Posted On June 6, 2022
There are few items that require more care, planning and regulatory compliance for shipping than pharmaceutical products.
Many pharmaceutical companies employ compliance teams and partner with third-party logistics providers to ensure their supply chain practices meet specific standards, but unforeseen snags and evolving regulations still make shipping pharmaceuticals a challenge. While risks will always exist, careful planning and expertise can mitigate issues and support a seamless supply chain process.
Managing temperature throughout the supply chain
On the list of challenges for pharma transport, maintaining the right temperature is almost always at the top.
While all pharmaceutical products need to be shipped with care, newly developed and specialty pharmaceuticals in particular require an exceptionally tightly monitored cold chain. As new drugs hit the market, the parameters around temperature requirements are lesser known, and companies tend to err on the side of caution until the drugs have been exposed to temperatures outside of a small range.
Temperature ranges for pharmaceutical products
There are five main temperature ranges for cold chain logistics needs:
Non-controlled ambient – This range includes interior spaces (like warehouses) that are enclosed but can still get fairly hot, upwards of 29 to 33+ degrees Celsius (about 85 to 90 degrees Fahrenheit), depending on the location. Shipments stored in non-controlled ambient locations typically don’t need to maintain a certain temperature.
Controlled ambient – The next level above non-controlled ambient is ambient controlled, or room temperature. Typically these spaces range between 15 and 25 degrees Celsius, or 20 degrees Celsius plus or minus 5 degrees.
Refrigerated – Prescription drugs that need to be kept between 2 and 8 degrees Celsius are kept in refrigerated spaces.
Frozen – Specialty drugs, including many injectables, need to be kept in a frozen temperature range from -18 to -25 degrees Celsius.
Deep frozen – Some vaccines like the COVID-19 vaccine require ultra-cold temperatures known as “deep frozen.” These pharmaceuticals ship in temperature ranges from -25 to -30 degrees Celsius, and in many cases, even colder.
Cold chain logistics technology and storage options
Shippers have numerous options for managing cold chain logistics, and need to consider budget, timing and drug requirements when designing their cold chain.
Domestic pharmaceutical shipping typically involves refrigerated trucks (also called “reefer trucks” or “reefer trailers”) and climate-controlled trucks.
International pharmaceutical product shipments might be transported via multiple shipping modes through one of two strategies:
Active shipping solutions
The first type of temperature control for international pharma shipments is known as an active shipping solution. These options include packing the pharma products in some form of a portable refrigerator unit (known as RAP or RKN units), which might require an electric source or come with its own motor. This option is typically more reliable, and while there is risk of the power sources failing, active shipping solutions are able to maintain temperatures despite most shipping delays.
Passive shipping solutions
Typical passive shipping solutions include insulated containers that are preconditioned to meet temperature requirements, typically through gel packs or other coolants. These options don’t require a power source or have active temperature monitoring and are only rated to stay within temperature ranges for 96-120 hours, or four to five days. However, these solutions are less expensive and can be adequate for shorter transit times without delays.
Once the medical products make it to their distribution center or final destination for packaging and manufacturing, the cold chain might also include a refrigerated warehouse or refrigeration unit to maintain temperatures.
Devices such as data loggers or smart container monitoring systems can track the temperature and humidity of containers throughout transit, so that once the pharma products make it to their final destination, logistics teams can read out the data and ensure the pharmaceuticals were kept within the ideal temperatures.
Optimizing transit time for pharmaceutical shipping
Clearly, timing plays an important role in successfully shipping pharmaceuticals, especially when they’re being shipped in a temperature-controlled environment. When pharmaceuticals are shipped via air, the consideration for shipping express versus general comes into play.
Typically, pharmaceuticals and other medical equipment are loaded at a higher priority than other goods. But airline carriers often overbook, betting that some freight won’t show up in time to make the flight. Shippers that pay for express service, even for non-medical cargo, are loaded first and can sometimes bump pharmaceuticals off a flight, causing a ripple effect of consequences. Shipping pharmaceuticals and other perishable goods via express shipping is the best way to ensure this doesn’t happen—but of course, the option comes with added cost. Companies that ship pharmaceuticals need to weigh whether potential delays (and therefore, the risk of cargo going outside acceptable temperature ranges) is worth the additional expense.
Ensuring accurate, thorough pharmaceutical supply chain record keeping
Documentation is vital to a pharmaceutical supply chain. Shippers need to ensure their records are completed correctly and shared with the right parties, often including government agencies like the Food and Drug Administration. Narcotics require even more documentation than over-the-counter and prescription drugs, including special permitting concerns from the Drug Enforcement Agency.
Flat World’s pharmaceutical shipping teams stress the importance of due diligence and finalizing details before a shipment goes out. Especially with temperature-controlled shipments, rushing to get medicines on the road only to have the shipment delayed and the goods potentially ruined by temperature excursions, doesn’t do anyone any good.
Costs also come into play, especially for generic and over-the-counter medicines. With a more competitive market, companies need to keep transportation, distribution and storage costs low.
Navigating customs requirements for exports and imports
Similar to other products, shipping pharmaceuticals often involves importing and exporting.
Although the data isn’t exhaustive, it’s estimated that besides the United States, most active pharmaceutical ingredients used to manufacture drugs in the U.S. are sourced from Ireland and China. And as of 2019, pharmaceutical products exported from the U.S. were estimated to be valued at more than $60 billion. Clearly, customs is an important consideration for transporting pharmaceuticals.
Most pharmaceutical shippers (and customs brokers) are well-versed in the import regulations for their own countries. But for exports, medical companies need to be particularly aware of regulations within the destination country. Various countries task different government agencies with overseeing the pharmaceutical import process, and shippers should know the right questions to ask and paperwork to fill out.
Pharmaceutical industry security regulations and requirements
Handling pharmaceutical shipments comes with many risks, all of which need to be addressed to avoid cargo theft and contamination. Several transportation solutions can help companies prevent issues.
To prevent tampering along the supply chain (and to easily discern whether goods have been tampered with), tamper-evident tape can deter criminals and indicate whether a box has been opened before reaching its final destination.
Security is always important to consider for warehouses and distribution centers, no matter the cargo. But for the safety of both the pharmaceuticals and the teams transporting them, buildings should be outfitted with working security systems and locking dock doors to minimize the risk of break-ins. Pharmaceutical warehouses that store specialty pharmaceuticals that fall into specific Drug Enforcement Administration categories might also have vault facilities or a safe-like mechanism that requires a code to unlock.
Pharmaceutical companies will often send their director of security to inspect pharmaceutical warehouses before they’ll authorize partners to start shipping products.
Finding the best pharmaceutical 3PL
Third-party logistics providers (or 3PLs) are an important resource for managing costs and ensuring compliance for shipping pharmaceuticals. When looking for a logistics partner, make sure to ask about pharmaceutical expertise and previous experience working with customers in the pharmaceutical industry, and what custom solutions they’re able to offer.
If you have questions or want support shipping pharmaceuticals, Flat World can help. We assist pharmaceutical businesses in finding the best transportation, packaging, storage and delivery options that meet requirements while also being as cost-effective as possible. Reach out to get started.