At NextBeam, we are experienced with transferring medical devices from ethylene oxide to electron beam sterilization.
Comparing Ethylene Oxide to Electron Beam
Looking for alternatives to ethylene oxide? Many EO sterilized products are compatible with electron beam. Advantages of E-beam include:
- Shorter turnaround time (no preconditioning or aeration)
- No sterilant residuals
- Good materials compatibility
- Fewer critical parameters to consider in risk assessments and test plans
- Simple regulatory and technical requirements – electron beam is an “Established Category A” method of sterilization with a long history of safe and effective use, and uses the same industry standards for sterilization validation as gamma.
4 Step Process to Transfer Medical Devices from Ethylene Oxide to Electron Beam Sterilization
1. Contact us for a free consultation to determine if your product is a good fit for electron beam sterilization. Based on a few simple factors we can help determine the extent of testing required to support a transfer to E-beam:
- Product and packaging materials and configuration
- Device regulatory classification
- Bioburden data
2. Perform dose mapping study to confirm dose distribution within the product and establish parameters for routine processing.
3. Testing and documentation (the below list is appropriate for medical devices)
- List of candidate part numbers and descriptions
- Determine the extent of testing required based on device type and regulatory classification:
- Device functionality
- Aging
- Packaging validation
- Biocompatibility
- Sterilization / microbiology validation
4. Determine the extent of regulatory activity required, if any, based on device type and regulatory classification.
How Long Does It Take to Qualify a Product for E-Beam Sterilization?
Typically an electron beam sterilization validation would take the same amount of time as a gamma sterilization validation, with the following steps:
- Evaluation – Can be done within a day if all information is available.
- Dose mapping – Typically completed within a few days.
Testing and Documentation – This depends on the extent of testing required, as well as manufacturer resources and prioritization. NextBeam may be able to provide assistance generating the required documentation if internal resources are not available. - Regulatory activity – This step has the greatest impact on time and expense for transferring a product from EO to E-beam, and depends mostly on the device regulatory classification. Some low risk devices may not require any regulatory activity while for others this may be a significant obstacle.