Though hard to believe, two short decades ago the world used Styrofoam with water-based gel packs to transport the most delicate temperature-sensitive materials. Packaging was validated for specific time and temperature ranges. However, excursions were more frequent causing significant loss of time and money from damaged product shipments.

As regulatory requirements grew in the pharmaceutical industry and new, more expensive drugs came to market, the need for additional temperature ranges emerged. The risk tolerance for costly excursions also decreased. Early cold chain packaging innovators began experimenting with phase change material (PCM) to replace Styrofoam and water-based gel packs. New packaging using PCM proved more reliable with the ability to keep high-value products at the desired temperature using less overall material.

With so much innovation over two decades, it is challenging to keep up with the cold chain industry. And for someone just beginning to explore temperature-controlled packaging, where to start is overwhelming. Our top five considerations for cold chain packaging help create baseline knowledge, focus and the structure required to assess temperature-controlled solutions.

Types of temperature-controlled systems

In 1938, the first refrigerated truck was invented and drastically changed the world of temperature-controlled transport. This technology is still used today to move food, pharmaceuticals, flowers and other temperature-sensitive products around the globe. Though useful, refrigerated trucks have limitations, most notably when shipping overseas.

Styrofoam and water-based gel packs were introduced to fill the gap, and later temperature-controlled packaging using PCMs. Now, three types of temperature-controlled systems exist. Each comes with its own unique advantages and disadvantages, serving a purpose for specific applications.

Active systems
Active containers are most similar to refrigerators. They use mechanical or electric systems powered by an energy source, combined with thermostatic control to maintain product temperatures. Systems often require “plug in time” to charge prior to use and at key touch points.

Active systems require a closed-loop distribution system to ensure appropriate maintenance and recovery of reusable equipment. While these systems maintain good temperature control, they are expensive to purchase, run and maintain. They are also more costly to ship because they are heavier, they could require maintenance during transit and they are available in fewer sizes than other types of shippers.

Hybrid systems
Hybrid systems are similar to active systems, but they incorporate a PCM bunker. The active element of the system charges a “PCM battery” that is used when the system is not being charged by a power source.

Hybrid systems share many of the same advantages and disadvantages as active systems. However, hybrid shippers have fewer components that may require maintenance.

Passive systems
Passive systems use PCM, water coolants or dry ice and advanced insulation to keep a payload at the required temperature. Once components are conditioned, passive systems require no touch points to recharge. These systems offer more flexibility than active and hybrid systems. Passive systems have fewer shipping restrictions and their lower weight offers reduced freight costs. There are also more size options and no maintenance required during transit. However, passive systems do have generally shorter shipping durations than active and hybrid systems.

Single use and reusable systems

Passive systems are the most widely used in the pharmaceutical industry. They offer the benefit of versatility and the lowest cost per use. This type of temperature-controlled packaging is available in both single use and reusable options. Though the application is similar, users often evaluate when to use each option based on cost, transportation and sustainability.

Single use shippers are one-time use and inherently less sustainable or environmentally-friendly than reusable shippers, even when components are recyclable.
These shippers also require a larger internal resource investment in cold chain shippers–both cost and time. There is real estate required to store inventory and additional costs associated with housing, running and maintaining conditioning equipment, as well as staff and training expenses.

But single use shippers serve an important purpose. This became more pronounced during the COVID-19 pandemic when companies began switching from reusable to single-use packaging out of sanitization concerns. Now many companies use single-use packaging as a risk-mitigation strategy when global transportation challenges prevent the timely delivery and return of reusable packaging.

Outside of the pandemic, shipping lanes can impact the decision on which type of thermal packaging to use. Some countries have onerous import and export requirements or customs challenges that impact reverse logistics–the return of reusable packaging. This is particularly true for some countries in the Middle East and Latin America. Single-use packaging could also be the best choice when the frequency of shipments to a location is low and collection is not economical.

Reusable packaging offers cost advantages for companies shipping with frequency and also supports sustainability goals. This type of shipper is more sturdy and able to withstand rugged conditions. It also allows companies to use reusable data loggers or temperature recording devices with high-value payloads or on challenging shipping lanes.

Rent or purchase considerations

If companies decide reusable temperature-controlled solutions best meet their needs, they also need to consider whether to rent or purchase packaging. Purchasing packaging offers full, onsite control of the cold chain process and flexibility to use packaging immediately or add it to inventory for later use. But it also requires dedicated storage, conditioning equipment, maintenance plans and trained staff to manage cold chain operations. Companies must also consider track and trace protocols to enable reverse logistics by understanding the nuances of shipping lanes and the challenges of monitoring temperature excursions.

Currently, the pharma industry is moving toward rental and fully outsourcing the cold chain. Long term leasing and pay-per-use options eliminate the need to purchase, manage and maintain a large fleet of temperature-controlled shippers. Instead, the cold chain packaging provider is responsible for employing the right staff with the right skill sets to implement a rental program.

Rental programs offer a number of advantages, including spreading the cost over time while delivering the performance needed for global pharmaceutical payload requirements. Rental is also often more cost effective if a company makes regular shipments on a regular route or plans to make high volume shipments. Enlisting the services of a temperature-controlled packaging provider can offer access to a broad portfolio of products, as well as a one stop shop for services.

Cold chain companies recently began offering pre-conditioning and just-in-time packaging for reusable temperature-controlled packaging. Though not available from all cold chain packaging companies, some now also offer the same service for single-use packaging to help pharmaceutical companies conserve valuable real estate and eliminate barriers to picking the right packaging option for their business. These services continue to set the stage for pharma companies to fully outsource their cold chain operations.

Product performance needs

The last step when selecting temperature-controlled packaging is to consider product performance needs. Both single-use and reusable passive shippers are available in parcel and pallet options, spanning 1 liter to 3,174 liters. Temperature ranges cover 2°C to sub -65°C with shipping durations up to 168 hours, depending on the type of shipper, coolant and packaging material.

The payload efficiency of newer systems can be more than twice that of the traditional water based and foam insulated shippers proving more cost effective when it comes to logistics services. Although these more sophisticated shippers can be more expensive, the trade off is fewer temperature excursions en route, which also means less damaged products and the benefit of cost savings over time.

Performance measures are the most straightforward consideration, and many product selection tools help users select the right product to meet their specific performance needs.

Service network and support

Temperature-controlled shipping requires a skilled workforce ready to navigate the challenges associated with difficult shipping lanes, reverse logistics, tracking and tracing packaging, and more. The global nature of the pharmaceutical industry makes this work even more challenging. The final consideration in cold chain logistics is the service network and support of a chosen cold chain packaging provider.

It is no surprise that a larger, strategically placed global services network is better. Locations situated in specific markets have a better understanding of how to navigate logistics challenges unique to that market. They also build a familiarity with customers they serve locally, making it easier to offer the best solutions.
Additionally, they can better accommodate last-minute packaging or conditioning needs when urgent situations arise and reduce costs through more efficient reverse logistics–returning packaging to a location near delivery while maintaining an inventory ready to meet customer needs at its locations across the globe.

Choosing the right type of temperature-controlled packaging is not a one-size-fits-all approach. It depends on the unique shipping needs of each pharmaceutical company, from product requirements to staff to shipping lanes to organizational sustainability goals. Baseline knowledge will not provide all of the answers, but it will help those talking with temperature-controlled packaging manufacturers assess the right packaging and partner to meet their needs. 

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Adam Tetz is director of worldwide marketing at Peli BioThermal and has more than 25 years of marketing experience. His areas of responsibility include brand identity, product launch and communication strategy. Prior to Peli BioThermal, Tetz held positions in product management and marketing communication across a variety of industries, including medical software, financial software, information services and professional consulting services. Contact: adam.tetz@pelican.com.