[0:05] Intro: 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.

[0:23] Bill White: Hi, this is Bill White for the Testo Information Network. On this podcast, we're talking with Karen Greene, Vice President, Client Solutions for Network Partners Group with the main office in Blue Bell, Pennsylvania, and also a Principal Consultant with Canyon Labs of San Diego, CA. Karen, welcome to the Testo Information Network.

[0:46] Karen Greene: Yeah, thank you, Bill. It’s a pleasure to be here and have a chat with you.

[0:51] Bill White: Very good, thanks, and probably the first of many we'll have. Karen, before we get started, can you give us a background on you, your professional career, and what's brought you to a time and place here where your client companies look to you for advice and direction on cold chain applications in, I guess, the pharma, biotech, logistics-related companies. Let us know.

[01:16] Karen Greene: Yeah. So, I've been a packaging engineering professional for the entirety of my career, which, it's hard to believe, but it's spanned over 40 years now. So, I've been in the life sciences industry, as you indicate. And in my role as a package engineering professional, I've worked for several med device clients, pharmaceutical clients, testing laboratories, and I've been able to continue to build my skills in packaging engineering, which is a very broad discipline around designing, developing, qualifying, packaging, and helping clients with compliance. And as you look at the industry, both in med device and pharmaceutical, biotech, many products are temperature sensitive, so I've dug in and honed my skills in the area of compliance systems, thermal solutions, and have tried to bring that experience and expertise to many different clients to help them understand maybe what the risks are for their products, for temperature control, and then how to pursue compliance, there is regulatory compliance, and guide them towards different solution providers that can assist to bring temperature sensitive products to market.

[02:34] Bill White: Well, we certainly learned those lessons during COVID, those of us who are not totally in that business, certainly sensitive to it now. Karen, in one of our early discussions, you referenced an organization called ISTA. Can you tell us more about what that is, what it stands for, and what you do there?

[02:53] Karen Greene: Sure, sure. So, ISTA or I.S.T.A., the acronym is “International Safe Transit Association.” And it is a professional organization. It's been around, the name has changed, but I believe it's been around for at least 40 years, maybe a little bit longer than that, and it was founded with the idea to help people in industry, safely transport all kinds of products. It doesn't have to be a life science product.

[03:25] Karen Greene: They've focused in somewhat of a narrow but broad area of distribution, distributing the product, not necessarily designing the product, but how it's distributed, and also understanding what the hazards are that are in the distribution environment, and there are many: shock, vibration, temperature, humidity. So, this organization is a standard-setting organization. They've developed many different test standards that are used by many different industries to evaluate distribution packaging, and they also bring thought leadership to the industry and distribution packaging. I don't recall how many years ago it was, but they've developed, you know, a niche of those hazards that are experienced in transportation, which is temperature, so they have an interest and developed a pharmaceutical committee, and that Pharma Committee, that's the name, it's largely concerned with temperature control. Many pharmaceuticals and medical devices are temperature-sensitive.

[04:31] Karen Greene: So, the focus is on helping end users, engineers, other professionals, safely distribute and ship their products that are temperature sensitive. So, we've published white papers, test standards, test profiles, qualification guidance around how to safely ship temperature-sensitive products, and I'm on the board of directors of ISTA Global, which is a bigger umbrella than just temperature sensitivity. And I'm also on the board of directors of the Pharmaceutical Committee, which has that focus on temperature control.

[05:07] Bill White: So, a lot of what we hope to learn from you today relates to a couple of key areas to start out with. We'll talk about some of these things in later podcasts, but, the first is the data acquisition and management, including where AI comes into play there. And another is how all of this information, the proliferation of information can support the development of shipping products in that process going forward. So, where do we start here?

[05:35] Karen Greene: Yeah, that's a current topic for sure. So, as you might imagine with most things technical, you know, data, data is king. So, an area that it's still developing, there's much more to do, is, “How can an organization like ISTA support people with data acquisition?” So, probably many people listening to this are aware of tools for data acquisition, but you can acquire data, but then, you know, what do you do with the data? So, ISTA does have a digital platform that they've launched, so that's a good platform to aggregate the data, but then the big question is, “What do you do with the data?” So, in terms of temperature data and distribution, I'll just kind of give my own personal commentary on that, is that knowing that temperature exposure is a potential risk to certain products, understanding what temperature your product would experience in the supply chain is very important, right? You wanna know how cold it gets in some regions, how warm it gets, as product moves through the supply chain, it's not just weather, it's not, just environmental, the supply chain is different than the great outdoors, right, it's, it moves from, you know, an airplane or a truck to a warehouse, right, so that exposure period and those exposure profiles are different than if you just put something out in your backyard, obviously, so, where data acquisition can be useful, is to characterize what goes on in those shipping lanes, in the supply chain, and then use that data, to kind of assess the risk of temperature exposure to your product, and, you know, from a laboratory testing perspective, you could use more accurate and appropriate temperature data to more accurately simulate what the product would see in that environment, by means of a temperature profile, that you could simulate in an environmental chamber to challenge the protective packaging that you're gonna use to maintain that temperature control. So, data, you know, maybe in summary, it's valuable, understanding where you got it and how you obtained it, of course, is important, and turning it into something that you can act on.

[07:54] Bill White: And that's exactly where the, the Testo product line is coming into play with the, sensors and acquisition and transmission and aggregation. We're on with Karen Greene. We'll be back after this message.

[08:09] Intermission: You're listening to Measuring Up, Thinking Out Loud, news and information from Testo.

[08:18] Bill White: We're back with Karen Greene. Karen, we're talking about getting a sensitive product from point A to point B and your experience, with big numbers and over the years, as well as over the geographic and seasonal attributes of getting something to where it needs to be. Talk about your idea of thermal modeling.

[08:45] Karen Greene: Yes, certainly, and for the audience, I'm not a thermal modeling expert. I am interested and aware of thermal modeling and how I perceive it's being used, and how I think we could use it in commercial applications. So, thermal modeling, the idea of that is if you're able to create a computer simulation of environmental or shipping lane exposure, most companies are looking at shipping lanes, I'm moving product from a particular origin point to a particular destination point, I may have many of those types of shipping lanes, or just a few shipping lanes, maybe some shipping lanes are more aggressive than others, right? So, the value of creating a thermal model or having commercially available thermal modeling software is through temperature and shipping lane data acquisition, and there could be many tools to obtain that data from a specific shipping lane.

[09:49] Karen Greene: That could be turned into, say, a custom thermal model that an end user can use to simulate that temperature hazard that their product may see in that particular shipping lane, and the value of the simulation is just a better understanding of how your product or payload would react to that, those environmental temperatures or shipping lane temperatures.
 

[10:14] Karen Greene: And, you can use it to better select around a temperature-controlled solution for your product. Perhaps you want to pursue cost savings, or perhaps you have identified a temperature sensitivity of a product that's very sensitive, and you really need to know quite accurately what those exposures are, and the importance of selecting the right solution to protect your product. So, acquiring data is the first step, and then, of course, somebody smarter than me or with different capabilities could either create a thermal model, or it could perhaps be fed into an existing thermal model to modify that commercially available computer simulation and use it to more effectively design and screen temperature protective packaging for your temperature-sensitive product.

[11:08] Bill White: OK, well, if we have all of that information, do we have the technology and materials and acumen to be able to put these solutions together? Has the technology caught up with the information we now have, or information that we can gather?

[11:26] Karen Greene: Yeah, the list is long of solution providers that are experts in temperature control, you know, commercially available temperature-controlled packaging solutions. It usually kind of falls in that arena of packaging, so many bright minds and good businesses exist, both on the temperature data acquisition solution providers, such as Testo, and many others that are providing the insulated shipping solutions that are available commercially. 

[11:58] Karen Greene: What I think is happening, though, is the ability to gather more data and more discrete data could probably outpace the innovation that's in the industry of creating solutions, right? Usually, to manufacture a temperature-controlled solution, you need the material knowledge, the infrastructure, the distribution structure to, you know, make your temperature-controlled packaging and then get it out to a customer, but there are many great suppliers in this industry. Many of them participate with ISTA, so we get together, not in a commercial way, but really in a technology way. How do we help the industry? How do we accelerate bringing the technology of these companies, their innovation? How do we bring that to the end user more quickly? So, organizations like ISTA can be a clearing house of people coming together to help the industry.

[12:50] Bill White: Sounds like the intellectual property repository for the whole industry, at least that sector, and it all begins with accurate measurement at the very root level. You have to have accuracy with respect to your sensors, no matter what you're measuring, whether it's temperature, humidity, pressure, anything that could be measured could be, captured and transmitted and aggregated and massaged and reported, which is where Testo comes in, and, and I think that the evolution of the Teso sensor family and the, Saveris and some of the new technologies there are going to be, they're quite valuable.

[13:35] Karen Greene: I would say absolutely, Bill. Companies like Testo and others they've got quality management systems; with their technology, they're probably manufacturing to international standards, they can certainly make use of calibrating their instrumentation per ISO 17025, that's a quality management system for a testing laboratory or a calibration laboratory, so, there are standards that can help companies developing this technology, make sure that whatever the stated accuracy is verified by another standard. So, there's a lot of tools in the industry for companies making temperature monitoring products to ensure their, you know, their accuracy and their efficacy.

[14:22] Bill White: Karen Greene, it's great to talk to you today. One final thought, how do we get in touch with you if one of our listeners wants to pick up a conversation and learn more from you?

[14:36] Karen Greene: Sure, absolutely. So, they could reach me at my network partner's email, which I'm happy to talk to folks and see if our services could help them there, and that's Karen.Greene, G R E E N E at one NPG.com, and one is spelled out, or for testing services, Karen.Greene@ Canyon Labs.com.

[15:05] Bill White: We've been talking with Karen Greene. Karen is the Vice President, Client Solutions for Network Partners Group, the main office in Blue Bell, Pennsylvania, and she's also a Principal Consultant with Canyon Labs of San Diego. Karen, thanks so much for being here today.

[15:22] Karen Greene: I enjoyed it, Bill. Thanks for having me.

[15:27] Outro: You've been listening to Measuring Up, Thinking Out Loud, news and information from Testo, your resource for precision measurement technology and digital solutions for pharmaceutical, industrial, and allied industries worldwide.