At McDowell & Company, we specialize in manufacturing USP Class VI certified gaskets engineered for critical pharmaceutical and medical device applications. Our gaskets undergo rigorous USP Class VI testing and validation to ensure they meet the highest standards of biocompatibility and material safety. When your application demands documented biocompatibility and complete traceability, selecting the right USP Class VI certified gasket manufacturer is essential. Our expertise ensures compliance with all USP testing protocols while maintaining optimal sealing performance.
USP Class VI Certified Gasket Technical Aspects
Materials
- USP Class VI PTFE
- USP Class VI Silicone
- USP Class VI Viton®
- USP Class VI EPDM
- USP Tested compounds
- Medical-grade elastomers
- Custom formulations
- Validated blends
Manufacturing Capabilities
- Clean room production
- Validated processes
- Bioburden control
- Particle-free processing
- Custom molding
- Precision fabrication
- Change control
- Clean packaging
Quality Standards
- USP <87> Biological Reactivity
- USP <88> Class VI Testing
- ISO 10993 compliance
- FDA 21 CFR compliance
- European Pharmacopoeia
- Material validation
- Process controls
- Full traceability
Industries Served
- Pharmaceutical Manufacturing
- Medical Device Production
- Biotechnology
- Healthcare Products
- Research Facilities
- Laboratory Equipment
- Diagnostic Systems
- Drug Delivery Devices
End Applications
- Pharmaceutical Processing
- Sterile Manufacturing
- Bioprocess Equipment
- Medical Devices
- Laboratory Systems
- Research Apparatus
- Diagnostic Tools
- Drug Production
USP Class VI Certified Gasket Frequently Asked Questions (FAQs)
1. What testing is required for USP Class VI certification?
USP Class VI testing includes
- Systemic Toxicity Test
- Intracutaneous Test
- Implantation Test
- Physiochemical Testing
- Biological Reactivity
- Acute Systemic Toxicity
- Material Characterization
- Extractables Analysis
2. What validation documentation is provided?
We provide comprehensive documentation including
- USP Class VI certificates
- Test reports and protocols
- Material certifications
- Process validation
- Lot traceability
- Change control history
- Biocompatibility data
- Material master files
3. How do you maintain USP Class VI certification?
Our maintenance program includes
- Regular material testing
- Process monitoring
- Change control systems
- Supplier qualification
- Quality oversight
- Documentation updates
- Material controls
- Continuous validation
4. What sterilization methods are compatible?
Our USP Class VI gaskets are validated for
- Steam sterilization
- Gamma radiation
- Ethylene oxide
- Autoclave cycles
- Chemical sterilization
- Multiple cycles
- E-beam processing
- Dry heat
5. How do you ensure material traceability?
We maintain traceability through
- Unique lot identification
- Raw material tracking
- Process documentation
- Testing records
- Material certification
- Change control
- Quality records
- Manufacturing logs
