Medical Device Link.

Originally Published PMPN October 2002

STERILIZATION SUPPLEMENT

Service providers are adding to their lineups, offering more square feet and more services.

Daphne Allen, Editor

Titan Scan Technologies's new electron-beam production line at its San Diego, CA, facility has increased capacity by 70%.

If supplier investment is any indication, the trend toward increased use of contract sterilization services and related support just deepened.

Larger facilities and more of them, as well as an expanding roster of services, are giving medical device manufacturers more reason to rely on contract sterilizers. And these expansions also feature the latest in scientific advances.

For instance, Titan Scan Technologies, a manufacturer of electron-beam technology for the sterilization of medical products, announced in August the addition of a second electron-beam production line at its San Diego service center. The center was commissioned in 1996 and has been serving medical device manufacturers in Southern California and the Maquila, Mexico, area since then. The addition of the second line increases capacity by about 70%, allowing consistently rapid turnaround time.

Titan Scan's new line is designed as a PrecisionScan 1500 machine. It consists of a 10-MeV, 18-kW linear accelerator, a floor-mounted track conveyance system, and fully integrated computer and process control systems. "Our patented E-beam technology enables processing to be done in minutes, not days, resulting in efficient turnaround time, improved inventory turns, and speed to market for our customers," says CEO Lou Ruggiero.

September saw the opening of Centurion Sterilization Services's new two-chamber EtO sterilization facility in Yuma, AZ. Response to the new facility has been "great," says Brenda Sparks, who handles contract sales. She adds that the firm is considering adding additional chambers. The facility is currently 45,000 sq ft and is expandable to 100,000 sq ft.

While IBA Medical Sterilization & Analytical Labs (Chicago) hasn't added any square feet this past year to its 37 facilities, it is focusing on expanding its overall capacity and its capabilities.

Known for its GammaStat service, its 24-hour gamma sterilization processing, IBA has been whittling down EtO sterilization time as well. "EtO sterilization and processing used to take seven to 14 days," explains Brett Barthel, senior director of business development and marketing. "Now we can do all the sterilizing and processing in one chamber, in one day." Called CyclEOne, the new service will be available in every facility next year. Barthel admits that the service may not be for every customer, so he says that IBA is also working to make parametric release available in every facility as well. "Our goal is for any medical device manufacturer to have product processed in one day, using either gamma or EtO," he says.

IBA is also working to expand its Dock-to-Doc distribution services as well. "By handling our customers' distribution to hospitals or other sites, we can take 10 to 14 days out of the supply chain. We can reduce their inventory requirements, and we keep products moving," Barthel says.

To support medical device manufacturers' sterilization endeavors, third-party laboratories often step in to ensure method efficiency and effectiveness. One such lab is Nelson Laboratories, which is also expanding its offerings. The firm recently invested in a laboratory unit for vaporized hydrogen peroxide sterilization from Steris Corp. (Mentor, OH), to help manufacturers determine the method's compatibility for their devices. (For more details, see the news story)

Firms like Nelson Labs, as well as contract sterilizers like IBA and Titan Scan, are also expanding their analytical services. The trouble is that many packaging professionals turn to them at the last minute to solve incompatibility issues. "Some packaging professionals wait until package validation to give sterilization any thought," explains Niki Fidopiastis, market development manager for IBA's SteriPro services unit, which provides analytical consultative services from concept to sterilization. "If they had consulted a sterilization expert sooner, they would have saved themselves a lot of time and money." She suggests that packagers at medical manufacturing firms bring experts in at the "ground level, during package design."

Fidopiastis explains that, in addition to its internal expertise, SteriPro will also outsource projects to a pool of experts, including those at labs like Nelson Labs. "Together, we can handle any aspect of supply chain management," she says.

Nelson's Gordon Ely, identifications and packaging section leader, agrees. To help medical device packagers get started in their study in sterilization, Ely has put together a list of questions commonly asked by such professionals. (See the list below.)

When medical packagers do ask questions and keep in touch with their contract packagers, they often influence the contractor's service lineup. For example, Centurion is adding more services to meet customer demands. "We are currently looking at adding even more offerings to our new Arizona location, like parametric release and more analytical services, at the request of our customers."

Gordon M. Ely, identifications and packaging section leader for Nelson Laboratories Inc. (Salt Lake City), an independent testing laboratory that handles sterilization evaluations, answers some tough customer questions.

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