Keeping up supply

By Natalie Brandweiner, Deputy Editor

NGP talks to Robert Arendal, Chairman of the Cool Chain Association, about the issues faced by the pharmaceutical supply chain.

“We can create a global standard, beginning first with Europe”
-Robert Arendal, Cool Chain Association

The handling and transportation of perishable and temperature sensitive products has led to an increase in waste by those companies with an inadequate program of disposal. As Chairman of a non-profit association, Robert Arendal is focusing the organization’s strategies on ensuring improvement through partnering with pharmaceutical companies to produce better quality for the end user.

“We established the CCQI Master Table together with Germanischer Lloyd, the certification body for shipping and produced Master Tables for the perishables, mainly the foodstuffs,” explains Arendal. “We thought they would be a good PR company to look at this. We then invited in a representative from service providers, such as the airline industry, the handling companies, the trucking companies; all those companies involved within the cool chain procedure. We addressed the issues of shipment and transportation to meet the highest standards of the customers and improve the quality, reducing the waste.

“We then met with the pharmaceutical industry for their opinion of this and what specific requirements they might have.” Says Arendal. The Cool Pharmaceutical event in Brussels provided the setting for a question and answer session between association and Pharmaceutical Company, both exchanging views and comments to examine the issue of waste disposal and provide a better solution.

“One of the things that we needed to do was to compare the CCQI Master Tables to what might already exist out there. The pharmaceutical industry said that they had looked at various programs and had established certain guidelines, and so our aim was then to analyze that and ensure there to be no and ascertain whether the CCQI will go much deeper into the handling and transportation of pharmaceuticals than what they have already”

For Arendal, this remains to be seen as the analysis stage is currently in full swing. The event being the first exclusive meeting between Arendal and the pharmaceutical industry, the association was able to explain the introduction of the Master Tables and CCQI. “It was based on the feedback from having presented this that we decided it was necessary to have a special CA event, focusing on the pharmaceutical industry and how to now proceed,” notes Arendal.

Standards

Currently, companies only have their own corporate standards to follow, there being no general guidelines for the entire pharmaceutical industry to adhere to. “There are some stipulations, but they do not go as deep in it as the CCQI Master Table does. Each manufacturer or pharmaceutical company has their own specific requirements, adopting policies through the use of their service provider.

“We feel that it's important to have a global vase. The use of service providers by pharmaceutical companies will continue, but it is important to have a baseline to start from. We can create a global standard, beginning first with Europe,” explains Arendal. This is the reasoning for the industry discussion between the companies Europe and the association, to formulate a base standard that could be the CCQI.

For Arendal, the importance of global guidelines for shipping and handling is the result of the ever-growing global relationship between the pharmaceutical industry and solution providers. “Shipment from A to Z goes through various phases. It starts with maybe a manufacturer of pharmaceuticals in South Africa. He then harvest, the shipment to turn it over to a forwarder, who then takes care of it, prepares the documents, truck it to the warehouse, either in the harbor at the airport. It's shipped by air or sea, and then at the other end does the same kind of procedures in reverse. So you have here a range of six to twelve different service providers in order to handle one shipment from.” This demonstrates the importance communication between service providers and the guidelines upon which they must deliver.

“For example, if the shipment of berries or fruits from South Africa is not in the correct packing from the very beginning and therefore is not the right temperature, it's very difficult to correct that temperature during the transportation. You might, just after harvest, go into a blast cooling facility to get the temperature down, but if it's not at the right temperature once it has started the transportation chain, it's not easy to correct it. We need to make sure that each of these service providers know exactly what they have to do from the beginning, and we will then with the CCQI check that they have done that.

“We have now working together with Cargo 2000 to introduce temperature check during the transportation, temperature of the shipment is taken while it's in transportation, to make sure that when let's say the airline takes it over from the warehouse handling, it has the right temperature, and vice versa when it happens at the other end. When the airline delivers to a trucking company, it must make sure that it has the right temperature.

Guidelines

“This is the role of the CCQI. Each Master Table explains exactly how a service provider should handle perishable or PTSP shipments, so each has a clear set of specific guidelines. The service provider can operate according to the guidelines as a certified supplier or not, but of course it has so much more value when it's certified in terms of acquiring business,” explains Arendal.

“By applying the CCQI, you can also achieve an improvement in CO 2 reduction, which of course is a very important issue these days, due to a far less amount of waste produced. Certain products, when they're shipped by air, do emit CO 2, we cannot avoid that, but we have to do it in the best possible way to the least possible environment.

“We haven't finalized this certification as of yet, we are currently in the process of checking what other guidelines the pharmaceutical industry has, and once we have that, we will sit down and make the exact agenda,” adds Arendal. The amalgamation of various company guidelines into a uniform system is due to start before 2008 ends, with the workshops operating during the first quarter of next year.

The specifications of the pharmaceutical industry provide more complexities and challenges when attempting to bring together a set of certified guidelines than most industries due to its special needs. “Most pharmaceutical products are shipped in a container and you have to be very careful not to open that container unless specifically authorized to do so. So what you have to do is to check that the container, at least from the outside where you can read that the temperature inside is within the range that they have requested, which will require the container to be supplied with electricity while waiting for it to be loaded. Once it’s loaded, there is nothing else that can be done to control the temperature, so ensuring all is done beforehand is imperative,” explains Arendal.

“Another challenge is that these containers have to be stored in a certain temperature also, which can often be within two to eight degrees. Some of these containers can withstand the short periods of external temperature, but most containers will be affected. For example, cooler containers will be unable to retain their desired temperature if they were standing outside in the sun for several hours, so consequently, there's a specific care for and handling there.

“The pharmaceutical companies also do not usually want their products to be stored with those products that are not pharmaceuticals, such as food. In the setting of an aircraft, there will undeniably be one container with pharmaceuticals stood directly next to another of food, which is unavoidable.

“Certainly there are times when the forwarder is asking maybe if the container could be loaded in a specific position on the aircraft on behalf of the manufacturer. This is often very difficult because an aircraft needs weight and balance, and consequently, it's almost impossible to do that. You could certainly argue that if you load the containers in the lower belly, you could keep a certain temperature down there during the transportation. However, it's more difficult maybe to do that on the main deck due to the volume of the container. Also, if there are some pallets that have been standing in the sun and they are then loaded together with some containers or other products that are to be of a cooler temperature, one will affect the others,” explains Arendal.

The various factors that pose problems for the service providers is what is currently being addressed by the pharmaceutical industry and the service providers themselves. “We try to find solutions to this, so we at least need to know what are the sensitive parts of the pharmaceutical shipments when it's being transported,” adds Arebdal.

Shipments

Pharmaceutical shipments are often very high value and have increased security requirements, providing further challenges to service providers. “Many pharmaceutical companies prefer that their boxes are neutral boxes without labels, so as not to give away what it is. Consequently very important in all this is to stipulate the temperature that is required during transportation on the shipping documents, as well as on a label, and that's why we have worked with IATA trying to develop a specific label for PTSP shipments where we want the shipper or the forwarder to write down the temperature that this shipment should be maintained at during transportation.

“The reason for this is very simple in that why the temperature might be mentioned on the airway bill or the shipping documents because some airlines, especially US airlines, do not always like or accept that there's a temperature specified on the airway bill, so it could be in some other part of the shipping documents. However, the shipping documents are not normally seen by the warehouse people, so how should they know that this is a shipment that has to be mentioned at a specific temperature? This is why a specific label for PTSP shipments with the temperature stated on the label is very important.”

For Arendal, the effects of rising food prices due to the current economic crisis and potential food shortage provides a setting in which there is a greater need for protection of products, both food and pharmaceuticals. “What we are doing here is becoming increasingly more valuable as people are wanting a better quality of their product. If we can help by applying the CCQI standards and Master Tables, then it can produce a longer shelf life, better quality for the end user, and less waste.”

Robert Arendal has been Chairman of the Cool Chain Association since he founded the association in 2003. Previous to his position at the CCA, he held a management position with cargo airline company Cargolux, he founded the Luxembourg Air Cargo Club (LACC) in 2001, together with other industry leaders in Luxembourg 2001, and appointed Chairman of the Club.