At McDowell & Company, we specialize in manufacturing FDA approved gasket materials designed for regulated industries where material compliance is critical. FDA approved gaskets ensure safety and compliance in food processing, pharmaceutical manufacturing, and medical device applications. With over 50 years of experience, we maintain strict adherence to FDA regulations while delivering superior sealing performance.
FDA Approved Gasket Technical Aspects
Materials
- FDA-compliant silicone
- FDA-grade PTFE
- USP Class VI elastomers
- FDA-approved Viton®
- Platinum-cured silicone
- Medical-grade Buna-N
- 3-A Sanitary Standards materials
FDA Approved Gasket Manufacturing Capabilities
- Clean room production
- Validated processes
- Sanitary fabrication
- Certified material handling
- Lot control systems
- Documentation packages
- Quality assurance testing
FDA Approved Gasket Quality Standards
- FDA 21 CFR 177.2600 compliance
- FDA 21 CFR 177.1550 compliance
- USP Class VI certification
- 3-A Sanitary Standards
- GRAS certification
- Material traceability
- Biocompatibility testing
FDA Approved Gasket Industries Served
- Food Processing
- Pharmaceutical Manufacturing
- Medical Device Production
- Biotechnology
- Dairy Processing
- Beverage Production
- Healthcare
- Cosmetics Manufacturing
FDA Approved Gasket End Applications
- Sanitary Process Equipment
- Sterile Transfer Systems
- Food Contact Surfaces
- Pharmaceutical Processing
- Clean-in-Place Systems
- Sterile Filling Equipment
- Bioreactor Sealing
- Medical Device Assembly
FDA Approved Gasket Frequently Asked Questions (FAQs)
1. What FDA regulations apply to gasket materials?
Our materials comply with FDA 21 CFR 177.2600 for rubber articles and FDA 21 CFR 177.1550 for perfluorocarbon resins, ensuring safety for food contact and pharmaceutical applications.
2. Do you provide documentation for FDA compliance?
Yes, we provide comprehensive documentation packages including FDA compliance certificates, USP Class VI certifications, and material test reports for full traceability.
3. What is the difference between FDA-grade and medical-grade materials?
FDA-grade materials meet food contact requirements, while medical-grade materials undergo additional testing and certification for biocompatibility and USP Class VI compliance.
4. Can FDA approved gaskets handle sterilization?
Yes, our FDA approved gaskets are compatible with common sterilization methods including steam, EtO, and gamma radiation, depending on the specific material selected.
5. Do you offer custom FDA approved gasket compounds?
Yes, we can develop custom compounds that meet FDA requirements while providing specific performance characteristics for your application.
