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USP Class VI Compliant Gasket Manufacturing & Distribution
At McDowell & Company, we specialize in manufacturing USP Class VI compliant gaskets engineered for the most stringent pharmaceutical, biotechnology, and medical device applications. Our USP Class VI gaskets undergo rigorous biocompatibility testing and validation to ensure they meet the highest standards of material purity and safety. When your application demands documented biocompatibility and complete material traceability, selecting the right USP Class VI gasket manufacturer is critical. Our expertise ensures full compliance with USP testing protocols while maintaining optimal sealing performance.
USP Class VI Gasket Technical Aspects
Materials
- USP Class VI PTFE
- USP Class VI Silicone
- USP Class VI FEP/PFA
- USP Class VI Viton®
- USP Class VI EPDM
- Platinum-cured silicones
- Custom USP compounds
- Validated blends
Manufacturing Capabilities
- Clean room production
- Validated processes
- Particle-free manufacturing
- Bioburden control
- Custom molding
- Precision fabrication
- Controlled environment
- Clean packaging
Quality Standards
- USP Class VI certification
- ISO 10993 compliance
- FDA 21 CFR standards
- European Pharmacopoeia
- ASME BPE standards
- Material certifications
- Change control systems
- Full lot traceability
Industries Served
- Pharmaceutical Manufacturing
- Bioprocessing
- Medical Device Production
- Laboratory Equipment
- Sterile Processing
- Research Facilities
- Diagnostic Equipment
- Clean Room Systems
End Applications
- Biopharmaceutical Processing
- Sterile Fluid Transfer
- Clean Steam Systems
- WFI Systems
- Pharmaceutical Equipment
- Laboratory Apparatus
- Medical Devices
- High-Purity Systems
Frequently Asked Questions (FAQs)
1. What does USP Class VI certification include?
USP Class VI certification involves comprehensive testing including
- Systemic toxicity
- Intracutaneous testing
- Implantation studies
- Physicochemical testing
- Biological reactivity
- Extraction analysis
Each test must be successfully passed before certification.
2. How are USP Class VI gaskets validated?
Our validation process includes
- Raw material testing
- Biocompatibility studies
- Extractables testing
- Leachables analysis
- Process validation
- Clean room monitoring
- Sterilization validation
- Full documentation packages
3. What documentation is provided with USP Class VI gaskets?
We provide comprehensive documentation including
- USP Class VI certificates
- Material certifications
- Lot traceability records
- Manufacturing controls
- Testing results
- Validation reports
- Certificate of Analysis
- Change control history
4. Are your USP Class VI gaskets suitable for steam applications?
Yes, our USP Class VI gaskets are validated for
- Pure steam service
- WFI systems
- Clean steam
- SIP processes
- CIP compatibility
- Multiple sterilization cycles
5. What sterilization methods are compatible?
Our USP Class VI gaskets are validated for
- Steam sterilization
- Gamma irradiation
- Ethylene oxide
- Autoclave cycles
- Chemical sterilization
- Dry heat
