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Pharmaceutical Manufacturing and Packing Sourcer

Partnerships at Work

Ameet Sareen at Air Canada Cargo gives a breakdown of the roles training and communication play in each step of the cool chain and air cargo transport process

Strong partnerships are the framework of any successful business venture. While they play an instrumental role in any industry, they are of the utmost importance to the pharmaceutical industry, especially when it comes to the handling of shipments within the cool chain process.

Every participant in the cool chain process plays an equally important role. Freight forwarders, trucking logistics providers, airlines and drug manufacturers work in tandem to achieve the seamless transportation of commodities. Participants need to understand the importance of handling temperaturesensitive pharmaceutical shipments not only because of the normally high commercial value of these types of goods, but notably because these shipments have an impact on communities around the world. Years of research and development are at risk if these shipments are not handled in the most efficient manner.

Cool chain processes have improved dramatically over the last few years. Today, all stakeholders understand the importance of managing temperature-controlled pharmaceutical shipments adequately. Many regulatory bodies have played a leading role in formulating guidelines that have been adopted effectively by the participants. Additionally, participants have developed well defined processes that best fit their roles in the cool chain. Traditionally, the cool chain process is comprised of the steps laid out in Figure 1.

ALL PARTIES HAVE A ROLE TO PLAY

In simple terms, success in a cool chain process consists of maintaining the desired product temperature range, hence maintaining the integrity of the temperature-sensitive shipment. Figure 2 (page 30) identifies the key participants in the cool chain process. The process begins with the pharmaceutical company, where products are manufactured and packaged usually in a temperature-controlled environment. The company is usually responsible for the packing of the shipment, be it an active temperature-controlled environment or passive packagingcontrolled environment. The shipper is also responsible for communicating the specific handling requirements of the shipment to the other participants in the process.

The freight forwarder’s responsibility is to liaise between the drug manufacturer and the airline. It is critical that all the operating procedures of the manufacturer are well understood by the freight forwarder and well communicated to the airline. Often freight forwarders will incorporate the manufacturer’s standard operating procedures (SOP) into their own. The freight forwarder, together with the manufacturer, is responsible for the transportation of the temperature-sensitive shipment in a temperature-controlled environment to the airline.

The airline is a key participant in the cool chain process. Airlines that opt to be in this part of the business must have clear SOPs for the handling of these unique shipments right from acceptance to final delivery. Generally, the pharmaceutical shipment is in the airline’s possession for the longest period of time in comparison to other participants. There are several steps that the airlines have to perform, including:

  • Keeping the shipment in either a refrigerated environment or in an ambient holding area
  • Monitoring the shipments and maintaining a log for temperature recordings
  • Expediting tarmac times to minimise exposure of shipments to the outside temperatures

While all participants have a crucial role to play in the cool chain process, the importance of strong business partnerships is felt most during irregular operations; when each participant must not only be able to adapt, but work in cohesion to mitigate any potential negative impact to the shipment.

CASE STUDY

The cool chain process and its participants are often challenged during irregular operations. Although one can successfully tackle a broad scope of challenges if they follow defined business processes, some tasks are too unique in their nature and require experience and crafty thinking to tackle head on.

Cooperation in Action
In the winter of 2008, our airline was required to transport 21 active temperature-controlled units for a large pharmaceutical drug manufacturer from a major Canadian station to a similar European station. Needless to say, customer expectations were high and there was no room for errors. The containers were scheduled to travel on a direct flight from origin to destination and the aircraft type was appropriate to carry the determined volume. From a planning perspective, all seemed to be in place and alongside the other players in the cool chain, we were ready to move these containers.

However, as luck would have it, on the morning of the flight’s departure the aircraft was downgauged due to weather conditions resulting in the inability for us to transport all 21 containers on-board the plane. Following the SOP, the customer was immediately contacted and two options were presented: either defer the move to the following day or transport 20 containers by truck to a nearby city (approximately 600 kilometres away), and subsequently fly them from there to their final destination. One container would be flown on another flight to meet the other containers so they could all depart together for their final destination.

Although the deferred option would have been best under normal circumstances – due to certain issues on the customer’s side at the destination – the customer had no choice but to choose the latter option.

The saying, ‘when it rains, it pours’ held true that day. Mother Nature wreaked havoc with extreme winter conditions: low temperatures and blowing snow. Now that alternative plans had been made, new arrangements had to be put in place to ensure the shipment would be well on its way. The new origin station had to be alerted and manpower arranged to accommodate this big move. Ramp handlers were advised on the urgency of the move and the need for a quick connection as time would be very tight when the truck arrived.

Implementation
After battling the extreme weather conditions, two trucks carrying 20 containers arrived at the new origin station merely an hour before the flight’s departure time. The one container was flown in from the original station on another flight to make the connection.

To add to the exciting mix, the airport from which the 20 containers were intended to depart came under red alert. This restricts the loading process for ramp handlers and although this translated to additional time to get things in order, it also meant that there was a higher risk of exposure of the containers to extreme temperatures. Normally under similar circumstances, the airport authorities would not have permitted loading of the shipment onto the aircraft due to safety precautions. However, we followed an escalation process and were able to safely proceed with the loading process on the ramp. All containers were carefully loaded on-board, then, once again to our dismay, the flight faced a three-hour delay due to harsh weather conditions. This meant that the containers were exposed to extreme conditions (although not directly on the ramp), longer than what is called for in the SOPs.

Once at the destination, the containers were received at the ramp and the delivery of the containers expedited to the customer by the airline. A post-shipment analysis concluded that, although two containers had experienced temperature deviations, there was no impact on the quality of the shipment.

WHERE PARTNERSHIPS WORK

The success of the cool chain process hinges on the strong partnership between all participants involved. In every step, including seeking options for the customer, arranging for the trucks on a short notice, braving the extreme weather conditions, undertaking intra-department coordination, handling the goods on the ramp, involving various departments and authorities, and carrying out a post shipment analysis, communication and training played the most critical roles.

The importance of communication and training cannot be emphasised enough when it comes to the handling of specialised temperature-sensitive cargo. Training is crucial to be able to deal with extenuating circumstances and enables all those involved to work with one another to ensure the best practices are used. But of course, building a strong partnership is only as good as the open channels of communication and trust among all parties involved. A high volume of open communication can lead to the generation of an idea, which can enhance business processes so that they are best suited for all those involved, thus migrating a partnership from a working one to one of considerable strength.


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Ameet Sareen is Manager, Cargo Product Development, at Air Canada Cargo. He is an aviation professional with 15 years of industry experience, and holds an MBA in Aviation Management. In his present role with Air Canada, Ameet is responsible for cargo product development, including Air Canada Cargo’s cool chain solutions. Prior to his work at Air Canada Cargo, he held positions with various organisations in different parts of the world, including Qatar Airways, Bombardier Aerospace, FedEx and Emirates Airlines. ameet.sareen@aircanada.ca
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