2.6. BIOLOGICAL TESTS - tailingood.com

EUROPEAN PHARMACOPOEIA BIOLOGICAL TESTS01/2005 STERILITYThe test is applied to substances, preparations or articleswhich, according to the Pharmacopoeia, are required to besterile. However, a satisfactory result only indicates thatno contaminating micro-organism has been found in thesample examined in the conditions of the test. Guidancefor using the test for sterility is given at the end of this AGAINST MICROBIAL CONTAMINATIONThe test for sterility is carried out under aseptic order to achieve such conditions, the test environmenthas to be adapted to the way in which the sterility test isperformed. The precautions taken to avoid contaminationare such that they do not affect any micro-organisms whichare to be revealed in the test. The working conditions inwhich the TESTS are performed are monitored regularly byappropriate sampling of the working area and by carryingout appropriate controls (such as those indicated in theappropriate European Community Directives and associatedguidance documents on GMP).

EUROPEAN PHARMACOPOEIA 5.0 2.6.1. Sterility Table 2.6.1.-2 — Minimum quantity to be used for each medium Quantity per container Minimum quantity to be used for …

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