Sterility Method Development And Suitability Testing

By Beth Brescia, Application Scientist, Merck KGaA, Darmstadt, Germany

Sterility method development and suitability testing in sterile compounding face unique challenges due to the variety of formulations and product types.

A matrix approach based on the 'worst case' formulation—typically the one with the highest active dose and preservative concentration—is recommended for developing robust sterility testing methods. This approach not only ensures compliance with pharmacopeial standards, such as USP <71> and <797>, but also streamlines the testing process, making it both efficient and scalable across multiple product types and formulations.

This poster proposes a matrix approach for streamlining method development and suitability testing for sterility testing in the compounding industry. This approach aims to reduce redundancy and improve efficiency while ensuring patient safety.