Sterility control of biological products (absence of aerobic and anaerobic bacteria, molds, and yeasts). European Pharmacopoeia (v.11.0). 2.6 Biological Tests; 2.6.1. Sterility 04/2011: 20601.

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According to section 2.6.1 of the European Pharmacopoeia (EP), the sterility control test must be applied to substances, preparations, or articles that are required to be sterile. However, a satisfactory result only indicates that no contaminating microorganisms were found in the sample examined under the test conditions.

In accordance with section 2.6.1 of the EP, two culture media must be used: thioglycolate broth (primarily for anaerobic bacteria, but also detects aerobic bacteria) and casein-soy digest medium (for the culture of aerobic bacteria and fungi). The technique used must be validated against the following microorganisms: aerobic bacteria (Staphylococcus aureus, Bacillus subtilis, Pseudomonas aeruginosa), anaerobic bacteria (Clostridium sporogenes), and fungi (Candida albicans and Aspergillus brasiliensis).