White Silicone Components & Custom Parts

White Silicone Components & Custom Parts

Expert manufacturing of White Silicone components with FDA, USP Class VI, and ISO certifications. Custom parts for medical, pharmaceutical, and food processing applications.

White Silicone Components for Critical Applications

McDowell & Company specializes in manufacturing custom components using premium White Silicone materials. With over 50 years of expertise, we deliver precision-engineered solutions that meet the strict requirements of medical, pharmaceutical, and food processing industries.

Benefits of White Silicone

White Silicone provides essential properties for regulated industries:

• Temperature resistance from -60°F to +400°F
• FDA compliance for food contact
• USP Class VI certification available
• ISO 10993 biocompatibility
• Excellent compression set resistance
• Superior tear strength
• Low toxicity
• High purity formulation
• Easy visual inspection
• Steam sterilization capable

Common Applications

Our engineering team regularly produces White Silicone components for:

• Medical device manufacturing
• Pharmaceutical processing
• Food and beverage production
• Clean room environments
• Laboratory equipment
• Biotechnology applications
• Diagnostic equipment
• Fluid handling systems

Manufacturing Capabilities

McDowell & Company produces White Silicone components with precision:

• Custom O-rings and seals
• Gaskets and custom profiles
• Molded components
• Precision-machined parts
• Clean room processing
• Custom size ranges
• Prototype development
• Production quantities

Certifications and Compliance

Our White Silicone components meet key industry standards:

• FDA 21 CFR 177.2600
• USP Class VI
• ISO 10993
• 3-A Sanitary Standards
• European Pharmacopoeia 3.1.9
• REACH and RoHS compliant
• Clean room compatible
• Animal derivative free (ADI)

Frequently Asked Questions

Is White Silicone safe for medical applications?
Yes, our White Silicone compounds are available with USP Class VI and ISO 10993 certifications for medical applications.

Can White Silicone components be sterilized?
Yes, White Silicone is compatible with multiple sterilization methods including autoclave, gamma radiation, and EtO.

What sizes are available?
We manufacture custom sizes from micro-scale components to large diameter seals based on your specifications.

How does White Silicone compare to other materials?
White Silicone offers superior biocompatibility, temperature resistance, and flexibility compared to many other elastomers, making it ideal for medical and food applications.

Quality Assurance

• Material certifications
• Dimensional inspection reports
• Surface finish verification
• Cleanliness certification
• First Article Inspection (FAI)
• Certificate of Conformance (COC)
• Lot traceability
• Quality system documentation

Engineering Support

• Material selection guidance
• Design optimization
• Regulatory compliance assistance
• Custom solution development
• Prototype manufacturing
• Performance testing
• Documentation support
• Validation assistance

Contact our sales team today to discuss your White Silicone component requirements. With decades of experience in precision manufacturing and material science, we ensure your components meet all regulatory and performance requirements.