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Pharmaceutical Manufacturing and Packing Sourcer
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The ultimate purpose of a cold chain transporting temperature-sensitive
biopharmaceutical products is that at the end of the journey, when the
drug reaches the patient, its efficacy has not been compromised or
adulterated – allowing for the best possible result from the medication.
However, the globalisation of healthcare has complicated the
delivery of temperature-sensitive pharmaceuticals and, during the course
of distribution, products are likely to be exposed to a wide range of
ambient temperatures. This requires a focused evaluation of
transportation modes, processes utilised and secondary packaging
selected.
Difficult Conditions
Methods of
distribution can involve a combination of sea, ground and air
transportation, and packaging may include active or passive containment
with either a seasonal or universal pack-out design. The driver for
these considerations is the requirement to have scientifically sound
data that ensures a product will arrive uncompromised.
Some of the challenges include:
- Colder
ambient temperatures than that to which the passive packaging has been
qualified may cause payloads to drop below the required temperature
range. For example, on 6 January 2014, the temperature at Chicago O’Hare
Airport, US, was measured at -27ºC and, for 60% of the winter of
2013/2014, the temperature in the Chicago area averaged -7ºC. Packaging
had to withstand extreme cold for prolonged periods of time
- A
similar problem can occur when passive packaging is exposed to hotter
ambient temperatures than its tested range, causing payloads to rise
above the recommended temperature range. Almost all of the highest
globally recorded temperatures were set in the last eight years, with
greater highs recorded every year. This summer, most of mainland Europe
has been around 10-15ºC hotter than normal for a number of days at a
time. Again, packaging had to withstand more extreme temperatures for
longer than usual
- Delays in transport time – such as the
lengthy offloading of sea containers due to bad weather, labour
disputes, or insufficient availability of trucks or drivers – not only
increases inventory carrying costs, but also requires an assessment of
whether the packaging can handle the duration and conditions transport
requires
Available Options
Many
companies, along with governmental regulators, are reviewing existing
product stability data to determine whether there are reasons for
concern. When an opportunity for improvement is identified, biopharma
companies investigate the variety of cold chain packaging solutions
currently available. These range from active solutions with electronics,
compressors and heaters, to passive packaging with determined
temperature ranges, a wide variety of payload sizes, extended duration
times, and fluctuating degrees of packaging complexity and performance.
Although
active systems provide the best performance and are the most reliable,
their cost is prohibitive for some shipments. The next best solution is
universal passive packaging that is designed and tested to severe
ambient temperatures. However, as weather is not consistent, this may be
cost-prohibitive as it can result in an over-designed solution for the
majority of shipments. The question is: how often and how many of your
shipments will be subjected to weather extremes? If your distribution is
to markets susceptible to extreme heat or cold, you could jeopardise
four to five months’ business if you do not get it right.
Reusable Packaging
The
investment in the best available packaging can be high, yet the
industry standard is for the end-user to unpack their goods and discard
the packaging. However, as it seems inefficient to use good-quality,
reliable packaging once only, there have been many advances in reusable
solutions.
More and more biopharma companies are demanding
reusable packaging – not just to reduce their carbon footprint or
because the combination of sustainability and cost-saving makes a potent
business case, but because it makes little sense to support ‘throwaway’
options indefinitely. It is likely that reusable packaging could, in a
few years’ time, become the norm rather than the exception as it
continues to be adopted by forward-thinking biopharmas and ecologically
responsible companies.
There are two key contributors to the
success of reusability. One is that returned packaging is always ‘as
good as new’ – it has to perform to its original qualified specification
every time it is reused. The other is the educational aspect, because
customers need to buy into reusability wholeheartedly. They have to see
that it is easy to return the packaging and, once they do, they
understand the benefits for the environment and readily embrace it. In
addition, they need to have the assurance that when they receive the
packaging to reuse, the product will not be compromised.
Packaging Portfolios
But
what other best practices are being implemented within the industry?
What are the leading companies doing? It appears that many have been
adding complexity, while attempting to simplify their processes.
Businesses are now assessing their global packaging portfolio and are
finding that, in many cases, they are using hundreds of different
solutions, including many that are not qualified (or are qualified to
inadequate profiles for the particular use). With this in mind, they are
re-evaluating their packaging and logistical options.
Biopharma
companies should be assessing their true requirements both regionally
and globally – requiring a solution that works, is relatively simple to
use and is attainable at the lowest possible cost. Regional distinctions
may also include availability and designs for differing ambient
conditions.
This re-evaluation is causing organisations to look
at packaging providers differently – and the questions asked of their
suppliers have subtly changed. Can they provide genuinely global
solutions that are consistent with quality? Can these be designed with
simple pack-outs that include minor design changes to allow for regional
ambient conditions? Can they provide a range of options that vary from
shipping a large pallet of active pharmaceutical ingredients and
finished goods with strict temperature requirements, in addition to
packaging that can be used to deliver a small quantity the last mile?
Leading the Way
Responding
to these concerns and streamlining the supply chain goes beyond a
logistics problem: it is a financial imperative. Efficiencies in the
supply chain are a critical differentiator for the leading biopharma
companies, which see that they can turn their supply chain into a
competitive advantage and not a cost centre. To do so, they must analyse
the total value coming from the supply chain – everything from the cost
of packaging to the cost of capital. If they can offer customers a
better and more reliable supply chain, they can add value to their
businesses, as well as their own bottom line.
This is an
exciting time to be serving the life sciences industry because today’s
decisions should determine which companies will become the leaders and
which will remain stagnant – falling behind because of a reluctance to
change. Though the ultimate purpose of the cold chain will remain the
same, success within the biopharma industry will go to those businesses
which effectively evaluate, assess and balance complexity with
simplicity.
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News and Press Releases |
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Finalists Showcase Innovations in Sustainable Pharmaceutical Packaging, with Winners to be Announced at Connect in Pharma
London, UK – 25 May 2023 – Sciad Newswire – YewMaker and Connect In Pharma announce today the shortlisted finalists
for this year’s Sustainable Medicines Packaging Awards. Winners will be
announced at an in-person champagne ceremony at Connect In Pharma, an annual event connecting innovators in pharma and biotech to the world’s leading suppliers and manufacturers.
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Industry Events |
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The Pharmaceutical Manufacturing and Packaging Congress 2023 (PHARMAP 2023)
12-13 June 2023, Hilton Geneva Hotel & Conference Centre, Geneva, Switzerland
The Pharmaceutical Manufacturing and Packaging Congress 2023 (PHARMAP 2023) gathers top-level management from pharmaceutical
companies of manufacturing, primary and secondary packaging, purchasing,
and supply chain and procurement sectors, CMOs and CDMOs leaders, heads
from government and institution on 12-13, June, 2023 in Geneva,
Switzerland.
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