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FDA Approved Gasket Manufacturing & Distribution
At McDowell & Company, we specialize in manufacturing FDA approved gaskets engineered for food processing, pharmaceutical production, and regulated medical applications. Our comprehensive range of FDA-compliant materials meets all requirements under 21 CFR regulations for food and drug contact. When your application demands regulatory compliance and material safety, selecting the right FDA approved gasket manufacturer is essential. Our expertise ensures your gaskets meet all FDA requirements while delivering reliable sealing performance.
FDA Approved Gasket Technical Aspects
Materials
- FDA PTFE (21 CFR 177.1550)
- FDA Silicone (21 CFR 177.2600)
- FDA Viton® (21 CFR 177.2600)
- FDA EPDM (21 CFR 177.2600)
- FDA Buna-N (21 CFR 177.2600)
- FDA grade fluoropolymers
- Custom FDA compounds
- Food-grade materials
Manufacturing Capabilities
- Sanitary fabrication
- Hygienic processing
- Clean room production
- CIP/SIP compatible
- 3-A design standards
- Custom molding
- Precision cutting
- Validated processes
Quality Standards
- FDA 21 CFR compliance
- 3-A Sanitary Standards
- USDA requirements
- NSF certification
- GRAS materials
- Material certifications
- Lot traceability
- Process validation
Industries Served
- Food Processing
- Beverage Production
- Dairy Manufacturing
- Pharmaceutical
- Medical Device
- Cosmetics
- Nutraceutical
- Biotechnology
End Applications
- Food Processing Equipment
- Dairy Systems
- Beverage Lines
- Pharmaceutical Processing
- Sanitary Connections
- CIP/SIP Systems
- Sterile Transfer
- Hygienic Equipment
FDA Approved Gasket Frequently Asked Questions (FAQs)
1. What makes a gasket FDA approved?
FDA approved gaskets must
- Be manufactured from materials listed in FDA 21 CFR
- Meet specific compositional requirements
- Comply with extraction limitations
- Be produced under good manufacturing practices
- Maintain documented traceability
- Meet food contact requirements
2. Which FDA regulations apply to gaskets?
Key regulations include
- 21 CFR 177.1550 (PTFE)
- 21 CFR 177.2600 (Rubber articles)
- 21 CFR 178.3297 (Colorants)
- 21 CFR 174.5 (General provisions)
- 21 CFR 110 (Good manufacturing practices)
3. What documentation is provided with FDA approved gaskets?
We provide comprehensive documentation including
- FDA compliance certificates
- Material certifications
- Lot traceability records
- Composition statements
- Testing results
- Manufacturing controls
- Certificate of Conformance
- Change control history
4. Are FDA approved gaskets suitable for CIP/SIP processes?
Yes, our FDA approved gaskets are designed for
- Clean-in-place compatibility
- Steam-in-place processes
- Hot water sanitization
- Chemical cleaning agents
- Multiple cleaning cycles
- Temperature cycling
- Pressure cycling
- Chemical exposure
5. What testing is performed on FDA approved materials?
Our testing includes
- Extraction studies
- Chemical resistance
- Physical properties
- Compression set
- Temperature stability
- Durometer testing
- Dimensional verification
- Performance validation
