Avoiding Mistakes in Cold Chain Transportation

Christoph Frick, Head of Quality Assurance and Pharmaceutical Development at KohlPharma, joins Helen Winsor from Pharma IQ, to discuss how to ensure the safety and integrity of products during cold chain transportation with an external carrier.

Pharma IQ: Firstly, could you sum up for us the pharmaceutical requirements for cold chain products?

C Frick: First of all, cold chain products mostly contain peptides or proteins, so to speak biological molecules, and they are heat and frost sensitive. Most people see that they are basically heat sensitive, but it is very important to talk about their frost sensibility. Heat and frost affect the structure of these molecules and so the three-dimensional structure of a protein is essential regarding efficiency and safety, and if heat or frost alter the structure of the protein, it cannot bind any longer to, for example, a special receptor on a cell surface and therefore it cannot take effect as needed by the patient. The worst case is a complete alteration of a protein, meaning denaturation, and then it is not possible that it is effective in any way any longer.

Pharma IQ: In summary, what are the pros and cons of active and passive cold chain transportation? What are the advantages and challenges?

C Frick: If you look at active cold chain transport, it is independent of outside temperature, meaning active transport can be fully validated. However, passive is not. It is limited by extreme heat or frost temperature. Second, outside temperature during active transport corresponds to the temperature inside your packages, so if a transport is validated, no data logs are needed any longer in your pack, meaning the active transport. The third item is that active transport holds the temperature needed all the time: there’s no limit. There’s no time limit, whereas passive packs are limited by time, so traffic jams, and delays can affect their efficacy. The last issue I think, and it’s an important one, passive packs need storage rooms and, due to their weight and volume, they are more difficult to handle, and afterwards more expensive to handle.

Pharma IQ: Next can we turn to the vehicles themselves? What are the key requirements for carriers and trucks?

C Frick: I think the basic requirements have to be all fulfilled. First, I think, is that a carrier has to maintain a system according to good distribution practice requirements, and the trucks which are on the way, they have to be qualified. So temperature has to be met. There has to be an alarm system installed. For example, technical bases for the trucks should be ATP and FRC recommendations and requirements. The next item is that of course employees should be trained. There should be SOPs, driver manuals, or what a driver has to do when there is an alarm, and hygiene concepts and careful handling with the packages. Most of these sensitive cold chain products are made of glass, or they have glass containers, so careful handling is very important. Then a correct packaging system on the truck, so that the air stream circulation is okay, so that the stream will reach each place on the truck. [inlinead] Pharma IQ: How do you go about qualifying a carrier? What are the requisites there?

C Frick: First, there is a visit and, so to speak, an interview. I think, from the first questions and answers you will get an impression how good a potential carrier is. There is a basic understanding regarding pharmaceutical and quality requirements. Or, in contrast, has carrier experience in transporting milk and cheese at 30°, but has no knowledge about, for example, 2OSIS and training qualification, calibration of temperature and something like this. It cannot be your task to introduce a quality system to a potential carrier, so he has to provide it for you. Then afterwards, if you have a good impression, you will do an audit with special questions about task duties, about training, hygiene concepts, and all this, and afterwards I think you can try to install, for example, dummy packages which are transported and will be totally checked by your own temperature devices, so that you have a clearer overlook about the whole process. Afterwards, if it is okay, then you can start with the first shipment of your products. So it’s step by step that you will get more an impression and more clarification that you are on a good run.

Pharma IQ: To give an overview, what do you see as today’s key challenges in cool chain transportation?

C Frick: I’m based in the pharmaceutical industry and I have come from a cosy GNP world. However, especially truck carriers, they have no official guidelines comparing to these GXP regulations, or ICH Pick and FDA and all this that we have, and USP and so on. So we have to select and choose carriers which fulfil the basic requirements we need from the pharmaceutical side, and there are several who offer these requirements. We have to inform them about further needs and we have to develop cooperation together - further steps - meaning the first time there is not a need to ask a potential carrier to have a pukka system and a risk system and all this stuff we need from the pharmaceutical world. However, after a while you can develop it with them. And basically the truck carriers are not covering the last mile, especially the handling and transportation from wholesaler to public pharmacy, and then from the pharmacy to the patient. I think this seems to be a field of high interest, and my impression is that, at the moment, especially, these points are very weakly ruled and regulated, and I think here’s the challenge for the future too.

Pharma IQ: Are there any advances in the pipeline which you think will benefit the industry going forwards?

C Frick: Absolutely; I think. first of all, that we will have good competition regarding carriers in the future, and I think that carriers seems more and more to be informed, and some are very keen and prone to develop and present new technologies. For example, to locate truck position and temperature by satellite, and to develop smart cooling systems that a temperature not lower than 2° is provided by the airstream, and of course afterwards new guidelines will be published in the future. For example, I think, too, the EMA, a draft was provided by October/November last year, and, especially, it was created for the wholesaler, so the pharmaceutical wholesaler will be asked more, and we will have more responsibility in the future.

Pharma IQ: You’re going to be speaking at the event about ensuring the safety and integrity of your product during cold chain transportation with an external carrier. What do you think is going to be the key message of your presentation? C Frick: The key points - that there are many questions and requirements still to be solved; that we are in a field which was not so important for health authorities in the past, but which will be more important, more and more at the moment and in the future, and I think, of course, that we are well on the way to solve these problems with partners who are not so strictly pharmaceutical-related, for example truck carriers.

IQPC Please note that we do all we can to ensure accuracy within the translation to word of audio interviews but that errors may still understandably occur in some cases. If you believe that a serious inaccuracy has been made within the text, please contact +44 (0) 207 368 9425 or email helen.winsor@iqpc.co.uk.