Rubrik: Produktion
(Treffer aus cleanroom & processes, Nr. 04, Seite 184 (2024))
Berridge C
An overview of sterility testing / The impact of Annex 1 and a look into the future of sterility testing · Berridge C · Ecolab Ltd., Andover
Sterility Testing False Positives Membrane Filtration Isolators Rapid Methods Sterility testing is a process which must be performed as part of the manufacture of sterile products, to provide confidence that they are free of any viable microorganisms which could harm patients. As it is not possible to test every single vial or ampoule of product that is being manufactured, a number of samples representative of the whole batch are taken at separate times during the filling operation and tested for microbial contamination. The World Health Organisation adopted requirements for sterility testing in 1973 and today the guidelines for conducting sterility testing ...