The biopharma industry loses approximately $35 billion annually due to failures in temperature-controlled logistics, according to data from the IQVIA Institute for Human Data Science. These numbers fail to quantify the risks that compromised pharmaceutical products pose for human health. As a result of temperature excursions during transport or storage, pharmaceutical products not only become ineffective, but can also lead to life-threatening consequences for human beings who rely on them.
Temperature-sensitive pharmaceuticals include medicines, vaccines and any other pharmaceutical products which require special handling. In addition to temperature requirements, many types of pharmaceuticals also react to humidity, light, vibration and require transportation within certain time limits. Certain pharmaceutical products are classified as dangerous goods and require transport and handling in accordance with dangerous goods regulations.
Temperature Ranges and Methods of Control
Storage, as well as transportation, of pharmaceuticals must be carried out under specific requirements. Exposure to light, humidity or outside temperature must be regularly controlled and logged at regular intervals. For this purpose, it is common to use temperature and humidity loggers, GPS monitors and other devices which notify the stakeholders about temperature excursions or other deviations.
The temperature spectrum for pharmaceuticals ranges from ambient, or controlled room temperature (20°C to 25°C), to refrigerated (2°C to 8°C), to frozen (below 0°C to as low as −150°C) or cryogenic (below −150°C to absolute zero).
Temperature-Controlled Shipping Systems
To maintain temperatures for pharmaceuticals during transport, active or passive shipping systems may be used considering the manufacturer’s requirements, time of the year, weather conditions, distance, etc.
This involves transport using ordinary vehicles with insulated, thermostatically controlled cargo compartments, enabling the temperature range to be maintained. Refrigerated vehicles may come in the form of trucks and vans of various dimensions, equipped with electronic control systems to manage and log temperature. Some smaller trucks and vans rely on the engine to power the refrigeration unit, larger vehicles have independently powered refrigeration units.
Passive Shipping Systems
Passive shipping systems involve using insulating material and temperature-stabilizing media such as dry ice, gel packs, etc. for keeping temperatures within a desired range. While minimizing human or external input to operate, the passive shipping system can maintain temperature for a limited period of time, making it a good solution for shipping pharmaceuticals at ambient temperatures over short distances by road or longer distances by air.
Passive cooling can be used as a stand-alone solution or alongside other major types of temperature control systems as an additional layer of protection. When used as a stand-alone solution, it must only be used if the route, distance, weather conditions and the container meet the required criteria for temperature control.
Active Shipping Systems
Active shipping systems are widely used in air freight and sea freight and involve thermostatistically controlled cargo containers, which allow for longer transport times and better reliability. Such containers come in two types, cooling only and cooling and heating. In airfreight, these containers are powered via internal batteries and temperature-stabilizing media such as dry ice (cooling types only) or phase change materials (heating and cooling types). In seafreight, active shipping systems rely on the ships’ onboard power supply such as compressors or heat pumps.
Shipping containers in both air freight and sea freight are generally leased by manufacturers, carriers or third-party logistics service providers. In airfreight, the most popular container types used for active cooling are RKN and RAP, manufactured and leased by Envirotainer.
Managing Shipping Risks for Pharmaceuticals
Routes can be long and complex, involving multiple carriers and transit points and no single party has ultimate control over the shipment’s integrity. This raises the stakes for all parties involved, especially the freight forwarders who are often responsible for managing the overall movement of the shipment - from the factory floor to the clinic. A properly implemented quality management system helps reduce risks of temperature excursions, time delays or mishandling across multiple touch points along the supply chain.
Industry Standards & Regulations
Whether you outsource your pharma logistics to 3PL providers or have your in-house logistics team directly working with carriers, it is important that the personnel involved in handling pharmaceuticals are equipped with appropriate training in accordance with the industry standards, both at national and international levels. Some of the commonly used international regulations / standards in the pharmaceuticals industry include:
Temperature Control Regulations (TCR) - IATA
Perishable Cargo Regulations (PCR) - IATA
CEIV Pharma Program - IATA
European Union Good Distribution Practices (EU GDP)
World Health Organization Annex 5
Importance of Communication
The shipper must supply the forwarder with complete and reliable information on the characteristics of the pharmaceutical product and put forward any special requirements for transport. Relying on the shipper’s instructions, the forwarder will coordinate all stages of the logistics.
If the pharma product is classified as dangerous goods, the shipper must provide an SDS (Safety Data Sheet) for the product. Paragraph 14 of this document contains complete information about the cargo, including proper shipping name, UN number, hazard class, etc. The document also states manufacturer's instructions for transportation by various modes of transport, requirements for packaging, labeling, etc.
The freight forwarder is required to carefully monitor the movement of cargo through all touchpoints, hire qualified third parties, and ensure highest possible shipment visibility for the customer. The forwarder must also check the availability of import, export or transit permits in the countries involved and ensure that the outer packing and labeling match the characteristics of the actual shipment.
The freight forwarder is expected to register any deviations from the established standards during transportation, take corrective and / or preventive actions and coordinate its actions with the customer.