Transcription of 5.1.3. EFFICACY OF ANTIMICROBIAL PRESERVATION
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5.1.3. EFFICACY OF ANTIMICROBIAL PRESERVATION
EUROPEAN pharmacopoeia EFFICACY of ANTIMICROBIAL preservationsuspensions may be presented in sealed ampoules. Biologicalindicators are prepared in such a way that they can be storedunder defined conditions; an expiry date is of the same bacterial species as the bacteriaused to manufacture the biological indicators may be inoculateddirectly into a liquid product to be sterilised or into a liquidproduct similar to that to be sterilised. In this case, it must bedemonstrated that the liquid product has no inhibiting effect onthe spores used, especially as regards their biological indicator is characterised by the name of thespecies of bacterium used as the reference micro-organism, thenumber of the strain in the original collection, the number ofviable spores per carrier and theD-value.
EUROPEAN PHARMACOPOEIA 7.0 5.1.3. Efficacy of antimicrobial preservation suspensions may be presented in sealed ampoules. Biological indicators are prepared in such a way that they can be stored
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