New England’s leader in the fluid sealing industry for over 35 years, Tri-State Packing is pleased to announce www.uspclassvi.com.
Tri-State Packing stocks all sizes of USP Class VI (Parker E3609-70) EPDM O-Rings at our facility in Scarborough, Maine. TSP can also provide USP Class VI Kalrez, Silicone, and Viton.
Along with standard O-Rings, Tri-State Packing offers the Pharmaceutical and Bio-Tech Industries an alternative to the high cost and long lead time of OEM Manway/Tank Cover Gaskets and Vulcanized O-Rings with a variety of USP Class VI and FDA-approved compounds, including: USP Class VI EPDM, USP Class VI Silicone (red and clear).
The FDA has established a list of rubber compounding ingredients that they have tested and fount to be neither toxic, nor carcigenic. Rubber compounds produced entirely from these ingredients, and which also pass the FDA extraction tests are said to “full meet the FDA requirements.” The FDA does not approve rubber compounds; it is the responsibility of the manufacturer to compound food-grade materials from the FDA list of ingredients and establish whether they pass the necessary extraction requirements to be fully compliant.
The USP Class VI outlines requirements from system toxicity and intracutaneous toxicity for these “cleaner” compounds. The USP Class VI compounds must be made from ingredients with clear histories of biocompatibility that meet tight requirements for low extractables.