Quality and standards

LaliCup menstrual cup is a high quality and safe product, made from medical-grade silicone is a portfolio of platinum catalyzed materials, which is FDA (US Food and Drug Administration) approved for medical use in accordance with ISO standard 10993 and USP Class VI. Silicone is hypoallergenic, toxin-free, biocompatible, safe and durable.

LaliCup menstrual cup is produced in Slovenia by highly qualified staff using modern, well-maintained injection molding machines. It is made of liquid, high-quality, medical-grade silicone, that is from original containers injected directly into the mold. The process ensures the production of high quality, flexible and durable products. LaliCup menstrual cup is optimally made for comfortable use and easy maintenance, such as cleaning and sterilization.
LaliCup menstrual cup is manufactured in a factory maintaining high quality standards, with constant striving for process optimization. Production process complies with the requirements of ISO standards 9001 and 14001.
We aim to minimize environmental pollution; heat exchange system is used for heating the inside of production facilities, and the amount of consumed energy is minimized by using energy-saving machines and closed recirculating cooling water system.

menstrualna čašica

Medical-grade silicones are tested for biocompatibility according to FDA (US Food and Drug Administration) standards and are therefore suitable for healthcare application. There are three types of medical silicones according to the potential use: not suitable for implantation, only for short-term implantation and for permanent implantation. Materials approved regarding the USP Class V and VI standards may be considered for medical use.  Typical characteristics of silicones used for LaliCup menstrual cup production are purity, clarity, strength and excellent stability.

Our LSR liquid silicone is a two-component, platinum (addition/heat) curable and pumpable silicone elastomer that can be molded and cured with very fast cycle times at elevated temperatures. The molding process allows complex part geometry and exact dimensions. (unlike peroxide curing process leaves behind byproducts, which can be an issue in food contact and medical applications.)

Menstrual cup is not regarded as medical device according to EU law, so there are no designations on the LaliCup menstrual cup to be approved by the Agency of the Republic of Slovenia for Medicinal Products and Medical Devices.

Health comes first, that is why silicone used for LaliCup menstrual cup production is tested according to the USP Class VI standard and/or ISO 10993 biocompatibility standard. The material is therefore suitable for healthcare application.

This carefully selected liquid medical-grade silicone is a platinum-based silicone cure system, also called an addition system (because the key reaction building polymer is an “Addition reaction”). With platinum as catalyst, two different chemical groups react, a silicone hydride and a vinyl. Characterized by excellent properties:

■ high thermal stability,

■ high stability and flexibility at low temperatures,

■ excellent biocompatibility,

■ sterilized with ethylene oxide, steam or gamma radiation,

■ good mechanical properties,

■ long life span with  high dynamic load bearing capability,

■ high resistance to ozone, oxygen and ultraviolet light,

■ excellent aging resistance,

■ thermal stability with wide temperature range,

■ not readily combustible, does not melt or drip

High quality and softness of silicone ensure maximum safety and comfort during movement.

Is a portfolio of platinum catalyzed materials. Silicone ready-to-use mixture is made from two components, A and B, with a precise dosing and mixing of the components. Mixture is injected directly into the molds using the injection molding machines, thus mixing of other components during the manufacture process of LaliCup menstrual cup is completely avoided.

Silicone mixture for LaliCup menstrual cup consists of two components in 1: 1 ratio. The mixture is injected a heated mold at a temperature of 170-230 °C.

Compliance with standards and regulations

■ A representative sample of analogous product meets the requirements of USP Class VI and ISO 10993, in accordance with good laboratory practice (GLP).

■ Listed to UL 94 HB (File No. E205753).

■ KTW approved.

■ In accordance with the requirements of the DVGW worksheet W 270.

■ WRAS approved product (BS 6920).

■ Compositionally compliant with 21 CFR 177.2600 for silicone products intended for multiple use (2).