Abstract
Adenosine triphosphate measurement based on bioluminescence is a rapid method for detecting contamination in injectable preparations. Filtration through a Steritest system or direct incubation with double concentration broth media (for non-filtrable solutions) was used. A specific medium to improve the fungal growth was selected: Sabouraud dextrose broth with 1% yeast extract. With the proposed protocol, the period of incubation can be reduced after validation using the European Pharmacopoeia requirements (from 72 h to 24 h). The method was tested on about 30 different injectable preparations and the sensitivity was compared with that of the sterility test according to the routine protocol. The advantages are a reduced incubation time, which allows an anticipated release of the products, and an easier interpretation of false-positive reactions of chemically interfering, opaque or non-filtrable solutions. Parametric standards are proposed for the released of injectable preparations.
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