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.
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.The TPE used in MeLuna cups is BfR, FDA, 2002/72/EC and ISO 10993-10 certified.
More importantly though the MeLuna USA version of the cup was put through the FDA clearance process and registered with the FDA in 2014.
This process goes way beyond just material safety and includes ongoing quality control meassures and inspections.
You can see the FDA clearance document here
This link shows our current FDA registration status
This is the link to the manufacturer's registration
This it the link to the US distributor's registration
Here is a blog post explaining the differences between the US version of the MeLuna cups and cups sold elsewhere
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 TPE 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.
The quality standard is 9001:2000 certified by an independent body to ISO and monitored. The TPE is processed under modern production conditions.
MeLuna USA cups are also documented separately by the MeLuna USA distributor in accordance with FDA Quality Control standards.