material menstrual cups
Information provided by the manufacturer*
What is Me Luna made of?
The Me Luna is made of TPE (thermoplastic elastomer). However, this is not just any TPE - it is a specially produced TPE, where the production is very strictly monitored. This TPE has been approved for the manufacture of medical products and devices. ("TPE" is the generic term for a type of thermoplastic, where by applying heat to the processed elastomers they become flexible.)
We buy our raw material from the manufacturer, Kraiburg GmbH Waldkraiburg. This particular TPE was developed especially for highly sensitive products, and has passed the mucosal irritation test. It is used in environments such as hospitals and pediatric clinics which require a high degree of sterilization, and is approved for use in the medical field. The material is produced in Germany.
Among other things, the Me Luna material is also used to make teats for baby bottles. Because of the high regulatory requirements for baby products in Germany, you can be assured that Me Luna is made with top quality materials.
BfR, FDA, 2002/72/EC compliant and certified ISO 10993-10
Why is Me Luna not made from silicone, like other menstrual cups?
Me Luna is made from TPE because this plastic is more practical and easier to process than silicone. These properties help us to keep Me Luna well-priced, and enable us to to create even more variations for our product line. Further, TPE has a better surface feel, as it feels smooth and dry, whereas silicone feels sticky. Many products originally made from latex or silicone are now made from TPE - you might just not notice!
What happens during production?
Me Luna is produced entirely in Germany. The manufacturing facility is located in Gunzenhausen.
During production, the high-quality pure plastic granules are put into a special plastic injection machine, then melted and injected under high pressure into a mould, which creates the Me Luna shape. This machine makes only one Me Luna at a time. It is removed from the machine after cooling, and every Me Luna undergoes immediate inspection. This means that it is checked on all sides, as well as for tiny air bubbles that may have formed in the plastic. If any fault is found, the piece is rejected.
In the production of colored Me Lunas, the colorless TPE granules are mixed with a tiny amount of color (2-4%). These colors are not used in the medical field, but are approved for food.
A medical approval for colors is very difficult and expensive, because so far no one wants to make catheters or syringes in bright colours!
*all certificates and diclaimers can be seen on the homepage of the manufacturer Me Luna under www.me-luna.eu