Seals used within the life sciences sector are heavily regulated. Their ability to perform impacts everything from shelf stability to consumer safety, particularly within the fields of food processing and pharmaceutical production.
Which seal certifications matter most within the life sciences sector? Here are four regulatory guidelines integral to the industry.
- FDA Approval
Food grade seals are subject to FDA approval. The U.S. Food and Drug Administration has a long list of guidelines specific to seals used for food preparation and processing, and these guidelines are generally considered to be the global standard (although their regulations are only legally enforceable within the U.S.) FDA-approval for seals considers chemical composition, durability, and sanitation.
- NSF Approval
The NSF, the National Sanitation Federation, is an independent non-profit group that writes standards for food, water, air, and consumer goods. NSF standards are recognized by the American National Standards Institute (ANSI). NSF-approved seals have been certified in the good of the public health; they are most often used in food, cosmetic, and medicinal contexts.
- USP Class VI
USP Class VI seals meet or exceed the biocompatibility requirements for medicines and medical devices. USP, the United States Pharmacopeia, is a non-profit group dedicated to creating standards within food, medical, and supplemental contexts. If a seal is certified USP Class VI it meets all regulatory requirements for those products that will eventually come into contact with human tissue; These standards have been formed through years of extensive testing of materials’ effects on other materials, extractables, and on tissue itself.
- VDI 2083
The VDI 2083 standards pertain to the use of cleanrooms. They specify the particulate air cleanliness of cleanrooms and the materials used within, including seals. These guidelines are particularly important within the sectors of pharmaceutical manufacturing and medical device manufacturing. VDI standards are set by the Association of German Engineers, but the standards are widely accepted around the world.
Life sciences is a complex industry that presents myriad challenges for seal manufacturers. From O-rings to machined shapes to extrusions, life sciences seals matter. Their performance ultimately impacts throughput, processing, and most importantly, consumer safety.
Wyatt Seal has developed a reputation as a leader in the production of high-quality seals for use within the life sciences industry. Our team regularly consults with food processors, pharmaceutical manufacturers, and other end-users on the best seal product(s) for highly specific applications.
Would you like to learn more about Wyatt Seal’s extensive catalog of regulation-grade seals? Reach out to our team today to order in-stock seals or to begin the fast and easy process of prototyping a completely custom seal solution.