ARDL's microbiological testing a critical service

BARBERTON, Ohio—Best kept secrets don't really ever stay secrets.

Because best kept secrets—by their very nature—are defined by the good stuff: the excellence, experience, depth and quality that lies behind. It's hard not to talk about those things.

At times, it may feel like Akron Rubber Development Laboratory's medical device testing services are best kept secrets, especially when you consider the depth and breadth of the company's polymer testing capabilities. And it just may be that the industry doesn't fully realize what ARDL has built over the last six decades, or how it can effectively and efficiently shape medical device development.

Fortunately, for the firm, that's exactly what Ana Barbur wants to talk about.

"We are a polymer-based, highly specialized company," Barbur, vice president of chemical and analytical services, told Rubber News.

ARDL, she noted, has built a catalog of services that fully support medical device manufacturers.

"We offer not only the typical function of testing that one needs to comply with (regulations and standards) … we also offer all the knowledge and experience behind the chemical composition of the device.

"We are also highly specialized in failure studies on these devices, not just in the functional testing (that) is common and offered by many other labs," Barbur added. "Our awesome ability to understand the device as well—not just that it's failing, but why it's failing, or how to improve it—that comes into play many times in our testing. This is our main advantage over all of those other places that do viral testing, that do antigenic protein content (analysis)."

What sets ARDL apart, Barbur said, is its drive to grow. Grow by expanding the kinds of services offered, but also by enriching the experience of its team. And to understand that drive, look no further than the company's microbiological testing group, which may be one of the best kept ARDL secrets.

ARDL's microbiological group was added in 2011, an expansion made possible because Senior Microbiologist David Kostyal joined the ARDL team that year. He brought experience with and understanding of latex protein testing that was nearly impossible to match.

Kostyal did, after all, develop the standards. Or rather the testing that served as the foundation for the ASTM standards.

Throughout the early 2000s, Kostyal played an integral role with Guthrie Foundation for Medical Education & Research, helping to identify and test for latex proteins responsible for allergic reactions.

"The problem early on with the protein testing was we had chemical tests, and the chemical tests were susceptible to interferences with other chemicals used in manufacturing the gloves, so we couldn't get desirable results," Kostyal said of his work with Guthrie. "So what we did was develop an immunological-based assay and an ELISA assay. We extracted latex proteins, injected rabbits, made antibodies and used that. And while the ASTM was working on refining or modifying the chemical analysis, we were doing the immunological analysis.

"People were sending gloves to us, and we got much better consistent results than they were able to get with the chemical (testing) at that time, so that was how we developed our testing service there."

That research set the bar.

And Kostyal is among those who are routinely working to raise it. Today he serves as sub-chair of the ASTM D11.40.04 committee, which leads protein testing across medical substrates.

"Not to toot Dave's horn for him, but in ASTM, he's sort of a major player," ARDL Microbiologist Erin Samples said. "Any time there is a question, any time there is an issue, they tell you, 'Hey, call Dave Kostyal at ARDL because he is your technical contact. He knows what he is doing because he literally developed these test methods.' There is no one else who knows more, and there is no one else I could learn from."

Turns out, Samples has been learning from Kostyal for just about six years. She joined the ARDL team in 2017. Her support and expertise allowed ARDL to expand cytotoxicity testing, viral penetration testing and blood penetration testing.

"I joined ARDL, and that was not only to learn from Dave all of the protein testing we were doing, it allowed us more manpower so we could open up our scope more," Samples said.

That turned out to be a very good thing because on the horizon was the COVID-19 pandemic. And all that ARDL experience was desperately needed.

"It helped with the market because we were testing to see if a virus could penetrate a polymer substrate like a glove or a surgical gown," Samples said. "So those are the two major players—the medical gloves and surgical gowns. And once the pandemic hit, (need for the testing) literally exploded. It just became so important; it became critical and essential."

And it wasn't just that the work ARDL did was needed, it was that those seeking ARDL services were scrambling to understand what the impact of the pandemic would be and ensure the safety of their products.

"It was panic," Samples said. "It was sheer panic, and it was everyone calling and everyone asking for rush testing."

Customers may have felt the panic, but ARDL didn't. Yes, the pandemic and all of its unknowns did bring a whirlwind of activity to the ARDL facilities, but it all had a familiar feel.

Especially for Kostyal.

It felt an awful lot like those early days of the AIDS epidemic, when demand for PPE such as medical gloves surged and manufacturers struggled to keep up with demand. As more manufacturers worked to bring latex gloves to the market, the instances of latex allergies rose.

And that was the space where Kostyal's research took root.

"Latex allergies arose in the late '80s early '90s in response to the AIDS epidemic when they put universal precautions in," Kostyal said. "So the demand for gloves exploded. And there wasn't enough capacity. … (Companies were) getting (into the market) for the first time who weren't quite up to the level of producing the gloves, and latex articles were not produced properly. They weren't leached properly—they had a lot of proteins—and people developed the allergies.

"We were kind of seeing the same thing with the pandemic. We had this explosion of demand, we were getting a lot of products in that were from newcomers or somebody wanting to find out if the product from this new manufacturer met the specifications."

That kind of overwhelming, rush-service testing demand has tapered, the ARDL representatives said. But overall demand for the company's services has not. In fact, demand hasn't fallen back to the pre-pandemic levels just yet.

And as demand for ARDL's medical device testing services spikes and plateaus, there are new trends emerging that require ARDL's microbiological testing capabilities to grow, adapt and expand yet again.

"One of the things manufacturers have been doing is to add antimicrobial substances to the gloves or gowns and other medical equipment," Kostyal said. "There are some other test standards—ASTM standards—for quantifying the effectiveness of the antimicrobials, and that is where we are starting to expand right now, getting into validating our test methodology, making sure we can replicate what the standard specifies.

"We started out with protein testing, expanding into viral penetration and are getting into antimicrobial, so you can see we are growing this."

And as it grows, its certain that breadth of ARDL's capabilities will continue to garner industry attention. Especially, Samples said, when you consider how important services like microbiological testing is for medical devices.

"I just think when people think of rubber, plastic or latex, they don't think of microbiology (testing), but it is really critical to have it, not only for the proteins … but also cytotoxicity testing," Samples said. "You are taking ... a glove and you're plating it with mouse fiberglass cells and you are going to see if there is an effect. Is something leaching out of that glove that is killing these cells? And that is the first line in your testing."