Medical Device Link.

Originally Published EMDM March/April 2003

PRODUCT UPDATE

Medical device OEMs sourcing services have two more reasons to consider Denmark, as an E-beam sterilization plant and surface treatment facility come on-line.

Norbert Sparrow

Sterigenics, formerly IBA’s medical sterilization business, offers gamma as well as EtO and E-beam sterilization services at facilities worldwide.

A little more than four years ago, IBA (Louvain-la-Neuve, Belgium; www.iba-worldwide.com) rocked the sterilization world by going on a buying spree. Between the end of 1998 and the summer of 1999, IBA acquired Scanditronix, Wellhöfer, Radiation Dynamics, Griffith Micro Science, and SteriGenics International. Almost overnight, the firm transformed itself from an acknowledged expert in particle accelerator technology to a world leader in gamma, EtO, and E-beam medical sterilization. Now, IBA is undergoing another transformation, as it changes the name of its medical sterilization business to Sterigenics, while continuing to expand its global operations by opening an E-beam plant in Espergaerde, Denmark, this summer.

Rebuilding an Identity

A need for clarity made a change in names necessary, says Brett Barthel, senior director of business development and marketing at the company’s US headquarters. “Each of our business units is called IBA, and we cover a lot of ground, from sterilization to brachytherapy to dosimetry,” says Barthel. “To streamline our communication with the outside world, it became clear that we had to associate our various offerings with an appropriate business unit.”

Barthel stresses that IBA is not turning back the clock by restoring the Sterigenics name. “This is a complete rebranding process, including a new logo and color scheme, for our gamma, EtO, and E-beam sterilization business.” The company will officially reintroduce itself to European industry as Sterigenics, a member of the IBA Group, at the MEDTEC Exhibition and Conference in Stuttgart, Germany, in March.

In other news, the firm has announced that it will open a new E-beam plant in Denmark along with a state-of-the-art EtO facility in Dallas, TX, USA, this summer. The fully automated 10-MeV E-beam plant in Espergaerde has been designed to deliver a wide range of doses via single-, double-, or four-sided passes. It can accommodate small or large batches, and a microbiological laboratory will be located on-site.

Sterigenics also intends to continue upgrading its EtO sterilization facilities with CyclEOne technology. (The new Dallas plant will hit the ground running, fully equipped with CyclEOne and parametric release capabilities.)

CyclEOne can dramatically reduce EtO sterilization and processing times, according to Barthel. By using high-performance vacuum systems to evacuate gasses from the chamber, Sterigenics is able to perform all of the sterilization and processing in a single chamber in one day.

Acknowledging that the benefit of a fast turnaround is dubious if the customer then has to wait several days for biological indicator results, Barthel adds that parametric release will be made available in the facilities, as well. To support parametric release, the company has even developed a microwave spectrometer that integrates a proprietary technology. “Our goal is to provide medical device manufacturers with the ability to have their products processed in one day using any of our gamma, EtO, or E-beam sterilization technologies,” says Barthel.

Company Expands Line of Device Coating Products

A company that has been providing coating services to medical device OEMs for the past five years has dramatically increased its product portfolio. Product Release Europe ApS (Kvistgård, Denmark) has been licensed by US-based STS Biopolymers, located in Henrietta, NY, USA, to supply its surface treatment technology on a contract basis to Europe-based companies. A new 500-m2 facility with a Class 100,000 cleanroom was scheduled to officially begin operations in mid-February.

“Our medical coating business was performing very well,” says Morton Saabye, chief technical officer of Product Release Europe, “when customers started asking us about hydrophilic coatings. We did some research and found that STS Biopolymers had developed some of the most well-regarded coatings on the market.” Following a two-year negotiation process, the two companies finalized a licensing agreement. STS Biopolymers produces a number of coatings that impart a range of properties to medical devices, all of which are available at the Danish facility.
An echogenic surface coating called Echo-Coat is designed to heighten device visibility during ultrasound imaging procedures. Echo-Coat can be applied to a variety of substrates and is routinely used on fine needles for aspiration procedures, breast localization needles, core biopsy needles, and coaxial introducer needles.

A reverse-phase graft polymerization technology developed by the firm allows a variety of polymer layers to be permanently bonded to difficult-to-coat surfaces such as silicone, latex, polyethylene, and fluoropolymers. Graft-Coat can be used to coat medical devices, including catheter lumens and odd-shaped geometries, without the use of plasma, or gamma or UV radiation. The coating can also incorporate a range of pharmaceutical agents that can be delivered at high concentrations at the device surface.

Polymer coatings containing heparin can be effective in preventing thrombosis caused by catheters and other in-dwelling medical devices coming into contact with blood. The company’s Medi-Coat system entraps a heparin complex on the surface of a medical device, which slowly releases the agent upon exposure to blood. The heparin concentration at the device surface results in prolonged antithrombogenic protection from less than one hour to more than two weeks, while maintaining low systemic concentration levels.

Product Release Europe will also offer Slip-Coat, a lubricious coating that adheres to wet and dry metal substrates.

The company is licensed to supply all of STS Biopolymers’ coatings on a contract basis to Europe-based OEMs. “Companies that wish to integrate these processes into their production lines to treat their own products may still do so,” notes Saabye. “But why would you?” he asks rhetorically. 

“There’s less paperwork, it’s more cost-effective, and just so much easier all around to subcontract the job.” 

More Products:
Puridec Irradiation Technologies
Linac Technologies
Product Release Europe ApS
Isotron plc
.E-Beam Services Inc.
Ebis Iotron
SurModics Inc.
H & W Technology LLC
Sterigenics

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