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Medical & Pharmaceutical Grade Gasket Manufacturing & Distribution
At McDowell & Company, we specialize in manufacturing medical and pharmaceutical grade gaskets engineered for the most demanding healthcare and life science applications. Our comprehensive range of USP Class VI and FDA-compliant gaskets ensures the highest standards of purity, biocompatibility, and regulatory compliance. When your application demands absolute cleanliness, traceability, and validation, selecting the right medical-grade gasket manufacturer is crucial. Our expertise ensures your gaskets meet the most stringent regulatory requirements while maintaining optimal performance in critical applications.
Medical/Pharmaceutical Grade Gasket Technical Aspects
Materials
- USP Class VI certified materials
- FDA-compliant compounds
- Platinum-cured silicone
- Medical-grade PTFE
- Pure PFA/FEP
- Biocompatible elastomers
- ISO 10993 compliant materials
- Custom validated compounds
Manufacturing Capabilities
- ISO Class 7 clean room production
- Automated precision fabrication
- Particle-free processing
- Clean packaging protocols
- Custom molding
- Validated processes
- Prototype development
- Lot control systems
Quality Standards
- USP Class VI certification
- FDA 21 CFR compliance
- ISO 10993 biocompatibility
- European Pharmacopoeia
- DMF documentation
- ISO 13485:2016
- cGMP standards
- Clean room validation
Industries Served
- Medical Device Manufacturing
- Pharmaceutical Production
- Biotechnology
- Laboratory Equipment
- Diagnostic Systems
- Clean Room Equipment
- Research Facilities
- Drug Delivery Systems
End Applications
- Sterile Processing Equipment
- Pharmaceutical Transfer Lines
- Bioprocess Equipment
- Medical Devices
- Diagnostic Equipment
- Laboratory Apparatus
- Clean Room Systems
- Drug Manufacturing
Frequently Asked Questions (FAQs)
1. What certifications are available for medical-grade gaskets?
Our gaskets are available with
- USP Class VI certification
- FDA compliance documentation
- ISO 10993 biocompatibility testing
- European Pharmacopoeia compliance
- Drug Master File references
- Material certifications
- Process validation documents
- Clean room certification
2. What validation documentation do you provide?
We offer comprehensive validation packages including
- Material certifications
- Biocompatibility testing
- Extractables studies
- Leachables analysis
- Sterilization validation
- Clean room monitoring data
- Process validation
- Certificate of Compliance
3. What sterilization methods are compatible?
Our medical-grade gaskets are validated for multiple sterilization methods
- Steam autoclave
- Gamma radiation
- Ethylene oxide
- E-beam
- Dry heat
- Chemical sterilization
4. How do you ensure material traceability?
We maintain complete lot traceability through
- Unique lot identification
- Raw material tracking
- Process documentation
- Quality control testing
- Certificate of Analysis
- Material certifications
- Manufacturing records
- Change control systems
5. What clean room capabilities do you offer?
Our ISO Class 7 clean room facilities provid
- Controlled environment manufacturing
- Particle monitoring
- Clean packaging
- Validated cleaning processes
- Environmental monitoring
- Personnel controls
- Clean room garment protocols
- Contamination prevention
