Originally Published EMDM September
2001
INDUSTRY NEWS
IBA Increases EtO Sterilization Capacity
Company also plans to harmonize quality systems worldwide.
If you harbour any doubts about the future of EtO sterilization, you might want to talk to IBA. The company has almost tripled the surface area and more than doubled capacity at its contract EtO sterilization facility in Petit Rechain, Belgium. Further expansion is planned.
“It was quite popular to declare that EtO was on its way out in the early 1990s,” says Luc Drieghe, sales director, Belgium. An independent market study commissioned by IBA suggested otherwise. The report predicted that EtO and ionization would continue to be the dominant sterilization methods for devices well into the next couple of decades. The success of procedure packs in the medical market is one of the reasons for EtO’s rebound, according to Drieghe.
“Because they include
all of the instruments necessary to perform a procedure, custom sets bring
together complex components and diverse materials in a single package,”
says Drieghe. Some of these materials are not gamma resistant, he adds, and
EtO is the most suitable alternative for neutralizing contaminants.
The increasing complexity of high-tech medical devices has also steered OEMs toward EtO sterilization, according to Drieghe. “These products require a sterilization method that has little or no impact on physical and chemical properties, and EtO remains the best solution.”
To satisfy demand, IBA has added two EtO chambers, bringing the total to four lines at the Petit Rechain facility. Space has been earmarked for two more units. The new EtO chambers that went on-line in February increased treatment capacity from approximately 15,000 to more than 40,000 pallets per year.
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To
keep up with demand from device OEMs, IBA put two new EtO chambers on-line
at its Petit Rechain facility in February, and it has set aside space
for two more units.
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The original lines are fully automated, with pallets moving from stock to the degassing area without human intervention. Automation of the new chambers will commence once IBA has decided on a system that is best able to meet current and future customer demands.
“We are continuously optimizing our processes,” explains Drieghe. “The new lines were designed to have a 16-pallet capacity, because international transport trucks can carry 32 pallets. So, we are evaluating automation systems that can load 12 and even 16 pallets.”
Even with the two additional chambers and high-throughput automation systems, IBA expects to be operating at near capacity within two years, according to Drieghe. “Last year, we processed approximately 15,000 pallets, and we expect to end this year at 25,000 pallets. We are forecasting an additional 10,000 pallets in 2002,” he says. Space has been set aside for two more lines, for which all the preparatory work has been done. “The connections for the vacuum, pressure, and EtO lines are already installed,” says Drieghe. “It’s truly in plug-and-play mode.”
Quality Systems Harmonization on Track in Europe
Petit Rechain is one of 47 sites in 12 countries that IBA operates. To streamline operations for its customers, many of whom use several facilities to process their products, IBA has embarked on a plan to harmonize its quality systems (QS) worldwide. Harmonization was implemented at facilities in North America and Thailand in January, and it is scheduled to be completed in Europe by 2003.
The IBA programme incorporates a policy manual, which itemizes QS procedures common to all sterilization methodologies, and a process procedures manual that details validation and regulation requirements relevant to a specific technology and business unit. According to Lisa Foster, vice president of corporate quality assurance for IBA North America, the initiative has been received enthusiastically by IBA customers.
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Implemented
in IBA's North American facilities since January, the harmonization of
quality systems will be completed at its European operations by mid-2003.
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“It has certainly been a selling point for our clients, who appreciate the fact that they can walk into any North American IBA facility and write one sterilization specification for their products,” says Foster. She is working closely with her European counterpart Hans Aeschlimann to achieve the same efficiencies in the Europe-based facilities. Industry is extremely eager to see harmonization implemented here, she says, because in some respects there is an even greater need.
“Griffth MicroScience [which IBA acquired in 1999] had purchased companies one at a time. Although all of the facilities are certified to ISO 9000 and EN 46000, there are still some differences in their individual quality systems because of language barriers [and other local issues],” says Foster. Having all of the facilities operate according to a standard set of practices benefits not only the customers but also internal operations. “I know from where I sit that [all of the sterilization plants] are doing the same thing,” she says. “I don’t have to worry that they’re writing their own procedures.”
The global quality policy manual, which includes all relevant ISO, EN, and US FDA standards, has already been introduced in all of the European divisions, according to Aeschlimann. Because of linguistic and related issues, the manual of process procedures and working instructions probably will not be finalized until mid-2003, he adds.
Norbert Sparrow
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IBA to Build Denmark’s First E-Beam Center IBA has announced the signing of a contract with Coloplast to construct an E-beam sterilization facility next to the device manufacturer’s production plant in Mørdrup, Denmark. The facility will be equipped with an IBA Rhodotron TT 200 for priority treatment of Coloplast medical products. It is scheduled to be operational in July 2003 and will be able to process up to 120,000 m3 of medical products per year. This will be IBA’s first sterilization plant in Scandinavia. The company is also moving forward with its x-ray sterilization facility for food and medical devices. It is on the verge of officially announcing the location of the site, said to be somewhere in western Europe. Although the feasibility of the use of x-ray sterilization for medical devices has been questioned by some, Luc Drieghe, sales director, Belgium, notes that it has better penetration properties than E-beam and that it can treat a greater number of pallets. X-ray sterilization may also be an attractive alternative in countries where there is strong opposition to the use of cobalt 60 sources. —N.S |
Femtosecond Lasers: A Solution Looking for a Problem
The industrial and commercial
use of high-power ultra-short-pulse laser systems has been limited thus far
to a handful of niche applications. According to some researchers, however,
the technology may have untapped potential for the precise, repeatable machining
of materials used in the medical device industry. Speaking at a recent conference
in Brussels, physicist John Girkin from the Institute of Photonics, University
of Strathclyde (Glasgow, UK), discussed the benefits and limitations of femtosecond
lasers, which he described as a “solution looking for a problem.”
Femtosecond lasers deliver pulse durations that can be as short as a few femtoseconds
(10-15 second). Girkin put this in perspective by pointing out that light travels
fast enough to circle the world seven times per second and crosses a human hair
in 100 femtoseconds. These pulses are too short to transfer heat or shock to
the material being processed. Consequently, there is little to no collateral
damage to the surrounding material, says Girkin. This represents a clear advantage
over thermal cutting and plasma ablation, the dominant laser-based machining
techniques currently used by industry.
Ultra-short-pulse lasers break the material’s intermolecular bonds in a manner similar to excimer lasers, notes Girkin, but they do so at near-infrared wavelengths. The UV light generated by excimer lasers can cause plasma to form in front of the workpiece, and these clouds absorb subsequent light pulses and distort the incoming beam. Femtosecond lasers deposit their energy so quickly that the beam does not interact with the plume of vapourized material. In principle, this enables “ultrashort laser systems to run at much higher repetition frequencies” than UV systems, according to Girkin.
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Achieving
pulse durations as short as 10-15 second, femtosecond lasers prevent the
transfer of heat or shock to the workpiece. In addition, they are capable
of ablating holes measuring less than 100 µm and machining inside
materials without producing surface deterioration.
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Girkin also emphasized the precision of these systems. Femtosecond lasers can ablate holes measuring less than 100 µm, he pointed out, and they are capable of machining inside materials without causing surface damage. To illustrate the laser’s precision and the minimal energy or mechanical shock that is transferred to the material, Girkin cited an experiment conducted at Lawrence Livermore National Laboratory in California, where researchers used the system to machine an unstable and highly explosive material without causing it to detonate.
Femtosecond lasers have been used to machine materials ranging from collagen to metal with equally remarkable results. In all instances, the workpieces exhibited a similar cutting profile, and little or no damage was observed on the surrounding surface. The repeatability does come at a price, notes Girkin. Cutting rates, “while reasonable, are not high”: The laser can cut a 100-µm-deep and 200-µm-wide groove in steel at a rate of 5 mm/min, and in plastic at 20 mm/sec.
When evaluating femtosecond lasers for an industrial application, “there are some considerations to keep in mind,” says Girkin. “They are not fast [in terms of throughput], they are not suited for drilling holes in the millimeter range, and the systems are currently priced at about $200,000.” On the other hand, for a device manufacturer looking for a tool to perform high-precision cutting with little or no collateral damage and at a reasonable speed, a femtosecond laser may indeed be worth investigating. As for the price tag? Everything’s relative, notes Girkin; if the femtosecond laser represents an enabling technology for an application that otherwise might not be feasible, then you might call it a bargain.
Girkin spoke at the Polymers for the Medical Device Industry 2001 conference, organized by Rapra Technology Ltd. An international organization providing industry with technology, information, and consultancy on rubber and plastics, the company has extensive processing, analytical, and testing laboratories. For more information on femtosecond lasers, contact John Girkin at the Institute of Photonics, Wolfson Centre, 106 Rottenrow, Glasgow G4 ONW, UK; phone: +44 141 5534120; fax: +44 141 5521575; e-mail: j.m.girkin@strath.ac.uk; website: http://www. strath.ac.uk/instituteofphotonics.
Norbert Sparrow
A New Source for Implantable PEEK
Device OEMs take note: you may want to add a new name to your Rolodex under implantable materials. Invibio Ltd. (Thornton Cleveleys, Lancs, UK) chose the recent Medical Design and Manufacturing East show in New York City to announce its official launch as the sole manufacturer and supplier of implantable PEEK.
A polyaryletherketone polymer, PEEK-Optima combines chemical and hydrolysis resistance, strength, and tribological properties with biocompatibility. Invibio currently has three grades available, which can be “custom tailored to meet specific applications, and offer virtually unlimited design solutions,” says company president Michael Callahan. Because the material can be extruded, moulded, and machined, it provides device manufacturers with broad design and production flexibility.
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Spinal
cages made of an implantable grade of PEEK promote bone stimulus and fusion.
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Invibio is wholly owned by Victrex plc, which previously offered the biocompatible
material. According to Callahan, traditional business models do not necessarily
apply to the medical implant market. Invibio was founded, he continues, to provide
this market with a focussed development, marketing, technology, and sales approach.
PEEK-Optima is manufactured under strict production guidelines, and has undergone
extensive biocompatibility and biostability testing. ISO 10993 and USP Class
VI test results are contained in a Device Master File at US FDA. Suitable applications
for the material include spine cages, bone screws and pins, hip implants, cardiopulmonary
devices, and dental implantables.
Recent applications include synthetic finger-joint products manufactured by Switzerland-based Mathys Medical. The company had been using acetal, but it switched to PEEK-Optima because it offered improved radiation resistance and CT and MRI compatibility, according to Callahan. The material was also specified by French company Scient’x for the production of cervical and lumbar spinal fusion cages, where it replaced titanium. PEEK-Optima was deemed a superior material for these devices because its elasticity modulus closely resembles that of cortical bone, thus promoting bone stimulus and fusion.
For more information, contact Invibio Ltd., Technology Centre, Hillhouse International, Thornton Cleveleys, Lancs FY5 4QD, UK; phone: +44 1253 866812; fax: +44 1253 851458; e-mail: info@ invibio.com; website: http://www.invibio.com.
Norbert Sparrow
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In Brief Upchurch, Sapphire under New Parent Company Upchurch Scientific (Oak Harbor, WA, USA) and Sapphire Engineering Inc. (SEI; Pocasset, MA, USA) merged to form a their new parent company, Scivex. SEI manufactures precision component parts from hard materials.
Upchurch Scientific supplies close-tolerance fluid transfer fittings, filters, valves, and tubing and accessories, while specializing in precision injection moulding, machining, and extrusion of engineering thermoplastics. Both companies will continue to operate independently but may collaborate on product development on projects involving liquid transfer engineering problems. For more
information, contact Upchurch Scientific, 619 W. Oak St., Oak Harbor,
WA, USA; phone: +1 360 6792528; fax: +1 360 6793830; Internet: http://www.upchurch.com.
Or contact Sapphire Engineering Inc., 53 Portside Dr., Pocasset, MA, USA;
phone: +1 508 5635531; fax: +1 508 5636908 Tyco Adhesives Supplies Custom Coating Services Tyco Adhesives
recently launched a custom coating segment to provide OEMs, converters,
and suppliers with coating services. The service is designed to reduce
risk for For more information, contact Tyco Adhesives, Nieuwlandlaan B15, B-3200 Aarschot, Belguim; phone: +32 16 553600; fax: +32 16 553674; e-mail: tyco1@ibm.net; website: http://www.tycoadhesives.com. Medica Group Expands to Brazil, Acquires Part of Italy-Based Ergotek Medica Group (Mirandola (MO), Italy) established a controlled company called Alvimed for sales, distribution, and customer technical support in São Paolo. In another move to strengthen its moulding capabilities, the company also acquired part of Ergotek S.r.l. (Roverto di Novi (MO), Italy). The Ergotek acquisition provides a cleanroom and a moulding facility for the production of medical-grade components, which will complement Tecnoideal’s moulding capabilities. Tecnoideal is a controlled company of Medica Group. For more
information, contact Tecnoideal S.r.l., Via Lea Cazzuoli, 43, I-41037,
Mirandola (MO), Italy; phone: +39 535 23653; fax: +39 535 27443; email:
info@tecnoidealsrl.com; Filtration Supplier Expands in France SaatiTech S.p.A. (Veniano (CO), Italy), the filtration division of the Saati Group (Appiano Gentile (CO), Italy), has established a new subsidiary, SaatiTech France. Founded in 1996, SaatiTech produces precision meshes for medical OEMs. For more information, contact SaatiTech France, 46 rue Lauriston, F-75016 Paris, France; phone: +33 1 56265040; fax: +33 1 44050015; email: info.fr@saatitech.com; website: http://www.saatitech.com. |
Low-Temperature Process Developed for Titanium Nitride Production
Chemists at the University
of Edinburgh in Scotland have developed a method to produce titanium nitride
at lower temperatures than are currently the norm. The energy-efficient process
may eventually lead to a reduction in the production costs of medical implants,
according to the researchers involved.
Titanium nitride is used to coat hip replacements and other implants, as well
as a host of nonmedical products. Production of the material typically requires
temperatures between 800° and 900°C and costly high-vacuum equipment,
because the rate of reaction between titanium and nitrogen is very slow at lower
temperatures. An electrochemical process that uses liquid ammonia as a solvent
has enabled Edinburgh’s team of researchers to cause a reaction between
the substances at temperatures ranging from –78° to 25°C.
While electrochemical methods of production have been attempted before, Colin Pulham of the university’s department of chemistry says the Edinburgh model is successful for two reasons: potassium amide has been added to the ammonia, and researchers have devised an innovative processing method.
“Most of the routes for [titanium nitride] production require high temperatures and expensive equipment, so there are significant energy and capital costs,” says Pulham. “There are also drawbacks if you want to make precision tools, because the high temperatures cause them to deform. Our process offers an alternative low-temperature route suited for nitriding precision titanium-coated components, with no need for subsequent reheating,” he adds. The method can also produce very pure nitride powders, with the particle size and amount being controlled by current and voltage conditions. This could enable the production of sintering powders for rapid prototyping.
The technology is available
for licensing, and the university is currently seeking collaborative agreements
with industrial partners. If you are interested in learning more, contact Ronald
Kerr at the University of Edinburgh, Old College, South Bridge, Edinburgh EH8
9YL, UK; phone: +44 131 6501000; fax: +44 131 650 2147; e-mail: communications.office@ed.ac.uk;
website: http://www.ed.ac.uk.
Norbert Sparrow
Discovery May Lead to Longer-Lasting Artificial Hips
Researchers at the Swiss Federal Institute of Technology (Zürich, Switzerland) have made a discovery that may significantly extend the usable life of the materials used in replacement hip joints. Performed on more than 300,000 people every year, hip replacement procedures frequently use a joint consisting of a titanium alloy base with a polyethylene cup that is fitted with a ceramic ball. Even these advanced materials, however, tend to degrade after 10 to 15 years, often because of inadequate lubrication. Although replacement hips use synovial fluid, which is present in natural joints, to reduce friction, they don’t receive the same level of lubrication.
Swiss researchers have focussed on the polyethylene sleeve as the source of the problem. Natural cartilage is hydrophilic; polyethylene, on the other hand, repels water. This condition causes the protein in synovial fluid to denature, turning it inside out and eliminating most of its lubricious properties. The team tested this assertion by treating polyethylene with oxygen plasma to reduce its water-repelling properties. Once treated, the material did indeed experience greatly reduced friction. “We would expect replacement hip joints constructed with similarly hydrophilic materials to have a longer life expectancy than current models,” summarizes researcher Nicholas Spencer. Spencer goes on to say that this discovery is particularly important as “bone structure deteriorates gradually over time, making repeat transplant procedures more and more difficult.” Because the polyethylene currently used only retains this increased lubricity for a matter of minutes after treatment, the research team is now working on developing derivative materials that have these traits intrinsically.
Zachary Turke
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MEDTEC Ireland Highlights Growing Irish Medical Device Industry The MEDTEC Ireland tabletop exposition and conference, hosted by the Canon Communications llc family of design and manufacturing publications, will display medical-grade components, materials, subcontracting services, and equipment for Irish and UK manufacturers. Held on 19–20 September in Galway, Ireland, the event’s conference includes seminars on design issues, materials, biocompatibility, packaging, QSR/ISO, plastic processing, process validation and risk analysis, and outsourcing. For more
information, contact MEDTEC Ireland, The Schoolhouse, Hurlingham & Chelsea
School, Peterborough Rd., London SW6 3ED, UK; phone: +44 20 73710637;
fax: +44 20 73717657 Forum Invites Discussion on Global Harmonization Issues The 9th Global Medical Devices Conference is being held in conjunction with the annual meeting of the Global Harmonization Task Force (GHTF). Held in Barcelona, Spain, on 17–18 October, the conference unites government regulators and industry representatives from countries with developed or developing regulatory systems. The conference will address the issue of a globally harmonized regulatory system for medical devices. Activities of the GHTF include dissemination of harmonized guidance documents on basic regulatory practices, the examination of medical device regulatory systems around the world, and the development of recommended procedures to promote harmonization in medical device regulation. For more
information, contact 9th Global Medical Devices Conference Office, Gilmoora
House, 57-61 Mortimer St., London, UK; phone: +44 1932 893882; fax: +44
1932 893893 Nanotechnology Conference Highlights Molecular Motors A conference sponsored by The Knowledge Foundation Inc. (Brookline, MA, USA) presents new data and research in applications for nanotechnology and nanomedicine, and brings together an international faculty to examine molecular motor mechanisms. Programme segments include biomedical applications of motors and bio and synthetic use of molecular motors for nanotech applications. The conference is to be held in Cambridge, MA, USA, on 14–15 September. For more
information, contact The Knowledge Foundation Inc., 18 Webster St., Brookline,
MA 02446-4938, USA; phone: +1 617 2327400; fax: +1 617 2329171 Seminar to Outline ISO 9000:2000 Revisions A seminar covering the new revisions of ISO 9000 is scheduled for 17 September at the Rembrandt Hotel in London. ISO 9000 topics listed on the agenda are: background of the new changes, the scope of ISO 9001:2000, how it affects the existing quality assurance system, how it interfaces with regulatory compliance, how notified bodies will be assessing the applications, implications for the medical device industry, and revision of ISO 13485, ISO 13488, and associated standards. For more
information, contact Management Forum Ltd., 48 Woodbridge Rd., Guildford,
Surrey GU1 4RJ, UK; phone: +44 1483 570099; fax: +44 1483 536424; Event Showcases New British Medical Technologies British medical equipment and software companies will exhibit their latest products and technology at Healthcare Solutions 2001 in Doncaster, Yorks, UK, on 20 September. Speakers at the event, which serves as a forum for discussion on the latest developments in the medical technology industry, will discuss product innovation and the commercial exploitation of intellectual property. For more information, contact Medilink Yorkshire and the Humber Ltd., 301 Glossop Rd., Sheffield S10 2HL, S Yorks, UK; phone: +44 114 2660987; fax: +44 114 2686000;e-mail: Info@medilink.co.uk website: http://www.medilink.co.uk. Motek Focusses on Robotics Featuring assembly and handling technology, Motek 2001 will be held 25–28 September at the Sinsheim Exhibition Centre in Frickenhausen, Germany. Robotics will be the central topic of the fair, and other technologies, including assembly, joining, controls, integrated systems, drive systems, and testing will be on display. For more
information, contact P.E. Schall GmbH, Gustav-Werner-Str. 6, D-72636 Frickenhausen,
Germany; phone: +49 70 2592060 |
Copyright ©2001 European Medical Device Manufacturer
