In the hose industry, especially in the category of pharmaceutical-grade hoses, we often find that XX hoses have passed USP class vi certification, so what is the source of this USP class 6 certification?
First, let's explain what USP actually is: The United States Pharmacopeia (USP) is a non-governmental organization that supports public health by developing relatively new standards to assure the quality of pharmaceuticals and other medical industry technologies. The organization focuses on the pharmaceutical and biotechnology industries. USP sets standards for the quality, purity, strength, and consistency of pharmaceutical-grade related products. These USP standards are published in the United States Pharmacopeia and National Formulary (USP NF). USP Class IV products undergo a series of biological tests. USP Class VI compounds must be made from ingredients with a proven history of biocompatibility to meet the stringent hygiene requirements of the pharmaceutical industry.
Sanitary products used in the medical field and biopharmaceutical field must have good biocompatibility and strong chemical stability. The components in the plastic material cannot be precipitated into the liquid medicine or the human body, otherwise it will cause toxicity and damage to tissues and organs, and cause toxicity to the human body. Therefore, in the United States, USP, as a non-profit organization, relies on experts from all over the world to develop production standards for medical devices and other related fields such as dietary supplements, food ingredients, pharmaceuticals and health care products. USP 6 medical equipment test is a relatively strict test for plastic materials in medical applications and pipeline products in biopharmaceuticals. It is a non-clinical laboratory research that meets various experimental specifications.
USP defines six detection levels, from I to VI (VI is still more stringent). Therefore, some pharmaceutical manufacturers find it beneficial to pass USP Class VI sanitary products, especially if it is a candidate for medical devices. Class VI certified sanitary tubing is expected to be more likely to yield favorable biocompatibility results.
For a product to pass USP Class VI, it must pass all testing requirements to exhibit very low toxicity. More end users often require compliance with USP Class VI requirements. Compliance testing includes assessing the impact of materials and extractables on the tissue.
