There’s no denying Big Pharma is big business, both here in the US and in the global economy. According to Pharmaceutical Research and Manufacturers of America (PRMA), the biopharmaceutical sector in the United States alone contributes $1.3 trillion to the world economy each year. That also translates into big bucks for the cold chain pharmaceutical transport industry—to the tune of $12.6 billion worldwide annually, according to Pharmaceutical Commerce.
As a shipper, the stakes are high. Temperature excursions due to incorrectly set refrigerated containers, unexpected delays, or other issues can result in damaged or destroyed product and millions of dollars in lost sales. Or worse yet, a compromised shipment could lead to fatal consequences for a patient.
With so much riding on the line, it’s time to take a closer look at pharmaceutical transport from a shipper’s perspective, what it is and the types of products involved. We’ll also examine some of the many challenges shippers of pharmaceutical products face, and offer a few best practices that will help ensure success.
Pharmaceutical Transport & Types of Pharma Shipments
It’s impossible to explore the topic of pharmaceutical transportation to any great depth without mentioning the importance of cold chain visibility. This is a realm where refrigeration and temperature control plays a crucial role in preserving the quality and stability of pharma products before, during, and after traveling through the supply chain. According to information from Shipwaves, 7 out of the top 10 pharmaceuticals in the U.S. require temperature-controlled shipping. Even the slightest temperature excursion, say 2 degrees, can ruin a product.
As such, quality must be maintained from the point of manufacture through last-mile delivery. This is where cold chain logistics plays such an important role in pharmaceutical transport of temperature-controlled products. ABCO Transportation does a nice job of presenting the steps involved:
- Supply: The drugs, vaccines or pharmaceutical products are made and packaged at a plant.
- Transportation: The medicines or pharma products are usually transported in a refrigerated or insulated truck. These trucks undergo routine inspections to make sure they are in satisfactory condition to keep inventory at the correct temperature.
- Storage: Pharmaceutical products might go into cold storage before they are distributed. The refrigerated warehouse can act as a middle ground before pharma products reach their final destination.
- Market: Generally speaking, the last step in the cold chain logistics process is delivery to the final destination where the pharmaceutical is sold or administered.
The types of pharma shipments generally fall into three ranges: Ambient, Refrigerated, and Cryogenic:
- Ambient (controlled room temperature, 20°C-25°C) – Pills, capsules, tablets, etc.
- Refrigerated (2°C to 8°C) – Vaccines (Polio, Measles, Tetanus, Hepatitis B, Smallpox, etc.; insulin, eye drops, etc.)
- Cryogenic (Below 0°C to -150°C) – Tissue products, biosamples used in clinical trials, new cellular/gene therapies, certain COVID vaccines).
However, maintaining optimal temperature ranges is by no means the only concern for shippers. Many pharmaceutical products can react negatively in certain conditions involved with humidity, light, vibration and shocks.
Challenges in Pharmaceutical Transport
Pharmaceutical transport is among the most challenging of all supply chain activities, and it’s easy to understand why. The shipments are usually quite valuable and highly susceptible to excursions that would render them useless. Taking a closer look, some of the specific challenges are:
- Pharmaceuticals have diverse and individualized properties that must be taken into account with each shipment.
- There are substantial risks to patient health from improperly transported pharmaceuticals.
- Numerous laws and regulations governing pharmaceutical products, from the UN, US Food and Drug Administration, and Drug Enforcement Agency, as well as state and local guidelines.
- Need for strict regulation of temperature, humidity and in some cases exposure to light and vibration.
- Higher shipping and insurance costs, given the specialized equipment and steps involved to preserve the integrity of shipments and the value of the cargo.
- The lack of qualified drivers. Operators must be knowledgeable about the products as well as the rules and regulations.
Best Practices in Pharmaceutical Transport
Following these best practices will help ensure the safety and integrity of shipments, as well as prevent the loss of shipments that are spoiled or unusable.
- Leverage end-to-end visibility solutions: Tracking each shipment through every stage of the pharmaceutical transport process should include real-time monitoring of not only temperature but also humidity, light, vibration, and shock events. Data logging plays an important part in not only monitoring the current shipment but also identifying trends and areas for improvement.
- Know your products:This is the golden rule of pharmaceutical transport. Knowing which products are sensitive to variations in temperature, humidity, moisture, and shock events is critical.
- Compliance is equally important: Not only is it a must to know the manufacturer-suggested best practices for handling and transporting each pharmaceutical product, you must also maintain strict compliance with all federal, state and local regulations.This includes FDA CFR 21 Part 11, CGMP regulations, DEA regulations for controlled substances, and state-specific DOT hazardous material laws for transporting live organisms or chemicals.
- Consider all options for controlling temperatures: Using refrigerated or insulated trucks and trailers; individual cooling units, such as freezers; dry ice and refrigerant gel packs are a few of the more common options.
- Give careful thought to packaging: Pharmaceutical transport often requires using specific packaging, such as corrugated shipping boxes, biodegradable air pillows, and insulated foam coolers, to name a few. And don’t forget the UN-compliant hazmat shipping labels and placards, when applicable.
- Secure and monitor your cargo at all times: Leverage total visibility solutions and satellite tracking to ensure valuable pharma cargo remains safe and sound throughout the transportation journey.
- Exercise due diligence when selecting partners: Do not trust your pharma shipments to just any 3PL or transportation service provider. The right partners will have all of the requisite licenses and permits needed to prepare and deliver pharmaceutical shipments.
The Tive Solution: Real-Time Condition Monitoring & Alerts
Tive has developed a proprietary sensor and software solution that enables shippers to monitor their pharmaceutical transport shipments in real-time. A multi-sensor tracker monitors the temperature, humidity, location, and shipment integrity, and sends the data to the cloud in real-time, where it can be accessed from the Tive software platform. Configurable real-time alerts notify the shipper as soon as a humidity or temperature excursion occurs. That’s how you can save a shipment from being a total loss. The reliability of Tive, along with the best practices described above, is what you need to succeed. Ready to get started? Request a trial today.