At McDowell & Company, we specialize in manufacturing FDA-compliant PTFE gaskets that meet all requirements of 21 CFR 177.1550 for food contact applications. Our PTFE gaskets are specifically engineered to comply with FDA regulations while providing superior chemical resistance and excellent sealing properties. When your application demands documented FDA compliance and material safety, selecting the right FDA-compliant PTFE gasket manufacturer is essential. Our expertise ensures your gaskets meet all regulatory requirements while maintaining optimal performance.
FDA 21 CFR 177.1550 PTFE Gasket Technical Aspects
Materials
- FDA-compliant virgin PTFE
- Regulated PTFE compounds
- Food-grade PTFE
- Pure PTFE resins
- Validated fillers
- Custom FDA compounds
- High-purity PTFE
- Sanctioned additives
Manufacturing Capabilities
- Controlled processing
- Sanitary fabrication
- Clean production
- CIP/SIP compatible
- Precision machining
- Custom molding
- Traceable processes
- Validated procedures
Quality Standards
- FDA 21 CFR 177.1550
- 3-A Sanitary Standards
- USDA compliance
- Good Manufacturing Practices
- Material certifications
- Extraction testing
- Process validation
- Complete traceability
Industries Served
- Food Processing
- Beverage Production
- Dairy Manufacturing
- Pharmaceutical
- Cosmetics
- Nutraceuticals
- Food Packaging
- Consumer Products
End Applications
- Food Contact Equipment
- Dairy Processing
- Beverage Systems
- Sanitary Connections
- CIP/SIP Systems
- Process Equipment
- Storage Vessels
- Transfer Lines
FDA 21 CFR 177.1550 PTFE Gasket Frequently Asked Questions (FAQs)
1. What does FDA 21 CFR 177.1550 compliance require?
Compliance includes
- Specified raw materials
- Composition requirements
- Extraction limitations
- Processing controls
- Documentation systems
- Testing protocols
- Use conditions
- Temperature limitations
2. What documentation is provided?
We provide comprehensive documentation including
- FDA compliance certificates
- Material certifications
- Extraction test results
- Composition statements
- Process validation
- Lot traceability
- Testing reports
- Change control history
3. 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
4. Are these gaskets suitable for CIP/SIP processes?
Yes, our FDA PTFE gaskets are designed for
- Clean-in-place systems
- Steam-in-place processes
- Hot water sanitization
- Chemical cleaning
- Temperature cycling
- Pressure cycling
- Multiple cleaning cycles
- Sterilization procedures
5. What testing is performed on FDA PTFE materials?
Our testing includes
- Extraction studies
- Composition analysis
- Physical properties
- Chemical resistance
- Temperature stability
- Dimensional control
- Surface properties
- Performance validation
