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Pharmaceutical Manufacturing and Packing Sourcer

To Re-use or Not to Re-use?

How important is the re-use programme in thermal shipping? Brian Kohr at AcuTemp Thermal Systems picks out the factors to consider when initiating a new programme

In today’s competitive marketplace, pharmaceutical companies are looking for ways to save money while supporting green initiatives at the same time. When it comes to the thermal shipping containers being used to ship temperaturesensitive materials, many are asking how they can establish a re-use programme that maintains the efficacy of their product by assuring the shipping package still meets the original package specifications. In addition, most companies are only interested in pursuing a green alternative in its thermal shipper fleet if that solution promises a true return on investment.

To decide if your company should initiate a re-use programme, it is important to understand the full extent of the economic and environmental impacts that are at play in this decision. Many thermal shipper manufacturers make ‘green’ claims that, on the surface, appear sound and very effective. This leads pharmaceutical companies to conclude that re-using shipping containers saves money while minimising negative environmental impacts. Fewer boxes required for shipments provide procurement savings, and the reduction of boxes in use is presumably better for the environment. This makes sense on the surface, but unfortunately may be an oversimplification of an issue that, on closer inspection, is slightly more complex once you unpack the box and look inside. A re-use programme must be placed in the proper context, which can quickly be summarised with the following key considerations:

  • What is the environmental friendliness of the materials being used and of the re-use programme?
  • What is the total cost of ownership, taking all factors into consideration?
  • What is the extent of the thermal qualification and assurance that the packaging is reusable?

While these three issues are somewhat interrelated, let us take a closer look to see how each should factor into the decision to initiate a re-use programme. Companies that recognise a double bottom line, where environmentally sustainable practices and profit are equally as important, are still very much the exception to the rule. The reality for most companies is that environmental sustainability is a goal, but it cannot come at the expense of profit margins. The good news is that those that are leaning toward a greener overall footprint but haven’t yet focused on supply chain sustainability (including the cool chain) may find that the right re-use programme could lessen its carbon footprint and improve the bottom line. In short, an innovative re-use programme is a win-win for both sides of the equation.

KNOW YOUR INSULATION MATERIALS

Thermal packaging manufacturers use a variety of insulation materials. A typical qualified shipping box has a cardboard corrugate or plastic corrugate shell, and both are either reusable or recyclable. The materials used for insulation inside the thermal shipping boxes are not as clear cut. Expanded polystyrene (EPS) is a rigid foam material that is often used as insulation because of its simplicity to produce and its thermal resistivity. Commonly referred to as Styrofoam, EPS has a hydrocarbon base, is not biodegradable and has an R-value of R-4 per inch. While EPS can be recycled for multiple purposes, it essentially creates a non-closed loop when used as fillers in other materials that cannot be recycled and are thrown away (for example, Styrofoam cups).

Similar to EPS, polyurethane (PUR) is a foam board material that is sought after in thermal shipping containers because of its ease of integration and thermal resistance. PUR contains gas in its cells (usually hydrochlorofluorocarbons [HCFCs]) which increases its R-value to as high as R-6 per inch. However, due to the loss of gas within the foam over time and due to shipping damage, the resistivity degrades and levels out at a lower value. If used in insulated shippers as part of a re-use programme, the R-value of the PUR would have to be continually retested to qualify its thermal performance. Known as the least friendly environmental packaging insulation, it poses more difficult biodegradation and recycling challenges than EPS.

At thermal resistivity values of up to R-45 and with a dramatically smaller physical footprint, vacuum insulation panels (VIP) offer a highly efficient, high-performance insulation alternative (see Figure 2, page 20). Vacuum insulation panels are formed by creating a barrier envelope (foil material) that surrounds an open cell core material and then evacuates the enclosed gases. The envelope is tightly sealed so that the vacuum can be maintained for years, providing high thermal performance for an extended life with greatly reduced thermal degradation. Boxes made with VIP are smaller and lighter, and as a result have less of a carbon footprint in the shipping process than PUR and EPS packaging. Both the foil and the open cell core are reusable and recyclable. Because all insulation types degrade over time, it is imperative that thermal retesting take place in boxes that are being re-used.

REDUCING THE TOTAL COST OF OWNERSHIP

An effective re-use programme can significantly reduce the total cost of ownership for a fleet of thermal shippers. Savings are accomplished in two ways. The first and most obvious is that multiple re-uses of the same shipping container decreases packaging costs (as opposed to one-time usage). Secondly, by initiating a high-performance temperature assurance programme, an organisation can protect against costly losses of product as well as potential regulatory violations. A re-use programme begins by identifying a company with the thermal shipping manufacturing expertise to offer a credible re-use initiative that ensures that the quality of the insulated shipper can be guaranteed prior to every use. Then it is a matter of working with that manufacturer to identify and qualify an insulated shipper for your company’s specific needs.

How a re-use programme is rolled out is very simple. Instead of shipping once to its destination for one-time-use, your box arrives at the receiver’s location with a prepaid return shipping label and instructions. The return label is placed on the box and is picked up the next day by the delivery company for shipment to the retesting facility using a low cost return shipping rate. Participation in this return is vital to the success of your re-use programme, so it’s important to notify those who will receive your goods that returning the box is encouraged. Communicating that participation in the programme provides environmental benefits and helps to assure that future shipments will be thermally qualified, which may be incentive enough to elicit participation. Some may go as far as instilling a non-participation penalty via a per-shipment charge.

Customer participation may be slower than anticipated at first, but in time the return rate should steadily climb as customers adapt. Fifty per cent participation is typically a good starting point, but results have shown up to 75 per cent participation after one year of starting a programme. Based on feedback from current proponents of re-use, the promise of reducing the negative environmental effects of one-time use without risking the quality of the products shipped is a concept that customers should enthusiastically embrace.

Regardless of the extent of return rates, the impacts on the bottom line can be felt immediately due to the re-use of shippers in the field. In many cases, the savings netted from the initiation of a re-use programme in the first year is approximately 60 per cent of what it would have cost to complete the same amount of one-time-use shipments. With the potential for such significant savings, the economic value of re-use is immediately obvious.

Perhaps the most important element of a re-use programme is its ability to thermally qualify each shipper before reuse. Without that, the monetary gains of using fewer shippers could be quickly overshadowed by the cost of product loss and degradation of your reputation.

DON’T RE-USE UNLESS RE-QUALIFIED

Many shipper manufacturers have re-use programmes that ignore the importance of thermal re-qualification of the insulated shipper. This is a flagrant oversight and one that regulatory bodies have started to identify as a gap. An insulated shipper that is re-entering the cool chain should be as thermally sound as it was the first time it was used. Requalification is the only way to have the assurance needed to ship your temperature-sensitive materials according to the strict pharmaceutical regulations.

Regulations aside, it’s important to consider that each box must be uniquely qualified for its specific shipping scenario. Using a ‘general’ guideline for re-use does not ensure quality. Some boxes may be subjected to harsher conditions than others during shipment and will deteriorate faster, while others may require a longer hold-time.

Stringent thermal testing provides the confidence and proper documentation for a customer to engage in a re-use programme. A customer can provide the necessary documentation to the FDA that certifies its shipper’s compliance. This is the only way a customer can achieve the peace of mind to know that its products are not degrading during the shipping process. Once a thermal shipping container is returned, it should be subjected to the following procedures to ensure reusability.

Inspection and Repair
Each shipper requires close visual inspection, including the tracking of the serial number of the thermal shipping unit. If there is damage to the outer shell, it should be replaced along with any internal components that were damaged. Items that can be re-used should be cleaned in compliance with FDA 21 CFR 211 Subpart 94.

Thermal Re-qualification
The thermal components of each shipper should be tested thermally to ensure they meet the original performance specifications prior to re-use. Any thermal components not meeting original performance specifications should be replaced with new, fully tested components.

Re-use
With inspection and requalification complete, the shipping box is reassembled and returned to the cool chain distribution process for re-use. While a minimal reclamation and retest fee applies each time a shipping unit is processed, it pales in comparison to the cost of purchasing individual shippers. In the end, when you weigh the benefits, re-use is economically and environmentally sensible to initiate. Of course it all depends on the effectiveness of the re-qualification process, because, without that, the programme quickly loses its value.


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Brian Kohr joined AcuTemp in 2004 as Chief Financial Officer and has served as the company’s President and COO since 2007. Brian also serves as general manager of CSafe LLC, the manufacturer of the AcuTemp RKN. He holds an MBA degree from the University of Notre Dame, as well as BScs degrees in Accounting and Finance from Wright State University. Brian is a Certified Public Accountant in the State of Ohio. Under his direction, AcuTemp has seen significant growth in its passive and active temperature line. Brian serves on several privately held company’s boards. He also serves as Chairman of the Board for the nonprofit Entrepreneurs Center in Dayton, Ohio.

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