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Information on materials and workmanship of MeLuna

Understandably we get many questions in regards to the safety of MeLuna. We would like to take this opportunity to try to answer some of your legitimate questions and give you comprehensive information on the material used.  

Nobadstuff  

Many people suffer from allergies. MeLuna contains no bleach, deodorizers or absorbent gels. MeLuna is free of PVC, silicone, alkylphenols, latex and proteins. It is considered hypoallergenic.


Disclaimer alkylphenol

 

What material is the MeLuna made from?

MeLuna consists of TPE (thermoplastic elastomer). However, this is not just any TPE - our TPE is specifically manufactured for the medical device industry. The production is very closely monitored.

The material is manufactured by Kraiburg GmbH in Germany. It was developed especially for such highly sensitive applications and has passed the mucosal irritation test with flying colors. You may have encountered this material before in items such as pacifiers. Due to the high standards that apply to baby products in Germany, you can be sure that it is top quality. The TPE used in MeLuna cups is BfR, FDA, 2002/72/EC and ISO 10993-10 certified.

Here you are able to view the actual documents and certificates:

 

Thermoplastic M and information security guarantee

TPE test results on Biosafety

ISO certificate for Biosecurity of TPE

TPE physicochemical test results

Certificate of test results of TPE

Why is the MeLuna not made from medical grade silicone like the other menstrual cups ?

Some of the reasons why we prefer TPE over Silicone are based on improved manufacturing practices that are possible with TPE.
Moreover, TPE feels smooth, dry and not sticky - its tactile properties are so different from silicone. Many products that have been made ​​previously out of rubber or silicone, are now made out ​​of TPE.

TPE has a lower incidence of causing an allergic reaction than silicone.

TPE is also a very pliable material that readily conforms to its surroundings for an even more custom feel for the wearer. You may find that over time your TPE cup becomes a bit more oval in shape after adjusting to its wearer’s shape. This is nothing to worry about. The cup will again conform to your shape the next time you wear it. If you ever would like to return the cup to its original completely round shape, simply boil the cup in hot water.

 

How are MeLuna cups manufactured?

MeLuna is manufactured in Gunzenhausen, Germany.
The high quality, pure plastic granules are placed in a special molding machine to be melted and are then injected under high pressure into the MeLuna molds. The machinery is dedicated for use in the production of menstrual cups only. No other materials come in contact with it. The finished cups are then removed after cooling and all cups are immediately checked one by one. This means they will be assessed from all sides, it is also verified that no tiny air bubbles exist. If any errors are present, the item is not released for sale.

 

Safety

 

The process is controlled and monitored using a quality control system that starts with the delivery of the granules from the world market leader and world's largest manufacturer of TPE, Kraiburg GmbH, through the final product. Everything is documented.


These documents can also be viewed. The quality standard is 9001:2000 certified by an independent body to ISO and monitored. The plastic is processed under modern production conditions