We get many questions about the safety of MeLuna. We want to give you comprehensive information on the material we use.
Many people today suffer from allergies. MeLuna contains no bleaches, deodorizers or absorbing gels. MeLuna is free from PVC, silicone, latex, proteins, and therefore hypoallergenic. Alkylphenols are not used in the making of MeLuna.
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.
Our used raw material has the medical approval in all countries of the EU and USA-FDA approval.
Additional the Me Luna® has the FDA approval as medical device class II.
No use of animal-based raw materials.
BfR, FDA, 2002/72/EC compliant and certified ISO 10993-10
What happens during production?
Me Luna® is produced entirely in Germany. Our 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.
The colors
In the production of colored Me Luna´s®, 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!
Safety
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From the delivery of the granules from Kraiburg GmbH, to manufacture and packaging, the entire process is carefully checked and documented. These documents are available for viewing. The quality is certified and monitored according to DIN ISO 9001:2000. The plastic is processed using resource-friendly, emission free and modern production conditions. |