USP Class VI

USP Class compliant seals and silicone parts for medical and pharmaceutical applications. The term refers to the United States Pharmacopeia, a binding set of rules for the quality assurance of medicinal products and medical devices and their materials.

What does USP Class mean for elastomers and seals?

In the rubber industry, this term is used in particular in connection with biocompatible silicones and medical seals. The United States Pharmacopeia is a binding set of rules for the quality assurance of medicinal products, medical devices and their materials.

What is USP Class VI?

USP Class VI sets the highest requirements for the biocompatibility of a material and is regarded as the international standard for medical-grade plastics and elastomers. A material that meets this class must not show any toxic, allergenic or carcinogenic effects in defined tests. The tests cover:

• systemic toxicity
• intracutaneous reactions (skin irritation)
• implantation compatibility

Why is USP Class VI relevant for rubber and silicone?

Many applications in medical technology or food technology require the seals used to be made of biocompatible materials. For silicone or rubber parts inside the body or in direct contact with pharmaceutical products, conformity is often mandatory. Typical applications:

• medical devices (e.g. ventilation, dialysis, infusion technology)
• seals and profiles for laboratory equipment
• pharmaceutical plants (reactors, filling systems)
• components in biotechnology

Which materials meet USP Class VI?

• Silicone (VMQ): temperature resistant up to +200 °C, FDA and EC 1935/2004 compliant on request
• EPDM (on request): for steam and CIP-relevant applications
• Other materials: FKM compounds for special pharmaceutical applications

Products and services offered

• Seals according to USP Class
• Hoses, profiles, O-rings and moulded parts
• Advice on material selection and regulatory conformity
• Documentation and test reports on biocompatibility

Important note

Not only the component but also the material is certified according to USP Class. Final responsibility lies with the user, who must verify the complete process in accordance with regulatory requirements.