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Pharmaceutical Manufacturing and Packing Sourcer
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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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