Medical Device Sterilization: What Manufacturers Need to Know I MDDI Online
`
`Page I of 7
`
`Medical Device Sterilization: What
`Manufacturers Need to Know
`Originally Published MODI September 2002 STERILIZATION
`How do you decide on a sterilization procedure? What's new in
`sterilization? What's ahead? Seven experts provide answers.
`William Leventon
`
`BIOMEDevice
`
`An MD&M Evont
`
`Meet 2,600+ Buyers and decision makers
`il1 New fog!and"s Largest
`medtech everit.
`
`ByWilliam
`
`Leventon
`
`September 1,
`
`2002
`
`STERILIZATION
`
`f (/#facebook) ~ (/#twitter)
`
`in (/#linkedin) m (/#email)
`
`+
`
`Originally Published MODI September 2002
`
`Get Medtech News in Your
`lnboxDaily
`
`How do you decide on a sterilization procedure? What's new in sterilization?
`
`What's ahead? Seven experts provide answers.
`
`William Leventon
`
`Before you can sterilize a medical device, you have to figure out how fi:l
`you're going to do it. And before you can figure that out, you have to
`
`know your sterilization options. You should also get an update on
`what's new in the field, so your sterilization process can be as fast,
`
`effective, and inexpensive as possible.
`
`Need help getting started? Read on and find out what seven experts
`
`have to say about some common sterilization methods. The experts
`also discuss a variety of new tools that could improve and shorten
`
`your sterilization process.
`
`COMPATIBILITY CONSIDERATIONS
`
`The Rhodotron TT300
`
`electron-beam
`
`accelerator also
`
`produces x-rays, which
`
`penetrate more deeply
`
`than electron beams.
`
`When deciding on a sterilization method, one of the first considerations should be
`
`product compatibility. "You have to eliminate methods that are incompatible," says
`Trabue Bryans, president of the Atlanta division of AppTec Laboratory Services (St.
`Paul, MN), which performs sterilization-related testing. For example, gamma
`irradiation may have to be ruled out because of adverse effects it may have on the
`
`product or packaging, even if it would be the most rapid sterilization modality.
`
`Today, gamma compatibility is less of an issue than it was a decade ago, according to
`
`Ruth Brinston, director of marketing for MDS Nord ion (Ottawa, ON, Canada), a maker
`of gamma sterilization equipment. She explains that, in the 1990s, suppliers
`
`introduced a variety of radiation-compatible materials that are now being specified by
`
`device manufacturers.
`
`Nevertheless, gamma-related concerns remain. For instance, MDS Nordion generally
`
`recommends that gamma irradiation not be used on products made with Teflon, which
`
`can degrade under gamma exposure. But this isn't always the case. "I've seen gamma
`work just fine on filters with Teflon," says Brinston.
`
`About 70% of products are compatible with electron-beam sterilization, according to
`
`Rod Wilson, vice president of sales and marketing for Biosterile Technology Inc. (Fort
`Wayne, IN), which makes in-line electron-beam sterilization systems. On the other
`hand, E-beam sterilization can be harmful to products containing batteries or
`
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`Medical Device Sterilization: What Manufacturers Need to Know I MDDI Online
`
`Page 2 of 7
`
`electronic components. It can also degrade rubber and polypropylene, but these
`
`materials now come in grades that are E-beam compatible, Wilson notes.
`"Manufacturers are looking for alternatives to ethylene oxide and steam sterilization,"
`
`he says. "So designers are trying to change materials in order to make devices
`radiation compatible."
`
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`
`Although it's a common sterilization technique, the use of ethylene oxide (EtO) can
`
`have a downside that must be considered. "Anything that goes through the process is
`
`going to absorb ethylene oxide," says John Walker, director of quality systems and
`regulatory compliance for Steris Corp. (Mentor, OH), which provides sterilization
`
`services and equipment.
`
`Some materials absorb more EtO than others. Certain plastics, for
`example, absorb large amounts of the gas, while stainless steel
`
`absorbs almost none. "The more the product absorbs, the more EtO
`
`you have to get out of it prior to sale," Walker notes. This is done by
`
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`DESIGN ISSUES
`
`In addition to materials, device designs can influence sterilization
`
`procedures. For instance, some devices can't be sterilized in their
`assembled form because a key component is sealed off from the
`
`sterilization process. These devices must be disassembled to expose
`all parts prior to sterilization, says Chris Dwyer, director of
`
`marketing and international sales for Raven Biological Laboratories
`
`(Omaha, NE), a manufacturer of biological indicators. (Biological
`indicators contain minute organisms and are placed in various
`
`locations on a product. Death of the organisms proves sterilization
`efficacy.)
`
`designed for low-
`
`temperature
`
`biodecontamination of
`
`isolators, workstations,
`
`and filling lines. The
`
`VHP cycle operates in
`
`an open-loop
`
`configuration consisting
`
`of four phases:
`
`dehumidification,
`
`conditioning,
`
`decontamination, and
`
`Before deciding on a sterilization procedure, manufacturers should
`
`aeration.
`
`consider how the device is going to be used. This determines which parts will need to
`
`be sterile-and which will not. "We may look at a device and think we've got to get the
`whole thing sterilized," Bryans explains. "But then the manufacturer tells us, 'No,just
`
`this end will touch the patient. The rest of it won't."'
`
`Aside from outer surfaces, some less-obvious parts of a device may also require
`sterilization. "A lot of devices have motors inside," says Bryans. "A motor might not
`
`OUR NEXT EVENT
`
`touch a patient, but it might generate air. What if bacteria get into that air? And what if
`
`that air is blown into a room?"
`
`Complex device designs can pose problems for EtO processes because the gas must
`reach parts of the device that may have limited accessibility. When products have
`
`these types offeatures, manufacturers can opt for a "harsher" sterilization cycle,
`Walker notes. "You can pull a deeper vacuum, which creates more driving force for
`
`moisture and EtO to get into the device," he suggests. "Or you can increase the gas
`
`concentration in the sterilization chamber. You can also do something that helps move
`along a chemical process-like increasing the temperature."
`
`When called on to sterilize a complex device, I BA Medical Sterilization &Analytical
`
`Labs (Oak Brook, IL) tailors a sterilization cycle for that product. These custom
`
`processes may include higher temperatures and longer gas dwell times, according to
`Patrick Hughes, vice president of sales and marketing for I BA, which offers electron(cid:173)
`
`beam equipment and a variety of contract sterilization services. The company might
`also overpressurize the sterilization chamber with nitrogen to force the EtO into hard(cid:173)
`
`to-reach areas. "You'd be surprised how EtO gets into nooks and crannies," Bryans
`
`says. "The process forces gas into a lot of the tough places."
`
`No tough places can escape gamma irradiation, according to Brinston. "Gamma
`doesn't care about design configurations," she says. "It goes through everything."
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`Medical Device Sterilization: What Manufacturers Need to Know I MDDI Online
`
`Page 3 of 7
`
`Electron beams aren't as certain to reach every crack and crevice in a device. So
`sterilizers put dosimeters in hard-to-reach areas to determine if the products have
`received a sufficient dose. If it is insufficient, says Wilson, the dose can be increased.
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`E-beam processes can also have trouble with "shadowing scenarios," Wilson explains.
`For example, the beam may not be able to reach a product stacked below another
`product. Sometimes, such a problem can be solved by changing one product's position.
`"You might put a product at an angle, turn it on its side, or turn it upside down," he
`says. "You have to figure out the best way to orient the product to the beam."
`
`MATTERS OF DENSITY
`
`In addition to orientation, E-beam users must be concerned with product density. "If a
`product is made of very dense material, an electron beam may not be able to
`penetrate it," Wilson says. The reason: the electrons in the beam are particles with
`mass. According to Hughes, this may limit the E-beam penetration distance to just half
`that of gamma radiation.
`
`But there are ways around the penetration problem. "We can penetrate most
`products by giving them a double side of radiation," Wilson says. "We'll run a product
`through the beam, flip it, and run it back through." In addition, he notes that some
`products composed of superdense metals (such as orthopedic implants) only need
`surface sterilization, which the E-beam process can handle.
`
`Package-related difficulties can also be surmounted. In most situations, Wilson says,
`E-beam sterilization is used for products in their final boxed form. If the packaging
`
`materials are too dense, however, the products can be removed from their containers
`before sterilization.
`
`Nevertheless, Wilson concedes that product density can limit the effectiveness of
`electron-beam sterilization. "E-beam isn't a miracle cure," he says. "Some products will
`probably always need gamma or EtO sterilization."
`
`EtO diffuses several millimeters into surfaces and penetrates all kinds of packaging,
`says Bryans. "But if something's really dense, it's not going to go through," she adds. "It
`won't go through half an inch of material. Only gamma radiation will get to enclosed
`places that need to be sterilized."
`
`At IBA, pricing for radiation sterilization depends on product density, dose, and
`
`turnaround time requirements. The price of EtO sterilization also depends on product
`density and turnaround time, as well as design complexity and time in the sterilization
`chamber. When manufacturers choose a sterilization method, Hughes explains, cost
`considerations are normally secondary to such issues as material compatibility and
`how effective each method will be in sterilizing the product.
`
`PARAMETRIC RELEASE
`
`Beyond a choice of sterilization methods, contract firms offer a number of optional
`capabilities. Perhaps the most important of these is parametric release, which can
`dramatically speed up the sterilization process.
`
`Following conventional EtO sterilization, product samples are sent to a laboratory for
`sterility testing, which shows whether the process has killed biological indicators that
`have been placed on the products. Sterility tests usually take two to seven days to
`
`complete.
`
`Because parametric release relies on measurements of key sterilization variables, it
`eliminates the need for such sterility tests. If the measurements obtained in the
`chamber during processing meet specified requirements, products can be released to
`the market immediately following sterilization.
`
`Cosmed Group Inc. (Queensbury, NY) offers parametric release as part of the
`company's contract EtO sterilization services. According to Clark Houghtling,
`Cosmed's vice president of technical affairs, parametric release requires three steps
`not required in conventional sterilization processes. These are direct measurements
`
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`https ://www.mddionline.com/medi cal-device-sterilization-what-manufacturers-need-know
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`
`

`

`Medical Device Sterilization: What Manufacturers Need to Know I MDDI Online
`
`Page 4 of 7
`
`of EtO concentration, relative humidity, and product temperature in the sterilizer
`chamber. In conventional processes, these values are determined by calculation.
`Direct measurement, however, "provides more-accurate data about what's going on
`inside the chamber," Houghtling says. "So parametric release gives you a higher level
`of confidence in the sterility of your product than release based on biological
`indicators."
`
`On the downside, parametric release requires more-rigorous validation than methods
`that rely on sterility tests. Manufacturers using parametric release also need "state(cid:173)
`of-the-art sterilizing equipment with all the bells and whistles for monitoring the
`process," Dwyer notes.
`
`Although the extra validation requirements are expensive and time-consuming, "the
`payback is faster product turnaround," Houghtling says. Parametric release also
`eliminates costs associated with the use of biological indicators, Dwyer adds, as well
`as the expense of warehousing products while waiting for sterility test results.
`
`EXPRESS SERVICE
`
`Parametric release is part of Cosmed's new EOExpress EtO sterilization process. As
`the name suggests, EOExpress is fast. The entire process takes just one day,
`Houghtling claims, compared with three to five days for the typical radiation process.
`"It's a very powerful tool," he says.
`
`To a large extent, EOExpress's rapid sterilization cycle is a result of so-called all-in-one
`processing. Years ago, Houghtling says, the entire sterilization process occurred in the
`sterilizer chamber. Over time, sterilizer equipment became more sophisticated-and
`more expensive. "That caused people to look for ways to get more out of this
`expensive asset," he says. "So the technology evolved in a way that moved parts of the
`process outside the sterilization chamber."
`
`Today, EtO sterilization is normally done in three phases that take place in three
`different places. First is the preconditioning phase, which occurs in a large room that
`usually contains many different products. Here, the products are heated and
`humidified to reduce the amount of time they must be kept in the sterilizer. Next is
`sterilization, which takes place in the sterilizer chamber. Finally, the products are
`aerated in a room similar to the preconditioning room. Altogether, the three phases
`take two to three days. In addition, however, some products require as much as three
`weeks' extra aeration to reduce EtO residuals to acceptable levels.
`
`In contrast, EOExpress uses the sterilizer chamber to accelerate both preconditioning
`and aeration. Inside the chamber, "you can do a more effective job in much less time
`because you can tailor the process to one product," Houghtling explains.
`
`This isn't the case in preconditioning rooms, which might contain products from a
`dozen companies at the same time. These rooms can only be as warm as is allowed by
`the most temperature-sensitive product. "If one product can only handle a maximum
`
`temperature of 105°F, then the room temperature must be 105°F or lower,"
`Houghtling notes.
`
`In the sterilizer chamber, on the other hand, each product can be subjected to as much
`heat as it can handle. Products can also be heated more quickly and uniformly than
`they can in a large room. The chamber can also provide high-speed air recirculation
`that can't be produced in a preconditioning room, where "there are just a couple of
`ceiling fans blowing a little air around," Houghtling says.
`
`In the aeration phase, the chamber heats products to their maximum temperature,
`quickly boiling off EtO. Meanwhile, high-speed air recirculation boosts airflow around
`the products to speed up the evaporation process. All this takes place during chamber
`evacuation, "so you're literally sucking EtO out of the products and packaging,"
`Houghtling says. As a result, when products come out of the sterilizer chamber, they
`are already at or below government-required EtO residual levels. No additional hold
`
`time is required for EtO dissipation.
`
`4/13/2018
`https://www.mddionline.com/medical-device-sterilization-what-manufacturers-need-know
`Regeneron Exhibit 1045.004
`
`

`

`Medical Device Sterilization: What Manufacturers Need to Know I MDDI Online
`
`Page 5 of 7
`
`To perform all-in-one sterilization, a contractor needs many more sterilizers than
`
`companies that do out-of-sterilizer preconditioning and aeration. "It's a change for the
`sterilization industry to look at the all-in-one cycle as something beneficial," says
`
`Hughes, whose company also offers all-in-one EtO sterilization. "Does it take more
`time in our chambers?Yes, it does. But is it better for the customer?We believe it is."
`
`EQUIPMENT ADVANCES
`
`Another time-saving change in some plants is more-automated sterilization. Recently,
`
`MDS Nord ion built what Brinston calls a fully automated irradiator for a medical
`
`customer. The machine features automated product loading and unloading, as well as
`a system that immediately reads dosimeters, which eliminates several-day waits for
`
`dosimetry readings from a laboratory.
`
`During the sterilization process, some of MDS Nord ion's customers now use the
`World Wide Web to check product status. The tracking system includes a bar code
`
`reader, which is used to enter product data. MDS Nord ion provides the tracking
`
`equipment, while the customer provides the Web site used to access product
`information. "With this system, any sales rep can see where a product is in the
`
`process-in the sterilizer, out of the sterilizer, or at the shipping dock," Brinston says.
`
`Also new from MDS Nord ion is a batch gamma sterilizer. Smaller and less expensive
`
`than the company's other offerings, the machine is meant for customers who want to
`sterilize two or three pallet-loads of product at a time.
`
`The new machine "gives you flexibility," Brinston says. "If you have a lot of different
`
`products, you can sterilize a low-density product in one batch and then do a very
`heavy product in the next batch. With a conventional sterilizer, it might be more
`
`difficult to schedule something like that."
`
`Like MDS Nord ion's batch unit, Biosterile's new E-beam sterilizer is smaller than other
`
`machines of its kind. For shielding purposes, large E-beam systems require stand(cid:173)
`alone rooms with thick concrete or steel walls. Biosterile's small in-line unit, however,
`
`incorporates patented self-shielding that keeps radiation contained within the unit.
`This means users don't have to build special walls or make other facility modifications
`
`to isolate radiation from the sterilizer.
`
`Wilson compares owning the compact E-beam sterilizer with owning an x-ray
`
`machine. Besides being simple to operate, he says, the machine lets manufacturers
`keep their sterilization processes in-house. This eliminates the necessity of shipping
`
`products to and from a contract sterilizer-reducing costs and turnaround time.
`
`Another new system, this one from Steris, sterilizes products with vapor-phase
`
`hydrogen peroxide. According to Walker, vapor-phase hydrogen peroxide sterilization
`is a fairly gentle, low-temperature process that offers good material compatibility and
`
`does not leave harmful residuals. The process is well suited to metals and certain
`polymers.
`
`COMING SOON
`
`A number of other sterilization innovations are in development, but are not quite
`ready for the marketplace. One such product is I BA's x-ray sterilization system. Like
`
`E-beam radiation, the system's x-rays are generated by a machine rather than cobalt.
`Although x-ray sterilization isn't as fast as electron-beam processes, x-rays penetrate
`
`much more deeply than particle-based electron-beams, Hughes claims.
`
`The system may cost a bit more than gamma processes; however, Hughes believes
`x-ray sterilization will be much faster than gamma, which will shorten turnaround
`
`times. X-rays also penetrate deeper than gamma radiation, and may be less harmful to
`
`some products owing to shorter exposure times. "The longer some plastics stay in
`front of radiation, the more likely it is that they'll turn yellow," Hughes explains.
`
`4/13/2018
`https://www.mddionline.com/medical-device-sterilization-what-manufacturers-need-know
`Regeneron Exhibit 1045.005
`
`

`

`Medical Device Sterilization: What Manufacturers Need to Know I MDDI Online
`
`Page 6 of 7
`
`X-ray sterilization is still in the experimental phase, but Hughes expects the
`technology to reach the market within two years. Meanwhile, sterility testing will get
`faster thanks to new chemical- and biological-indicator technology. Already, Walker
`notes, there are indicators on the market that require only two or three days of
`incubation, unlike the traditional seven-day incubation period. Nevertheless, even
`these indicators are slow when compared with a four-hour biological indicator that
`may soon be available. Houghtling believes the four-hour indicator may win FDA
`approval by the end of the year.
`
`When that approval is granted, Cosmed and many other firms will have to decide
`whether parametric release is still worth the extra time, money, and trouble. "Does
`parametric release make sense when you can use a four-hour biological indicator?"
`Houghtling asks.
`
`Waiting has always been a hallmark of sterility testing. "With microbiology, you have
`to wait for things to grow," Bryans explains. "There may be live organisms there, but
`you don't know until they grow to a visible state." Soon, though, testers may be able to
`locate organisms using electronic equipment. For example, instruments could spot an
`organism that fluoresces to show its presence. "This would let you detect it
`immediately," Bryans says. "You wouldn't have to wait for standard viable growth."
`
`CONCLUSION
`
`Common medical device sterilization processes all have advantages and drawbacks,
`which device manufacturers should consider before deciding on a procedure for their
`products. Manufacturers should also decide whether such optional capabilities as
`parametric release are worth incorporating into their sterilization processes. All-in(cid:173)
`one sterilizers, automation features such as product tracking, batch systems, and
`vapor-phase hydrogen peroxide or x-ray processes are among other possibilities. As
`technologies continue to advance, the decision may be whether to drop parametric
`release in favor of new chemical- and biological-indicators that allow superfast
`sterility testing.
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`networks. VP Engineering, VP R&D, VP Operations, and Sourcing Directors will benefit from watching this
`webinar.
`
`Brought to you by Flexan
`
`William Leventon is a freelance writer living in New Jersey and a frequent contributor to MD&DI.
`
`Copyright ©2002 Medical Device & Diagnostic Industry
`
`4/13/2018
`https ://www.mddionline.com/medi cal-device-sterilization-what-manufacturers-need-know
`Regeneron Exhibit 1045.006
`
`

`

`Medical Device Sterilization: What Manufacturers Need to Know I MDDI Online
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