement number, if necessary, and the expiry date.
GSI Healthcare’s Standards
So far, many of the leading healthcare stakeholders in Europe have opted to use, for FMD compliance, the system of identification standards drawn up by the Brussels-based GSI Healthcare, a user group of manufacturers, distributors, healthcare providers, industry associations and regulatory authorities.
The GSI Data Matrix ECC 200, its most up-to-date standard, is based on a series of dark and light dots for encoding data of up to 2,335 alphanumeric characters and 3,116 numbers. The size of the Data Matrix is dictated by the amount of data to be encoded. The larger the amount, the smaller the dots.
In its GSI Data Matrix guide issued this year, the organization stresses the importance of sufficient contrast to enable the scanner to discriminate clearly between dark and light areas of the code.
Although a variety of colors can be used, it states that the “use of black and white is generally accepted to be the best color combination. Of critical importance for the final quality of the printed symbol is the ability of the printer to achieve the selected (dot size),” it added.
The GSI study lists thermal transfer, inkjet, laser etch and dot-peening or indentation as the processes “most suited” for printing GSI Data Matrix. But inkjet is the only one able to achieve the standard on all of the five main substrates of paper, corrugated board, glass, plastic and metal. Even with inkjet, it points out, edges tend to be printed in an irregular shape due to the absorbency of the substrate and the irregular shapes of single dots.
An increasing number of leading pharmaceutical manufacturers in Europe are opting to apply thermal inkjet for the Data Matrix code because of its speed and ease of use.
AstraZeneca has recently installed seven coding stations at Macclesfield, England, provided by Travec Ltd., to meet the requirements of 2D Data Matrix high-density codes. “From a coding perspective, this is one of the most challenging projects we have undertaken,” said John Currie, an AstraZeneca project manager.
The GSI Data Matrix ECC 200 allows some room for errors caused by printing problems, interference with reflection during scanning and degradation of the printed surface. However, the bigger the allowance for error corrections in the code, the less space will be available for actual data.
Some printing errors can be spotted and removed during a verification procedure with in-line monitoring equipment at the end of printing process. But some of the causes of these errors, particularly ink degradation, are likely to emerge between the packaging plant and the dispensing of the medicines.
“People forget that it can be as long as three years between the packaging of the medicines and their dispensing, “ said Stobie. “In that time the package will have gone through a variety of conditions during transportation and storage, including differences in temperature, moisture and light. That is why it is important that ink formulations are subjected to accelerated weather testing before they are applied, which is something that some producers of serialization coding inks do not do.”
The striving for quality in identification code printing will not just be confined to primary packaging, but will have to extend to tertiary and secondary packaging as well.
Amidst all these challenges, serialization may show itself to be prone to a disproportionate level of errors. As a result, ink producers are maintaining and expanding their portfolios of brand protection technologies as well as other traceability inks.
At the same time, they are ensuring that these remain consistent with the trend to even shorter runs and a greater variability of information on the label.
At the end of this year, another piece of EU legislation on consumer information – for food products – will be coming into force. Food labels will have to carry information on, for example, allergens, nanomaterials and origins of meat products, some of which will in certain cases have to be highlighted.
Sun Chemical has just launched an improved version of its SunLase laser marking coating, which enables a variety of barcodes, Quick Response (QR) codes, logos, text and serial numbers to be printed after the filling and closure of a pack.
Lasering has the advantage over inkjet of being cheaper while being able to deliver a higher quality image.
“(It) avoids the potential cost implications of more flexible, shorter-run package production and allows packaging to become more adaptable to what consumers demand,” said Eric Dejean, Sun Chemical’s product manager for water-based products in Europe.
Until it deals with the problem of costs and liability to scanning errors, inkjet could struggle to gain a predominant position in the printing of increasingly complex identification packaging codes.
European Editor Sean Milmo is an Essex, UK-based writer specializing in coverage of the chemical industry.