Article | REF: P3352 V1

Microbiology analysis - Non-sterile products

Authors: Yves ROCHÉ, Philippe NIEL

Publication date: June 10, 2006

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1. Classic techniques from the European Pharmacopoeia

by Yves ROCHÉ

1.1 Quantitative methods

The tests described for the microbiological control of non-sterile products (also known as "total viable aerobic count" – European Pharmacopoeia Monograph 2.6.12) enable the enumeration of mesophilic bacteria, molds and yeasts capable of growing aerobically.

The main purpose of these tests is to determine whether a product complies with the microbiological requirements specified in its monograph or in the Pharmacopoeia.

However, for the European Pharmacopoeia (chapter 2.6.12), these techniques can also be used to verify the efficacy of antimicrobial preservatives (see chapter on preservatives), as well as to monitor the quality level of raw materials or pharmaceutical preparations....

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Classic techniques from the European Pharmacopoeia