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5 Challenges Of The Pharmaceutical Cold Chain

Cold chain logistics started long before electricity was invented, by primitive steps as storing and transporting food packed in snow. With the distances certain goods need to cover nowadays, this is almost impossible to imagine. These days, cold chain logistics is known as a temperature-controlled supply chain. Or otherwise, the transportation chain that maintains freight at an agreed upon temperature throughout the logistics process. All temperature-controlled goods are at risk when there is a rise or fall in temperature, especially health wise. A small fluctuation in temperature of pharmaceutical goods can already impact the use of the medicines, or even be unsafe to take for the patient. Another aspect for pharmaceutical products is that because of their high-value, the risk occurs that the goods can’t be used or sold if the temperature has not been consistent during their lifecycle which result in a loss of capital. This blog will dive into 5 main phases of the pharmaceutical cold chain and their challenges.

  1. Packaging of pharmaceutical products

Maintaining your pharmaceutical products on their restricted temperature is the first challenge. It is already vital that the products are being packed at the desired temperature. Cold chain packages are designed to keep the temperature constant, not to bring a shipment to the desired temperature. First to keep in mind with choosing the right packaging type is the desired temperature range of your product. Frozen products should be kept at a temperature of -18°C, while cool products can be kept between +2°C and +8°C. Choosing the right packaging depends on the amount, type of transport, transit time, environment, sustainability requirements and quality.

  1. A reefer container is one of the most known and commonly used packaging mode for transport temperature sensitive items. Especially a reefer with its own power unit can keep the products at a constant temperature. Rising use of reefers does unfortunately also mean a rise of drug crime within this packaging type. In 2019, an article  by Staring, Bisschop, Roks, Brein en van de Bunt (2019) was published about drug crime in Rotterdam, in which especially reefer containers were examined. Investigation that drugs was often hidden in the engine compartment of refrigerated containers as well as the construction. The article made clear that reefer containers were especially popular for drugs crime due to their location, often in a separate part of the terminal and not stacked high due to their power connection.
  2. In case the cases are not transported/stored in a container, thermal packaging is optional. This is an outer pack of corrugated board, molded polyurethane foam and frozen gel packs. This is designed to keep a pre-defined temperature range during external factors in the supply chain.
  3. Lastly the use of cold materials within the packaging. Dry ice is about -80°C and particularly used for shipping of pharmaceuticals and can keep goods frozen for an extended period of time. Liquid nitrogen is similar to the dry ice although it is about -196°C, although this is considered as a hazardous substance while transporting. Gel packs or eutectic plates are mostly used for pharmaceuticals which are classified as chilled products and keep products within the 2 to 8°C range. Lastly, there are quilts or covers which are placed over the cargo to keep the temperature constant.

 

  1. Cold transportation

What should you keep in mind when moving pharmaceutical products from A to B? Modal choice is of course the obvious but also the characteristics of these transport modes. General factors to keep in mind are costs, speed, flexibility and safety. Most used in cold pharmaceutical logistics is intermodal trucking. To read more about these factors, please take a look at: https://www.broekmanlogistics.com/en/insights/blog/what-are-the-different-modalities-in-logistics

Another factor to keep in mind while transporting pharmaceuticals is the protection from theft. Theft does not only result in product loss for the seller, and a disservice to patients who need the medicines, these stolen medicines can also end up on the black market. While storing the goods is often very secure, most thefts occur during transit. Pharmaceutical company SensiTech even states that 75 percent of pharmaceutical product thefts occurs when the products are on the road. Securing products with GPS cargo tracking can be an solution. Another prevention is discrete labelling the packaging of the products, packaging that states what is inside can be an invitation to potential theft. Another tip is to reduce the handling of this cargo, the more handling and parties in the supply chain, the higher the risk of products being lost or stolen during the handling.

  1. Cold Storage of pharmaceuticals

While storing pharmaceuticals, product specifications and requirements regarding sensitivity to moisture, air, light and heat need to be fully understood. The best place to store pharmaceutical products is often in a cool and dry place.

In addition, the warehouse provider must meet the regulatory standards outlined by the Food and Drug Administration (FDA). These regulations for storage will be discussed in a separate blog.

  1. Extra documentation for cold transport

While normal supply chains are restricted by multiple regulations, the cold supply chain has even more rules to overcome. Requirements obligate that carriers maintain temperature control logs to document the temperature of their cargo, often every hour. If the temperature logs are not filled correctly, multiple fines and even the change that commercial shipping license suspension can occur.

  1. Technology

Due to all the characteristics of cold chain logistics, technology has developed massively regarding these features. Some of recent developments stated below:

  1. Data loggers who automatically register temperature, humidity, shock and vibration during storage and transport. Making sure that all documentation is up to date and digital available.
  2. Trailer technology such as insulated containers, different kind of reefers or emission compliant trailers to save on costs.
  3. Human technology such as personnel and driver training for loading or technology. Minimizing the risks which comes with pharmaceutical products while handling. It is important that, for example, the driver is knowledgeable about the workings of refrigerated trucks to make sure that the truck remains at the correct temperature.

 

So, what is the most challenging of the cold chain? Probably all the above mentioned since there are several links in the cold chain, value of these goods is higher and the health of the patients taking the medicines are at risk when these goods are not packed, stored and transported correctly. Estimated by Grand View Research Inc is that the cold chain logistics market size will reach 447,5 billion dollars by 2025 and therefore will continue to strive improvement in the packing, processing and cold storage procedures. It is therefore extremely important to be up to date with all changing elements like documentation needs, regulations, etc. as well as ways to improve your chain continuously. So, how to minimize the risks? Well, a common trend is to outsource the whole chain to a logistical third-party which has more experience and expertise with cold chain logistics. They are probably more up to date with all the regulations in the different countries, standard practices and have the connections needed for this complex chain.

At Broekman Logistics we have the knowledge, experience and connections to be this reliable logistic third party for pharmaceutical products. Not only can we provide the cold storage facilities, we’ve a broad network of reliable parties involved in this pharmaceutical industry. Would you like to know how Broekman Logistics can help you with your pharmaceutical challenges?

Please get in contact with our expert Leonard Stokla.

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