As with most processes these days, medical device sterilization is being looked at for potential cost savings. For some medical device manufacturers, switching from in-house sterilization to contract sterilization reduces operating and labor costs. For other firms, bringing sterilization in-house eliminates costs associated with shipping and scheduling.
But not all manufacturers need to make such dramatic switches to realize savings. The first step, experts say, is to look at every component in the sterilization process—packaging designs, methods and supplies, cycle times, volumes, schedules, contractor location, etc.—and then check with suppliers, consultants, and contractors for possible refinements.
What device firms shouldn't expect, however, are discounted rates or equipment. With OSHA and EPA requirements regarding EtO sterilization becoming more stringent, for instance, costs associated with particular methods aren't likely to come down. However, by utilizing equipment or tote space more efficiently, device firms can save. Experts recommend the following for potential savings:
Reduce cycle times. Sterilization costs are highly correlated to cycle duration, so reduce duration where you can, says Dan Carestio, vice president of sales and marketing for Steris Corp.'s Isomedix Services (Mentor, OH). For instance, Carestio says that Isomedix performs dose evaluations for companies that use radiation sterilization to ensure they aren't paying for more radiation than their products actually need for sterilization. "Dose is time dependent, so if we can determine that a product needs only 20 kilogray instead of 30 kilogray for sterilization, we can sell that time to others, reducing a customer's costs," Carestio explains.
A similar evaluation is also possible for EtO sterilization, says Gregg Mosley, president of Biotest Laboratories Inc. (Minneapolis). "Many products demonstrate microbial lethality with shorter exposures to EtO, so you need to troubleshoot with different cycle lengths and EtO concentrations to determine the right length of exposure." Mosley, along with John Gillis of SGM Biotech Inc. (Bozeman, MT) and James Whitbourne of STS Duotek (Rush, NY), just published an article on this topic in the February 2002 issue of PMP News's sister publication, Medical Device & Diagnostic Industry, titled "Calculating Equivalent Time for Use in Determining the Lethality of EtO Sterilization Processes."
Use of vaporized hydrogen peroxide (VHP) may also help device makers speed in-house sterilization. "With a cycle time of approximately two hours and no extensive postcycle aeration time required, Steris's VHP MD sterilizer lends itself to just-in-time sterilization when integrated into in-house assembly and packaging operations," says Larry Lachowski, sales and marketing manager, VHP MD, for Steris. "In many cases, by using VHP rather than EtO, you can sterilize in-house with faster turnaround times. Reduced turnaround time translates into lower inventory requirements and lower costs."
The VHP MD system is fully automated and is available in two chamber sizes, 8.8 cu ft and 20 cu ft. It features a racking system to maximize load throughput. While the process is ideal for high-value, low-volume products, its short cycle allows multiple batches to be sterilized per day. "Even small custom lots," adds Lachowski.
Get products into the supply chain faster. If you can rely on parametric or dosimetric release, you can get products into the supply chain faster, says William Young, director of IBA Medical Sterilization and Analytical Labs (Itasca, IL). These methods rely heavily on close monitoring of sterilization parameters and dose exposure rather than on the postprocess testing of biological indicators, so product release to the marketplace is much faster by comparison. For example, when VHP sterilization is performed in-house and sterilized product is released via parametric release or reduced-incubation-time biological indicators, a device manufacturer can reduce turnaround, in some cases by as much as 50%, says Steris's Lachowski.
Calculating the microbial lethality of certain combinations of temperature, EtO concentration, and exposure can help device firms prepare for parametric release, says Mosley. However, not all device firms are comfortable with abandoning the venerable biological indicator. If firms feel more comfortable with biological indicators, they could turn to reduced-incubation-time versions. Mosley points to some two- to three-day biological indicators, such as those from 3M (Minneapolis), Raven Biological Laboratories (Omaha, NE), and SGM Biotech. SGM Biotech's Releasat uses a biological-indicator strip combined with specialized media for a 72-hour incubation period at 37°C, and Raven's Prospore2 has a 48-hour incubation period at 35°C.
Maximize load capacity. Carestio says that because many companies pay per tote or chamber, not per case or shipper, there may be opportunities to maximize tote or chamber space. For instance, if carton configurations only allow use of 35 cu ft of a 45-cu-ft tote, the carton should be redesigned to use all the available tote space, he says. "The tote costs will be nearly the same as before, but now you are using 25% more of it."
Pick the right contractor location. Find a contract sterilization facility close to key distribution points. "Hidden costs, such as freight, can substantially affect the bottom line when you are processing medium-to-large volumes of product," explains Brenda Sparks of Centurion Sterilization Services (Howell, MI). "Along with the initial freight cost of getting the product to the sterilizer, many sterilization sites use an off-site laboratory to test samples and biological indicators to ensure sterility. This can add additional shipping costs along with delays, since you are now adding shipping time to the test release date."
Many contractors have locations in or near common distribution points. And contractors are always adding more locations, like Centurion's new facility in Yuma, AZ, which will open this summer.
Volume may also translate into better service. Phil Cogdill, director of corporate sterilization and biocompatibility at Boston Scientific, says his firm originally expected to benefit from using a contractor with multiple centers. However, Cogdill found that he gets the best service from the location at which Boston Scientific has the highest volume. "If we are their base loader, comprising 40– 50% of their volume, they are more likely to accommodate more of our special requests," he explains.
Partner with vendors that are willing to help keep costs down. Carestio says that Steris can help customers to evaluate their entire sterilization process for potential savings. "We can work with customers to develop a program that will drive out inventory costs or logistics time." Steris can take a customer's inventory system into its own facility, if it will help the customer save costs in the long run. "We will also store and build loads and ship them to distributors," he says. Such creative inventorying can help device firms save transportation and warehousing costs.
Partners who can cut weeks down to days can also help device firms save. Centurion's Sparks says that when device firms are trying to bring a sterile product to the market, they may experience long delays during the initial validation stages. To expedite the process, Centurion offers complete in-house testing, as do IBA, Steris/Isomedix, and a few others, which allows customers to get product to the market faster.
IBA's Young points to another way of cutting sterilization time. "When dealing with a contractor, a schedule is the device firm's best friend because the firm has to work with a queue. However, to reduce waiting time for some customers, we have shown equivalency among several of our chambers, so customers don't have to wait for a particular one if it is occupied."