Really Cleaning Up
It’s not much too look at--boxy and gray, about the size of a small refrigerator. But the machine is considered a thing of beauty at Advanced Sterilization Products, the Irvine company that created it.
Executives hail their Sterrad sterilizer as a major breakthrough in the field of sterilizing medical equipment. It’s now being distributed to hospitals throughout the world, generating healthy sales and fueling an expansion.
Since the sterilizer won the approval of the Food and Drug Administration on Oct. 1, 1993, the company has sold more than 1,000 sterilizers, which carry a price tag of $100,000 each.
Advanced Sterilization’s work force, which totaled 45 employees when the company opened its Irvine Spectrum office three years ago, has swelled to 300. The company is selling the sterilizer in 22 countries, and plans to expand to another 18 this year.
This month, the company, a unit of Texas-based Johnson & Johnson Medical Inc., said it also has signed contracts with purchasing groups that could place sterilizers in almost half of the hospitals in the United States.
For Tralance O. Addy, Paul Jacobs and Szu-min Lin, the researchers who devised the sterilization technique--and engineer Bob Spencer, who later built the machine--it has been a dizzying experience.
“The response to the technology has been overwhelming,” said Addy, a charismatic biochemical engineer who led the research team.
Gregg Lauder, who handles purchasing for hospitals throughout the nation, said there is a growing demand for the new sterilization equipment. “It’s a major advance,” said Lauder, director of capital equipment for American Healthcare Systems/Premier/SunHealth in San Diego, which recently signed a purchasing contract to distribute ASP’s sterilizers.
For years, hospitals have used high-pressure steam sterilizers, first developed in the 19th century, that require temperatures too hot for many sensitive instruments. In the 1950s, hospitals added low-temperature sterilizers, but the process is time-consuming--requiring about 12 hours per cycle--and relies on ethylene oxide, a carcinogenic gas.
The market was ripe for new technology.
“There are concerns about [ethylene oxide] being carcinogenic,” said Ann Baldwin, director of technology and regulatory affairs for the Health Industry Manufacturers Assn. “If more simple systems are made available. . . . If something out there is easier to use or cheaper to use, of course they’re going to go to it.”
For the ASP team, the process began 13 years ago when Johnson & Johnson Medical directed the three researchers to develop new medical technology to prevent infection.
They turned their attention to a simple household chemical long used as a weapon against infection: hydrogen peroxide.
“Conceptually, it was an ideal kind of molecule to use,” Addy said. “So we tried it.”
The low-temperature sterilizer is fueled by a pellet of hydrogen peroxide inserted into the machine, starting a chemical reaction that cleans the instruments. The process takes just over an hour, and leaves no toxic residue.
Success, of course, did not come easily.
“We would come in sometimes and be elated because [an experiment] worked only to find out two weeks later we faced some challenge we couldn’t overcome,” Addy remembers. “We then had to go back and redesign or go in some other direction.”
In 1986, after the researchers developed miniature prototypes, the company hired engineer Spencer to develop a product they could sell.
Spencer brought on five co-workers, rented an office in San Juan Capistrano and set out to build a sterilizer that would be ready for delivery by New Year’s Day, 1987.
“It was a whole lot of 16-hour days,” Spencer said. “We took off four hours on Christmas Day to go home and have dinner with our families. We worked all night on New Year’s Eve because we needed to make that delivery on the 1st.”
And they did.
The battles, however, weren’t over.
Lin, now senior research associate at the company, remembers how, at times, skepticism rose like a wall, threatening to block the project.
A pivotal moment occurred in the spring of 1987.
The prototype was finished and clinical trials were set to begin when Spencer said he received a call from a Johnson & Johnson Medical executive who said the company was halting the project to invest the money elsewhere.
Spencer called Addy, who appealed to executives at New Jersey-based Johnson & Johnson, the pharmaceutical giant and parent of Johnson & Johnson Medical. Addy’s effort kept the project alive.
And the successes began to mount.
The first Sterrad sterilizer was installed for testing at Hollywood Presbyterian Medical Center. In 1988, Spencer and his band of workers, who by then numbered 25, moved to a larger facility in Mission Viejo. A year later, the company began shipping the sterilizers to Germany, France, Canada and Japan.
In 1993, the company moved into its current Irvine home, which it has already outgrown. Over the next couple of months, ASP will expand into three nearby buildings, Addy said.
While the FDA clearance in 1993 was a milestone, for Spencer the high point occurred on the day last November when ASP shipped its 1,000th machine.
Finally, the employees took time to have a party.
Last year was also the first year the company made money, said Spencer, now director of technology development. “After investing for all those years, we finally also made a profit.”
In 1994, Lin, Spencer and Jacobs, now a senior research fellow at the company, each received a Johnson Medal, Johnson & Johnson’s highest honor, for their accomplishments. Only three people could be selected, so Addy had nominated his co-workers.
And last year, Addy was named president of Advanced Sterilization.
“It is extremely gratifying,” Addy said, “after all the struggle, and sometimes even doubt . . . to finally have a product out there, and for people to say to you that it really makes a difference to what they do.”
(BEGIN TEXT OF INFOBOX / INFOGRAPHIC)
Tralance O. Addy
Title: President/CEO
Company: Advanced Sterilization Products
Age: 51
Residence: Coto de Caza
Personal: Married, four children
Education: Bachelor’s degrees in chemistry and mechanical engineering, Swarthmore College, 1969; master’s degree in mechanical and aerospace engineering and doctoral degree in biomechanical engineering from University of Massachusetts, 1973; graduated from Advanced Management Program at Harvard University, 1987.
Background: Research scientist and program manager at Scott Paper Co., 1973-1980. Joined Johnson & Johnson Medical Inc. in 1980 as a research project engineer. Became vice president and general manager of Advanced Sterilization Products in 1990.
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Advanced Sterilization Products
Headquarters: Irvine
Founded: 1988
Employees: 300
Business: Low-temperature sterilization equipment
Parent company: Johnson & Johnson Medical Inc., Arlington, Texas
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Sterilization Breakthrough
Since the 1950s, hospitals have used ethylene oxide gas to sterilize equipment that cannot withstand high temperatures. But ethylene oxide is highly toxic, extremely flammable and must be mixed with ozone-depleting chlorofluorocarbons. The Sterrad system is seen as a simpler, nontoxic method of sterilization. How it works:
1. Instruments to be sterilized are placed inside chamber, which is sealed.
2. Air pumped out of chamber to create a vacuum.
3. Solution of hydrogen peroxide and water injected into chamber via a cassette inserted by the operator.
4. Solution vaporizes and surrounds instruments.
5. Radio frequency energy is applied to create an electromagnetic field, which causesvapors to form a cloud-like plasma.
6. Combination of hydrogen peroxide vapor and plasma sterilizes medical instruments andmaterials without leaving toxic residue.
9. Sterile instruments ready for use in about one hour.
Source: Advanced Sterilization Products
Researched by JANICE L. JONES / Los Angeles Times
