FDA-Compliant Pharmaceutical
Sealing Solutions
Ensure product purity and regulatory compliance with our comprehensive range of pharmaceutical-grade sealing solutions. From API processing to sterile filling, our materials meet the strictest industry standards.
Bioreactor Sealing System
Pharmaceutical Manufacturing Applications
From upstream bioprocessing to final drug product manufacturing, our sealing solutions ensure product integrity and regulatory compliance throughout the pharmaceutical value chain.
Bioprocessing Equipment
Critical sealing for bioreactors, fermenters, and cell culture systems where sterility and contamination control are paramount.
API Manufacturing
Precision sealing for active pharmaceutical ingredient synthesis, purification, and processing equipment requiring chemical compatibility.
Drug Product Manufacturing
Hygienic sealing for formulation, filling, and packaging operations ensuring final product quality and patient safety.
Pharmaceutical Equipment Applications
Upstream Processing
Downstream Processing
Manufacturing
Support Systems
Regulatory Compliance & Validation
Our pharmaceutical sealing materials meet the most stringent regulatory requirements and are supported by comprehensive validation documentation.
FDA Compliance
Complete FDA compliance documentation including material safety data, extractables testing, and regulatory support for submissions.
USP Standards
USP Class VI certification with comprehensive biological reactivity testing and extractables/leachables analysis per USP guidelines.
Global Standards
International regulatory compliance including European regulations and global hygienic design standards.
Extractables & Leachables Analysis
Testing Protocols
• pH 3.0 buffer and pH 11.0 buffer
• GC-MS and LC-MS analysis
• Isopropanol and hexane solvents
• Comprehensive organic analysis
• Actual media and temperature exposure
• Long-term stability testing
Typical Results (ppm)
| Material | Water | Alcohol | Buffer |
|---|---|---|---|
| Pharma Silicone | < 0.5 | < 1.0 | < 0.8 |
| EPDM Pharma | < 1.0 | < 3.0 | < 1.5 |
| FKM Pharma | < 0.3 | < 0.5 | < 0.4 |
| FFKM Ultra-Pure | < 0.1 | < 0.2 | < 0.1 |
Validation Package Includes:
- • Complete analytical reports (GC-MS, LC-MS)
- • Toxicological risk assessment
- • Certificate of compliance
- • Regulatory support documentation
Pharmaceutical-Grade Materials
Our comprehensive range of pharmaceutical-grade elastomers are specifically formulated and tested for biocompatibility, purity, and regulatory compliance.
| Material | FDA | USP VI | SIP Temp | Extractables | Applications |
|---|---|---|---|---|---|
| Pharma Silicone | ✓ | Class VI | 275°F | < 1 ppm | General purpose, biocompatible |
| EPDM Pharmaceutical | ✓ | Class VI | 300°F | < 3 ppm | Steam sterilization, aqueous |
| FKM Pharmaceutical | ✓ | Class VI | 316°F | < 0.5 ppm | Chemical resistance, solvents |
| FFKM Ultra-Pure | ✓ | Class VI | 350°F | < 0.1 ppm | Ultimate purity, aggressive media |
| PTFE Encapsulated | ✓ | Class VI | 400°F | < 0.05 ppm | Universal compatibility |
Steam-in-Place (SIP) Performance
- • Compression set after 1000 SIP cycles
- • Tensile strength retention > 80%
- • Dimensional stability verification
- • Extractables level maintenance
Clean-in-Place (CIP) Compatibility
Pharmaceutical Quality ROI Analysis
Calculate the business impact of pharmaceutical-grade sealing on your manufacturing operations, product quality, and regulatory compliance.
Quality Impact Calculator
Annual Quality Impact
Current Risk Profile
With Pharma-Grade Seals
Net Benefits
Additional Quality Benefits
Get Your Pharmaceutical Compliance Quote
Our pharmaceutical specialists understand your regulatory requirements and quality standards. Get a comprehensive quote with full compliance documentation within 24 hours.
Compliance Requirements
Complete Compliance Package
Regulatory Documentation
Complete FDA, USP, and international compliance certificates with extractables/leachables analysis.
Validation Support
Technical validation packages for SIP/CIP testing, biocompatibility, and process compatibility.
Expert Consultation
Direct access to our pharmaceutical engineers for material selection and application guidance.
Quality Cost Analysis
Detailed ROI analysis showing quality improvements and risk reduction benefits.