Industry Interest in Alternative Radiation Technologies in Light of Current Events
This questionnaire aims to gather information on the current and future state of the medical sterilization marketplace, evaluating factors relevant to the transition away from gamma sterilization. Responses will also assess the impact of current events, including developments in the EtO industry and COVID, on the market and choice of sterilization modality. Survey open until the end of the week. Stay informed!
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Industry Interest in Alternative Radiation Technologies in Light of Current Events Suresh Pillai, Texas A&M University, Rod Parker, Stryker Instruments, Byron Lambert, Abbott Laboratories, Paul Wynne, International Irradiation Association, Jodi Liberman, Sandia National Laboratory, Joseph Adduci, Argonne National Laboratory
Survey Background This questionnaire, prepared by the organizing committee and a joint team from Sandia, Fermi and Argonne National Laboratories, is meant to gather information to characterize the current and future state of the medical sterilization marketplace. Your responses will be used in a study which intends to identify trends in the sterilization marketplace, evaluating factors relevant to the possible transition away from gamma sterilization. Additionally, responses will gauge the impact the impact of current events, including current EtO industry developments and COVID, on the market and choice of sterilization modality. Thank you for your participation. The survey will be open through the end of the week if you have not yet completed it. September 17, 2020 2
Survey Demographics September 17, 2020 3
Survey Demographics Sterilization Services Provider (for External Customers) 7 Sterilization Services Provider (for In-House Products) 7 Medical Device/Pharmaceuticals Manufacturing 18 Sterilization Technology/Sub-Unit/Accessory Provider 4 Other 10 September 17, 2020 4
Survey Demographics 5 September 17, 2020
Survey Question # 3 Sample Comments Only contract EBeam installation based in Mexico as a service provider. We are Medical Device/Pharmaceuticals Manufacturing, and our products are irradiated by Gamma - Low energy X-rays : up to 100 kV - Low energy E-Beam: up to 300 keV - Medium energy X-rays and E-Beam: up to 2.5 MeV - High energy X-rays: 5 and 7 MV - High energy E-Beam: 10 MeV Our irradiation Platform includes low, medium and high Energy EBeam accelerators and X ray plants We provide gamma irradiated Single Use Assemblies for pharmaceutical manufacturing. These assemblies are sterilized at a contract sterilizer. Currently high volume E-beam and X-ray R&D only in CA. Building brand new high volume E-beam/X-ray facility in TX slated to be in operation by 3rd quarter 2021 September 17, 2020 6
Survey Question # 7 Results September 17, 2020 7
Survey Question # 7 Sample Comments the limitation on capacity for E-beam/X-ray will force to research other sterilization modalities Despite industry pressure, I see EO still increasing because radiation based technologies (especially gamma) will not be able to keep up with market growth in the short term. Long term, I expect machine based radiation to catch up. Although growth will come from EBeam/X-Ray and new modalities/technologies, EtO and Gamma use will continue to be widespread, specially since the COVID-19 pandemic has exacerbated current need for reliable technologies (and great demand/volumes). There are concerns about the long term supply of Cobalt 60, this is also a monopoly. The cost of gamma irradiation continues to increase; the nature of our custom Single Use Assemblies (non homogeneous, varying geometries/densities) used for pharmaceutical drug manufacturing, may benefit from Xray sterilization . over the next 10 years volumes of DMD will almost double. In the same time the Industry can not rely on the two existing main modalities (Gamma and EtO) for all the reasons we know. The only existing alternative with for H-volumes capability is E-beam and X-ray. Also, thanks to the great DUR and high dose rate, ALL products irradiated today in Gamma can be sterilized in X-ray September 17, 2020 8
Survey Question # 9 Results Cost of eBeam sterilization services Economic profitability for the irradiation service provider Ease of sustaining the equipment and facility 9
Survey Question # 9 Sample Comments Cost and Economic considerations will change over time and will only go up. Considering poor conversion of electric energy to X-ray (5-6%) large scale switch to X-Ray would have massive effect on CO2 emissions as long as electricity is generated by fossile fuels. Although very useful and promising, its use is under concern as regulations on the shipment and transportation of radioactive material (the driving force of the technology, cobalt 60-based) are becoming stricter. Gamma pricing is increasing. September 17, 2020 10
Survey Question # 11 Results Cost of eBeam sterilization services 7 Cost of X-ray sterilization services 5 Economic profitability for the irradiation service provider Ease of sustaining the equipment and facility September 17, 2020 11
Survey Question # 11 Sample Comments A big advantage for X_ray is the pallet treatment instead of boxes treatment for E-beam. Also, dose mapping is easiest and more accurate in X-ray than Gamma Finally, DUR is better in X-ray... which should also allow more products EtO to switch to X-ray Our companies produced medical products which we both sterilize ourselves as well as outsource our sterilization needs. E-beam/X-Ray technology and power always improving thereby reducing costs and increasing throughput. September 17, 2020 12
Survey Question # 23 Results September 17, 2020 13
Survey Question # 23 Sample Comments it depends on the material. EtO is historically very well used for fluoropolymers (see Bard having their own facility that closed), and fluoropolymers do not do well with irradiation sterilization (xray being less known), so there would need to be extensive research done to prove efficacy and change in material properties. X-ray is a relatively "new" option that is getting more attention as of late, and may be considered for future projects in the near future as modality availability and capacity increases. Would also investigate other Novel technologies such as VPA. It will be very challenging, if not impossible, to completely replace EO for all products that are sterilized using EO It all depends on material compatibility. In most cases, those products that have historically moved from EO processing to radiation have already done so September 17, 2020 14
Survey Question # 39 Sample Comments 39. Please list any barriers or concerns your company has when considering would it take to construct additional non-gamma irradiation-based sterilization infrastructure Time it takes to assemble equipment (limited capacity) and/or build EBeam facility and time it takes for companies to switch technology modalities. moving from a batch process to an in-line process would require significant changes in the manufacturing process and facilities. The unknown and costs are an issue with alternate modalities. I have run into this with novel technologies - since some are still in a "research mode," material effects and designing product around the technology can be problematic. Regulatory acceptance for X-Ray, cost of validating sterilization of existing/new devices to irradiation-based methods, cost of new sterilization infrastructure, lack of experience/understanding with irradiation-based methods (esp. X-Ray) Resources and funding from R&D to investigate alternate modalities for current product portfolio, and commitments from Development engineers to investigate alternate modalities for new products. Also, availability of X-ray technology is scarce, so material investigations are difficult to perform September 17, 2020 15
