Logistics is considered a mission-critical component of the pharmaceutical industry since its activities are extremely sensitive to time and quality assurance.
Despite the pharmaceutical industry facing unprecedented challenges related to globalisation and government controls over pricing, major challenges still lie in ensuring optimal shipping.
This is because, fundamentally, pharma products require temperature-controlled storage and distribution, with strict regulatory control.
The industry is striving to deliver life-saving products to the end customers, at the right time and place, in a secure manner and at a competitive operational cost. This is why we thought it prudent to uncover some of the elements that underpin the shipping of pharmaceuticals.
How are pharmaceutical products transported?
Pharma products are typically transported in refrigerated containers called offshore reefers similar to the 10ft offshore refrigerated containers we provide.
These reefers usually undergo routine inspections to ensure they are in satisfactory condition to maintain medicinal inventory at correct temperatures.
Generally, pharma logistics demand strict adherence to regulation codes to ensure drugs and vaccines are safely delivered, without spoilage or losing their potency.
However, pharma supply chain tasks are very challenging as most shippers are required to uphold cold chain procedures whilst preventing theft in transit, and implementing special precautions to move specialised pharma products.
This is because pharma shipping procedures are arguably a matter of life and death as mismanaged shipments put the health of many at risk.
What is involved in pharmaceutical logistics?
Fundamentally, pharma logistics require special conditions to store drugs, and preferably fast delivery.
Air transportation is the fastest option, especially for long distances. However, due to limited equipment, standardisation and transparency, and high costs involved, sea transportation is more prevalent and preferred nowadays for large shipments.
Sea transportation can easily accommodate specialised refrigerated containers (reefers) and better supply chain organisation. Overall, despite the high risk involved during drug handling, road and sea carriers seem best placed to control the whole pharma shipping process with refrigeration mechanisms.
These mechanisms, like offshore reefer containers, allow consistent control of the conditions in which the pharma products are kept, as well as transportation of pharma that requires unique temperature ranges.
Read: “Offshore reefer container temperature range.”
Besides appropriate temperature management, shippers also need to keep a keen eye on air humidity. For example, medicinal products should not be in direct contact with ice packs.
Additionally, pharma products should be collected directly from the manufacturer or a warehouse, with the entire journey documented– for example, time, changes in container temperatures, etc.
Overall, the pharma logistics cold chain process is underpinned by four key steps:
- Supply: This initial phase involves manufacturing and packaging the drugs, vaccines or pharmaceutical products.
- Transportation: This next step typically involves transporting the pharma products in refrigerated or insulated containers/trucks. Usually, these trucks/containers usually undergo routine inspections to ensure they are in optimal condition to maintain inventory at correct temperatures.
- Storage: In this phase, pharma products are kept in cold storage in a refrigerated warehouse before being distributed. The refrigerated warehouse essentially acts as a middle ground before the products arrive at their final destination.
- Market: This last step in the pharma cold chain logistics process focuses on the delivery to the final destination where the pharma products are sold or administered.
Pharmaceutical transportation regulations
Drug distributors typically commit themselves to following a variety of standardised rules. For example, drugs being stored in suitable conditions at any moment to avoid the risk of contamination by external factors.
Drug distributors also have a duty to institute procedures for tracking medicines and locating defective products to take them out of circulation.
Generally, pharma transportation regulations encompass everything from refrigerated vehicle designs and temperature-control abilities to warding off potential contamination.
Similar to other time-sensitive and hazardous materials, sensitive pharma products require strict, documented and standardised training procedures covering:
- Cleanliness: Any area pharma products spend time at cannot risk contamination.
- Temperature control: Since some drugs are rendered useless or even hazardous if the environment is not temperature-controlled to exact specifications.
- Protection: As pharma products can be a prime target for theft. For example, shipments of opioids are usually targeted by thieves. As such, it’s imperative to ensure that drugs arrive at hospitals or pharmacies with unbroken seals.
- Documentation: Documentation is arguably the bread and butter of pharma logistics. This means that pieces of training should cover good record keeping.
What are the risks involved in shipping pharmaceuticals?
Any valuable shipment comes with inherent high risks, and pharma products are no different.
For example, without proper temperature control mechanisms, drugs can become ineffective or even deadly. In fact, a minor change of as little as three degrees in temperature can ruin a drug product.
This is because more specialised pharmaceuticals come with more stringent temperature requirements. So, it is imperative to always communicate with shippers your unique freight needs in order to have safe delivery.
With this in mind, shippers must also always be diligent and proactively keep a keen eye on their temperature logs to prolong the effectiveness of drugs.
Another risk is theft. As alluded to earlier, prescription drugs like opioids usually attract bad actors. Therefore, most pharmaceutical warehouses are encouraged to institute high-security measures. However, most theft incidences occur while in transit.
Important aspects in pharmaceutical shipping
1. Packaging is crucial
Because pharma packages are prone to shifting during the shipment process, it is important to ensure proper packaging. To further exacerbate issues, during the shifting process chemical reactions of the products can be altered. Or equipment could break.
To avoid the losses that could occur from such unpredictable occurrences, pharma products need to be appropriately fitted into containers with packaging options like individual compartments, ice, or even added light mechanisms.
2. Maintaining and tracking pharmaceutical temperatures
The integrity of the cold chain is one of the most important elements of pharma supply chain management. Most pharmaceuticals need storage between 55-77 degrees Fahrenheit.
Unfortunately, temperature fluctuations of only a few degrees can damage the efficacy of some products. So, “controlled” room temperatures are recommended that do not fluctuate drastically.
3. Choosing the right reefer containers
An active cold chain needs transportation modules with built-in cooling units designed to maintain constant temperatures. The modules are referred to as “reefers” and offer a regulated environment to protect pharma contents against external changes in temperature.
Such containers or trailers typically maintain sealed walls and even reflective roofs to block sun rays to prevent materials from rotting, deteriorating, or becoming hazardous.
Check out the range of products under offshore reefer containers at MGSIcestorm.
4. Understand the laws and regulations
Like alcohol and perfumes, pharma items can be considered hazardous substances. As such, they are typically subject to stringent government regulations and laws.
So, determining how to ship your pharma products, you must be aware of the laws and ensure your shipping process follows them.
5. Keep proper licensing
In addition to knowing the law, using a shipping company that maintains proper licensing is key. There are typically specialised licensing requirements dictated when shipping pharmaceuticals.
While you don’t need to know details about these requirements, you must ensure your chosen shipping company knows the requirements and holds all necessary licensing to operate a pharma shipping line.
6. Documentation is important
Inspections are part and parcel of pharmaceutical shipping.
Whenever a shipping pharma container is received, extensive inspection is performed for any signs of contamination.
After inspection, consistent documentation and record keeping is required to highlight broken pallets, torn stretch wraps, or even pest infestations.
7. Stay insured
Insurance is necessary as pharmaceuticals shipping is full of inherent risks. As with any ‘risky business’, insurance covers uncertainty to your business, and your shipment.
Unfortunately, the level of uncertainty can significantly affect one’s bottom line, if unprotected. However, with insurance cover that allows one to show that they followed industry standards to avoid any loss, insurance companies can promptly payout to help mitigate the financial damage that may occur during the shipment process.
8. Hygiene
Facilities that handle and store pharma products must be large enough to allow proper cleaning, and airflow around pallets.
Furthermore, they should also boast separate quarantine areas for medications which are damaged, expiring, or deteriorating.
Hygiene is critical as any signs of infestation from insects, or animals will cause a pharma shipment to be unusable.
9. Security
Facilities for pharma storage need security mechanisms that control and restrict access into spaces where medications are being stored.
For example, surveillance cameras, access control keys, and automatically locking doors.
10. Telematics for Cold Chain Monitoring
Telematics technology allows fleet managers to better control their cold chain fleets by providing continual data on the specific temperatures of refrigerated cargo. Generally, from refrigerated warehousing to intermodal storage, pharma shipping chains need a detailed history of temperature conditions.
Pharmaceutical shipping companies: Should you partner with one?
The shipment of temperature-sensitive pharma products is highly challenging, as businesses involved in the service must establish quality risk management mechanisms to achieve the goals of patient safety, without apprehension of drug regulatory measures.
As such, it is important for pharma entities to partner with companies that adhere to strict regulations set by government authorities and are licensed appropriately to handle temperature-sensitive goods.
Pharma shipping companies that fit this description are rarely prone to instances of product degradation due to incorrect shipping, or temperature sensitivity damage due to a broken cold chain.
Conclusion
Pharmaceuticals shipping is a lucrative industry that also carries high risk and responsibility. Hence, the strict regulation.
With this in mind, pharma industries and organisations should always ensure to choose a freight forwarder with:
- Extensive experience in pharma transportation.
- Familiarity with legal regulations regarding the transportation of drugs, including specific temperature-sensitive product requirements.
- A reliable cold chain where medicines are stored in constant temperature and humidity is controlled on an ongoing basis with appropriate sensors.
- Good documentation procedures, including the recording of potential inadequacies, since any improperly stored drugs can negatively affect people’s health.
Learn about our DNV 2.7-1 certified 10ft & 8ft offshore reefer container for your pharma shipping needs.
Reach us at MGS Icestorm for more information on shipping your pharma products safely.
Business Director
A graduate (Business) from KDU, Jason Tan, is the current Business Director (Sales) for MGS Icestorm and has been associated with the company for the past 10 years.
With over 13 years in the shipping industry, he has had a significant contribution to Malaysia’s oil and gas industry in the engine and boat supply sector.
His expertise includes managing offshore catering business, offshore reefer containers, AI technology, offshore gas tanks, A60 pressurized cabins, etc. His contributions have helped establish MGS, in partnership (joint venture) with Thermo King and Honeywell to produce state of art Offshore Reefer Container products.