Applicability of an Alternative Method for Sterility Testing of Medicinal Preparations

Abstract

The aim of the present work was to examine the applicability of an alternative method for detecting CO₂ using an automated BacT/ALERT 3D colorimetric microbiological detection system and analytical parameters for sterility testing of medicinal preparations (MPs) that were selected, justified, and harmonized with leading global pharmacopoeias. The tests used microorganisms and samples of 38 MPs and compared the results with defined criteria for pharmaceutical microbiology. The experimental results showed that the alternative method did not cause discrepancies and was suitable for MPsterility testing. However, the lack of regulations for validation standard procedures in the RF currently limits replacing routine methods by alternative ones.