Pharmaceutical Cold Chain Packaging Process: PCM Packs vs Gel Packs

November 30, 2023

In our most recent blog post, Everything to Know About Cold Chain Logistics, we provided a brief overview of the key steps involved in the cold chain logistics process. When it comes to logistics, the packaging stage entails making critical decisions regarding the choice of packaging materials, containers, and refrigeration methods.

This blog will provide a more detailed exploration of the packaging process, focusing on the essential factors that pharmaceuticals and biologics must consider as they move through the supply chain.

How should you prepare your temperature-sensitive pharmaceuticals before shipping?

When it comes to packaging pharmaceutical products prior to delivering to laboratories, hospitals, patients, and other destinations, critical cold chain data must be considered before initiation.

Payload Size: Understanding the weight and volume of the product to be packaged plays a critical role in selecting the type of insulated container. Large and heavier payloads will require higher insulative properties along with robust construction to withstand mechanical stress during transportation.

Ideal Payload Temperature: Efficacy of pharmaceutical products is directly dependent on its environmental conditions. The packaging strategy must strive to keep the products close to their ideal storage temperature, eliminating excursions below and above their critical limits. These upper and lower temperature limits must be established during the initiation phase of the packaging process. As a laboratory manager or facility, you likely know what temperature your products need to be maintained at; this will help you choose a suitable cold chain refrigerant.

Estimated Transit Time: The duration for which your pharmaceutical products need to be stored and transported is another important consideration. While some medications or vaccines require overnight storage/transportation, others may be suitable to last for over 48 hours. Matching the method to the duration ensures your products remain within the safe temperature range for the entire journey.

Cost Effectiveness: A majority of cold chain packaging material is often disposed of at the end of its journey because the cost of returning may far exceed the cost of procurement. The supply chain operator must consider the costs of disposal along with the cost of procurement or return when deciding which packaging material is best suitable for their facilities needs. This decision can be instrumental in the supply chain’s carbon footprint.

Components of Cold Chain Packaging:

Once the critical parameters for packaging are identified, we can confidently move into selecting appropriate materials to keep samples protected. Along with others, these materials include:

Insulated Containers: What It Is and Why You Need It

Insulated containers are used to store and preserve products that need to be maintained at a specific temperature during transportation to avoid external temperature fluctuations.

Choosing an insulated container depends on your laboratory’s specific applications, and are made up of several parts which may include outer packaging, protective packaging, and the insulated material itself.

Refrigerants: Choosing a Refrigerant Best Suitable for Your Application

Cold Chain refrigerants are used to stabilize the internal temperature of the packaging. These substances, which are often in the form of Ice Packs, Gel Packs, Dry Ice, or Phase Change Materials (PCMs), regulate temperature during transportation.

These refrigerants are packaged within insulated containers. Depending on the specimen’s required payload temperature, different refrigerants may only guarantee protection at specific temperatures (frozen, refrigerated, or controlled room temperature).

Temperature Monitoring Devices: Why it’s Important to Monitor Temperature

To maintain a consistent temperature range, temperature monitoring devices can be employed. Temperature fluctuations can harm pharmaceuticals, underscoring the need for establishing cold chain traceability to ensure patient safety.

Activated at the start of each journey, these real-time monitoring systems offer continuous traceability, providing instant notifications for temperature excursions around the clock. The selection of the monitoring device depends on the criticality of the cold chain, the urgency of required responses, and the necessity for compliance reports.

Cold Chain Refrigerants: Gel Packs vs PCM Packs

As we briefly touched on above, there are different types of refrigerants that may be used to protect your pharmaceutical products. Depending on your product’s temperature requirements, certain refrigerants work better for certain applications.

Standard Gel Packs

Standard Gel Packs are water based gels that may be used to ship temperature-sensitive products at frozen, refrigerated, or CRT temperatures. They are designed to absorb and release thermal energy as specific heat. For example, a frozen gel pack at -20°C will absorb heat as its temperature rises from -20°C to 0°C.

The length of time a gel pack lasts depends on the size and shape of the parcel, along with the controlled environment that keeps the pack from releasing heat.

Phase Change Material (PCM) Packs

Another popularly used cold chain refrigerant are Phase Change Material (PCM) Packs which absorb and release thermal energy as latent heat.

PCMs absorb cold energy as it changes its state from liquid to solid – releasing stored heat providing a warming effect. Vice versa, it absorbs heat energy releasing cold energy providing a cooling effect. This allows PCM technologies to have a unique capability to maintain precise temperature for cold chain packaging.

When used in the pharmaceutical industry, PCMs are used to ship products including vaccines, blood samples, insulin, antibiotics, and other temperature sensitive specimens.

You can read more about pharmaceutical product temperature requirements here.

Compared to a standard gel pack that utilizes specific heat, PCMs utilize latent heat. The use of latent heat allows PCMs to have precise temperature control for longer durations.

Similar to standard gel packs, the lifespan of PCM Packs depends on the application and other environmental factors. However, PCM Packs have a varying solid-to-liquid temperature (compared to gel packs which have one melting point of 0°C (32°F). Because of this, PCM Packs have the ability to maintain temperatures in frozen, refrigerated, and CRT ranges.

When used as a refrigerant, PCM Packs are mostly used for multi-use applications. The durability and longevity of the packs makes them a more sustainable option for businesses looking to minimize waste within the logistics process.

If you are actively managing your logistics process in a closed loop system, multi-use PCM Packs show to be a great alternative to standard gel packs by:

Reducing temperature fluctuations and specimen rejections
Increasing the lifespan of your shipping refrigerants
Cutting down on costs associated with single-use refrigerants
Minimizing waste by utilizing multi-use refrigerants

Final Thoughts

Selecting the right-temperature control for packaging pharmaceutical products is a crucial decision that can have a significant impact on the integrity of your goods and your organization’s environmental footprint.

While standard gel packs are suitable for many cold chains, PCM technology offers a precise temperature control capability, making them ideal for various applications in the pharmaceutical industry.

PCM Packs also stand out due to their durability and longevity, making them a sustainable choice for businesses looking to reduce waste of packaging materials.

Our savENRG® PCM Packs offer the right product for each of your applications: