Why is radiation sterilisation growing in popularity compared to EO?
Radiation is an efficient, reliable, and residue-free sterilisation method. Unlike EO, it does not bear the risk of contaminating products, and therefore does not pose an additional health risk to users and patients.
Can you provide examples where this method is particularly beneficial?
For example, it’s ideal for sterilising devices with delicate sensors, which could be compromised by traditional methods. It’s also widely used for single-use surgical items such as gloves, scalpels, and implant packaging. Additionally, biologically based wound dressings and tissue matrix products, which are sensitive to high temperatures, greatly benefit from radiation sterilisation.
What about challenges, such as the reliance on Cobalt-60 for gamma sterilisation?
Cobalt-60, the primary source for gamma radiation, is limited and subject to geopolitical constraints. This is driving the adoption of alternatives like electron beam (e-beam) and X-ray sterilisation. These methods are faster and better suited for specific products, becoming more popular as backups or replacements for gamma. For instance, products with thin walls like IV tubing, dense or complex items such as orthopaedic implants or pacemaker components, small-batch or high-value items or products with sensitive packaging.
How do e-beam and X-ray compare to gamma? Why are they still more expensive?
E-beam and X-ray also use high-energy radiation to sterilise products. E-beam is efficient for smaller batches or thinner materials, while X-ray is better for thicker items due to its higher penetration depth. However, both are more expensive to set up due to specialised infrastructure and high energy requirements. Shared facilities and partnerships are helping smaller manufacturers reduce costs, and as the technology matures, prices are expected to decrease.
What about safety and regulations? Radiation sterilisation involves high energy levels, right?Â
Yes, strict protocols ensure the safety of workers and the environment. Standards like those from the IAEA and ISO 11137 regulate radiation doses, ensuring products are sterile without being damaged. These guidelines are crucial for maintaining safety and efficacy.
And compared to EO, is radiation sterilisation better for the environment?
Exactly. EO facilities pose the risk of toxic emissions, which can drastically lower air quality. A study performed by the U.S. Environmental Protection Agency (EPA) even showed elevated cancer risks in areas surrounding EO sterilisation facilities. Radiation sterilisation doesn’t produce harmful residues, making it safer and more environmentally friendly. Many companies are switching to radiation as part of sustainability efforts to reduce their environmental impact.
How does ISO 14971, the risk management standard, apply here?
ISO 14971 requires manufacturers to evaluate risks like microbial contamination and radiation effects on materials. For instance, extensive material testing and irradiation studies ensure products remain safe and functional post-sterilisation. Proper documentation is critical for compliance.
What’s the future of radiation sterilisation? Will it become more affordable?
Yes, as EO use declines, radiation sterilisation is set to become more cost-effective. Technological advancements and innovations, like regional manufacturing initiatives, are making methods like e-beam and X-ray more accessible. Over time, I believe radiation sterilisation will become the preferred option industry-wide.
Lisa is happy to help you with further questions via lisa.kamber@eumediq.eu.Â