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aquatherm passes most stringent USP Class VI medical device testing

TN8/01.07.16 The U.S. Pharmacopeial Convention (USP) was established in 1820 to create a national set of requirements for pharmaceuticals and health products. This non-profit organization is now a global entity relying on experts around the world to create standards for medical devices and materials along with many other areas such as dietary supplements, food ingredients, medicines and other healthcare products.  USP standards are recognized by and integrated into US federal legislation and used in more than 140 countries.

In addition to medicines, the USP publishes biocompatibility protocols for the plastics and polymers used in medical devices or surgical equipment that may come in contact with human tissue. This strict standard was recognized as a good test for other products, and is now used in a large variety of medical and pharmaceutical applications. Depending on the specific use of the plastic, as well as other factors such as the length of patient contact time (limited, prolonged, or permanent), materials are categorized into one of six classes. The USP Class VI designation is considered the most stringent and is now the standard requirement for many products and materials.  

In addition to demonstrating an extremely low level of toxicity by passing the Class VI tests, the material will be subjected to several elevated temperature assessments for set periods of time. As such, materials and products that meet USP Class VI standards are generally considered to be of a higher quality level and are more readily accepted with the FDA and USDA. 

Aquatherm sponsored a study to determine if the green pipe material, fusiolen®, would comply with the requirements of USP Class VI testing. This is the most stringent level of testing for plastic materials in medical devices, and is used as a reference for plastics products such as piping systems pharmaceutical plants.  The study was conducted in full compliance with 21 CFR 58 Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies. As noted in the study report, “Based on the criteria of the protocol and the USP Guidelines for Class VI Plastics – 70°C, the test article, aquatherm Greenpipe, meets the requirements of the test.”

This helps to ensure that when Aquatherm piping is being used in highly sensitive areas such as pharmaceutical and biochemistry plants and applications, the piping will not contaminate or otherwise interfere with the biological and chemical processes being used.   

For a summary of the study results, please contact your Regional Sales Manager.

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