Custom Viton® Seals for Pharmaceutical Applications
How CTG Specializes in Pharmaceutical Viton® Seals
CTG excels in manufacturing high-performance Viton® fluoroelastomer seals specifically engineered for the stringent requirements of pharmaceutical processing. Our specialized manufacturing processes ensure compliance with regulatory standards while delivering optimal performance in environments with aggressive process chemicals and cleaning agents. We leverage extensive pharmaceutical industry experience to deliver Viton® seals that provide reliable service in GMP-critical applications.
Pharmaceutical Viton® Seal Features
Our pharmaceutical Viton® seals feature:
- FDA compliance options
- USP Class VI certification availability
- Exceptional API compatibility
- Superior CIP/SIP resistance
- Low extractables and leachables
- Outstanding steam resistance
- Excellent compression set properties
- Extended service life in sterile environments
Pharmaceutical Applications
CTG’s Viton® seals excel in pharmaceutical applications including:
- API reactor vessel seals
- Sterile filling machine components
- Filtration system seals
- Centrifuge and separator seals
- Fermentation equipment
- Lyophilization system components
- Process valve seals
- Sterilization equipment seals
Industry Standards & Compliance
Our pharmaceutical Viton® seals meet:
- FDA 21 CFR 177.2600 (where applicable)
- USP Class VI testing
- ISO 10993 biocompatibility (where required)
- 3-A Sanitary Standards
- ASME-BPE standards
- EU 1935/2004 regulations
- cGMP requirements
- Customer-specific pharmaceutical standards
Pharmaceutical Viton® FAQ
What makes Viton® ideal for pharmaceutical production?
Viton® offers excellent chemical compatibility with aggressive pharmaceutical ingredients and cleaning agents, while specialized formulations provide compliance with FDA and USP requirements, making it the optimal choice for critical pharmaceutical processes.
How do your Viton® seals handle repeated steam sterilization?
Our pharmaceutical Viton® compounds are engineered specifically for steam resistance, withstanding thousands of SIP cycles at 275°F (135°C) with minimal degradation or compression set, ensuring long-term seal integrity in sterile processes.
What extractable and leachable testing is performed on your pharmaceutical Viton® materials?
Our pharmaceutical-grade Viton® compounds undergo comprehensive extractable and leachable testing using advanced analytical techniques to document compliance with regulatory requirements and ensure product purity.
Can your Viton® seals handle aggressive cleaning agents?
Yes, our pharmaceutical Viton® seals offer excellent resistance to the full spectrum of cleaning and sanitizing agents used in pharmaceutical facilities, including caustic solutions, acids, oxidizers, and solvents used in CIP processes.
Do you provide documentation packages for validation?
Yes, we offer comprehensive documentation packages for our pharmaceutical Viton® seals, including material certifications, testing data, compliance certificates, and traceability documentation to support customer validation requirements.
Custom Solutions for Pharmaceutical Applications
CTG offers:
- FDA-compliant Viton® formulations
- USP Class VI tested compounds
- Low extractable profiles
- Enhanced steam resistance
- CIP/SIP-optimized designs
- Rapid prototype development
- Material certification packages
- Comprehensive validation support
Contact our technical team today at 800.299.1685 or email ctgsales@ctgasket.com for expert guidance on your pharmaceutical Viton® seal requirements.
24/7 Emergency Delivery Available
TECHNICAL LIBRARY
For available materials, sizing, geometry, gland considerations and more, view our technical library.
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24/7 Emergency Delivery Available
For urgent needs call 800.299.1685
