Stefan Rowinski, Product Manager, Atlantic Zeiser GmbH01.30.18
Time is short. Serialization of prescription medicines will become mandatory in the EU on February 9, 2019, resulting in new labelling requirements as a prerequisite for market access. Other countries and regions are already further ahead. Pharmaceutical manufacturers must therefore invest in suitable solutions now. Simultaneously, late stage customization is getting increasingly important due to continuously decreasing batch sizes. If both digital printing processes can be combined in one step, the opportunity to implement compliant and cost-optimized production arises.
The first logical step is to consider where in the production process to most sensibly perform serialization. During the offset printing of sheets for the later folding cartons? In a contract packaging facility, in special logistics centers, or in the packaging lines of pharmaceutical manufacturers? The solution chosen by the pharmaceutical company will depend on the existing infrastructure as well as several other factors.
Therefore, the advantages and disadvantages of any given decision, but also the opportunities associated with them, must be evaluated well in advance.
Since every product will soon require a unique serial number, the production of batch sizes of one will soon become compulsory anyway, as it were. What savings in logistics and simplifications can therefore be achieved by coding the carton as late as possible?
Decreasing batch sizes as an opportunity
Interest in late stage customization is increasing for a reason: special products and combined drugs, a growing demand for test batches, and the desire to reduce the costs for the logistics handling of pre-printed packages as well as the storage costs for ready-to-ship products reinforce the trend towards smaller production runs. But since the production volume as a whole is not decreasing, this all happens on high-performance packaging lines. Production on order is the most pronounced form of this development.
Small batch processing requires many changeovers and thus packaging lines can no longer reach their potential efficiency. In such cases, late stage customization can help maintain their economic viability.
Late stage customization offers various possibilities to increase cost efficiency:
The most pronounced form of the late stage customization approach is production to order based on an almost blank folding carton that becomes large-scale printed. A limiting factor may be its varnish coating that can reduce the adhesion of any ink applied later in the production process. It may therefore be necessary to use an adapted varnish instead.
Late stage customization can occur at various degrees of technical requirement for different applications, including:
The opportunity to link serialization and late stage customization suggests itself, allowing manufacturers to design products that are both compliant with regulations and cost-effective.
The place in the production process where this can be best implemented depends on several factors, such as existing infrastructure, production volume per product, production speed, frequency and duration of changeovers, the need for expiry date and batch information in the target market, and many others.
Additionally, questions must be answered regarding savings potentials through decreased stock values, less storage space, and a reduced number of warehouses as well as the number of folding cartons that can feature a “country-neutral” design, and costs for printing equipment.
Taking into consideration the above-mentioned factors, any decision for a solution will be as individual as the requirements and needs of a specific company.
Nevertheless, there are typical constellations enabling the complete or partial linking of both marking processes, thereby contributing to a compliant and cost-optimized production with substantial savings potentials regarding warehouses and logistics. Essentially, there are the following options.
Integration during the production of folding cartons
Until now, the standard practice has been for the country-specific design to be applied to the carton by the producer. If that also includes serialization, the pharmaceutical manufacturer does not need to invest in printing and checking technology (see also Figure 1, scenario 1a). The number of folding carton styles does not increase through serialization, since every country version requires its own design anyway. Combined with late stage customization in a single work step, the folding carton manufacturer can achieve logistics savings: they can react quickly and flexibly when pharmaceutical manufacturers order very small quantities.
Integration directly before the packaging line
The two above-mentioned steps can also be implemented by the packaging company, which further increases flexibility. If serialization and late stage customization take place directly before packaging, considerable savings can be made regarding storage and logistics, since efforts for procurement, storing, and especially logistics management of country-specific packaging are no longer required (see Figure 1, scenario 1b). Further advantages include a more versatile production without delays caused by ordering and transporting packaging material from external providers, and easy supply of very small and test batches.
All current regulations allow for serialization and late stage customization to take place completely offline and before the actual packaging process, which means that all marked packaging material can then be fed into a mostly unchanged line. Thereby, several packaging lines can be fed by one digital printing machine. It is not necessary to invest in printing technology for each individual packaging line and then incur loss of production time for its integration.
Integration directly into the packaging line
The currently best-known option leads itself well to large-scale production: packaging material already bearing country-specific graphic designs and markings is produced and then serialized for each country on the packaging line (see Figure 1, scenario 2). Depending on the number of export countries, it may be necessary to stock many folding carton styles, which results in increased efforts for storage and logistics. A conscious decision for the scenarios 1a or 1b shown in Figure 1 might be beneficial for every product or product line.
Integration in the logistics warehouse
In order to efficiently operate packaging lines with high-volume production runs, manufacturers can produce “brite stock,” i.e. filled country- and market-neutral packaging. Country-specific design and serialization are applied in the delivery warehouse by means of late stage customization. Thereby, many short production runs can be combined on the packaging line (see Figure 1, scenario 3), improving its efficiency. It must be noted that this approach is only suitable for products with country-neutral primary packaging, such as blisters, and that the package insert may have to be multi-lingual, since the packaging can no longer be opened afterwards.
If not only the secondary packaging, such as the folding carton, but also the primary packaging, such as the blister, must bear a country-specific design and marking, this can also be implemented in the logistics warehouse. A country-specific design and serialization code is printed on the empty, flat folding carton (see Figure 1, scenario 4). In this case, a DataMatrix code containing, for instance, the product code, EXP and LOT, has already been applied to the blister in a blister machine to ensure process safety, preventing mix-ups during later marking processes.
This marking and packaging step usually takes place in the delivery warehouse, where packing is often done manually. Therefore, this constellation is most suitable for very small batches or very valuable pharmaceuticals with relatively small quantities that are delivered to many different markets.
In general, it must be noted that in all scenarios featuring late stage customization, a packaging design where all relevant sides can be easily reached for country-specific marking via a printing system is most favorable. Thereby, expenditures for storage and logistics can be considerably reduced, and whole warehouses can be made redundant.
Management of serialization data
Irrespective of where exactly serialization takes place, pharmaceutical manufacturers are responsible for their products. As soon as the products enter the market, they must report their serial numbers to a higher authority or governmental agency. A software solution at ISA level 3 or 4, such as Atlantic Zeiser’s MedTracker, is required for the management, and, if required, aggregation of serialization data. This software must collect data from the packaging lines, map aggregation processes, export results, and, depending on the constellation, generate and manage serialization data.
Decision criteria for late stage customization variants
Before investing into a late stage customization solution, several criteria must be assessed, including:
To manage serialization data, users need a powerful serialization software which ensures process safety while generating, printing, and storing the codes as well as checking them with a camera and transmitting them to downstream processes. Further requirements include suitable printing technology that delivers high-quality printing results—regarding contrast, color brilliance, and lightfastness—for late stage customization applications and serialization at high speeds.
This can be achieved by means of contact-free drop-on-demand printing combined with a special UV ink. DoD color printers with a 600 dpi resolution manage transport speeds of up to 50 meters per minute. Since most packaging lines are not prepared for DoD printer integration, offline solutions are an alternative. These can feed several packaging lines, thus implementing late stage customization and serialization in one step while ensuring optimal capacity utilization.
The robustness of the line and software design in case of disturbances and malfunctions is a key factor, especially for serialization. This means that the machine software and the machine architecture must match the requirements based on practical experiences, and the interface between the machine and the serialization software must operate seamlessly and without any interference in order to ensure stable processes.
Atlantic Zeiser combines these features in one solution: all variable information regarding the market, language, or product is printed on a flat or glued carton one step upstream the packaging process in multiple colors, while serialization takes place during the same work step. Due to the new Omega Pro generation of drop-on-demand UV inkjet printers, the Digiline Versa system is capable of printing graphics, text, and serialization codes in four or six colors and to verify the complete layout by means of a high-resolution camera system.
Due to the use of UV curing inks, the print is especially high-contrast and resistant to water, light, and wear. The integrated Unique Code Software ensures process reliability during generation, printing, and storing of codes that have been checked by a camera, including reporting for downstream processes. Moreover, the system is very robust regarding disturbances and special situations, which is a key factor for serialization. A stable process requires machine, printer, and software to be perfectly coordinated and to have a robust connection to the higher-level serialization software.
New technology and individual design result in savings
Late stage customization and serialization processes can be combined at several steps during the production process. Moreover, the combination with late stage customization opens up savings potentials through optimized line utilization and through considerable cost reductions for storage and logistics. The choice of the process stage where it makes most economic sense to link serialization and late stage customization depends on a wide range of individual factors. Each pharmaceutical manufacturer will evaluate these differently regarding their products and production facilities—corresponding decisions are therefore company-specific. The above-mentioned scenarios show model options with existing technical solutions that can be found in practice.
Manufacturers considering the combination of both marking processes should therefore consult a one-stop supplier of both hardware components and the required serialization software. Thereby, in-house staff is not burdened with the tasks of system integration.
Stefan Rowinski, Product Manager in Atlantic Zeiser‘s „Pharma & Packaging Solutions” division, specializes in the development and marketing of system solutions for serialization, late stage customization, and track and trace applications. In addition, his expertise includes a deep knowledge of processes and workflow in sensitive environments and data management solutions. Prior to his position as a product manager, Stefan Rowinski spent years designing, implementing and planning one-stop solutions for product individualization and headed the projects to implement these solutions. Stefan.rowinski@atlanticzeiser.com
The first logical step is to consider where in the production process to most sensibly perform serialization. During the offset printing of sheets for the later folding cartons? In a contract packaging facility, in special logistics centers, or in the packaging lines of pharmaceutical manufacturers? The solution chosen by the pharmaceutical company will depend on the existing infrastructure as well as several other factors.
Therefore, the advantages and disadvantages of any given decision, but also the opportunities associated with them, must be evaluated well in advance.
Since every product will soon require a unique serial number, the production of batch sizes of one will soon become compulsory anyway, as it were. What savings in logistics and simplifications can therefore be achieved by coding the carton as late as possible?
Decreasing batch sizes as an opportunity
Interest in late stage customization is increasing for a reason: special products and combined drugs, a growing demand for test batches, and the desire to reduce the costs for the logistics handling of pre-printed packages as well as the storage costs for ready-to-ship products reinforce the trend towards smaller production runs. But since the production volume as a whole is not decreasing, this all happens on high-performance packaging lines. Production on order is the most pronounced form of this development.
Small batch processing requires many changeovers and thus packaging lines can no longer reach their potential efficiency. In such cases, late stage customization can help maintain their economic viability.
Late stage customization offers various possibilities to increase cost efficiency:
- Minimizing storage space in the delivery warehouse, for instance for 28 country styles in the EU;
- Cost saving by replacement of logistic warehouses in many countries with one centralized and more efficient delivery warehouse for several countries is possible;
- Dramatic decrease of tied-up capital through stored material value;
- Decrease of losses due to damage because of lower stock volume;
- Less rework required in case of production errors; and
- Less re-packing effort in case of changes in regulatory labelling.
The most pronounced form of the late stage customization approach is production to order based on an almost blank folding carton that becomes large-scale printed. A limiting factor may be its varnish coating that can reduce the adhesion of any ink applied later in the production process. It may therefore be necessary to use an adapted varnish instead.
Late stage customization can occur at various degrees of technical requirement for different applications, including:
- Serialization only with black print;
- Monochrome printing of symbols and text, such as dosage;
- Color print of individual markings with or without serialization; and
- Large-scale color print with symbols and serialization.
The opportunity to link serialization and late stage customization suggests itself, allowing manufacturers to design products that are both compliant with regulations and cost-effective.
The place in the production process where this can be best implemented depends on several factors, such as existing infrastructure, production volume per product, production speed, frequency and duration of changeovers, the need for expiry date and batch information in the target market, and many others.
Additionally, questions must be answered regarding savings potentials through decreased stock values, less storage space, and a reduced number of warehouses as well as the number of folding cartons that can feature a “country-neutral” design, and costs for printing equipment.
Taking into consideration the above-mentioned factors, any decision for a solution will be as individual as the requirements and needs of a specific company.
Nevertheless, there are typical constellations enabling the complete or partial linking of both marking processes, thereby contributing to a compliant and cost-optimized production with substantial savings potentials regarding warehouses and logistics. Essentially, there are the following options.
Integration during the production of folding cartons
Until now, the standard practice has been for the country-specific design to be applied to the carton by the producer. If that also includes serialization, the pharmaceutical manufacturer does not need to invest in printing and checking technology (see also Figure 1, scenario 1a). The number of folding carton styles does not increase through serialization, since every country version requires its own design anyway. Combined with late stage customization in a single work step, the folding carton manufacturer can achieve logistics savings: they can react quickly and flexibly when pharmaceutical manufacturers order very small quantities.
Integration directly before the packaging line
The two above-mentioned steps can also be implemented by the packaging company, which further increases flexibility. If serialization and late stage customization take place directly before packaging, considerable savings can be made regarding storage and logistics, since efforts for procurement, storing, and especially logistics management of country-specific packaging are no longer required (see Figure 1, scenario 1b). Further advantages include a more versatile production without delays caused by ordering and transporting packaging material from external providers, and easy supply of very small and test batches.
All current regulations allow for serialization and late stage customization to take place completely offline and before the actual packaging process, which means that all marked packaging material can then be fed into a mostly unchanged line. Thereby, several packaging lines can be fed by one digital printing machine. It is not necessary to invest in printing technology for each individual packaging line and then incur loss of production time for its integration.
Integration directly into the packaging line
The currently best-known option leads itself well to large-scale production: packaging material already bearing country-specific graphic designs and markings is produced and then serialized for each country on the packaging line (see Figure 1, scenario 2). Depending on the number of export countries, it may be necessary to stock many folding carton styles, which results in increased efforts for storage and logistics. A conscious decision for the scenarios 1a or 1b shown in Figure 1 might be beneficial for every product or product line.
Integration in the logistics warehouse
In order to efficiently operate packaging lines with high-volume production runs, manufacturers can produce “brite stock,” i.e. filled country- and market-neutral packaging. Country-specific design and serialization are applied in the delivery warehouse by means of late stage customization. Thereby, many short production runs can be combined on the packaging line (see Figure 1, scenario 3), improving its efficiency. It must be noted that this approach is only suitable for products with country-neutral primary packaging, such as blisters, and that the package insert may have to be multi-lingual, since the packaging can no longer be opened afterwards.
If not only the secondary packaging, such as the folding carton, but also the primary packaging, such as the blister, must bear a country-specific design and marking, this can also be implemented in the logistics warehouse. A country-specific design and serialization code is printed on the empty, flat folding carton (see Figure 1, scenario 4). In this case, a DataMatrix code containing, for instance, the product code, EXP and LOT, has already been applied to the blister in a blister machine to ensure process safety, preventing mix-ups during later marking processes.
This marking and packaging step usually takes place in the delivery warehouse, where packing is often done manually. Therefore, this constellation is most suitable for very small batches or very valuable pharmaceuticals with relatively small quantities that are delivered to many different markets.
In general, it must be noted that in all scenarios featuring late stage customization, a packaging design where all relevant sides can be easily reached for country-specific marking via a printing system is most favorable. Thereby, expenditures for storage and logistics can be considerably reduced, and whole warehouses can be made redundant.
Management of serialization data
Irrespective of where exactly serialization takes place, pharmaceutical manufacturers are responsible for their products. As soon as the products enter the market, they must report their serial numbers to a higher authority or governmental agency. A software solution at ISA level 3 or 4, such as Atlantic Zeiser’s MedTracker, is required for the management, and, if required, aggregation of serialization data. This software must collect data from the packaging lines, map aggregation processes, export results, and, depending on the constellation, generate and manage serialization data.
Decision criteria for late stage customization variants
Before investing into a late stage customization solution, several criteria must be assessed, including:
- What are the potential savings through the reduction of: stock value; management of many packaging and product variants; storage area; number of warehouses; losses due to damage; expenses due to changes in marking requirements; and increased flexibility;
- How many folding cartons can be designed in a country-neutral style and what is the quantity to be produced per layout;
- How much effort results from a possibly necessary change of packaging design and packaging approval;
- What are the handling costs for a staff of in-house printing shop or logistics warehouse;
- Cost for printing facilities; and
- Increased cost of inkjet ink compared with offset printing ink.
To manage serialization data, users need a powerful serialization software which ensures process safety while generating, printing, and storing the codes as well as checking them with a camera and transmitting them to downstream processes. Further requirements include suitable printing technology that delivers high-quality printing results—regarding contrast, color brilliance, and lightfastness—for late stage customization applications and serialization at high speeds.
This can be achieved by means of contact-free drop-on-demand printing combined with a special UV ink. DoD color printers with a 600 dpi resolution manage transport speeds of up to 50 meters per minute. Since most packaging lines are not prepared for DoD printer integration, offline solutions are an alternative. These can feed several packaging lines, thus implementing late stage customization and serialization in one step while ensuring optimal capacity utilization.
The robustness of the line and software design in case of disturbances and malfunctions is a key factor, especially for serialization. This means that the machine software and the machine architecture must match the requirements based on practical experiences, and the interface between the machine and the serialization software must operate seamlessly and without any interference in order to ensure stable processes.
Atlantic Zeiser combines these features in one solution: all variable information regarding the market, language, or product is printed on a flat or glued carton one step upstream the packaging process in multiple colors, while serialization takes place during the same work step. Due to the new Omega Pro generation of drop-on-demand UV inkjet printers, the Digiline Versa system is capable of printing graphics, text, and serialization codes in four or six colors and to verify the complete layout by means of a high-resolution camera system.
Due to the use of UV curing inks, the print is especially high-contrast and resistant to water, light, and wear. The integrated Unique Code Software ensures process reliability during generation, printing, and storing of codes that have been checked by a camera, including reporting for downstream processes. Moreover, the system is very robust regarding disturbances and special situations, which is a key factor for serialization. A stable process requires machine, printer, and software to be perfectly coordinated and to have a robust connection to the higher-level serialization software.
New technology and individual design result in savings
Late stage customization and serialization processes can be combined at several steps during the production process. Moreover, the combination with late stage customization opens up savings potentials through optimized line utilization and through considerable cost reductions for storage and logistics. The choice of the process stage where it makes most economic sense to link serialization and late stage customization depends on a wide range of individual factors. Each pharmaceutical manufacturer will evaluate these differently regarding their products and production facilities—corresponding decisions are therefore company-specific. The above-mentioned scenarios show model options with existing technical solutions that can be found in practice.
Manufacturers considering the combination of both marking processes should therefore consult a one-stop supplier of both hardware components and the required serialization software. Thereby, in-house staff is not burdened with the tasks of system integration.
Stefan Rowinski, Product Manager in Atlantic Zeiser‘s „Pharma & Packaging Solutions” division, specializes in the development and marketing of system solutions for serialization, late stage customization, and track and trace applications. In addition, his expertise includes a deep knowledge of processes and workflow in sensitive environments and data management solutions. Prior to his position as a product manager, Stefan Rowinski spent years designing, implementing and planning one-stop solutions for product individualization and headed the projects to implement these solutions. Stefan.rowinski@atlanticzeiser.com