Company insight
Sterilisation methods and their applications
Sterilisation is a key component of reducing the contamination risk posed by medical devices and pharmaceutical products, but there are several different modalities to choose from, all of which carry their own benefits and limitations. Miguel Morales, sales director of sterilising specialist IONISOS, explains the different use cases for each technique and some of the latest developments in the field.
What does a medical device sterilisation specialist do? Miguel Morales: The sterilisation of medical devices is a cross-discipline activity that incorporates various aspects, among which are: material characteristics and their compatibility with the different sterilisation modalities, microbiology, process performance and operational qualifications. The sterilisation specialist is the expert who brings together all this knowledge to make sure that the sterilisation method of choice is the best one for the product, from a functional and sustainable point of view. IONISOS, as an industrial sterilisation provider, works closely with medical device producers bringing its knowledge and experience to achieve these objectives.
How does the process of ionising radiation sterilise medical devices? Ionising radiation is a physical sterilisation method capable of reducing the number of viable microorganisms present in a product. One can use different types of high energy radiations (gamma ray, electrons or X-ray) to alter the DNA of these microorganisms. The high energy particles or photons interact with the DNA molecules, breaking their chains and preventing the microorganisms from reproducing. If the product is not compatible with irradiation, ethylene oxide can also be used with the same effect against microorganisms.
In what cases would you use ionising radiation over the other available sterilisation techniques? All existing sterilisation modalities in the market, once the process has been validated, are well proven and reliable methods. We need to keep in mind that the sterilisation of medical devices and pharma products is a highly regulated and standardised activity.
Experience tells us that there are technologies that are better adapted to one or another type of product. In some cases, we have products where, for example, the prime materials are not compatible with heat, or in other cases where they are not compatible with ethylene oxide because they have areas that are not accessible to the gas. In these cases, radiation modalities can become the main alternative.
Has the Covid-19 pandemic boosted cold sterilisation? Yes, during the Covid-19 period the industrial sterilisation market experienced a huge demand increase in products such as: in vitro testing, intensive care kits, primary packaging, or biotech products. This increase has been absorbed mainly by gamma irradiation, but ethylene oxide or e-beam have also taken an important role in the fight against the pandemic.
What are the latest developments in ethylene oxide sterilisation? The main developments experienced by ethylene oxide in the past years relate to automation and process control. We can now, for example, achieve more efficient processes by adding dynamic aeration chambers to the process that reduce the total cycle time and the EO residual presence in the products. Process control has also experienced an evolution allowing batch parametric release. Finally, the automation of the handling of the products between chambers (preconditioning, dwell cycle and aeration) has reduced the human intervention in the process to a minimum.
What are the challenges that ethylene oxide sterilisation will face? EO is the modality generally used for the sterilisation of medical devices either at
Medical Device Developments /
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in-house facilities or through industrial suppliers such as IONISOS. Both in the European Union and in the US, the authorities are evaluating regulatory changes to reduce the EO concentration and emission limits for workers and public in general to values much lower than the actual ones. The challenge for the industry will be to adapt existing facilities. There are still some years ahead until the new regulation will be in place, so this adaptation can be implemented progressively as the existing facilities are renewed or revamped. In IONISOS, all our existing sites have been upgraded to reduce the EO concentrations, and our new EO sites are designed and constructed to fulfil the lowest concentration values. A good example of this is our brand new site in Kleve, Germany, that has just started operations.
What is IONISOS envisioning for trends in cold sterilisation for the mid-long term? We foresee that the irradiation modalities will evolve with the inclusion of more X-ray capacity over the next years. This will allow us to free some gamma capacity and to keep with the growth of the sterilisation needs of the market. We also think that EO will continue being one of the predominant technologies in the mid-long term, after of course, going through the changes previously indicated.
IONISOS is a technology-neutral industrial sterilisation supplier, which means that we will continue expanding our capacity in all the modalities that the market demands. Our objective is to supply our clients with an outstanding service and to grow with them in all the actual existing technologies: gamma, e-beam, X-ray and EO. ●
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