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Medical-Grade Silicone Gasket Manufacturing & Distribution
At McDowell & Company, we specialize in manufacturing medical-grade silicone gaskets engineered for critical healthcare, pharmaceutical, and biomedical applications. Our platinum-cured silicone gaskets meet the most stringent requirements for biocompatibility, purity, and performance. When your application demands the highest level of material purity and documented compliance, selecting the right medical-grade silicone gasket manufacturer is crucial. Our expertise ensures your gaskets meet all regulatory requirements while maintaining optimal sealing performance.
Medical-Grade Silicone Gasket Technical Aspects
Materials
- Platinum-cured silicone
- USP Class VI silicone
- Implant-grade silicone
- Low durometer compounds
- High durometer grades
- Optically clear silicone
- Custom formulations
- LSR (Liquid Silicone Rubber)
Manufacturing Capabilities
- ISO Class 7 clean room
- Automated molding
- Flash-free production
- Custom shapes
- Precision cutting
- Surface texturing
- Prototype development
- Validated processes
Quality Standards
- USP Class VI certification
- ISO 10993 compliance
- FDA 21 CFR 177.2600
- European Pharmacopoeia 3.1.9
- DMF registration
- Biocompatibility testing
- Material validation
- Clean room certification
Industries Served
- Medical Device
- Pharmaceutical Processing
- Biotech Manufacturing
- Laboratory Equipment
- Diagnostic Systems
- Healthcare Products
- Research Facilities
- Life Sciences
End Applications
- Medical Devices
- Drug Delivery Systems
- Fluid Transfer
- Sterile Processing
- Diagnostic Equipment
- Laboratory Apparatus
- Surgical Tools
- Implantable Devices
Frequently Asked Questions (FAQs)
1. What makes medical-grade silicone different from standard silicone?
Medical-grade silicone gaskets offer
- Platinum-cure system (vs peroxide)
- Higher purity levels
- Strict manufacturing controls
- Comprehensive testing
- Full traceability
- Validated processes
- Biocompatibility certification
- Clean room production
2. What sterilization methods are compatible?
Our medical-grade silicone gaskets are validated for
- Steam sterilization
- Gamma radiation
- Ethylene oxide
- Autoclave cycles
- Dry heat
- Chemical sterilization
- Multiple sterilization cycles
- E-beam processing
3. What validation documentation is available?
We provide comprehensive validation including
- USP Class VI certificates
- ISO 10993 test results
- Biocompatibility studies
- Extractables data
- Leachables testing
- Process validation
- Material certifications
- Lot traceability records
4. Can you customize medical-grade silicone properties?
Yes, we can customize
- Durometer (Shore A)
- Color options
- Surface finish
- Compression set
- Tear strength
- Elongation
- Tensile strength
- Specific gravity
5. What quality controls are in place for medical-grade silicone?
Our quality system includes
- Clean room monitoring
- Particle testing
- Bioburden control
- In-process testing
- Final inspection
- Dimensional verification
- Material testing
- Change control systems
