class vi & fda materials

		Compound Offering		Life Science		FDA USDA NSF51 USP Approved

Description:  The Life Sciences Industry (medical, drug discovery, pathogen detection, pharmaceutical and bio-tech) has a variety of sealing challenges for critical components and processes. Typically, these applications require the elastomeric seals be made from materials compliant to either FDA or USP Class VI standards. The Food and Drug Administration (FDA) has established a list of rubber compounding ingredients which tests have indicated are neither toxic nor carcinogenic. Rubber compounds produced entirely from those ingredients and which also pass the FDA extraction tests are said to “fully 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. In addition, compounds that are made from exotic technologies can be tested to the extraction tests only for compliance.

The U.S. Pharmacopoeia (USP) Class VI outlines requirements for 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 tighter requirements for low extractables. Parker offers o-rings from 24 specially formulated recipes compliant to FDA Standards; five of these recipes are also compliant to USP Class VI.

Typical Applications:
FDA and USP Class VI materials are available in all standard o-ring dimensions (AS568), custom o-ring sizes, and specialty molded products. Parker’s recipes are formulated for excellent long term sealing properties in many Life Science applications, which include: steam, high temperature, and fluid resistance to aggressive chemistries, high purity, and low extractables.

Features and Benefits:

• USP Class VI materials (EPDM, Silicone, Fluorocarbon, and Perfluoroelastomer)
• 24 materials which are compliant to FDA, 21 CFR177.2600
• Specially formulated for long term sealing