Application of modified PTFE under the temperatures and pressures of sterilization and autoclaving processes

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Industry: Pharmaceutical OEM – Autoclaves. Customer: This customer is one of the well-known and high-quality manufacturers of sterilization equipment, supplying such equipment to large clients around the world from its base in Italy. To protect customers’ investments in key industries such as pharmaceuticals, bioprocessing, medical devices, and food production, its design and construction standards typically exceed the customer’s requirements. Background: Before using Garlock sealing materials, all sanitary clamp joints in the customer’s equipment utilized pure PTFE clean gaskets. Due to the high content of saturated steam used in these systems, pure PTFE tends to deform and develop pores, which causes PTFE seals to fail easily, with an average lifespan that is far shorter than the recommended 18-month warranty period. Facing challenges: As a global supplier, customers must ensure that all of their sealing materials meet the compliance requirements of the pharmaceutical industry, including those set by the FDA and EC1935. In addition, it is necessary to ensure that the gaskets maintain stable sealing properties under steam and high temperatures, and that the warranty period meets customers’ expectations. Operating conditions: Medium: Saturated steam; Dimensions: 12.7mm–63.5mm; Temperature: 152oC; Pressure: Vacuum from 0 to 4 bar. Solution: Garlock conducted in-depth discussions with the customer’s engineering team, and by understanding the client’s challenging application conditions and key requirements, it was determined that the best solution was the GYLON BIO-PRO® 3504 gasket material specifically designed for clamp connections. The GYLON® 3504 gasket material meets the requirements of pharmaceutical industry standards, and its modified PTFE structure ensures compliance with the temperature, pressure, and mechanical requirements of sterilization and autoclaving processes. Furthermore, the sealing life of the seals for customers and their end devices has increased significantly from less than 18 months to over 5 years; GYLON BIO-PRO® 3504 is now designated as the standard sealing solution for all sanitary clamp connections of customers. For more details, please visit: www.garlock.com.cn. Customer service hotline: 400 894 1288. Email: sales.china@garlock.com