Saint-Gobain Seals’ Rulon® 1439 material has achieved full USP Class VI certification, complying with stringent disposable and reusable medical device requirements. USP (United States Pharmacopeia) is an independent public health organization that promotes public health by establishing state-of-the-art standards, and USP Class VI compliance is often requested by end users such as medical device and pharmaceutical processing companies as it does provide added assurance for the quality and performance of utilized materials.
USP defines six plastics classes from I to VI, with VI being the strictest. Tests are designed to assess the biological reactivity of various types of plastics materials in vivo, and therefore assign a USP Class. To meet the requirements for Class VI certification, a specific "in vitro" study (based on the USP General Chapter <87> biological reactivity test to determine potential cytotoxicity) and an "in vivo" study (under USP General Chapter <88> biological reactivity test) are conducted. Three in vivo tests are utilized in the classification of plastics: (1) Systemic Injection and (2) Intracutaneous tests are designed to determine the systemic and local biological responses to plastics and other polymers by a single dose injection of specific extracts prepared from a sample; and (3) Implantation test is designed to evaluate the reaction of living tissue to a test material.
Rulon® 1439 material has also been certified as compliant for repeated contact with food or drugs for oral consumption under Title 21CFR §177.1550 of the United States Food and Drug Administration (FDA). With these two certifications, the Rulon® grade is ideal for use in the medical devices, pharmaceutical, food, and beverage processing industries. An example of a successful Rulon® 1439 application is use within a metering pump of a kidney dialysis system. The metering pump requires a shaft seal that can (1) resist water which can cause premature wear, (2) resist flushing action of debris, (3) run against a ceramic shaft, and (4) meet regulatory requirements. A combination of the material’s composition and Saint-Gobain Seals’ manufacturing processes create a formable shaft seal with low friction and high chemical resistance, meeting the performance requirements of the metering pump and providing long wear life.
Other popular applications of this Rulon® material include utilization as bearings in mixers and compounding blenders. Additionally, the material is recommended in submerged applications as it is resistant to many harsh chemicals, and its white color is often preferred in pharmaceutical, food, and beverage applications.
Saint-Gobain Seals also offers three additional Rulon® grades compliant with USP Class VI and/or FDA Title 21CFR §177.1550:
- Rulon® 641 material was developed over 20 years ago for the pharmaceutical and food processing industries to replace bronze, greased rolling elements. The monomer used in the product is listed and complies with the European Regulation 1935/2004 and 10/2011 in conjunction with materials and articles made of plastics and intended to come into contact with food items or toys.
- Rulon® 123 material is one of the earliest developed. The grade also complies with European Regulation 1935/2004 and 10/2011; the Federal Food, Drug, and Cosmetic Act (FFDCA); and all applicable food additive regulations. As a result, it is acceptable under USDA regulations for use as bearings, bushings, and seals in contact with meat and poultry. Moreover, the grade meets the 3-A Sanitary Standard 20-18 test criteria, which cover the material requirements of plastics for multiple uses as product contact and/or cleaning solution contact surfaces in equipment for production, processing and handling of milk and milk products.
- Rulon® 1337 material is chemically compatible with most chemicals, offering more flexibility in wash-down environments of pharmaceutical and food processing environments.