These parameters can generally be more accurately controlled and measured, so they are more reliable in predicting sterility assurance than is end-product sterility testing.

Sterility Testing Take advantage of innovative solutions in design and ergonomics, and enhance performance of sterility testing by membrane filtration.

The procedure for handling sterility test failures takes into account the guidance provided in official pharmacopeias (Schedule B to the Food and Drugs Act ).

Sterility testing or alternatives (e.g., container/closure integrity testing) should be performed at a minimum initially and at the end of the proposed shelf-life.