What is USP certification?

The United States Pharmacopeia (USP) is a non-profit organization that sets standards for drugs, food ingredients, dietary supplements, and healthcare technologies. Its purpose is to ensure that products meet USP quality standards for safety and efficacy, including ingredient accuracy, manufacturing process specifications, and stability.

USP grade testing is one of the most commonly used test methods for determining the biocompatibility of materials. There are six grades of testing criteria established by the United States Pharmacopeia and National Formulary (USP-NF), the organization responsible for medical device and food quality and safety; VI is the most stringent. VI tests are designed to demonstrate that there will be no harmful reactions or long term physical effects due to leaching of chemicals from the plastic material. Test methods include: acute systemic toxicity testing, intradermal testing, and implantation testing.

USP Class VI is the universal standard for pharmaceutical tubing, fittings, disposable systems and manufacturing components.

The TEADIT TF1570, 24SH, 30SH, 28LS-LE from TEADIT Group, Austria, has been tested and certified to United States Pharmacopoeia (USP) Class VI (Generic Sections §88 and §87).