Time Vault

As differences between the most used sterilization techniques become fewer, contract sterilization companies are competing for medical device manufacturing customers by reducing time-to-market

By Chris Anderson

In a world brimming with technological advancements, it seems almost impossible that a thriving and growing industry can rely on tried and true methods that are in some cases decades old.

Yet, such is the lot of the contract sterilization industry, which continues to grow in part due to increases in the number of medical devices being brought to market. While the market grows, however, big and small players alike continue to use the same sterilization methods they've used for years—ethylene oxide, gamma radiation and, to a lesser extent, electron-beam.

These methods represent well over 90 percent of all contract sterilizations for medical devices. Industry executives say this won't change at all. Currently, ethylene oxide sterilization, alternately referred to as EO or EtO, accounts for more than 50 percent of the medical device contract sterilization business. And the balance may be tipping more heavily toward the use of ethylene oxide as large and small contract providers alike work to streamline the process.

In some cases, providers have been able to take more than a week off the processing time for EtO sterilization, which has virtually eliminated the time advantage gamma radiation once enjoyed.

It's an old cliché, but time is money, and a shorter sterilization process can save medical device manufacturers some serious dough. But in the mature sterilization market, where the sterilization itself is more of a commodity these days, the big contract providers are working to do more than just make the process faster—they're looking for other ways to work more closely with clients and find operational levers that can further reduce time-to-market.

The players

Like the domestic auto industry, contract sterilization has its “Big Three”: Sterigenics, Steris Isomedix Services and Cosmed. All three providers provide EtO sterilization, with only Sterigenics and Steris also selling radiation sterilization services. After these companies, there are perhaps a couple dozen smaller providers, almost all of which use EtO as their method of choice and working specific niches in the industry.

An example of the latter is 13-year-old Professional Contract Sterilization, Inc. (PCS) of Taunton, Mass. The company got its start as many medical manufacturers were dumping their in-house EtO programs and looking to outside companies to provide the service.

“There were a lot fewer regulations 15 years ago than there are today,” says Gary Cranston, president of PCS. “But when companies saw the regulations coming about emissions, combined with the potential liability issues of working with a lethal gas, they felt EtO sterilizing would simply be too expensive to keep in-house.”

Beverly Whitaker, founder and president of Indigo Consulting Group, Beaufort, S.C. (a consultant for small- to mid-sized medical device manufacturers with a concentration on sterilization issues), says EtO sterilization was once on the ropes due to the high capital costs associated with new regulation compliance. “Everyone thought ethylene oxide was going away and that everything would be either Cobalt 60 (gamma radiation) or electron beam,” she says. “The EO industry really took off when companies figured they could invest in these very expensive scrubbing devices that got them down to the low parts-per-million emissions, and then spread that cost over a number of different customers.”

Once EtO was established as a contract service, the battle was on with gamma radiation. In simplified terms, the decision to use one method over the other was based on turnaround time (gamma took only a couple of days while EtO could take 10 days or more) versus material compatibility (EtO can sterilize almost anything, while gamma rays can cause structural damage to certain materials, such as plastics).

Erasing the time difference

While ethylene oxide sterilization may have been time-consuming in the past, today, the turnaround time edge once enjoyed by gamma radiation is virtually gone.

Both Cosmed and Sterigenics actively promote 24-hour turnaround for EtO sterilization, named EO Express and Cycle One respectively. Though Steris Isomedix Services doesn't actively promote it, Thad Wroblewski, the company's director of sales, says Steris can also provide the service.

While quick EtO sterilization is not a breakthrough technology—Whitaker says it's been around for more than 20 years—contract sterilizers are now pushing the service as they attempt to differentiate themselves from the competition. In the case of Cosmed, whose sole business is EtO sterilization, it was a necessary step if the company had any hope of erasing the “gamma is faster” hurdle.

“The historical advantages of gamma were cost, turnaround time, and no residuals (left on the device being sterilized),” says Clark Houghtling, vice president of technical affairs for Cosmed. “The advantages of ethylene oxide, people always said, were cost—which is interesting—and universal material compatibility. But now with a one-day turnaround, you've now taken time, which used to be the gamma advantage, and put it on the ethylene oxide side.”

To shorten what was once a 10-day cycle to a single day, EtO sterilizers have combined three separate functions into one: pre-conditioning (bringing the product up to an appropriate temperature), gas sterilization in a vacuum chamber, and aeration/outgassing. But the most time-consuming process eliminated is the need to use biological indicators (BIs) to confirm bacterial kill—a process that could take up to a week.

In “parametric release,” the sterilization companies do the heavy lifting up front, devising a system that includes pressure measurement, gas concentration and aggressive “washing” of EtO residuals. If validation of these sterilization parameters shows that the process will achieve a 100 percent kill rate with residual EtO below government regulatory thresholds, then the product can be released to the customer immediately —as long as the process stayed within the pre-determined parameters.

In a nutshell, parametric release eliminates the need to use and test BIs, cutting days out of the process. “People chose to use gamma because EO took too long,” says Brett Barthel, senior director of business development at Sterigenics. “We already know EO is kinder on some products than radiation, but it is going to take a long time for things to move to that one-day process. Gamma is still around and gamma will always be around.”

But the process improvement in EtO sterilization doesn't leave gamma radiation sterilization out in the cold. When compared with EtO, sterilization using gamma radiation is decidedly less complex and is just as efficient at producing the needed kill rate.

“I prefer radiation because it is easier to validate,” says Whitaker. “So, if someone comes to me with a new product, I will recommend that they try to use radiation-stable materials.”

If you think this leaves smaller operators out in the cold, think again. Even operators like PCS have been able to whittle away at EtO process time by using a combination of validation techniques and in-house BI testing. While he can't turn a shipment around in a day, Cranston says PCS can get product moving back to the customer in about 48 hours.

Beyond sterilization

So, with the turnaround time difference between gamma and EtO erased, competition between contract sterilization companies focuses now on…time. At least among the big players in the market, competition for new accounts has moved beyond who uses which method of sterilization and onto which company can help get the product to market quicker.

“It takes 40 to 50 days from the time a medical device leaves the dock, comes to us, and then goes back through the distribution chain before it finally reaches the customer,” says Barthel. “What we are doing is continuing to look up and down the supply chain—what happens before it gets to us, and what happens when it leaves us—to find ways to save time for our customer.”

With both gamma radiation and EtO offering same-day processing, time-to-market has been reduced by anywhere from a couple of days to as many as 10 days. These reductions can have huge monetary implications as medical device manufacturers can decrease the amount of money they have tied up in inventory.

“We are becoming more involved in our customers' supply chains, not just the sterilization,” says Wroblewski. “We are looking for ways to better understand our customers and their systems, to understand their manufacturing volumes, when they are coming, and how we can integrate them in our system.”

One example of moving beyond sterilization is having the sterilization company ship the product directly to medical device distributors instead of sending it back to the client. “That's a way that we can leverage our business and our warehousing to cut time out of the system, to the benefit our customers,” notes Barthel.

In essence, contract sterilization has become commoditized. With so little to differentiate methods and providers, service beyond sterilization may become the next competitive battleground.

“So, what do you do to differentiate yourself?” asks Wroblewski. “Any little thing to drive cost out of the system for your customers. It's no longer just enough to accept the product, sterilize, it and ship it back out again.”

Chris Anderson is a special correspondent for CleanRooms. He's based in Portland, Maine, and can be reached at [email protected].

Get that contract sterilization call in early

Virtually every contract sterilizer for the medical device industry has seen it before. A new product is brought to them for validation of a sterilization process and, due to its design, materials composition or packaging, the product is either harder to sterilize or can't be sterilized using the client's preferred process.

“I think medical device manufacturers should call a sterilization company when they are in the design phase of a new product,” says Clark Houghtling, vice president of technical affairs for Cosmed. “The sooner sterilization is taken into account, the better off a company is when looking for its options and keeping costs to a minimum.”

Beverly Whitaker, president of Indigo Consulting Group, wishes more of her clients would heed this advice. “Manufacturers often forget that they are going to have to actually sterilize a product that is marked as sterile in the early R & D phase,” she says. “It would be helpful to have that strategy up front so they know how to package the product and what materials they can use for it.”

This may be changing, albeit slowly. Thad Wroblewski, director of sales for Steris Isomedix Services, thinks some of this may be due to the increase in customers looking for EtO sterilization with parametric release. “Companies are making product changes and packaging changes, and it is really a combined scientific effort that involves manufacturing, packaging device design, designing the sterilization cycle, and validating it properly,” he says.

Still, while Houghtling thinks manufacturers are beginning to understand the importance of engaging the sterilization company early, it is rarely put into practice. “We're typically not brought into the consultative phase until the end of the process,” Houghtling notes. “So, even though people are more in tune with this, it is still a pretty rare occurrence for people to call us before the end of the process.”


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