Transcription of 5.1.4. MICROBIOLOGICAL QUALITY OF …
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5.1.4. MICROBIOLOGICAL QUALITY OF …
EUROPEAN PHARMACOPOEIA MICROBIOLOGICAL QUALITY of pharmaceutical preparations Table - Parenteral and ophthalmic preparations Category 1. Log reduction Preparations required to be sterile by the relevant 6h 24 h 7d 14 d 28 d monograph on the dosage form and other preparations labelled sterile. Bacteria A 2 3 - - NR*. - - Test for sterility ( ). B 1 3 NI**. - - - Category 2. Fungi A 2 NI. - - - Preparations for topical use and for use in the respiratory B 1 NI. tract, except where required to be sterile, and transdermal *NR : no recover patches. **NI : no increase Total viable aerobic count ( ). Not more than The A criteria express the recommended efficacy to be 102 micro-organisms (aerobic bacteria plus fungi) per achieved. In justified cases where the A criteria cannot be gram, per millilitre or per patch (including the adhesive attained, for example for reasons of an increased risk of and backing layer). adverse reactions, the B criteria must be satisfied. Transdermal patches : absence of enterobacteria and Table - Topical preparations certain other gram-negative bacteria, determined on Log reduction 1 patch (including the adhesive and backing layer).
EUROPEAN PHARMACOPOEIA 6.0 5.1.5. Application of theF0 concept to steam sterilisation In addition to the micro-organisms listed in Table 5.1.4.-1, the significance of other micro-organisms recovered is
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