The Future of Radiation Processing
As the global population ages, there will be rapid growth in the demand for sterile healthcare products.
Existing irradiation methods will be refined and new applications found for irradiation technology.
Sterilization companies will continue to develop versatile, flexible, technology-neutral global operations
The Future of Radiation Processing article was published in Medical Device Development 2006 Vol. 1 published by SPG Media Ltd, London.
Trends, directions and opportunities
By John Masefield, STERIS Isomedix, David Liu, Johnson & Johnson and Ruth Brinston, international irradiation Association (iiA)
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 not only grown in size, but also in its diversity and sophistication.
Since then the world has undergone monumental changes: demographically, technologically, economically and politically. All of those changes have had an impact on the radiation processing industry and its outlook for the future.
The fact remains that gamma radiation is an established technology that’s extremely flexible, versatile and cost-effective method for sterilizing a vast range of consumer and industrial products. Meanwhile electron beam (e-beam) radiation processing technology continues to be ideal for those large volume products that are of light-density, uniform composition, with compact packaging. Finally high-energy x-ray is a nascent technology, one with significant capital and processing costs at this time.
So what are the most significant trends and opportunities emerging for tomorrow?
Radiation Processing and Healthcare Products
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.
There will obviously be a significant requirement in such an environment for sterile devices and the development of unique and novel human healthcare products. Anticipate rapid growth in single-use combination type drug, biological, electronic and device products. A simple example is drug eluting stents which can carry multiple drugs, including infection control, pain control, and regenerative medicines. This evolving science enables the introduction of a vast array of combination products that enable the delivery of bioactive materials and drugs directly to sites in the body requiring therapy.
Healthcare providers are generally not inclined to prefer one mode of sterilization to another; they simply depend on the manufacturer to “take care of it.” This leaves the manufacturer to assess and implement the most appropriate method in an environment where delivering the most effective and economical healthcare is paramount.
The successful irradiation of these high value-added combination products is requiring fresh thinking. Manufactured under highly controlled conditions and in small quantities for just-in-time delivery, these products will likely have an extremely low bioburden. Most likely they will have very tight dose tolerance requirements.
Current revisions to the radiation sterilization standards ISO 11137, parts 1, 2, and 3 for healthcare products help set the stage for future developments in this area. Among other items, new are the inclusions of e-beam energy levels and x-rays for sterilization and dose-setting for products with low bioburden. Opportunities are being presented to introduce Methods Vdmax15 for the substantiation of 15 kGy for the sterilization of product with an average bioburden below 1.5.
Looking forward we envision equally creative approaches for establishing safe doses for sterilizing tissue-based, biological and combination drug and device products. We envision modifications to irradiator systems be adapted to treating these products with tight overdose ratios, and safeguards against product overdosing. Absorbed dose calculation using advanced modeling techniques will enable manufacturers to effectively determine the dose on any product before it is sent through an irradiator, thereby accelerating time-to-market and avoiding costly mistakes.
A broader horizon
Radiation is on par to ethylene oxide in the variety of medical devices and healthcare products it can sterilize 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 foods.
The global food industry represents a potentially immense, emerging market for irradiation. 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 percent of all food produced worldwide. In just the United States alone the cost of food-borne illness has been estimated to exceed $6.5 billion per year 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 the population or agriculture. A current example is the irradiation of anything containing feathers, such as: duvets, quilts, pillow, sofas and many other items to prevent the spread of avian influence or bird flu.
Radiation processing is very successfully used in material modifications. It is used to produce lightweight durable, fire-retardant automotive and aircraft parts, wire and cables, plastic pipes, and heat-shrinkable tubing or films among other industrial products. In this environmental-conscious age there is a trend towards using radiation as a curing method and playing a role in the reclamation of recycled plastics and rubbers.
A different world
As one might assume, concerns about the security of radiation-related industries rose sharply around the world, and particularly in the United States, following the destruction of the World Trade Center towers on September 11, 2001. Some suggested that the cobalt sources required for gamma irradiation might be stolen and used to create so-called â€˜radiological dispersion devices” – weapons of terrorism.
The truth is that these concerns are unfounded. The design of industrial irradiation facilities, stringent control over the shipping of source in massive containers, and the detailed safety and security plans irradiator owners have implemented ensure gamma irradiation continues to be safe and effective and make cobalt-60 virtually useless as a tool of terrorism. In addition to the inherent safety of gamma technology, the industry has consistently regarded security as a top priority throughout its 50-year history, and has fulfilled that priority with regulatory rigor.
A changing industry
As was stated in the introduction to this article, not only has irradiation industry grown over the past decades, but it has also evolved. In the late 1980s, sterilization activities were divided nearly fifty-fifty between in-house and outsourced contract services. Today, the proportion is slightly more in favour of contact sterilization, which now sits at about 65%.
The nature of these contractors has changed over the years. Years ago they used to be technologically differentiated, today many are technology-neutral, offering a mix of process options and service to clients. Whereas they were small and regionally based, the trend is towards becoming larger, more global operations.
The business rationale for such neutrality is clear. Service providers can offer the technological solutions that best meet specific customer needs. To offer such a range of possibilities to customers around the world, service providers continue to expand their operations and construct genuinely global networks, replicating organization requirements to ensure consistent, standardized service wherever they set up shop. The are also having to build in increasing flexibility, remaining open to new opportunities and new approaches as the list of products eligible for irradiation grows ever longer.
Making the best of these opportunities demands a consolidated industry response. Fortunately, over the years, our industry has grown closer. Partnerships abound; knowledge is shared in a spirit of real cooperation. One need not look further than the upcoming IMRP conference in Kuala Lumpur, Malaysia where some 300 plus representatives from over 40 countries will come together to exchange insights and explore business prospects. One can also look at the re-vitalized international irradiation Association (iiA) with the aim to become the global hub for the collection and dissemination of business-critical, technical, legislative and regulatory information about radiation processing. It also plans in the future to host seminars that discuss current topics such as technology issues associated with the radiation sterilization of drug device combination products.
Radiation processing has a strong role to play in transforming prospects and business opportunities in to profitable realities that benefit mankind. Its diversity, flexibility and sophistication present valuable options and a compelling choice to users and consumers that can benefit from irradiation.