Life Sciences FDA & USP VI Seals
FDA & USP Class VI Seals for Life Sciences Applications
In the life sciences industry, sealing solutions must meet the highest standards of purity, safety, and regulatory compliance. FDA-approved and USP Class VI seals are specifically designed for applications involving medical devices, pharmaceutical processing, and food-grade environments.
Ashton Seals provides high-performance sealing solutions that ensure reliability, compliance, and long-term performance in critical applications.
What Are FDA & USP Class VI Seals?
FDA and USP Class VI seals are elastomer and polymer sealing components manufactured to meet strict regulatory requirements for contact with food, pharmaceuticals, and medical products.
- FDA compliance ensures materials are suitable for food contact (e.g. CFR 21 standards)
- USP Class VI certification confirms suitability for biocompatibility and medical applications
These standards are essential where sealing materials come into direct or indirect contact with sensitive media.
Why Compliance Matters in Life Sciences
In life sciences applications, selecting the correct sealing material is critical to patient safety and product integrity.
High-quality FDA and USP Class VI seals provide:
- Biocompatibility for medical and pharmaceutical use
- Resistance to sterilisation processes (steam, gamma, CIP)
- Low extractables and contamination risk
- Compliance with global regulatory standards
Failure to meet these requirements can result in product contamination, regulatory issues, and operational downtime.
Materials Used in Life Sciences Seals
A wide range of materials are used depending on the application:
- EPDM – excellent resistance to steam and sterilisation
- Silicone (VMQ) – ideal for flexibility and biocompatibility
- FKM / FFKM – high chemical and temperature resistance
- PTFE – low friction and exceptional chemical resistance
These materials are often specially formulated to be free from animal-derived ingredients and suitable for sensitive environments.
Applications in Life Sciences & Medical Industries
FDA and USP Class VI seals are used across a wide range of industries, including:
- Pharmaceutical manufacturing equipment
- Drug delivery systems
- Medical devices and implants
- Food and beverage processing systems
- Biotechnology and laboratory equipment
Seals must perform reliably in environments requiring strict hygiene, sterilisation, and contamination control.
View and download the brochure: OES-7010-Drug-Delivery-Sealing-Solutions.pdf
Types of FDA & USP VI Sealing Solutions
We offer a comprehensive range of compliant sealing products, including:
- O-rings and custom elastomer seals
- FEP encapsulated O-rings
- PTFE-based sealing solutions
- Custom-engineered seals for specialised applications
Many of these solutions are manufactured using ISO-certified processes and high-quality materials to ensure consistent performance.
Why Choose Ashton Seals?
- Extensive experience in life sciences sealing applications
- Access to FDA-approved and USP Class VI materials
- Custom sealing solutions tailored to your requirements
- Technical expertise and application support
We work closely with customers to deliver safe, compliant, and high-performance sealing solutions.
Need Help Selecting the Right Seal?
Choosing the correct FDA or USP Class VI seal is critical for compliance and performance.
Request a Quote
Need help choosing the right seals?
Email: ask@ashton-group.co.uk
Call: +44 (0) 1226 273700
1. What are FDA and USP Class VI seals?
FDA and USP Class VI seals are sealing components made from materials that meet strict regulatory standards for food, pharmaceutical, and medical applications, ensuring safety and compliance.
2. What is the difference between FDA compliance and USP Class VI?
FDA compliance confirms materials are suitable for food contact, while USP Class VI certification tests for biocompatibility, making it suitable for medical and pharmaceutical use.
3. What materials are used in FDA and USP Class VI seals?
Common materials include silicone, EPDM, FKM, FFKM, and PTFE, all selected for their purity, chemical resistance, and suitability for sterilisation processes.
4. Where are FDA and USP Class VI seals used?
These seals are widely used in pharmaceutical manufacturing, medical devices, biotechnology equipment, and food processing systems where hygiene and compliance are critical.
5. Why are compliant seals important in life sciences applications?
They help ensure product safety, prevent contamination, and meet regulatory requirements, which is essential for protecting patients, consumers, and production processes.