PURPOSE
To determine whether a substance or preparation meets a pre-established specification for microbiological quality.
These tests apply to substances, preparations and medical devices intended for human or veterinary use. They allow the enumeration of mesophilic bacteria and moulds and yeasts which are capable of growing aerobically.
To ensure the feasibility of the test on the test product, it is necessary to perform an applicability test before any BioBurden test is performed.
EUROPEAN PHARMACOPOEIA:
Chapter 2.6.12 – microbiological inspection of non-sterile products: microbial enumeration tests.
STANDARD 11737-1
Sterilization of Health Products – Microbiological Methods – Part 1: Determination of a population of microorganisms on products
THE METHOD
Membrane filtration
Membrane filtration is carried out by means of an Oasis type filtration device. To do this, the sample to be analyzed is filtered on a membrane with 0.45µm diameter pores, which is deposited on culture media and placed in incubation under conditions allowing the growth of microorganisms.