For the MyMicrobiome Vulvo-Vaginal Standard 25.10, the following bacterial species were defined whose presence must not be impaired by a product:
The test criteria for Standard 25.10 vulvo-vaginal microbiome
This step ensures that the product is not contaminated by microbes. A screening examines the occurrence of mesophilic and aerobic microorganisms, i.e. bacteria, yeasts or molds (TAMC and TYMC). Since products for the intimate areas can come into contact with mucous membranes, the limit value is ≤ 1 x 10 2 cfu /g or ml a .
Here, co-cultures are created with the two most common vaginal microbes, L. crispatus and the pathogenic bacteria G. vaginalis and are brought into contact with the vaginal product to be tested. After a certain period of time, the ratio of the two microbes is compared to an untreated control group. The product must not affect the natural balance of the microbiome dominated by lactobacilli.
The microbes typical of the vulvo-vaginal tract are cultured, namely L. crispatus, S. epidermidis, C. tuberculostearicum and C. acnes and a co-culture is prepared.
The co-culture is exposed to the test product for a certain period of time and the change in growth is compared with the untreated control group. For an intact vulvo-vaginal microbiome, the growth behaviour must be maintained.
A Microbiome-friendly vaginal care product must not only maintain diversity but must also not impair the growth of the microorganisms. The vitality test is carried out on a skin contact model, i.e. the key microbes are brought into direct contact with the product and in a second approach the key microbes are covered with an agar layer. The agar layer simulates the protective upper skin layer, as it represents an additional barrier through which the product must diffuse. The growth of the microbes in the two approaches is compared with the untreated control group. The product must not significantly inhibit the growth of the microbes.
"The standard 25.10 dedicated to the vulvo-vaginal microbiome ensures that the microbial balance of the female intimate area is not impaired. This prevents infectious diseases and other imbalances that can be caused by the products used."
Dr. Lisa Bäumer, Laboratory management
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