Announcer 0:05

Welcome to Measuring Up, Thinking Out Loud, featuring news and information from Testo, your consultative resource for precision measurement technology and digital solutions, serving the pharmaceutical, industrial, and allied industries worldwide.

Bill White 0:22

Hi, this is Bill White. Welcome to the Testo Information Network. And with us today is Jonathan Friesen. Jonathan is joining us from his office in Zurich, Switzerland. Jonathan, thanks for being with us today.

Jonathan Friesen 0:37

Yeah, thank you for having me, Bill.

Bill White 0:39

Jonathan, your industry background offers us many avenues to discuss cold chain logistics from source to delivery, from ground to the air and back, an evolution, I guess, in both processes and technology. So tell us first about your career and what you're doing today.

Jonathan Friesen 0:58

Okay, thanks, Bill. I guess to stick on the logistics part of my career, I started working for Swiss World Cargo, which is the cargo division of Swiss International Airlines back in 2015. I was actually hired in an IT role, but they quickly uh moved me into the sphere of special cargo, where I focused on temperature-controlled products such as pharmaceuticals, perishables, uh, moving animals. And in that context, we were getting very involved in the IATA CEIV Pharma Certification Program, which is an IATA's version of a GDP or good distribution practices certification. And there I was uh working as the responsible person for the pharmaceutical product and the CEIV certification and program. Uh as well, we were getting into at that time and infancy the whole question about data loggers and real-time tracking devices, which I think is the focus of our discussion today. So I was acting as the gatekeeper uh at Swiss Royal Cargo for getting approvals from the various vendors and manufacturers in the industry. And I was doing that until the end of 2021, where I uh took an early pension. And since then, for the last five years, I've been working with IATA, the International Air Transportation Association, which is really sort of the governing body and regulator for airlines around the world. Within that organization, they have a division of the cargo area. And within there, we have this CEIV pharma certification program where I've been working as a consultant for IATA, doing both instructor and a validator or auditor for the program. And we've been focused on improving uh visibility of cargo and especially temperature-controlled cargo throughout the coal chain. And I think, you know, there's been a tremendous growth in this industry, especially due to the COVID uh epidemic, which I'm sure we'll talk a little bit about. But this really brought this whole uh question about high visibility of highly sensitive and valuable pharmaceutical and healthcare products that were moving both over the air and uh road transportation networks.

Bill White 3:32

And that's where the Testo product line comes into play with their sensor technology and the integration and acquisition of data and management of all of that, both in real time and certainly in the cloud. Let's talk for a moment about you mentioned active and passive devices. Can you articulate what that means?

Jonathan Friesen 3:53

Sure. I think when the industry first started using some sort of a device to monitor the temperature, we were very much working in the sphere of passive data loggers, which were placed into and onto shipments at the origin. Uh, the shipper is normally responsible for that. So again, they might place a data logger itself inside of a box where they could monitor the temperature of their product inside. And as well, they also would often put a data logger on the outside of the box in order to sort of monitor the various suppliers that were transporting their product for them, were maintaining the special operating procedures or SOPs, which were agreed to. The normal process there is these devices would have a manual on-off switch. You would be able to program them with maybe a variable of time, but you were going to take a reading that might be anywhere from 10 seconds up to every five minutes. You'd usually have that choice. Sometimes there were issues with space available on the chip inside of the data logger. Then at the end of the journey, they would remove the data loggers, plug them into a laptop over a USB port, and download the data into a computer and then be able to do an analysis to look for temperature excursions or such. One of the improvements also in the industry there was the introduction of Bluetooth, which also allowed rather than actually physically removing shipments, but you could actually read the shipments over an app on your phone or laptop while the data loggers were still inside the boxes. But to be honest, I don't think this has proved to be too effective a solution. Now, moving forward, about 10 years ago, I would say roughly is when the whole advent of real-time devices came into uh play and we started approving these devices at the airlines. And these again as real-time, meaning that they're going to be gathering data, both temperature, humidity. They also have light and shock sensors in them. And they would gather this data and on a pre-defined interval, they would then transmit that data up through either through a Wi-Fi network or more generally through a GSM network and send that information up into a cloud-based system. One of the big pluses here is if there would be a temperature excursion along the way, it could actually signal to the customer right then and there that there's a temperature excursion. So we would have the opportunity maybe to react on those shipments quicker and maybe even resolve an ongoing temperature excursion before we damage the cargo. Now, one of the problems with these real-time devices is because of the transmission mode, all the manufacturers for air travel were forced to build in an automated flight mode capacity so that during flight, these units would no longer transmit data until the aircraft landed, and then they would automatically turn on and then send all the data back that it had been gathering during the flight time. And this again requires an approval by the air carriers to review each vendor's technology package and see that battery requirements, especially lithium battery requirements, were up to speed. They had the right reporting, UN 38.3 reports were in place, and that this flight mode would show the ex evidence that was working correctly.

Bill White 7:41

Okay. Jonathan, we're talking about transportation. We have air and ground and probably sea. Tell us about the differences in these modes of transportation and the impact of the types of sensors and data acquisition systems that are used.

Jonathan Friesen 8:25

Yeah, thanks, Bill. Well, again, if we're going to be using these devices, any type of real-time or passive data loggers in shipments, they need to first get a pre-approval from the carriers in order to use them in the air specter of the world. And as I mentioned already, they require that they have an automated flight mode. Where with road transportation, we have much less limitations and restrictions on them. I think there's always an interest and concern for lithium battery to make sure that they're coming from a proper manufacturer and have been safely manufactured. And that's part of the approval process that we do. But you know, we have to be careful that you know we don't accidentally crush a device with a lithium battery in it when we're either packing goods inside of an aircraft or in a truck or in C container, even, because uh this is where uh we could potentially have a fire situation. Again, from the road transportation part of things, we are seeing, especially here in Europe. I think to be honest, we're a bit more advanced in that area where a good number of the trucking firms have integrated some sort of IoT solution in their truck so that they can monitor the internal temperature of the trucking units or in the C containers so that they can keep a close eye on these devices.

Bill White 9:53

So uh do you think we have the technologies that we need right now to assure the viability and efficacy of these pharmaceutical products from point A to point B?

Jonathan Friesen 10:04

I think we certainly have. The data is there. It's really a matter of making use of the data. We're finding more and more in the industry, though, that uh especially organizations like the FDA in the US actually make it mandatory that in order before companies can release these drug products, they have to show evidence that they were safely transported from the, let's say, the origin manufacturing center to the points where they're being distributed out to the public.

Bill White 10:36

Uh Jonathan, we all uh shared uh an experience, an unpleasant one a few years ago with COVID. Uh, as an industry professional, what did what did you learn during those times?

Jonathan Friesen 10:50

Yeah, the COVID times brought a lot of initial challenges to us as airlines. There was a lot of concern about the need for having to have ultra-cold temperatures that we might have to have through our coal chain. Uh, we very quickly found that by using dry ice and such, we were able to find uh solutions based on already existing GDP processes that we had in place in our organizations. One of the requirements that was coming from several of the large manufacturers of the COVID vaccines was again this need for real-time visibility. This was where we really there was a takeoff in of the uh need for the real-time tracking devices so that companies could see where this very valuable cargo was, could see that it was being transported under the right conditions and that the product itself was maintaining the temperature ranges that were required by the manufacturers.

Bill White 11:51

Okay, and the Testo product line is, I think, nicely positioned with respect to all parameters, different parameters and different uh types of measurements that their systems can do and certainly integrated with their Severus system. What do you think is the next best thing, the next thing coming in technology with respect to the cold chain logistical oversight and monitoring? What's what's next?

Jonathan Friesen 12:18

Well, I keep hearing about AI, and so I think we're collecting a lot of data right now in the industry from all these real-time devices and the data loggers that uh are being put into shipments. And as all of this information is gathered up right now, I think it's often just sitting sitting on hard drives around the world. But I think with the uh introduction of more and more AI tools, there'll be an opportunity to maybe have a bit more predictive analysis, looking at patterns and stuff to better plan the cold chains, uh, look for the risks that might exist on those cold chains and be able to mitigate those risks before they materialize.

Bill White 13:00

And of course, COVID was a shared international experience. Do you see a modification of processes, procedures, best practices that are more global than uh specific to one country or one market?

Jonathan Friesen 13:16

Well, it turns out that every country almost has developed some sort of GDP or good distribution practice, let's say guidelines, or uh I think the guidelines are the best way to describe them. As I said, almost every country, whether it be the FDA, Health Canada, Swiss Medic, these are all examples of national regulators who laid out a set of rules and guidelines that are both for the transportation. And I think we shouldn't forget about the storage also of these products when they're transiting airports or waiting at cross docks of different organizations. And um again, I think generally the GDP guidelines are somewhat similar from country to country. There are some regional differences, and that's where I again I'd like to say that the Ayata CEIV pharma program, we try to incorporate all the various GDPs from around the world. And I think that's what makes that organization and what we're doing there, let's say, somewhat superior to just a basic GDP certification, because we bridge all countries and try to take a holistic approach to the GDP that way.

Bill White 14:35

And Jonathan, about the Testo product line, where do you see that fitting in across the board with respect to this logistics enterprise in the pharmaceutical industry?

Jonathan Friesen 14:46

Right now, I think Testo's uh main area of focus is perhaps offering a mapping solutions for customers so that they can get their various temperature-controlled storage chambers temperature mapped, which is also a GDP requirement. Also, they have an interesting product line for the longer-term temperature monitoring of their warehouses, which would then also, besides providing a record that they have a stable and consistent temperature in the various cold rooms that you would find in different warehouse and airport facilities. It also is important that they have uh an alarm process in place so that people can be notified if we have a temperature deviation, whether it be too hot or too cold in the warehouses and how we're going to react to those particular cases. They have an interesting product on the market now that can certainly be used for just a simple passive monitoring of cargo shipments. And we're actually in the process now of helping them get approvals at a number of carriers across the globe so that this can be a product they can offer to be used on aircraft.

Bill White 16:07

Jonathan, where can we reach you if we want to learn more about what you're doing and what you can do for us and for any company?

Jonathan Friesen 16:16

I think the easiest way to get me is through uh my LinkedIn profile. I'm on it fairly regularly, so I can uh take any inquiries or questions that come from your audience and be happy to assist them how we can with either uh consulting in GDP or looking at temperature mapping exercise or just reviewing your existing processes and look for potential risks that we could mitigate to uh give you a better overall uh cold chain in your organization.

Bill White 16:48

We've been talking with Jonathan Friesen, who is an industry consultant in the pharmaceutical cold chain world, operating from his office in Zurich, Switzerland. Jonathan, thanks so much for being with us today. Yeah, it was my pleasure, Bill. We'll talk with you again. There's uh we have a lot of questions, and I'm sure you've got the experience you can provide those answers to us. Thank you, Jonathan Friesen, Industry Consultant. This is Bill White on the Testo Information Network.

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