A Rental or Leasing Program for Small Reusable Package Shippers for Temperature – Controlled Products

Substantial sums of budgets and resources are spent annually to design packages (containers) to ship temperature-controlled products. Most of the designs use expanded polystyrene foam (EPS) or polyurethane foam (PUR) insulation with gel packs as the cooling medium. Recently, some vacuum panel insulation has been used in package design and phase change material (PCM) has been implemented as a cooling medium in addition to the gel packs. The foam insulated shipper cooled by gel packs was invented in the late 1950’s and this technology is still the major design being employed in package design and development to produce small shippers for temperature-sensitive products instead of using some of the newer technologies.

Generally, the shipper of a cold chain product does not necessarily want to design a package. What the shipper really wants is a safe and successful shipment of the product. However, the shipper has not stopped to question if the old “tried and true” methods that have always been used are antiquated and need to be replaced. In addition, due to the increased regulatory requirements to ensure that the quality, integrity, potency, efficacy and safety of the temperature–controlled medicine are not compromised during handling, storing and shipping from the manufacturer to the end user, the capability of these small, “old technology”shippers is being pushed to the limit.

In the cold supply chain, the package shipper and carrier are the means to accomplish the task of shipping a temperature–controlled product from one point to another while ensuring that its temperature does not experience excursions below or above the specified minimum or maximum temperatures and the product arrives at the destination without physical damage. The shipper typically chooses the packaging and duration of shipment (e.g., overnight, 2 day) while the carrier chooses the mode of transportation (e.g., truck, air) and the route.

Most of the above mentioned shipping containers are designed to be used once and then be discarded. This has not been environmentally friendly. The impact of the packaging insulating components and the refrigerants on the environment should be investigated in regard to toxicity, energy used, created pollution, emission, biodegradability, recyclability and reusability. A non-exhaustive overview of various global directives and waste stream for packaging components used to distribute temperature-sensitive products in the last mile is discussed in Section 6.3 of the PDA Technical Report No. 46, “Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User” [1]. Proposed requirements and directives from the Chinese [2], Japanese [3] and EU [4] authorities include the responsibility of the brand owner to “take-back” post-consumer packaging and packaging producers to be fiscally and physically responsible for their products at the post-consumer stage of their life cycle. Currently, there are no legislated requirements in the USA except for nickel-cadmium batteries.

Most shipments of pharmaceuticals to consumers such as physicians, pharmacies, hospitals, and patients, particularly most injectables and biologicals, utilize EPS packaging, which usually become landfill items. The Alliance of Foam Packaging Recyclers has posted a resource document on its website listing available recycling/reclamation sites in the United States for EPS packaging [5]. Solutions using biodegradable, reusable, and sustainable materials in the construction of the small shipper packages would address the previously discussed environmental challenges.

This article presents a model for a program for the renting or leasing of small reusable package shippers for temperature–controlled products where the customer could rent a container on a per trip basis to ship its product from its location to the destination. The high-tech container guarantees transporting the goods successfully. In addition, the cost of the rental of the reusable small container is less than the cost of purchasing a container that is used once and is then discarded. A turnkey, all-inclusive service could be provided by logistics integrators that would include the container rental, the freight cost, customs clearance, and the handling fee in one set price.

Reusable containers have been proposed for many years, but unless a company has a closed loop system, they are not usually economically feasible. The two main reasons that reusable containers have not been feasible are the containers change from an expense to an asset which then must be managed and the cost of returning the containers for inspection, cleaning, and repair negates the advantages.

Sustainable Reusable Pallet Shipper Model

Currently, a successful model for reusable actively cooled palletsized containers is operated by some companies. The two main reasons this pallet shipper model is successful are the customer does not own the container and only pays for the shipment and the container does not have to be returned to the origin. It is sent to the nearest depot, thus reducing the return cost.

Sustainable Reusable Small Package Shippers

A similar system is needed for shipments of small packages since many more of them flow through the cold supply chain than pallet-sized bulk container shipments. Currently, the majority of these small package shippers end their life cycle as landfill.

The small reusable package shipper industry needs to implement a set of standardized specifications for reusable containers for shipping through the cold chain. These high-tech reusable containers would be qualified for all types of shipping configurations and for different temperature extremes for the lanes over which they move. If a central industry data base is established, then, each shipment of these containers would add to the qualification database and strengthen the qualification model, thus eliminating the need for extensive testing for every new product entering the market.

The specification of the small reusable package shippers should include:

• The container must be well built to withstand the harsh handling in commercial shipping systems and must be capable of numerous shipping cycles.
• Loading of the container is simple without a complicated pack out procedure.
• The container must have an active temperature control so it automatically adjusts to the ambient temperature.
• The container must automatically handle winter or summer shipping profiles, and ship hot–arrive cold, or ship cold–arrive hot profiles.
• The container must tolerate extended durations at hot or cold temperatures without allowing temperature excursion of the product.
• The container must have a high payload volume to tare weight ratio.
• The container must have a dual channel logger to measure the ambient (environment) and internal temperatures of the product.
• The logger must quickly download the data via an on-board global Internet system. Thus, within minutes, the product would be approved for use.

Current industry best practices, as per PDA Technical Report No. 39 [6], is to perform Design/Component Qualification (DQ/CQ), Operational Qualification (OQ) and Performance Qualification (PQ) for the development of a package shipper and the qualification of a specific shipping lane. However, in the future, using this standardized container and the industry qualification database system model described above, all a company must do to get a product to market is design its primary and secondary packages to maximize the cube in one of the standard container sizes and the job is finished. The need for extensive thermal testing is eliminated since the qualification database created from thousands of live shipments can be used to qualify the use of the standard container in the required lane.

The success of the shipping system for small reusable package shippers requires the establishment of depots at various geographical locations to accept containers so they do not have to be shipped back to the originating location. The receiving customer of the small reusable package shipper would unload the material and then route the shipper to the nearest depot in the shipping system where it would be cleaned and prepared for its next use. In contrast, a use-once–and-discard shipper would become landfill. In some European countries such as Germany, it would have to be shipped out of the country or the shipper would have to pay special disposal fees since disposal of EPS or PUR is not permitted in landfills [7].

Shipping models

Two different shipping models should be considered. The first will be the pay-per-trip model where the container will be ordered from the depot conditioned and ready to accept the customer product. The container will be brought to the customer location by the driver. The material will be loaded while the driver waits. The driver will take the container to the airport where it will depart on the designated flight. At the destination airport, the container will be picked up and taken to the destination. On arrival at the consignee’s location, the driver activates the logger to transmit the temperature data over the cellular network so the material can be deemed fit for use. The container will be opened and the material will be unloaded. The driver will take the container away and route it to the nearest depot. This shipping model is currently in operation in the United States and Europe. It is also offered by logistics integrators as a turnkey solution. For example, Company A in cooperation with Company B, will deliver a fully-charged dry LN2 shipper (used to ship cells, tissue and other cryogenic substances) to a customer. After loading the product into the shipper, the customer notifies Company B who picks up the shipper, and delivers it to the customer-chosen destination. When the customer is finished unloading the LN2 shipper, Company B picks it up and returns it to Company A for refurbishing and recharging with liquid nitrogen and the cycle is repeated.

The second is the leasing model. It consists of a customer leasing a quantity of containers that are maintained at the customer’s site. The customer is responsible for conditioning the containers and preparing them for shipment. The customer can contract an integrator for the shipping service or it can handle the logistics itself. At the end of the trip, the consignee is responsible for activating the logger to transmit the temperature data, unpacking the product, and then routing the container to the destination depot. As soon as the container is received by the destination depot, a replacement container is shipped to the customer from a depot near the originating location. The container lease could be paid monthly for a term of 36 months, as an example. The lease payments include annual inspections and annual recalibrations of the logger. A depot handling fee will be charged by the destination depot.

In a recent article, the author indicated that, “There is a developing trend among packaging providers of insulated packaging systems to issue to its customers pay-per-use, high-performance insulated packaging”[8]. He addressed the implementation of the leasing or renting system for healthcare products as it relates to total cost of ownership for insulated packaging systems. His conclusion was that when the total cost of ownership is considered, the pay-per-use system is competitive.

Conclusion

With a strategically located depot system where the customer can rent or lease small reusable package shippers for temperature-controlled products, the reusable container program becomes economically feasible and environmentally friendly. In addition, the customer benefits from the elimination of the high cost of cold chain package development. The reusable container is much more sophisticated than the standard oneway foam and gel pack container which virtually guarantees a successful shipment, thus reducing product scrap due to temperature excursions. All these benefits are realized without the customer having to invest in a large inventory of its own reusable shipping containers. Finally, at the end of its useful life, the reusable container would be returned to the manufacturer who would recycle all possible content and properly dispose of the remainder.

Acknowledgement

The author would like to acknowledge the cooperation of Mr. John Howe, Active CC Boxes, LLC, and Edward J. Smith, Ph.D. PACKAGING SCIENCE RESOURCES, Pharmaceutical Packaging Training and Consulting, in preparing this article.

References

1. PDA Technical Report No. 46, Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User; Parenteral Drug Association: Bethesda, MD, 2009.
2. China: http://www.researchandmarkets.com/categories.asp?cat_id=329.
3. Japan: JIS Q 0064:1998: Guide for the inclusion of environmental aspects in product standards.
4. EU: http://www.greendotcompliance.eu.
5. USA: www.epspackaging.org.
6. PDA Technical Report No. 39 (Revised 2007): Guidance for Temperature- Controlled Medicinal Products: Maintaining the Quality of Temperature- Sensitive Medicinal Products Through the Transportation Environment; Parenteral Drug Association: Bethesda, MD, 2007.
7. The Recycling and Waste Act - Federal Republic of Germany 7 October 1996.
8. Kevin O’Donnell, “No Deposit, No Return?- Considering Total Cost of Ownership for Insulated Packaging Systems”, Contract Pharma,November/December, 2010, 32-34.