Your Gamma-Validated Product Can Now Use E-Beam for Dose Audits
A 2025 update to ISO 11137-1 gives medical device manufacturers more flexibility in where and how they complete routine dose audits.
Manufacturers with gamma-validated products may now be able to complete their dose audits using an E-Beam provider without changing the radiation modality used for routine sterilization.
That creates an opportunity to make a recurring compliance requirement faster, more cost-effective, and easier to manage.
First, What Is a Dose Audit?
Manufacturers must periodically (typically once a quarter) confirm that the validated sterilization dose remains appropriate for the product and its current microbiological conditions. A dose audit, commonly performed quarterly, provides that ongoing verification.
During the audit, representative product samples receive a specified verification dose and undergo sterility testing. The results help determine whether the established sterilization dose continues to provide the required sterility assurance. In simple terms, a dose audit helps confirm that the original sterilization validation still holds.
Keep Reading: “Maintaining a Sterilization Validation with Dose Audits” →
What Changed in ISO 11137-1:2025?
ISO published the second edition of ISO 11137-1 in April 2025. The standard covers the development, validation, and routine control of radiation sterilization processes for medical devices.
Among its updates, ISO identifies simplified requirements related to the transfer of verification and sterilization doses.
For manufacturers, the practical significance is greater flexibility. A routine dose audit does not necessarily have to be performed using the same radiation modality or at the same irradiation facility used for routine sterilization.
For example, a product sterilized and validated using gamma may be eligible to have its routine dose audit performed using E-Beam at a qualified facility.
Does This Mean Changing from Gamma to E-Beam?
No. The product can remain gamma sterilized. E-Beam is used to deliver the verification dose required for the audit.
The manufacturer must still follow the applicable ISO 11137 requirements, document the transfer appropriately, and confirm that the selected provider can accurately deliver and document the required dose.
Why Consider a Different Dose Audit Provider?
A dose audit is a recurring requirement. For many manufacturers, that means repeating the process several times each year across multiple validated products. Greater provider flexibility allows manufacturers to evaluate dose audit services based on practical business considerations, including:
Reason 1: Turnaround Time
A faster audit process can help manufacturers maintain established schedules and avoid unnecessary delays. NextBeam offers routine dose audits with turnaround in five business days, with expedited service available if needed.
Reason 2: Cost
Manufacturers may no longer be limited to the pricing and service structure of their routine gamma sterilization provider. Working directly with an E-Beam provider can create a more cost-effective option, particularly for organizations managing quarterly audits across a large product catalog.
Reason 3: Direct Service
Working directly with the irradiation provider can reduce handoffs, simplify communication, and limit unnecessary administrative work. NextBeam performs dose audit irradiation directly, giving manufacturers a clear point of contact throughout the process.
Enterprise Onboarding
Supplier qualification can be a significant hurdle for large medical device manufacturers.
NextBeam’s MedAccred accreditation can help simplify supplier qualification and support faster onboarding. Individual audit and approval requirements will still depend on each manufacturer’s quality system.
A More Flexible Approach to Routine Dose Audits
The 2025 revision of ISO 11137-1 gives manufacturers an opportunity to reconsider a process that may have remained unchanged for years. For gamma-validated products, using an E-Beam provider for routine dose audits may offer a faster and more cost-effective path without requiring a change to the validated routine sterilization modality.
NextBeam provides dose audits for gamma- and E-Beam-validated products, with service available in as few as five business days.
Ready to schedule your next dose audit? Work directly with NextBeam for a fast, cost-effective dose audit.
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