The Future of Radiation Processing

28 February 2006 (Last Updated February 28th, 2006 18:30)

A look at future trends and opportunities in the radiation processing industry. John Masefield of Steris Isomedix, David Liu of Johnson & Johnson and Ruth Brinston of the International Irradiation Association give their thoughts.

The Future of Radiation Processing

The International Irradiation Association serves as a global hub for the collection and dissemination of information and educational materials relating to all the significant scientific, regulatory, legislative and business developments affecting the industrial irradiation industry.

In the mid-1950s, the rising demand for sterile single-use medical devices paved the way for the expansion of radiation processing. Over the ensuing decades, the industry has grown, not only in size but also in its diversity and sophistication. Since then, the world has undergone monumental changes – demographically, technologically, economically and politically. All of these changes have had an impact on the radiation processing industry and its outlook for the future.

At the moment, gamma irradiation remains an extremely flexible, versatile and cost-effective method for sterilising a vast range of consumer and industrial products, while electron beam (e-beam) radiation processing technology continues to offer an ideal solution for large volume products that are of low density, and have a uniform composition and compact packaging. High energy X-ray is a nascent technology, with significant capital and processing costs. But what will be the most significant trends and the greatest opportunities in the future?

RAPID GROWTH

By 2050, the number of people in the world aged 80 or older will be six times greater than it is today. As the global population ages, we can expect the demand for healthcare services and the strain on healthcare systems to intensify, and there will be a greater need for sterile devices and unique and novel human healthcare products. We can expect rapid growth in single-use combination-type drug, biological, electronic and device products, such as drug eluting stents, which will carry drugs, including drugs for infection and pain control, and regenerative medicines. Scientific advances will enable the introduction of a vast array of combination products that facilitate the delivery of bioactive materials and drugs directly to those sites in the body requiring therapy.

NEW THINKING

Healthcare providers are generally disinclined to prefer one mode of sterilisation to another; they simply depend on the manufacturer to take care of this. This leaves the manufacturer to assess and implement the most appropriate sterilisation method in an environment where delivering the most effective and economical healthcare is paramount.

The successful irradiation of high value-added combination products requires fresh thinking. Manufactured under highly controlled conditions and in small quantities for just-in-time delivery, these products are likely to have an extremely low bio-burden. Probably they will have very tight dose tolerance requirements.

"Anything containing feathers, such as duvets, quilts, pillows and sofas, can be irradiated to prevent the spread of bird flu."

Recent revisions to the radiation sterilisation standards ISO 11137, parts 1, 2, and 3 for healthcare products have helped set the stage for future developments in this area. Among other things, new energy levels have been set for e-beam and X-ray sterilisation, while dose levels have been set for products with a low bio-burden.

Looking forward, we foresee creative approaches to the establishment of safe doses for sterilising tissue-based, biological, combination drug and device products. We expect to see modifications to irradiator systems that will allow these products to be treated with tight overdose ratios, and we anticipate the development of safeguards against product overdosing. Advances in radiation processing modelling and dosimetry will enable manufacturers to effectively determine the dose for any product before it is sent through an irradiator, thereby accelerating time to market and avoiding costly mistakes.

BROADER HORIZONS

Radiation sterilisation is on a par with ethylene oxide processing in the variety of medical devices and healthcare products it can sterilise successfully. Radiation can be successfully used to destroy harmful bacteria in a great number of goods and products outside the medical realm – everything from cosmetics and dog chews to spices and food products.

The global food industry represents a potentially immense emerging market for irradiation technologies. The United Nation’s Food and Agriculture Organization endorses irradiation as a means of preventing food-borne illness and reducing after-harvest losses caused by spoilage, infestation and contamination. These losses affect some 25% of all food produced worldwide. In the USA alone, the cost of foodborne illness has been estimated to exceed $6.5bn in medical and other costs. Irradiation represents a cost-effective solution and offers consumers a healthy choice for those concerned about food safety.

Irradiation is also routinely used to treat quarantined goods brought into a country that pose a risk to either its population or agriculture. Currently, for example, anything containing feathers, such as duvets, quilts, pillows and sofas, can be irradiated to prevent the spread of bird flu.

Radiation processing is used successfully to modify materials. It is used to produce light, durable, fire-retardant automotive and aircraft parts; wire and cables; plastic pipes; and heat-shrinkable tubing or films, among other industrial products. In this environmentally conscious age, there is a trend towards using radiation as a curing method and in the recycling of plastic and rubber.

"The irradiation industry has not only grown over the past few decades, it has evolved."

RADIATION SAFETY

As one might expect, concerns about the security of radiation-related industries have risen sharply around the world, particularly in the USA, following the destruction of the World Trade Center on 9/11. Some people have suggested that the cobalt sources required for gamma irradiation might be stolen and used by terrorists to build weapons, so-called radiological dispersion devices.

These concerns are unfounded. The design of industrial irradiation facilities, stringent control over the shipping of radiation sources in massive containers and the detailed safety and security plans irradiator owners have implemented ensure that gamma irradiation continues to be safe and effective.

Steps have also been taken to make cobalt-60 virtually useless as a terrorist weapon. The industry has consistently regarded security as a top priority throughout its 40-year history, and it has fulfilled its security obligations with regulatory rigour.

CHANGING INDUSTRY

As already stated, the irradiation industry has not only grown over the past few decades, it has evolved. In the late 1980s, sterilisation activities were divided equally between in-house and outsourced contract services. Today, the ratio has shifted slightly in favour of contract sterilisation, which now accounts for about 65% of activity.

The nature of contract services has changed over the years. Years ago, sterilisation service providers tended to specialise in one particular sterilisation technologically. Today, many are technology-neutral, offering a mix of process options and services to clients. And whereas in the past sterilisation companies tended to be small and regionally based, the trend is now towards larger, more global operations.

The business rationale for such neutrality is clear. Service providers can offer the technological solutions that best meet their clients’ specific needs. To offer a range of possibilities to customers around the world, service providers continue to expand their operations and construct genuinely global networks, replicating organisation requirements to ensure consistent, standardised service wherever they set up shop. They are also having to build-in increasing flexibility and remain open to new opportunities and new approaches as the list of products suitable for irradiation processing grows ever longer.

CONCERTED EFFORT

Making the best of these opportunities demands a consolidated industry response. Fortunately, over the years, our industry has grown closer. Partnerships abound, and knowledge is shared in a spirit of real cooperation. For an example of this cooperation, one need look no further than the upcoming IMRP conference in Kuala Lumpur, Malaysia, where over 300 representatives from over 40 countries will come together to exchange insights and explore business prospects.

The revitalisation of the International Irradiation Association bodes well. The association aims to become the global hub for the collection and dissemination of business-critical, technical, legislative and regulatory information about radiation processing. It also plans to host seminars that discuss important topics, such as the technology issues associated with the radiation sterilisation of drug device combination products.

Radiation processing has a strong role to play in transforming prospects and business opportunities into profitable realities that benefit mankind. The diversity, flexibility and sophistication of the industry offers valuable options and a compelling choice to users and consumers alike.