How to perform skin irritation tests for menstrual cups - Sigmatest

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How to perform skin irritation tests for menstrual cups

How to perform skin irritation tests for menstrual cups?

A menstrual cup is a receptacle which is inserted in the vaginal canal to hold menstrual blood. They are becoming increasingly popular and are used as an alternative to tampons, sanitary napkins and period underwear. One very important thing to know about menstrual cups is that they are a very good step in the direction of sustainability. They are reusable and last for up to ten years. Additionally, they are very economically viable as well.

They come in various sizes and are washable to be used over and over again. They are inserted inside the vagina and hence as its function they are very close to the skin during all times of their use. Hence it becomes very essential to test it for skin irritation. They are made of silicon and may also contain rubber or the components of rubber.
Menstrual Cups and their Biocompatibility
As a product falling under the medical category, its biocompatibility has a huge role to play in its success. For menstrual cups, they should not only be biocompatible initially, but should remain the same despite being used multiple times through its life. The material’s clinical relevance needs to be accounted for in order to avoid any toxic responses by the skin tissues or any unintended complications which can lead to severe health hazards.

Testing the material for biocompatibility forms a very critical part of the testing process as it facilitates in getting regulatory approvals when a medical device or a product which has medical application is concerned. This happens to be a very essential step in the process because at times the best materials can react unexpectedly when put to day to day use.
Skin Irritation Tests
Skin irritation basically means any kind of reversible damage to the skin post the application of a test substance. To evaluate the safety of any substance which is to be used on the skin, it is important to learn how probable it is to cause irritation to the skin. It is very important to keep them clean as a first step to avoid any signs of irritation to the skin.

The EpiDerm Skin Irritation Test has been developed and designed to anticipate the skin irritation potential of test substances. In the context of menstrual cups, the EpiVaginal tissues are used to conduct tests. They help in studying vaginal-ectocervical related phenomena. The EpiVaginal tissues are a curation from regular, human derived vaginal-ectocervical and dendritic tissues. These tissues are very close to actual human tissues and help in assessing possible irritation, toxicity or any other kind of infections.
They are very helpful and facilitate all kinds of skin safety tests. It not just helps in testing hygiene related products but also HIV and other diseases that are sexually transmitted. These tissues are used as a base to test the performance of the cup against the skin.

These tissues are coming into rapid use as they are a replacement for animal testing or other forms of expensive clinical tests. Earlier the rabbit vaginal irritation test was done to test such products, but with the development of epivaginal tissues, we have come a long way in avoiding animal testing. For confirmation of these tissues as a replacement to animal testing, the tissues had been exposed to a single application of ingredients which are found in feminine hygiene products and then see the viability of it. The processes have shown positive signs and are headed in the direction of substituting animal testing for the good.
Other Important Factors
Further, the menstrual cups are also evaluated in various temperatures to see how they react to the skin along with viability assessment of its rubber for vaginal pH levels. The size and dimensions are also considered when checking skin irritation possibilities. Also, since the cups have rubber components in them, it’s necessary to check if that is compatible with the skin. Any skin allergic to rubber might have irritation in using the cup, this becomes any crucial point to factor in.
To test for skin irritation, post the actual use, it should also be stored for sometime and re-checked to have assurance of good quality throughout and not just for one time use. They can’t be stored in air-tight containers and moisture may not evaporate which may lead to fungi or bacteria developing and cause a skin irritation when used the next time,

A thorough test is required both tried before and after the use to pass it as safe.


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