Now Available on Chamfr: Medical-Grade O-Rings from PAI

When sealing performance is critical, material compliance and availability make all the difference. Chamfr now offers a comprehensive range of FDA- and USP Class VI–compliant O-rings and seals from PAI, designed for high-performance applications in medical devices, bioprocessing systems, and pharmaceutical production.

This new product category features 504 unique o-rings and seals across six material types. With in-stock and quick-turn (3-4-week lead time) options available, engineers and sourcing teams can now find compliant, high-integrity O-rings in just a few clicks. No need to chase down material certs, wait on supplier quotes, or wonder if parts meet the required compliance levels.

Whether you’re designing a sterile fluid path or upgrading a valve seal, these O-rings provide the performance, flexibility, and traceability required in regulated environments. 

Product Specs Overview

Total SKUs: 504

Availability:

• ~50% In stock and ready to ship 
• ~50% Quick-turn (ships in 3-4 weeks) 

Size Range: 

• Inner Diameters: 0.056″ – 2.234″ 
• Outer Diameters: 0.176″ – 2.512″ 

Certifications & Compliance: 

• FDA 21 CFR 177.2600
• USP Class VI (biocompatibility)
• Cleanroom manufacturing and packaging (select materials)
• Detectable additives (for contamination control) 

Material Options & Performance Characteristics

Each O-ring material available through PAI serves a distinct purpose, with variations in temperature range, chemical compatibility, flexibility, and biocompatibility. 

1. Oil-Resistant FDA Grade Buna (Nitrile Rubber)

• Compliance: FDA 21 CFR 177.2600 
• Temperature Range: –40°C to +120°C (–40°F to +250°F) 
• Strengths: 
  • Excellent resistance to petroleum oils, fuels, and some chemicals 
  • Strong mechanical strength and abrasion resistance 
• Applications: 
  • Equipment where oil or grease exposure is common 
  • General industrial sealing where FDA compliance is required 

This Buna formulation strikes a strong balance between cost-efficiency and durability — ideal for engineers looking to maintain FDA compliance without over-specifying material. 

2. Metal Detectable Buna

• Compliance: FDA-compliant with added metal-detectable agents 
• Strengths: 
  • All the oil resistance of standard Buna 
  • Includes metallic additives detectable by inline food safety systems 
• Applications: 
  • Manufacturing environments focused on contamination prevention 
  • Conveyor systems, mixers, pumps, and filling lines 

These are a must-have for operations where foreign material detection is critical for regulatory compliance and safety assurance. 

3. Metal Detectable FKM (e.g., Viton®)

• Temperature Range: Up to ~230°C (450°F) 
• Strengths: 
  • Exceptional chemical resistance 
  • High temperature tolerance 
  • Metal detectable for in-line quality control 
• Applications: 
  • Clean-in-place (CIP) and steam-in-place (SIP) systems 
  • Pharma lines using aggressive cleaning agents 
  • Any environment where thermal and chemical durability are key 

This FKM compound is a step up for engineers needing performance beyond Buna, especially in high-temperature washdown or reactive process environments. 

4. Medical Grade Cleanroom FKM (USP Class VI) 

• Compliance: USP VI + Cleanroom manufacturing 
• Strengths: 
  • Biocompatible, non-toxic 
  • High chemical resistance 
  • Withstands sterilization (steam, radiation, chemical) 
• Applications: 
  • Medical device sealing (fluid paths, valves, filters) 
  • Biopharma and laboratory processing 
  • Single-use systems and sterile assemblies 

This material is specifically engineered for regulated medical and pharmaceutical use. Cleanroom packaging reduces risk during integration into final assemblies. 

5. Medical Grade Cleanroom Silicone (USP Class VI)

• Temperature Range: –60°C to +200°C (–76°F to +392°F) 
• Strengths: 
  • Highly flexible and compressible 
  • Biocompatible and inert 
  • Cleanroom produced 
• Applications: 
  • Soft seals for life science devices 
  • Microfluidics, diagnostics, and implantable assemblies (non-permanent) 
  • Applications where sealing must occur with minimal compression force 

Silicone’s softness and clarity make it a go-to material for teams prototyping or validating biocompatible systems in sensitive settings. 

6. Medical Grade Cleanroom EPDM (USP Class VI)

• Strengths: 
  • Excellent resistance to water, steam, and many chemicals 
  • Low extractables 
  • Steam sterilization–ready 
• Applications: 
  • Biopharmaceutical fluid transfer 
  • Fermentation or mixing systems 
  • Gaskets and seals exposed to water-based solutions 

EPDM is often the first choice in wet, steam-heavy environments where oil exposure is not a concern, offering excellent performance with a high level of compliance. 

Explore & Source Directly from Chamfr 

Whether you’re sourcing for a cleanroom pilot line or scaling a certified product, these O-rings offer the range, quality, and convenience you need to stay on track. 

Every SKU in the PAI O-ring collection is listed with technical specs, availability, and materials so you can find what you need when you need it — all in one place.

Shop the full PAI O-Ring collection → 

Not finding what you need? Submit a custom RFQ directly to PAI through Chamfr for your next project.