Global thermoplastic elastomer manufacturer tailors a medical-grade material for first Mexican menstrual cup approved by COFEPRIS
BUFORD, Ga. – October 25, 2022 – (Newswire.com)
KRAIBURG TPE has partnered with ProFemme to supply the Mexico-based manufacturer of menstrual cups with a specialized, medical-grade thermoplastic elastomer compound. ProFemme sells its products in a variety of stores — from Walmart and Amazon to local South American chain stores, such as laComer and SanPablo Farmacia. This is the first menstrual cup made in Mexico to earn regulatory approval (No. 1066C2019SSA) from COFEPRIS, the Federal Committee for Protection from Sanitary Risks (or Comision Federal para la Proteccion contra Riesgos Sanitarios). COFEPRIS is the department within the Mexico Ministry of Health that deals with the importation of medical devices and also issues advertising permits for these products.
KRAIBURG TPE worked closely with ProFemme to define and meet all product specifications and material requirements. The risk assessments included medical compliance with ISO 10993-5 (cytotoxicity) relative to blood contact since the product is to be inserted inside the body. ProFemme manufactures the menstrual cup using a certified hypoallergenic TPE material that also is 100% recyclable. The cup is transparent and lasts for up to 12 hours of usage, with a product life span of five years.
KRAIBURG TPE determined that a grade from its THERMOLAST® M product family was the appropriate material to bring the menstrual cup design concept to fruition. This medical-grade TPE is primarily used in medical/pharmaceutical applications as it is a safe and sterilizable compound that can be used in direct contact with blood, allowing it to remain inside the body for a designated period.
The material complies with international standards, including ISO993, making it biocompatible and safe for the use of menstrual cups. The compound is also free of latex and PVC, making it non-toxic, which prevents irritation. It is also free of any animal ingredients or byproducts.
All KRAIBURG TPE medical compounds are tested according to ISO 10993-5 (cytotoxicity). Selected medical compounds are tested according to required medical approvals, including USP Class VI (Chapter 88), ISO 10993-4 (hemolysis, indirect in human blood), ISO 10993-10 (intracutaneous irritation), ISO 10993-11 (acute systemic toxicity), and ISO 8871-1 (Part 1: extractables in aqueous autoclavates).
With the number of healthcare applications on the rise, KRAIBURG TPE continues to design and develop specific material grades with a focus on medical devices and applications, including pharma packaging, medical devices, and drug-delivery systems.
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