Medical Device Link.

Originally Published November/December 2000

Product Update

Sterilization Services, Supplies, and Equipment

Suppliers comment on the advent of x-ray technology and the potential bottom-line benefits of process control systems.

Although a wide range of proven, effective sterilization options are available to device manufacturers, each with specific advantages and limitations, alternative methods continue to be developed. One such technology is x-ray sterilization. According to Ion Beam Applications S.A. (IBA; Louvain-la-Neuve, Belgium), this method has demonstrable benefits for device OEMs.

A product of electron-beam conversion, the x-rays have penetration properties similar to gamma rays, according to IBA European sales and marketing director Ludwig Bastiaansen. "A high-power 200-kW, 7.5-MeV machine produces an output equivalent to a midsize gamma plant," he says. "X-ray technology permits pallet irradiation of medium-density products," Bastiaansen adds, "and that is why we think this form of sterilization will become a player in the device industry in the years ahead."

X-ray technology is currently being evaluated by the food industry in the United States at the behest of the US-based IBA Food Safety Division, which recently opened an x-ray test centre in Edgewood, NY. The sterilizer is equipped with IBA's proprietary technology that enables food companies to treat products with precise x-ray doses. Thus far, more than a dozen companies, including some of the country's largest red meat and poultry processors, have scheduled x-ray testing at the facility, according to IBA. The company has announced plans to install similar facilities in Belgium and the UK in 2001, where it will offer test programmes for the medical device industry.

Requiring no analytical chemical training to operate, the Compu-Dose dosimetry system supplied by MDS Nordion provides an immediate readout of the absorbed dose.

IBA is also at the forefront of another industry trend: consolidation. Having acquired SteriGenics International (Fremont, CA, USA) and Griffith Micro Science (Herentals, Belgium), the group is now the world's largest contract sterilization services provider with expertise in EtO, gamma, E-beam, and x-ray technologies. According to Bastiaansen, EtO will remain the most popular form of sterilization among device manufacturers because it is the most flexible process. "For example, medical kits have a variety of components that make use of nonwoven, metal, and plastic materials," he notes, thus ruling out gamma or E-beam sterilization as an option because of incompatibility. "For larger-density products, however, gamma is ideal," says Bastiaansen. For more information about the array of IBA's sterilization services, see the company description in this section.

The Importance of Validation

Device manufacturers can't afford to neglect process control and dosimetry systems, say suppliers, not only for reasons of safety and efficacy, but because they can help to reduce sterilization costs. That is an argument put forth by Puridec Irradiation Technologies (Chesham, Bucks, UK), which has developed I-CON, an integrated plant control system for gamma sterilization processes.

I-CON can generate ongoing annual savings of up to 14% in the unit cost of sterilization, according to marketing manager Cathie Deeley. The PC-based system achieves this in part because it enables multitasking, notes Deeley, thus reducing cycle times. In addition, it allows plant operators to provide enhanced customer support by increasing the product turnaround rate and by generating custom documentation for QA and regulatory compliance. Read the product description in this section to find out more about I-CON.

E-beam users will be happy to learn that industrial dosimetry services have been developed for low-megaelectron-volt systems by National Physical Laboratory (NPL; Teddington, Middx, UK). A 0.6-mm-thick pellet designed for use with accelerators in the 1–4-MeV range reportedly is the first of its kind to be fabricated in that thickness, according to Peter Sharpe, head of NPL's chemical dosimetry section. The article on NPL in this section explains how thin-film dosimeter calibration is performed using such a pellet.

Other products highlighted in the following pages include an easy-to-use dosimetry system that allows users to verify absorbed-dose measurements on-site, indicators designed to monitor most commonly used sterilization methods, and a recently launched line of test and validation EtO sterilizers.

Avignon Hosts Radiation Processing Meeting and Exhibition

Developments in industrial radiation technology will be the liturgy at the renowned Palace of the Popes when the 12th International Meeting on Radiation Processing (IMRP) convenes in Avignon, France, 25–30 March 2001. Under the theme of bridging the gap from academe to industry, the biennial conference will cover all aspects of gamma, E-beam, and x-ray processing. According to conference organizers, particular attention will be given to the development of new ideas into industrial-scale businesses.

Application areas of interest to device manufacturers will be grouped on the first two days of the meeting and will cover topics such as process control, product liability, and polymer modification. Pharmaceutical sterilization and radiation sources will also be addressed at the conference.

Reportedly the largest international meeting devoted to radiation technology, IMRP will include a trade show grouping the major suppliers of ionizing radiation equipment, technology, and services to the device industry.

For further information about the event, contact Cathie Deeley, Puridec Irradiation Technologies, 6 Chiltern Court, Asheridge Rd., Chesham HP5 2PX, Bucks, UK; phone: +44 1494 777459; fax: +44 1494 777457; e-mail: cathie_deeley@reviss. co.uk; Internet: www.puridec.co.uk.