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Panelists say sterility expectations remain high; bioburden approaches may justify alternatives
Summary
When gamma radiation or other non-terminal methods are the only viable sterilization options, panelists said applicants must provide supporting studies; for high-risk routes like injectables or ocular products the agency generally expects sterility.
Sharif Ahmed, from Avon, asked whether the agency would accept a lower sterility assurance level (SAL) when full-dose gamma irradiation is not viable and what justifications would be required.
Dr. Chen answered that for high-risk products "we want the product to be sterile," and explained that when terminal sterilization is not possible applicants may use bioburden-based sterilization techniques and should submit studies showing the product's bioburden and other validations to justify alternate approaches. The panelist noted such issues are best discussed in predevelopment or pre-meeting interactions because they can be complex and time-consuming to address during review.
The panel did not announce any change in policy during the session; the guidance given was procedural and focused on the types of evidence the agency expects when applicants propose alternatives to terminal sterilization.
