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Pharmaceutical Manufacturing and Packing Sourcer

Sticking Point

As with many industries, the pharmaceutical sector has felt the effects of globalisation. Sales of drug products in countries such as India, China, Indonesia, Malaysia, Brazil, Thailand and South Korea are rising rapidly, and the Asia-Pacific region is now the fastest-growing pharma market in the world, making a presence within this location of strategic importance for all stakeholders.

From a labelling standpoint, globalisation brings up several issues for companies. To take an example, increasing numbers of pharma businesses are buying active ingredients in one region, then producing and packaging their products in another. In addition, it is increasingly common for manufacturers to install production lines in just a few countries, while selling products globally. As a result, labels for pharmaceutical applications must now be able to work across multiple locations.

Worldwide regulatory authorities have also become more concerned about counterfeiting and label-adhesive migration into medication, as a consequence of the use of new materials and processes, as well as a longer supply chain – which is making labels easier targets for imitation and fraud.

Many regulatory groups are demanding additional testing, approvals and certifi cations to ensure pharma companies use labels that are safe and secure for end-users.

Market Growth

Primary drug packaging options are numerous, and include vials, test tubes, pre-filled injectables, insulin pens and ampoules. Of these packaging types, the pre-filled syringe and injection device market is one of the fastest-growing in the industry.

According to a 2013 report by Transparency Market Research, factors driving the growth of the pre-filled syringe market include a global rise in the number of cancer and diabetic patients, as well as improved patient compliance and technology advancement.

The US and other regions are expanding their portfolios internationally, and moving from ampoules to unit dose packaging. Benefits of pre-filled syringes over other drug delivery methods range from improved accuracy, through to reduced drug waste and fewer dosing errors.

High Demand

While vaccines have traditionally been a high-growth area for the pre-filled syringe market, a key contributor to the market’s double-digit growth is increased demand for conveniently packaged products. Pre-filled syringes and injection devices also offer patients the ability to self-administer drugs outside of the hospital setting. This advantage is ever-more important with the rise in the number of lifestyle diseases such as type 2 diabetes, for which patients often use insulin pens for self-treatment. This need will only continue to grow – the International Diabetes Federation estimates that there will be approximately 438 million people with diabetes in the world by 2030.

With clear benefits in patient safety, convenience and reliability, pre-filled syringes have gained widespread acceptance among pharma companies and healthcare workers. More than 20 businesses are now manufacturing pre-filled syringes for delivery of at least 50 injectable drugs and vaccines, according to a 2011 report by the International Journal of Pharmaceutical Investigation. These companies working in the field of pre-filled syringes and injection devices require careful label consideration.

To meet growing demand for medical devices, organisations are looking for ways to produce these products more efficiently and costeffectively. Increasing the speed on filling and packaging lines is one popular solution, while installing fully automated lines in place of manual processes is another. However, this shift to faster production lines and equipment presents new challenges for manufacturers in terms of product performance, identification and security.

Production Efficiency

Today, packaging engineers, label manufacturers and technical consultants are working more closely with pharma companies to develop solutions that address new labelling challenges, while, at the same time, protecting brands and their end-users. One of the areas now being addressed through label innovation is production efficiency.

The key drivers of production efficiency are the increased demand for products and the growth of generics, which require cost-effective manufacturing solutions. The biggest issue for pharma is finding a balance between high-speed labelling and label performance.

Problem-Solving

One common solution is coated glass syringes. This material is often used by companies to avoid or minimise damage to glass syringes on production lines. These applications benefit from label products with higher initial tack – which can endure faster labelling speeds – and superior adhesion properties to help them adhere tightly around coated glass products. Label adhesives and face stocks with excellent mandrel performance can also be used to ensure labels do not peel up or butterfly at the edges.

Transparent labels moving at high speeds may not be easily detected or correctly identified by a manufacturer’s equipment. An option which works well with faster production lines is using transparent labels that have luminescent inks or coatings. Under ultraviolet (UV) detection lights, the labels can be identified, allowing companies to remove any unlabelled products, improve safety and reduce inventory loss.

Label solutions that may have been successful in the past could now result in chemical migration, security issues or incompatibility with equipment. Label material manufacturers can not only evaluate the performance of an adhesive, but also its migration potential, and can offer advice on choosing the right low-migration adhesive for an application.

Another key aspect is convenience. Doctors or facilities using pre-filled syringes and injector devices may require duplicate peel-off labels. These labels help healthcare providers accurately track drug batch numbers and important medicinal information as devices travel from place to place.

Due to the nature of peel-off labels, it is possible to lose or misidentify drug information if labels are not torn off cleanly from the syringe or injection device. To tackle this, developers have begun introducing labels with better tear-off properties to ensure that a straight tear is made and peel-off labels remain intact.

Counterfeiting

Drug counterfeiting is a growing problem both for pharmaceutical manufacturers and the patients they serve. In first-world countries, it is estimated that 1% of all pharmaceutical products are counterfeit, while a staggering 10-50% of drugs in developing nations fall into this category, according to the FDA. Not only do counterfeit drugs contribute to billions of dollars in global counterfeiting costs, they are also linked to thousands of deaths worldwide – though the exact number is unknown. Meanwhile, the original manufacturers of these drugs experience damage to their brand image, sales and revenue.

Anti-Tamper and Security Labels

The internet is the preferred global distribution channel for counterfeit drugs. Approximately 50% of all drugs sold online are from non-FDA-approved sources. To help companies improve the security of their products, a number of national and global organisations – including the FDA, World Health Organization, World Customs Organization and INTERPOL – have introduced new regulations to require more secure pharmaceutical packaging. Further legislation encourages both anti-counterfeiting measures – to improve accuracy in product authentication – and anti-tampering solutions, which let end-users know when a product has been previously opened.

The EU Directive 2011/62/EU Falsified Medicines Act, which became valid in 2011 and is planned for full implementation in EU countries by 2017, introduces obligatory ‘safety features’ that require pharma businesses to start including tamper-evident features in packaging for all prescription and some over-the-counter products. Designed to increase transparency, the amended EU directive will also extend liability for falsified medicinal products to manufacturers, repackagers, distributors, retailers and other relevant players in the supply chain.

Compliance is a growing challenge for manufacturers, whose products often travel long distances in their journey to the consumer. Deciding which security measures to implement for which products can be a drain on time and profits.

Pharmaceutical packagers and manufacturers must ensure that their products are secure and can be authenticated in all phases of production. In addition, they must now include security features that allow wholesale distributors and pharmacists to verify authenticity of drugs through overt, covert or forensic devices; track and trace individual packs or units; determine whether packaging has been tampered with; and pinpoint fake or substandard products. Accordingly, more companies are now looking to label developers to help them with anti-tampering and anticounterfeiting strategies.

New Innovation

Today’s label technologies offer innovative and sophisticated solutions to defend against would-be counterfeiters and fraudulent activity. From two- and three-dimensional holograms to watermarks and tamper-evident void marks, labels can incorporate a wide range of overt and covert brand protection, giving companies a platform to implement multiple layers of product security.

Label technologies for brand protection are extremely versatile. Basic security features are provided by products containing security threads and holograms. Other options include low-resistance papers, destructible films and tamper-evident void labels. These off-the-shelf solutions are the most affordable and popular products for companies that want entry-level protection.

For a more advanced level of defence, additional features can be added and customised for further brand protection. UV fluorescent prints, microprinting, colour shift inks and customised holograms, voids and security papers, such as watermarks, are even harder for counterfeiters to duplicate. For manufacturers of drugs with a high risk of counterfeiting, these solutions are worth the investment.

Additionally, high-end solutions offer companies the greatest level of protection. Using unique and personalised security features – for example, infrared detection and forensics – developers can incorporate unique components into a label to identify and track products. A popular technology for product tracking and traceability is radio-frequency identification tags, which allow businesses to track a product through its lifecycle using its label.

The pharma industry has the dual challenge of keeping inauthentic products out of the supply chain and ensuring its own, authentic products are insulated from security threats. While regulatory bodies have introduced guidelines to encourage action against counterfeiters, regulators have largely left it up to manufacturers to determine how they will meet those principles.

Ultimately, choosing the label technologies which are needed for each application can vary greatly from company to company. Before implementing a protection strategy, pharmaceutical manufacturers should consider questions such as:
  • What level of security do we want to build in our packaging design?
  • Do we want overt, covert or forensic solutions?
  • How much do we want to invest in brand security?
Determining these needs will help manufacturers work better with packagers, label developers and printers to identify and implement solutions that ensure compliance, while aggressively counteracting drug counterfeiting and tampering.

Pharmaceutical manufacturers must differentiate their products and elevate their brands in this ever-evolving industry. The test for today’s label developers is creating products that meet the technical requirements of pharma companies, as well as their own operational, marketing and cost-reduction needs.

New label solutions are helping businesses solve these challenges. From low migration adhesives and temperature indicator products, to security products with incorporated functionality, anti-tamper and brand protection features, today’s innovative labelling options are helping companies deliver consumer packaging that is attractive and effective, but also safer, securer and more compliant for end-users and brands.

Technical Solutions

Pre-filled syringes and injection devices are now widely accepted as safe, reliable and convenient methods of drug delivery. But packaging materials, product specifications and production demands for injectable applications have continued to adapt to changing market demand and patient needs.

An ongoing hurdle for businesses producing medical devices is developing innovative packaging solutions. Labels that may have worked in the past could now result in chemical migration, security issues or incompatibility with equipment. However, by providing thorough technical solutions for syringe labelling and label stock, technical consultants can help companies solve these problems and deliver functional, convenient packaging to the marketplace.

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Mirta Zuccala is the Segment Leader for Pharma, Europe at Avery Dennison Corporation. Her role is to develop and generate new business opportunities in the European, Middle Eastern and North African markets. Prior to joining Avery Dennison, Mirta was the Sales Director, Italy for the Promens Group’s packaging division.
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