Gary Hutchinson on the Three Rs of Logistics: Reusable, Reverse & Requalification

Andrea Charles
Contributor: Andrea Charles
Posted: 03/20/2012

Gary Hutchinson, cold chain expert in thermal packaging engineering and controlled environment logistics for biotechnology and high risk product and President at Modality Solutions, speaks to Andrea Charles from Cold Chain IQ, about changes the temperature controlled logistics space.

Cold Chain IQ: You’re very well versed in obviously the temperature controlled logistics space. What would you say are the main business drivers for ensuring an effective cold chain?

G Hutchinson: Well, I think that the biggest driver out there is regulatory compliance and the need to get very good at temperature cold logistics on a global basis. There are so many new regulations out there. At the last count, I think there were 37 or 38 countries out there with GDP regulations that include a lot on temperature controlled logistics. So, I think there has just been a business imperative that if you want to go into some of these new emerging markets, we have to better understand what the requirements are and be prepared to talk about some very specific and tough challenges to how you validated your cold chain.

Cold Chain IQ: And as well as regulatory complaints, what are some of the other pressing supply chain issues that your clients in the community are facing this year?

G Hutchinson: Other than regulatory compliance, I think there’s a lot of pressure just for cost containment as well. At this point, I think there are a lot of companies who take a belt and suspenders approach to controlled environment logistics, so they over-engineer packaging, they over-engineer their freight lane and they spend a lot of cost and money on monitoring and controls.

And all that has a cost to it and when you start looking at that cold chain, are you taking the appropriate level of controls and using all the different systems you have available in an integrated approach? It can really reduce some of your costs.

Cold Chain IQ: Which BRIC country in your opinion presents the greatest opportunity for pharma in the next five years?

G Hutchinson: Next five years, that’s a little bit tough. I think the biggest emerging market right now that we’re helping clients with is in Brazil, because they’ve got some very specific regulations in cold chain and what their requirements are. I think the whole Middle East North Africa area is going to be a great opportunity as well. And they’re getting very serious and getting focused on their regulatory requirements. And the last area, I think you’d almost be remiss not to mention China, but I really don’t have a crystal ball to see what that market is going to look like in the next five years. I think you’re almost better off with a wait and see approach in China and focus on some of the other emerging markets, like the Middle East, North Africa and Brazil that have a pretty significant market opportunity already.

Cold Chain IQ: There are lots of country regulations out there. Apart from that, what would you say are the highest barriers to global expansion?

G Hutchinson: Actually, the regulatory hurdles are probably the largest challenge. I think you’re also looking at, after the regulatory challenges, just the infrastructure that’s in place in countries to help a pharmaceutical maintain temperature, especially if they’re very temperature sensitive products. Some of the emerging markets out there really just don’t have the infrastructure that, you know, some of the more developed markets have right now to maintain that cold chain. So, putting controls in place, putting the validated equipment in place and really understand what’s happening in each one of those lanes is really key to success because you don’t have the same level of expertise or infrastructure in place in these emerging markets.

Cold Chain IQ: Do you think the number of goods being shipped within the ambient temperature range is increasing and what are the primary methods of transport for high risk products?

G Hutchinson: Well, when you say ambient, I assume you mean controlled room temperature products. And I think that’s going to be a huge market. I don’t think the volume is necessarily increasing, but the stance that the regulators are taking and even internal quality people at each individual pharmaceutical company are really starting to ask some questions about at least our product at controlled room temperature and how do we maintain that temperature and show those controls in our distribution channels as well.

Cold Chain IQ: As a guesstimate, what percentage of temperature sensitive products shipped do you think are recorded as having an excursion or deviation whilst in the distribution chain?

G Hutchinson: I think the reality of it is the number of excursions is very low; I would say less than 1% or less than .5%. I think it’s just that the risk involved and the cost involved on these types of temperature excursions and the potential impact to product quality or patient safety give them a really high visibility; not only in the industry, but within the company itself. Because if someone is at risk from potential impact to product supply in a market, product quality and efficacy and in the worst case scenario, even a potential patient safety issue.

Cold Chain IQ: You’re going to be speaking at the upcoming in Saudi Arabia. For anyone interested in attending the event, what will be your key take home message and what are you most looking forward to about the event?

G Hutchinson: I think the Middle East North Africa are regions that will be a great opportunity as far as an emerging market over the next five years. And obviously the environmental conditions over there are going to make controlled environment logistics and maintaining proper temperature for pharmaceuticals a significant challenge. And I think getting involved right now in sharing some of the best demonstrated practices and helping them put together a good guidance document across the region right now is key because you don’t want to get to a point where it’s cost prohibitive or even impossible from an infrastructure point of view to maintain the controls that are being expected.

So, I’m involved there really to start sharing some of the best practices, we’re taking from some of the more developed countries and really start sharing this idea that integrated cold chain management system approach; that it doesn’t necessarily always have to be a packaging system, but looking at the carrier, how you manage your carriers, the quality agreements you have within partners, how do you control the ambient temperature to give the packaging its best chance for maintaining temperature. All of things have to be taken into when you look at a comprehensive cold chain management strategy.

And I think sometimes it too quickly devolves into a packaging system only approach and how do we design the most robust packaging for all the temperature extremes that we could possibly see? I think in the long run that’s really self-defeating and you have to look at how these systems all work together to give you what you’re looking for and this tight control of temperature in some very harsh extremes.

Cold Chain IQ: And Gary, what would be your dos and don’ts for integrating cold chain management systems?

G Hutchinson: Dos and don’ts; that’s a great question. I think you really have to start with characterising the environment and don’t make any assumptions about what temperatures you can maintain. A lot of times we get into conversations with people about some very extreme temperatures 50, 60, 70 – 50 to 60 degrees centigrade – and you don’t go and design packaging for that worst case scenario. If you’re seeing extremes like that, you have to design a logistics network to help moderate some of these extremes to get some controls around the ambient so you can really focus on a more robust or a simpler packaging design.

I think the other thing too is you really don’t want to start your cold chain management design until you have a really good understanding of your design space from a product characterisation point of view. You know, 2 to 8 degrees, refrigerated, it’s, sort of, an ideal or a target, but most of the proteins out there have been demonstrated through registration and stability studies to be able to routinely handle exposures outside of that. But explaining that to a regulator and reviewing it as a part of the marketing authorisation is really the first step, because if you try to make those changes after the fact or explain temperature excursions as normal or within your normal operating range without reviewing the data with the regulators can really end up getting you in some trouble.

So, we always take a very systematic approach. We start with product characterisation, doing stability studies, either registration stability studies or recommending some stability studies just to support the distribution environment, move on to good characterisation or understanding of your transport lanes and packaging qualification and then, from there, when you have that foundation, you’ll present a validation master plan for the controlled environment logistics process that clearly can be understood and followed by a regulators and they understand just exactly how all the component systems work together.

Cold Chain IQ: And where do you see the most innovation taking place in the supply chain?

G Hutchinson: I think where you’re going to see the greatest change in technology is going to be in the automated control system. Really a combination of a lot of different I think exciting technologies, from something as simple as really strong visual controls like freeze indicators or threshold heat indicators to really start identifying down to the package level what some of those extremes and making a yes or no decision on them, all the way up to a more sophisticated technology with cell phone and satellite GPS technology that will ably give real-time information where your shipments are, are there any deviations in the route, are you having any concerns or issues with temperature control on a route and, actually, proactively be able to respond to that. So, of all the places that I see really innovation really taking a lead in the next couple years, it’s not going to be so much on the packaging design or even on the logistics network design, that’s getting the feedback loop in place from the monitoring, the controls, the shell, that your validated system has been in control and you’ll be able to react very quickly to issues you have within your supply chain.

Cold Chain IQ: From your perspective, what are the logistical challenges of using a reusable shipping system and do you think we’ll see an uptake in the couple of years?

G Hutchinson: Well, the biggest challenge for any reusable system is always the reverse logistics. How do you return that? From wherever you shipped it, how do you get it back to reload it? And, I’m probably a little bit of a contrarian on this; I don’t think reusable packaging systems are going to get much of an uptake because I think the challenges are just really too great. Reverse logistics, obviously the validation or the re-testing of equipment to make sure that the reusable packaging is still reusable and how do you know that it’s still viable in the system. Because a lot of the reusable technology, especially the vacuum panels, are fairly fragile in the sense that they can very quickly end up losing their effectiveness if they’re damaged in transit. So, you’re going to have to put some sort of inspection or requalification in place to make sure the equipment that you sent out is still viable.

I wish it was different and there may be some technology out there in the future that would make it, you know, a little bit more palatable, but in my perspective, I do generally see the industry staying the same and not really embracing some of this reusable stuff, packaging, and really stay with the single use with better monitoring controls and qualifications on that. But I think from my perspective, I think more of the industry is seeing a movement towards reusable packaging than maybe I’m seeing right now as well.

Cold Chain IQ: How do you see temperature control logistics evolving in the next two to three years and what big changes can we expect?

G Hutchinson: Well, I think the biggest change on the horizon is not going to be just temperature controlled logistics. I think especially with the more complex proteins that are out there and some of the questions being asked around formulation and potential impact of other hazards in transport, I don’t think we’re going to be talking just about temperature; I think we’re going to be talking about the impact of shock and vibration, humidity and pressure changes along with temperature and talking about that. So, I think if I had to look into my crystal ball three years from now we’re not going to be talking about temperature controlled logistics; we’re going to be talking about controlled environment logistics. And we’re going to be asked to monitor and control and design around a lot of hazards in the supply chain other than just temperature excursions.

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Andrea Charles
Contributor: Andrea Charles
Posted: 03/20/2012


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