At McDowell & Company, we specialize in manufacturing FDA-compliant rubber gaskets that meet all requirements of 21 CFR 177.2600 for food contact applications. Our rubber gaskets are specifically formulated and tested to comply with FDA regulations while providing excellent sealing performance. When your application demands documented FDA compliance for rubber articles, selecting the right FDA-compliant gasket manufacturer is essential. Our expertise ensures your gaskets meet all regulatory requirements while maintaining optimal performance in food and beverage processing applications.
FDA 21 CFR 177.2600 Rubber Gasket Technical Aspects
Materials
- FDA-compliant silicone
- FDA-grade Viton®
- Food-grade EPDM
- Compliant Buna-N
- Regulated compounds
- Custom FDA formulations
- Sanitary elastomers
- Validated rubber blends
Manufacturing Capabilities
- Sanitary production
- Controlled processing
- Clean manufacturing
- Flash-free molding
- Precision cutting
- Custom shapes
- Validated processes
- Hygienic handling
Quality Standards
- FDA 21 CFR 177.2600
- 3-A Sanitary Standards
- USDA compliance
- NSF certification
- Good Manufacturing Practices
- Material testing
- Extraction studies
- Full lot traceability
Industries Served
- Food Processing
- Beverage Production
- Dairy Manufacturing
- Pharmaceutical
- Cosmetics
- Pet Food Production
- Food Packaging
- Nutraceuticals
End Applications
- Food Processing Equipment
- Dairy Systems
- Beverage Lines
- Sanitary Connections
- CIP/SIP Systems
- Storage Tanks
- Transfer Lines
- Processing Vessels
FDA 21 CFR 177.2600 Rubber Gasket Frequently Asked Questions (FAQs)
1. What does FDA 21 CFR 177.2600 compliance require?
Compliance includes
- Approved rubber formulations
- Specific compositional limits
- Extraction requirements
- Temperature limitations
- Use condition compliance
- Processing controls
- Testing protocols
- Documentation systems
2. What documentation is provided?
We provide comprehensive documentation including
- FDA compliance certificates
- Material certifications
- Extraction test results
- Composition declarations
- Manufacturing controls
- Lot traceability
- Test reports
- Change control records
3. What testing is performed on FDA rubber materials?
Our testing includes
- Total extractables
- Chemical resistance
- Physical properties
- Compression set
- Temperature stability
- Hardness testing
- Dimensional control
- Performance validation
4. Are these gaskets suitable for dairy applications?
Yes, our FDA rubber gaskets are designed for
- Dairy processing
- Milk handling
- Cheese production
- Ice cream manufacturing
- Clean-in-place systems
- Steam sterilization
- Hot water sanitization
- Temperature cycling
5. How do you ensure ongoing FDA compliance?
We maintain compliance through
- Material controls
- Process monitoring
- Regular testing
- Documentation updates
- Supplier qualification
- Change management
- Quality oversight
- Continuous validation
