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Silicone Gasket Manufacturing & Distribution
At McDowell & Company, we specialize in manufacturing silicone gaskets engineered for medical, pharmaceutical, and high-purity applications. Our comprehensive range includes medical-grade, FDA-compliant, and USP Class VI certified silicone gaskets that deliver exceptional temperature resistance and biocompatibility. When your application demands the highest levels of purity, biocompatibility, and temperature stability, selecting the right silicone gasket manufacturer is crucial. Our expertise ensures your silicone gaskets meet the most stringent regulatory requirements while maintaining optimal performance.
Silicone Gasket Technical Aspects
Materials
- Medical-grade silicone
- USP Class VI silicone
- Platinum-cured silicone
- FDA-grade silicone
- High-temperature compounds
- Clean room grade silicone
- Custom silicone blends
- LSR (Liquid Silicone Rubber)
Silicone Gasket Manufacturing Capabilities
- Clean room production
- Compression molding
- Liquid injection molding
- Precision die cutting
- Custom profiles
- Prototype development
- Flash-free molding
- Surface texturing
Silicone Gasket Quality Standards
- USP Class VI certification
- FDA 21 CFR 177.2600
- ISO 10993 biocompatibility
- European Pharmacopoeia 3.1.9
- DMF documentation
- Lot traceability
- Extractables testing
- Biocompatibility testing
Silicone Gasket Industries Served
- Medical Device
- Pharmaceutical
- Biotechnology
- Healthcare
- Food & Beverage
- Laboratory Equipment
- Clean Room Equipment
- Life Sciences
Silicone Gasket End Applications
- IV Equipment
- Medical Devices
- Pharmaceutical Processing
- Sterile Transfer Systems
- Clean Room Equipment
- Laboratory Apparatus
- Fluid Management
- Diagnostic Equipment
Silicone Gasket Frequently Asked Questions (FAQs)
1. What makes medical-grade silicone gaskets different?
Medical-grade silicone gaskets are manufactured under strict clean room conditions using USP Class VI materials, with comprehensive documentation, validation, and biocompatibility testing to ensure compliance with medical device regulations.
2. What temperature range can silicone gaskets handle?
Silicone gaskets perform exceptionally from -103°F to +400°F continuous service, with superior flexibility at low temperatures and stability at high temperatures. Special compounds can handle even more extreme temperatures.
3. What certifications are available for silicone gaskets?
We offer
- USP Class VI certification
- FDA compliance documentation
- ISO 10993 biocompatibility
- European Pharmacopoeia compliance
- DMF documentation
- Full lot traceability
4. Can you provide validation for medical applications?
Yes, we provide comprehensive validation packages including
- Material certifications
- Biocompatibility testing
- Extractables studies
- Leachables analysis
- Sterility validation
- Process validation
5. What sterilization methods are compatible with silicone gaskets?
Our silicone gaskets are compatible with multiple sterilization methods including
- Autoclave
- Gamma radiation
- EtO (Ethylene Oxide)
- E-beam
- Steam sterilization
