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Pharmaceutical Manufacturing and Packing Sourcer

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After a long period of industrialised economies’ domination of the pharma market, the emerging countries are outgrowing their developed peers. The rapidly increasing demand for medicines in Africa, Asia and Latin America (dubbed ‘pharmerging economies’ by IMS Health) is a fact that has to be addressed by the packaging industry (1).

Creating packaging that will resonate in the local market is critical to success in emerging regions. This is driving innovation in packaging and, in turn, coding and marking technologies – presenting pharma manufacturers with more options than ever before. However, an effective global pharma expansion strategy is built on a foundation of best practices that will help ensure products are safe to use for patients around the world.

Alongside their increasing economic wealth is a notable rise in healthcare spending among emerging markets. Investments in the healthcare system, made by government, nongovernmental organisations and the private sector, are fuelling the growth of the pharma industry. The combination of strengthening economies and an expanding middle class is the main stimulator for such expansion. Pharmaceutical spending in Asia-Pacific is expected to grow at a 12.5% compound annual growth rate through 2016, followed by Africa at 10.6% and Latin America at 10.5% over the equivalent period (2). At the same time, the developed markets of North America, Europe and Japan will see more modest single-digit spending growth between 2014 and 2017 (3). The global focus on pharma expansion in emerging markets is driving an urgent need for international serialisation and traceability, to secure both supply chain integrity and patients’ safety.

Coding is Key

With total global spending on medicines projected to reach over $1 trillion by 2017 (4), the demand for standardised serialisation of pharmaceutical packaging has become a crucial matter. Today, most industrialised economies are strengthening their legislation relating to preventing falsification of pharmaceutical packaging and protecting patients’ safety. It is a $7 billion problem for the pharma industry, with thousands of packaging lines needing to change.

Yet without precision coding and marking technology, serialisation efforts will be ineffective and, in the worst cases, will lead to costly product recalls and potential fines. Therefore, packaging manufacturers investing in pharmerging markets have to be aware of the challenges lying ahead, and secure their businesses by implementing cutting-edge technologies.

Packaging Growth


Correct product coding is vital for pharmaceutical packaging manufacturers – large and small – interested in emerging markets. The latest technologies enable companies to embrace more innovative packaging solutions by expanding their product portfolio, both in the range of materials used and in production efficiency. For example, blister packs are the most prevalent package type in pharmerging markets due to product protection, patient compliance, and support of daily and weekly dosages.

At the moment, coding technologies are applied primarily on secondary packaging (such as cartons), but the market is expressing a growing interest in coding on primary packaging like blisters. To this end, a range of printing solutions are now available to code both types of packaging; however, manufacturers need to consider the substrate characteristics and available print area in order to select the right technology. Substrate characteristics – as well as up-time and code resolution requirements – can all impact upon which printing solution is optimal for a given serialisation initiative.

Available Technologies

With these factors in mind, there are several advanced printing options to choose from for coding and marking applications. The two most common print technologies that can handle various substrates are laser marking systems and thermal inkjet (TIJ). Other reliable and efficient coding systems include continuous inkjet (CIJ), thermal transfer overprinting (TTO), print and apply labelling (LPA), and large character marking (LCM). Depending on the individual needs of the pharmaceutical packaging manufacturer, there will be a system that can be seamlessly integrated onto existing product lines for fast, accurate, and durable coding and marking.

Laser Marking
This technology uses a beam of either infrared (IR) or ultraviolet (UV) light, focused and steered with a series of carefully controlled small mirrors, to create marks where the heat of the beam interacts with the packaging surface. CO2 laser marking systems simplify the overall process, improving the appearance and readability of pharmaceutical coding by permanently etching the material surface without physical contact or ink supplies. Laser marking can be used to print a two-dimensional (2D) data matrix – the standard code carrier for a wide range of regional and country-specific serialisation requirements – as well as other barcodes. Laser is an ideal choice for use on pharmaceutical packaging such as cartons, bottles, labels, vials and ampoules, tubes and blister foils.

Thermal Inkjet
TIJ printers fire tiny ink drops through fine-gauge nozzles onto packaging as it passes a printhead or cartridge. This system is used for high-resolution, ink-based, non-contact printing, utilising heat and surface tension to move ink onto a package surface. TIJ is generally used to print traceability information, including 2D data matrix codes, onto cartons, labels, blister foils, and pouches and barrier materials. It is best for manufacturers looking to print highquality text and barcodes on paperbased substrates, ensuring that complex and detailed codes are clearly readable for downstream verification.

Continuous Inkjet
CIJ technology is used for fluid-based, non-contact printing of up to five lines of text. Extremely versatile, these systems can be used to print on nearly any product shape and are suited for a wide variety of packaging, including cartons, bottles, labels, vials and ampules, tubes, blister foils, pouches and barrier materials, and stick packs. Fast print speeds and a range of applicationspecific inks make CIJ a strong option for pharmaceutical packaging.

Thermal Transfer Overprinting
TTO systems use a digitally controlled printhead to precisely melt ink from a ribbon directly onto flexible films, providing high-resolution, real-time prints. This technique is a good choice for marking flexible packaging such as pouches and barrier materials, offering high-quality codes from date, lot and time stamps, to more complex barcodes, use warnings and ingredients lists.

Print and Apply Labelling
To meet increased demand for labels and high-grade barcodes on brown corrugate cases and bundles, LPA automatically prints and places labels of various sizes onto packaging. Advanced LPA systems have been designed without the need for a tamp or air blast applicator to remove the mechanisms that frequently cause everyday operational problems like label jams. As such, LPA technology can help pharmaceutical manufacturers ensure accurate label placement and high-contrast coding, without ever missing a label.

Large Character Marking

LCM systems provide ink-based, noncontact printing of multiple data types, including alphanumeric, logos and barcodes in larger sizes. LCM makes preprinted cartons and labels unnecessary by printing supply chain information directly onto the cases. Codes printed on white pharmaceutical cases offer sharp, machine-readable barcodes.

Track and Trace

After ensuring appropriate printing capabilities, the next step is capturing product data – such as device and production identifi ers – so it can be tracked throughout the supply chain. Stable product control is vital to avoid false rejects. Two different methods are considered best practice: integrating the print and inspect system directly into the cartoner; or using a dedicated transport system.

A complementary strategy is required to manage the vast array of product information created throughout the supply chain. This can be achieved through aggregation, where unique codes are created on outer packaging that is linked to all the units within. Aggregation avoids the repeated opening of cases and scanning while products are being transported. Downstream in the supply chain, when a case or pallet code is read, an inference is made that all the individual units linked to the outer case are contained inside. Obviously, this makes code quality and data integrity paramount. In order to aggregate cartons and bottles into cases, the serial number reading should be coded at the last possible moment – preferably once the product is already inside the case – to guarantee data integrity.

Finally, the manufacturer should use authoritative data sources, such as manufacturing execution systems, supervisory control and data acquisition, enterprise resource planning or similar. This way, the company ensures that proper information is pulled to the printer automatically when the job is selected. According to a UPS report, 56% of healthcare businesses have found that IT investments, including barcoding and e-pedigree technology, have helped them to successfully address product security (5).

Flexible Solutions


Since global track and trace serialisation regulations are evolving constantly (particularly in Latin and North America, Southeast Asia and Europe), careful consideration of the local market is key to success. Pharmaceutical packaging manufacturers must invest in a printing solution capable of addressing today’s and tomorrow’s regulatory demands, as well as specifi c local needs.

Given the sector’s rapid growth and uncertain regulatory future, the chosen printing solution should be flexible to make the producer’s life easier. Ideally, technology providers will offer an operator-friendly standard interface – compatible across printing systems – that can simplify user experience regardless of technology. As 50-70% of coding errors result from incorrect data entry, a centralised message management removes the task of message creation from the line, and helps ensure the right codes are placed on the right products. As a result, integrating the most suitable printer for a company’s needs can be a productivity driver in the face of growing complexity within the global pharma market.

References

1. Visit: www.quotidianosanita.it/allegati/ create_pdf.php?all=6540948.pdf, p15
2. Visit: http://infinitepotentials.org/wp-content/uploads/IPC-Datashots-2014-Week-30-Africa-is-theworld%E2%80%99s-second-fastestgrowing- pharmaceuticals-marketexpected-to-reach-30B-by-2016.pdf
3. Visit: www.imshealth.com/ deployedfiles/imshealth/Global/Content/Corporate/IMS%20Health%20Institute/Reports/Global_Use_of_ Meds_Outlook_2017/IIHI_Global_Use_ of_Meds_Report_2013.pdf
4. Visit: www.imshealth.com/deployedfiles/imshealth/Global/Content/Corporate/IMS%20Health%20Institute/Reports/Global_Use_of_ Meds_Outlook_2017/IIHI_Global_Use_of_Meds_Report_2013.pdf
5. UPS, Pain in the Chain, 2013


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Richard Nemesi is Global Vertical Marketing Manager for Pharmaceutical and Medical Devices at Videojet Technologies. His main responsibilities at the company are to develop a deep understanding of global trends and customers’ needs within the sector, create marketing content to support sales efforts, and provide counsel to product development teams on equipment functionality. Prior to Videojet, he was a Systems Sales Specialist in IBM's Systems and Technology Group.
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