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Saint-Gobain's Rulon® 1439 Material Certified USP Class VI Compliant for Medical & Pharmaceutical
Saint-Gobain Seals’ Rulon® 1439 material has achieved full USP Class VI certification, complying with stringent disposable and reusable medical device requirements.
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)
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 (http://www.seals.saint-
Other popular applications of this Rulon® material (http://www.seals.saint-
Saint-Gobain Seals also offers three additional Rulon® grades compliant with USP Class VI and/or FDA Title 21CFR §177.1550:
Rulon® 641 (http://www.seals.saint-
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.
About Saint-Gobain Seals Group (www.seals.saint-
Saint-Gobain Seals Group is a business unit under Saint-Gobain Performance Plastics’ Engineered Components division; our parent company is one of the world’s top 100 industrial groups. With more than 50 years of manufacturing experience and an established global presence (with strategic sites in Garden Grove, California, USA; Kontich, Belgium; and Minhang, Shanghai, China), we offer a diverse range of innovative sealing and polymer solutions:
· OmniSeal® Spring–Energized Seals
· OmniLip™ PTFE Rotary Shaft Seals
· OmniFlex™ Fluoroelastomer Seals
· OmniShield® EMI / RFI Shielding Solutions
· Rulon® High-Performance Fluoropolymer Compounds
· Meldin® 7000 Thermoset Polyimide Materials
· Meldin® HT High-Performance Thermoplastic Materials
Other products include Fluoroloy® (high-performance custom-formulated compounds and alloys), cup seals, hydraulic seals, metal seals, v-packings, piston rings, Marathon® (valves and vacuum pump diaphragms), Transband® (PTFE creepage band), custom parts, polymer bearings and stock shapes.
The majority of seals and polymer components manufactured are custom designed and matched with the best materials to optimize their performance in various applications and markets.
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