STERILIZING METHODS DUKE IT OUT IN MARKET

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ANAHEIM, CALIF. — Electron-beam processors are eating into the medical-device sterilization business. But providers of the dominant sterilization methods — ethylene oxide gas and gamma radiation — are fighting back.

Lecturer Robert C. Portnoy likened an industry conference to a session of Congress: ``EO people on one side, radiation people on the other.''

Portnoy lectured on commodity medical thermoplastics at the Medical Design & Manufacturing West show in Anaheim, independently from his duties as a senior staff scientist with Exxon Chemical Co. in Baytown, Texas.

``Electron beam is becoming more of an accepted technology as more people in the health-care industry embrace it,'' said Patrick Smith, director of sales and marketing for the San Diego-based Nicolet Electron Services unit of Thermo Electron Co.

``About 5 percent of contract sterilization in the U.S. is in E-beam, 50-55 percent is in EO and 40-45 percent in gamma,'' he said. ``In the next three to five years, I think we will see more E-beam processing facilities across the U.S. than we have ever seen before.''

Smith said interest in E-beam is growing ``because it is a quicker process, cost-effective and with less product degradation.''

``The new approach is higher-powered machines,'' he said.

Nicolet employs 27 and performs E-beam contract services for customers in the southwestern United States.

Manufacturers of plastic disposable medical devices need to make polymer and sterilization process choices with care and caution.

``Select the right material, minimize your radiation dose and mold the material with minimal stress,'' advised consultant Karl J. Hemmerich of Ageless Process Technologies in Solana Beach, Calif. ``Control of the product's bio-burden, or population of microbial cells, minimizes the sterilization dose required.''

Hemmerich identified thermosets and polystyrenes as the most radiation-stable medical polymer families. But he noted that most polymers can tolerate sterilization doses of radiation, and that PVC compounds, favored in many medical applications, are available in radiation-stable versions.

During the early 1990s, medical show visitors learned slowly about E-beam sterilization. Now, customers know the subject, but are ``more concerned with specific product tracking to get speed and turnaround, regardless of the size of their order,'' said Gerry Hare, product manager for Kanata, Ontario-based AECL Accelerators, a unit of Atomic Energy of Canada Ltd.

``Higher power sterilization machines are gaining momentum,'' Hare said.

Titan Corp. sold its first turnkey SureBeam On-Site medical device sterilization system to Guidant Corp.'s Vascular Intervention unit. Titan expects to complete installation of the unit in Temecula, Calif., during the first quarter of 1998.

Titan believes SureBeam is ``the only small, low-cost [E-beam] system available today for in-house manufacturing use.''

The system is built in Dublin, Calif., fits in a 30-foot-by-20-foot space and costs $2 million to $5 million, depending on options.

``Any manufacturer of a large volume of medical devices gains control and a competitive advantage by sterilizing disposables in-house,'' said Gary Webb, national accounts manager for Titan's Denver-based Scan Systems division.

The unit operates contract sterilization services for small- and large-volume manufacturers; a Denver site opened in 1993, and a San Diego facility, in January 1996.

Contract gamma radiation sterilizer SteriGenics International expects to commission a facility in Hayward, Calif., by March 31; and, this summer, to open a second Fort Worth, Texas, site.

Headquartered in Fremont, Calif., SteriGenics employs 290 and has 12 facilities, up from four in late 1994.

``We built five ourselves, and acquired three'' facilities in Rockaway and Salem, N.J., and Haw River, N.C., said Skip Davis, vice president of sales and marketing.

About 85 percent of SteriGenics' business involves sterilizing medical devices.

At least one EO/gamma sterilization supplier is adding E-beam technology. Isomedix Inc. will install E-beam sterilization equipment at a Chicago-area facility in 1997's third quarter.

``It's our first, and it will be the largest E-beam unit in the United States,'' said Dick Mathews, Isomedix director of global accounts in Libertyville, Ill.

Whippany, N.J.-based Isomedix employs 500 and operates 11 U.S. facilities, providing gamma radiation and EO services—80 percent of which involves medical devices.

``Uses of the process, whether ethylene oxide or gamma or electron beam, are expanding into other areas,'' he said.

``Various viruses can be killed, and the shelf life for food can be extended.''