Strong-Ty® PVDF Cable Ties for Bioprocessing Strong-Ty® natural cable ties are made with Kynar® PVDF for demanding bioprocessing, pharmaceutical, laboratory and chemical-processing applications. PVDF provides excellent chemical resistance, temperature capability, UV resistance and long-term durability compared with standard nylon cable ties. Qualification and Manufacturing Information Finished-tie ISO 10993-5:2009 cytotoxicity reports are available for NPC204N and NPC208N. USP Class VI documentation is available for the Kynar® PVDF resin. This is material-level support and is not a finished-tie USP Class VI certification. Strong-Ty® cable ties are injection molded and packaged in the USA in an ISO Class 9 cleanroom by Utah Medical Products, which operates an ISO 13485:2016-certified quality management system. Lot traceable with mold-cavity identification. NPC204N and NPC208N were evaluated after one reported 30-minute autoclave exposure at approximately 121 °C. This is not a repeated-cycle qualification and does not cover NPC204NS. Arkema documentation supports FDA 21 CFR 177.2510, RoHS and applicable REACH requirements at the Kynar® PVDF material level. UL 94 V-0 is a Kynar® PVDF material flammability property. Strong-Ty® finished cable ties are not represented as a separate UL-listed finished product. Strong-Ty® PVDF cable ties are intended for external securement and organization around single-use bioprocess assemblies, including tubing bundles, bag assemblies, sensor leads and process equipment. They are not intended to function as a fluid-path fitting or process-tubing clamp. Customers must confirm suitability for their installation, sterilization cycle and service conditions. Sizes and Packaging 4 inch (102 mm) standard - NPC204N 4 inch (102 mm) Flex - NPC204NS 8 inch (203 mm) standard - NPC208N Available in packages of 100 or 1,000 ties Manufactured in the USA for Nile Polymers.