New Test Method for Analysis of dose distribution changes in radiation processing using a continuous variable F-test and p-value
1. Scope
1. This test method applies to all irradiator technologies for the analysis of dose distribution following a change to the irradiator.
2. This test method is utilized to assess the impact of the change on the previously qualified processes.
3. This test method utilizes a continuous variable hypothesis test which is used to substantiate the null hypothesis using a p-value.
4. This test method can be utilized by itself or with other methods to determine the impact of a change to an irradiator.
As a requirement in ISO 11137-1, Sterilization of Healthcare Products - Radiation, Part 1, under change control, an evaluation of potential changes to dose distribution is conducted when change activities occur to an irradiator; Historically, change control evaluation of post-change distribution analysis have not been standardized and several methods are non-statistical. This method has been peer-reviewed, published and implemented in industry.
