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Pharmaceutical Manufacturing and Packing Sourcer

Made Simple

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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Brian Kohr is the President and Chief Executive Officer of CSafe Global, having previously served in those positions with CSafe LLC and AcuTemp Thermal Systems. He has held senior executive positions with various healthcare and technology companies, and currently serves on the Board of Directors for several private businesses, as well as being Chairman of the Board of Trustees for The Entrepreneurs Center in Ohio, US. Brian is a certified public accountant, has Bachelor of Science degrees in Finance and Accounting, and holds an MBA degree from the Mendoza College of Business at the University of Notre Dame.
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