The size of a sterilization operation can affect its ability to provide rapid-fire services, however. Synergy Health plc, a sterilization provider that just moved its corporate headquarters from the United Kingdom to Tampa, Fla., is able to take on large- and small-volume jobs in equal measure, whereas some smaller companies can only do large-volume jobs because they simply do not have the real estate or personnel to dedicate to small jobs that don’t pay as well.
“We have just about every single method of sterilization available out there: gamma, E-beam, EtO, as well as X-ray,” Glenn Thibault, president of Synergy Health’s Applied Sterilization Technologies Division told Medical Product Outsourcing. “So with those kind of technologies we can do the little guy that might bring us three or four cases a week on the back of his truck and sit there and wait for the product, to the big manufacturers who are sending us 15 or 20 truckloads a week.”
“Normally, we want to have three or four days,” said Rick Hunter, Ph.D., president and CEO of Mulberry, Fla.-based FTSI, a gamma sterilization and irradiation provider. “But if one of our customers calls us and says ‘I’m in a bind, I really need this now,’ we will move mountains to make that work. Let’s say an OEM here in Florida that’s working a typical Monday-through-Friday schedule, sends us a project on a Friday afternoon, and we would actually sterilize that over the weekend and get it back to them on Monday or Tuesday. They left on Friday, and the device was sitting back on their bench on Monday. To them, that’s almost like zero turnaround time. Because of the way we operate—and most sterilizers are built to be around the clock operations—I think last year we probably processed over 350 or 360 days a year.”
Lower Costs, Higher Quality: The Constant Struggle
The medical packaging and sterilization industry of course feels the same pressures the medical device industry as a whole is facing: costs. Companies remain in a state of tension post-medical device tax, which kicked in on Jan. 1. While packagers and sterilizers do not have to pay the 2.3 percent tax levied against medical devices, they are at the mercy of customer OEMs that are tightening belts to make up for the loss of revenue to the Internal Revenue Service. So how does a packaging and sterilization service provider cut costs to pass the savings on to its OEM clients?
“Unfortunately because of the way our industry is set up, our costs are really based on electricity, personnel and real estate,” explained Thibault.
Because these costs are somewhat fixed and completely unaffected by fluctuations in the medical device landscape, a sterilization service provider such as Synergy must find creative ways in which to save its clients money. Thibault believes that the most significant problem his industry faces today is logistical.
“Sometimes it costs companies a lot more to ship products to us than it does to actually process the product,” he explained. “So we work to develop a good network for our customers so that we’re where they’re going or we’re where they’re at so that they can save on logistics costs and overall costs of sterilization.”
Thibault explained how Synergy is leveraging its relationships with packaging partners to help lower costs for its OEM clients. For instance, Synergy might suggest to a client that it uses a particular packager that sits on the route between the OEM and Synergy’s sterilization facility. Then, instead of shipping the sterilized product back to the OEM only for it to be shipped out to a packager, the products can follow a more direct route and perhaps be shipped direct to its final destination from the packager’s facility.
“Those are the kinds of things we want to do for our customers to help them cut costs,” Thibault said.
Another factor that has been putting cost pressure on contract sterilizers, packagers, and OEMs, is the sharp increase in audit activity from the U.S. Food and Drug Administration (FDA). Since the Medical Device User Fee Amendments were reauthorized last year, the FDA has been experiencing an increase in operating funds due to an increase in user fees paid by OEMs seeking to gain quicker 510(k) clearances or pre-market approvals from the agency. The FDA’s Center for Devices and Radiological Health Director Jeffrey E. Shuren noted at the Medical Device Manufacturers Association meeting held in April that the agency has been making an effort to hire more personnel and reduce its employee turnover rate. This has resulted in a noticeable rise in FDA activity at facilities such as Synergy.
“It seems there has been an increase in regulatory activity from the FDA,” noted Thibault. “I think they’re out there more often with our customers, and obviously that gets us involved. Generally, when our customers get audited, FDA comes in and audits us as a follow-up, and we’ve been audited quite extensively over the last 24 months. It’s picked up quite a bit. It puts pressure on not only us but our customers to make sure they’re in compliance from a regulatory standpoint. It creates more cost for all the customers as well.”
Contract sterilizers don’t just get audited by regulatory bodies such as the FDA; they also get audited annually by every single one of their OEM customers. Said Millstone Medical Outsourcing President Kelly Lucenti: “With over 50 total quality audits hosted a year, Millstone has to operate under the highest quality standards on a daily basis. All Millstone facilities are FDA-registered and ISO 13485 certified and our Memphis facility is FDA-registered as a human tissue bank. Due to the quality-critical nature of our business functions—for example, inspection and sterile packaging—the FDA, our ISO 13485 registrar, and our customers come in and perform audits at least once a year. Because we’re in sterile packaging, a microbiologist for the BSI Group comes in every two years and audits us. When you are subjected to over 50 quality audits, you have no choice but to operate at a very high level of compliance. It makes us better. When you have the best auditors in the world coming to your company and identifying areas of improvement which we then act upon, the result is nothing short of a world class quality system, which we at Millstone, are very proud of.”
A traditional method of lowering costs in any manufacturing industry is offshoring operations. For packaging and sterilization outsourcers, however, location is all about being close to customers to ensure quick turnaround. Burlingame, Calif.-based thermoformpackaging provider Merrill’s Packaging Inc., established a plant in Costa Rica in 2011 in order to serve OEM clients there. Because Costa Ricahasbecomea hot spotfor medical device manufacturers, companies that choose to locate there are vying for the same talent, which hasdriven up salaries, benefits and other related costs. For a company such as Merrill’s, though, it’s worth it to be close to their customers and to offer them the advantages of local manufacturing, which reduces transportation costs and lead times for them.
And Merrill’s expansion efforts don’t end with Costa Rica. Brian Meltzner, sales manager for Merrill’s Packaging, explained that as OEMs consolidate and work tomove more manufacturingoffshore, Merrill’s may be expanding to other regions, including East Asia. While Merrill’s OEM clients may be moving offshore to save on costs, Merrill’s will follow to better service its clients and provide localized manufacturing, which is preferred by most medical device manufacturing companies.
“At the end of the day, “ Meltzner said, “the JNJs [Johnson & Johnson] and other major medical OEMs of the world can’t and won’tsacrifice quality. That’s non-negotiable. They’re willing to pay moretoobtain thisquality through working with companies like Merrill’s who have worked in the medical device industry for the past 30 years and understand the vast requirements of these medical device customers.”
Innovation in Sterilization
An ongoing concern for sterilizers is the emergence of more and more biologic devices that have drug coatings or other biologically active components that could be destroyed by sterilization. Irradiation methods of sterilization, while highly effective, may degrade or destroy a biologic device.
“One of our customers had a drug-coated stent, and the drug could only get 30 kilogray [kGy],” recalled Larry Nichols, chief operating officer of Nutek Corporation, an irradiation sterilizer based in Hayward, Calif. “But it had a very heavy handle, and in order to penetrate that handle, we had to give it 50 kGy.And when you give the handle 50 kGy just to get 25 inside, that meant the drug got 50 kGy. So we created a shield to knock out or block most of the radiation around the tip of the device. We had another customer that had a very unique product where 90 percent of the product couldn’t get any radiation at all, and only two inches of the product could get radiation. So we devised a shield so that only that small percentage of their product was getting irradiated. This customer’s product is manufactured in Germany, and they ship it to us, and we ship it back to Germany. They said they’ve tried every sterilizer in the world and we’re the only ones that could do it for them.”
The stainless steel and foam shield Nutek created to help its customers is just one of the many ingenious solutions contract sterilizers have to come up with to adapt to the changing types of devices that enter their facilities. Some products, said Nichols, are sensitive to temperature.
“We have found that if we freeze or refrigerate the product, and just give it part of a radiation dose, and then freeze or refrigerate it and give the other part of the radiation dose, then we’re able to successfully sterilize the product with radiation. Whereas without doing those processes, the radiation does not work,” Nichols said. “With radiation, there is approximately a 1 degree rise in Fahrenheit temperature for every kGy, and for the sterilization dose, it’s a minimum of 25 kGy generally speaking. So [an OEM’s] product is going to go up about 25 degrees Fahrenheit in temperature over whatever the ambient temperature is, so if we can freeze the product, that comes down significantly, and it never really gets hot.”
The other danger zone is devices with electronic components. Irradiation is an inappropriate choice for any electronic device besides the very simple ones that only feature wires, for instance. That, and different types of plastics, has increased the popularity of ethylene oxide as a sterilizer.
“There has been a rise in synthetics and plastics—inexpensive plastics—that may take the place of natural fibers,” said Bill Young, vice president of Global Steripro Services at Oak Brook, Ill.-based Sterigenics International Inc. “For the past decade those have tended to drive products into EtO. For biologic products, it is possible to use gamma and E-beam, but it requires the ability to control the dose and the range very tightly as well as the bioburden on the product and the product mix. EtO is the method that’s the most forgiving, provided that all the packaging is breathable and all the gas can permeate into all of the niche areas. It is generally the method appropriate for the widest range of products.”
While EtO is a better choice for electronic devices, it still poses its own challenge because the process involves humidity.
“You might need a vented package where you’re going to do a drying process after EtO sterilization—maybe you’ve got a foil package with a vent,” said Rick Crane, CEO of J-Pac LLC, a Comersworth, N.H.-based contract manufacturing, assembly and packaging services provider. “But you’re going to want to get those electronics dry before you permanently seal them. You might add a desiccant if you need to. Electronic components are a different animal—they need a case by case assessment to know what sterilization process is going to work best for them, especially if they carry a battery too.”
There is room for innovation on how radiation sterilization methods are used, certainly, but not much in the way of new radiation sterilization methods themselves.
“Radiation technology dates back to the [19]60s,” explained FTSI’s Hunter. “There are certainly enhancements that have occurred during that time to enhance dose uniformity—that is, the range of dose the product receives—and the efficiency of capture of gamma rays by the product. But the basic process itself, and that is exposing the product to a measured dose of radiation, is well established.”
For a few years now, Synergy Health has offered X-ray sterilization. X-rays have a narrow, angular distribution concentrated in the direction of the product being sterilized. This allows for excellent dose uniformity compared to a lot of other radiation technologies. Synergy Health provides this service through its partner in Switzerland, IBA Sterilization.
“It’s technology that’s been around for a long time, but only in the last five to six years has it come to the forefront,” said Thibault. “The technology has been able to support the environment in which we process. It actually uses an E-beam machine that shoots the beam into a target that then converts the electrons into X-rays. The nice thing about this technology is that it actually has the speed of gamma or cobalt—sometimes faster—but it has even better penetrating power so the maximum to minimum ratios in which you can process and keep nice tight dosing on product is excellent. We expect that this could, in the future, replace gamma or cobalt 60. This is a great technology and we’re excited about the fact that we have it in our repertoire, and we’re going to try to grow that technology here in the United States.”
The Green Effect: Packaging Becomes More Conscientious
Packaging in the medical device industry faces a particular challenge when it comes to being environmentally friendly. Because of the nature of medical devices and the environments in which they are used, there is necessarily a lot of packaging and therefore waste material involved. While packaging service providers as well as OEMs try to be efficient in packaging methods, and use as little material as possible, it is still very difficult to use, for instance, recycled plastics as it is impossible to verify the source of such recycled materials. So, while the outer packaging can be made of recycled materials, the primary sterile barrier—the section of packaging that is directly in contact with a medical product—cannot.
“We can do a lot in terms of reduction in packaging materials if this is requested by the customer. If the customer’s current package is large, wecan find ways of reducing its footprint,” said Merrill’s Meltzner. “We have created designs that will allow them to incorporate several different products into one package. There’s a whole host of ways to be more environmentally friendly. At Merrill’s, we are alwayslistening to ourcustomer to betterunderstand what their customers are looking for in their packaging designs. We spend a lot of time better understanding what their products are and how they are used. Sometimes, we have designed their packaging to allow them to put their trays into pouches.However, they can convert to sealing the trays with a lidstock in the future. This will allow themtoreduce packaging materials usedand costs associated with these materials and reduction in labor costs. I’ve actuallyspoken to some customers about the potential for using some materials with recycled content in the structure, but most companies are not interested inintroducing recycled content materials into their packaging. When you used recycled content material, you don’t know whatthe source was for the recycled content, so there’s a potential for contamination. For non-medical products, we can use recycled content based materials more frequently, but for medical,the requirements arejust too stringent.”
“There’s certainly an environmental move now that just continues to grow in importance,” said J-Pac’s Crane. “It’s been out there for a while now, but I think day by day it gets more important as we go. The down-gauging of the weight of materials that are being used is certainly an active consideration. You also want to use materials that are recyclable and renewable.”
There are currently no regulations in the United States surrounding recycling medical device packaging post-use. Europe, however, is a different story. The European Packaging and Packaging Waste Directive dictates that manufacturers selling in Europe that have products that include any kind of packaging are required to recover that packaging. This can be done by creating a system to recover one’s own packaging from the purchaser of one’s products—an option rarely chosen—or by paying a license fee to join a non-profit program, such as a Green Dot scheme, which releases a company from the obligation of recovering its own packaging waste placed in the European market. The Green Dot packaging program is the standard take-back program in more than two dozen European countries to date.
The German Grüner Punkt system is considered the forerunner of the European Green Dot scheme. It was originally introduced by Duales System Deutschland GmbH in 1991 following the introduction of a Packaging Ordinance under the Waste Act. Since the successful introduction of the German industry-funded dual system, similar Green Dot systems have been introduced in most other European countries.
“If you as the OEM provide a device for surgery you are responsible to do away with all the waste that’s related to providing that device for surgery,” explained Crane. “That’s really a strong statement.”
But Crane does not see a system like this coming to the United States.
“Germany is landlocked. They don’t have anywhere to take all their trash, so they’re going to be very stringent. Any country that has those limitations is going to be making those types of demands. There’s enough pressure on the healthcare industry as it is—I don’t think a move like that would be very acceptable [in the United States].”
Glossary of Terms • BSI Group. Known in the United Kingdom as the British Standards Institution, BSI is a business standards company that helps clients comply with international standards as set forth by the International Organization for Standardization (styled ISO). • Bioburden. The number of microorganisms contaminating an object pre-sterilization. • Cobalt 60. A synthetic radioactive isotope that is used as a power source for gamma rays. • Electron beam irradiation. Characterized by its low penetration and high-dosage rates, electron beam (E-beam) radiation is a form of ionizing energy that performs best when used on low-density, uniformly packaged products. • Ethylene oxide. Also known as EO or EtO, ethylene oxide is a simple chemical compound that is commonly used for gaseous sterilization of disposable healthcare products. A wide variety of materials and componentscommonly used in the manufacture of these products mayundergo ethylene oxide sterilizationin their final breathable packaging configuration. • Gamma irradiation. The gamma sterilization process uses Cobalt 60 radiation to kill microorganisms. Processing with gamma yields quick turnaround time and can penetrate both packaging and product. • ISO. The International Organization for Standardization, headquartered in Geneva, Switzerland, is an international standard-setting body composed of representatives from various national standards organizations. ISO 13485 is a standard published in 2003 that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. The ISO was established in 1947. • Kilogray. Equal to one thousand Gray, which is the unit of measurement for absorbed dose of radiation. Kilogray isabbreviated as kGy. |