Out in the cold chain26 July 2018
It is often the final stage of a drug’s journey that can be the most hazardous. Ensuring the cold chain is not broken means understanding a number of variables and options. Erik Agterhuis, senior manager of logistics and EU supply chain at Kite Pharma, outlines the considerations one must make in order to ensure successful delivery.
A biological cold chain shipment is on its way from the manufacturing site in South America to Europe. The refrigerated container arrives in a European port and is being forwarded by road to the local warehouse location in one of the continent’s states. The usual checks and releases are performed, signed off and then the products are placed in the local cold room. Although the previous journey is the longest part of the full supply chain, last mile distribution is far from a piece of cake.
Vaccines and a lot of other pharmaceutical products need to be kept in temperature-controlled conditions – 2–8 or 15–25°C – from the moment they leave the manufacturing site until they reach their final destination. The challenges faced in last mile distribution depend on different aspects.
Product and stability data
Understanding the shipment requirements and assessing the risk associated with the type of shipped product is essential. Alignment with regulatory affairs and the quality assurance department is required to understand all details and follow -up actions, especially in the case of excursions or other deviations.
Stability data provides the characteristics of the product and indicates how long it can be handled in a non-temperature controlled environment, without impacting the efficacy of the item. It is the label’s claim and the stability data that determine the structure of distribution.
Geographical location and logistic infrastructure
One of the challenges the industry faces becomes apparent once a cold chain product reaches its destination. Despite the item arriving in perfect condition, when products make their way through the supply chain, the cold chain can potentially deconstruct. This is due to the destination’s logistical infrastructure. In more rural areas, the energy can fail at a level where there is insufficient power or diesel, or if the pharmaceutical products travel long distances without adequate cold chain protection.
Unfortunately, the logistical infrastructure in some countries is not as sophisticated as stipulated by the World Health Organization (WHO) guidelines, pharmaceutical regulations or local inspectorates. Therefore, the pharma industry should think beyond the port of destination and support those countries operationally, as well as financially. - responsibility to ensure a product reaches its final destination under the right conditions, without impacting its efficacy.
Characteristics of last mile distribution
Once a product has arrived in the port of destination, it needs to follow practical steps in the supply chain to maintain its integrity. Those stages will normally encompass a mixture of storage locations and transportation lanes. And even within a country, the latter can be a cross between the different modes of transport for road, air and sea. In all those steps, a basis of requirements has been determined.
In accordance with chapter nine of the Good Distribution Practice Guidelines, it is the responsibility of the supplying partner to ensure that temperature conditions are maintained within acceptable limits during transportation. Regardless of the mode of transport, it must be possible to demonstrate that medication has not been exposed to conditions that may compromise its quality and integrity. A riskbased approach should be used when planning transportation.
The pharma industry, together with its network of partners, should put mapping execution in place and conduct lane validation studies based on risk analysis. Depending on the risk and local infrastructure, a different distribution model can be chosen.
In this instance, products are transported using temperaturecontrolled systems via an agreed commercial country model. At the point of destination, the medicines will be offloaded and temperature graphs will be checked to demonstrate the items have complied with the temperature storage conditions. Once approved, the customer QP will release the products to the market.
If temperature-controlled vehicles are used, the temperature monitoring equipment should be maintained and calibrated at regular intervals. Temperature mapping under representative conditions should be carried out and take into account seasonal variations. If requested, customers should be provided with information to demonstrate that products have complied with the temperature storage conditions.
Items are transported using passive shippers or systems, in accordance with the specific commercial country model. In the marketplace, there are several factors to consider, including the various boxes available and ensuring the right passive system is chosen, depending on the size of the shipment, the duration a product should be kept within its limits and reusability.
If cool packs are used in insulated boxes, they need to be placed in such a way, so that the product does not come in direct contact with them. Staff must be trained on the procedures for assembly of the insulated boxes and reusing cool packs.
Active and passive last mile distribution can be combined with additional devices that are added to the shipment, based on the validation, mapping of the systems and the vehicles being used.
Different types of devices are available in the market that can be USB-enabled and reusable, or can only be used in one way. Additional factors that are important to consider are the number of measurements per time interval and the calibration method used. The goal of using devices is to come to a correct conclusion about the status of a shipment when it arrives. As part of the release process, the data is used when required to serve the patient.
Last mile distribution, as aforementioned, is the most complex part of the supply chain, as failure to deliver a product on time and under the right conditions can have a serious effect on patients. Since compliance and cost are at stake, the industry, together with various governments and non-government organisations, should acknowledge and mitigate those risks.
To serve patients, it is important to support countries in which the logistical infrastructure is lacking an unbroken, temperature-controlled cold chain.
Andrea Gruber, head of special cargo at the International Air Transport Association, on cutting ‘tarmac time’
The transport of temperature-sensitive products requires a lot of attention and the airline industry is facing multiple challenges. For goods that are originating from the healthcare sector, the associated risks generate costs for the industry’s stakeholders. Customers are demanding that adequate facilities, equipment and handling procedures are in place that can guarantee that a constant temperature range is maintained to protect the integrity and quality of their products throughout the journey.
Because of the sensitive nature of the products being shipped, the procedures, practices and requirements of the healthcare industry must be understood and applied by all those involved in the supply chain.
There is also increasing pressure from regulators. The pharmaceutical sector is already heavily regulated, but there are an increasing number of countries issuing their own regulations and guidance to implement and comply with. In addition, there is no global standardised certification for the handling of pharmaceutical products.
Despite the challenging business environment, many airlines, freight forwarders and ground handlers have invested heavily in temperaturecontrolled supply chain solutions. To recognise the effort made by the industry to address the pharmaceutical manufacturers’ needs and to help foster air cargo competitiveness in the industry, the International Air Transport Association (IATA) has developed the Center of Excellence for Independent Validators in Pharmaceutical Logistics (CEIV Pharma), a globally consistent, recognised and standardised certification. This ensures that the right processes, people and infrastructure are in place to handle and transport sensitive shipments in compliance with existing international and national regulatory requirements. CEIV Pharma was introduced as an example of the commitment to certify the high-quality transportation of critical commodities and to address the concerns identified in the supply chain, especially those of pharmaceutical shippers.
Though transportation begins with the shipper, IATA is putting an emphasis on the initial booking, which is the key step to successful cargo transportation. It triggers appropriate handling and operational processes associated with healthcare transport and logistics. Booking as general cargo or for a specific temperature-control service will surely impact the tarmac time.
In recent years, increased communication between stakeholders has meant that there is now a better understanding of the concerns of shippers, as well as the complexity of the airport environment. This has led to improvements in avoiding temperature excursions. Today, while this still occurs, there is a common understanding that the roles and responsibilities towards eventual elimination are shared. Stakeholders work together to ensure appropriate packaging is used upfront, and the correct booking is made at the point of origin. These actions have helped to mitigate the potential risk of temperature excursions.
It is critical that supply chain stakeholders involved in the transport of time and temperature-sensitive products have a more collaborative approach. Improving industry logistical networks to achieve excellence in time and temperature supply chain management requires transparency and collaboration among all partners. This ultimately provides the high-quality services customers demand.
CEIV Pharma is one way to address the sector’s concern, but it is important to emphasise that it was developed by the industry for the industry, with a greater focus on the operational aspect of companies’ activities. With this connection, there are a growing number of CEIV airport communities in which a group of businesses operating at one airport decide to obtain the CEIV Pharma certification. With such an approach, the airport is facilitating the certification with its local stakeholders and this engagement leads to new developments to address industry needs.
The industry is also constantly innovating to provide pharmaceutical manufacturers with new packaging solutions, such as thermal blankets and ramps for pharma vehicles at airports, thus mitigating risks of temperature excursions.
Training is paramount for staff who handle sensitive cargo, in order to ensure that the integrity of a product is maintained in a comprehensive temperature-controlled environment. Therefore, training for stakeholders involved in the transport of temperature-controlled healthcare products by air is a requirement of IATA’s Temperature Control Regulations. It is essential that each member of the supply chain understands what the specific requirements for compliance are, as well as those of others in the supply chain. This allows a greater understanding of the entire supply chain process and smoother process integration.
Training – including the IATA’s Audit, Quality and Risk Management for Temperature Controlled Cargo programme, as well as its Temperature Controlled Cargo Operations – is also an integral part of CEIV Pharma, in addition to the assessment and validation to get the certification.
Continuous improvement is vital to a quality-driven strategy, and IATA will ensure that the CEIV Pharma programme is always up to date in terms of standards and regulatory requirements. In addition, IATA will follow and work closely with different industry initiatives such as Pharma. aero, which involves CEIV Pharmacertified entities in order to seek industry feedback and best practices.