At McDowell & Company, we specialize in manufacturing medical grade gaskets engineered for healthcare and medical device applications. Our medical grade gaskets meet stringent biocompatibility requirements and regulatory standards while ensuring reliable sealing performance. With 50+ years of experience, we maintain the highest standards for cleanliness, material purity, and documentation required for medical applications.
Medical Grade Gasket Technical Aspects
Materials
- USP Class VI silicone
- Medical grade PTFE
- Implant-grade elastomers
- Biocompatible compounds
- ISO 10993 compliant materials
- Platinum-cured silicone
- Custom medical compounds
Medical Grade Gasket Manufacturing Capabilities
- Clean room manufacturing
- ISO Class 7 facilities
- Validated processes
- Particulate-free production
- Bioburden control
- Sterilization compatibility
- Process validation
- Documentation packages
Medical Grade Gasket Quality Standards
- USP Class VI certification
- ISO 10993 compliance
- FDA device master files
- Material biocompatibility
- Lot traceability
- Sterilization validation
- Quality system controls
- Process validation records
Medical Grade Gasket Industries Served
- Medical Device Manufacturing
- Surgical Equipment
- Diagnostic Instruments
- Implantable Devices
- Laboratory Equipment
- Pharmaceutical Processing
- Biotech Research
- Healthcare Facilities
Medical Grade Gasket End Applications
- Surgical Instruments
- Diagnostic Equipment
- Medical Pumps
- Implantable Devices
- Laboratory Systems
- Fluid Management
- Drug Delivery Systems
- Sterilization Equipment
Medical Grade Gasket Frequently Asked Questions (FAQs)
1. What certifications are available for medical grade gaskets?
We provide USP Class VI certification, ISO 10993 compliance documentation, biocompatibility test reports, and full material documentation packages.
2. Are your medical grade gaskets sterilization compatible?
Yes, our materials are validated for multiple sterilization methods including EtO, gamma radiation, steam autoclave, and chemical sterilization.
3. What cleanliness standards do you maintain?
Our medical grade gaskets are manufactured in ISO Class 7 clean rooms with full particulate control and bioburden monitoring systems.
4. Do you maintain device master files with FDA?
Yes, we maintain device master files (DMFs) for our medical grade materials and can provide reference numbers for regulatory submissions.
5. Can you develop custom medical grade compounds?
Yes, we can formulate custom compounds meeting specific durometer, compression set, and biocompatibility requirements for your application.
