In the medical device industry, reliability, precision, and regulatory compliance are non-negotiable. Components such as tubing, seals, gaskets, cords, and custom extrusions must withstand repeated sterilization, maintain flexibility, and perform consistently under mechanical and chemical stress.

SantopSeal Corporation specializes in manufacturing custom medical components using industry-leading elastomers such as Santoprene® TPV, TPE, and Silicone. With expertise in extrusion, blow molding, and injection molding, SantopSeal transforms these materials into high-precision, application-ready parts for commercial medical devices.

Whether your project requires small prototype runs or high-volume production, SantopSeal delivers custom shapes, multiple durometers, color options, and rapid lead times, ensuring your device components meet the highest standards.

Why Medical-Grade Elastomers Matter in Extrusions

Medical-grade elastomers must meet stringent requirements:

• Biocompatibility: Conforming to USP Class VI and ISO 10993 for safe patient contact
• Sterilization Resistance: Withstanding autoclave, gamma, or EtO sterilization
• Mechanical Performance: Maintaining shape under compression and tension
• Chemical & Thermal Stability: Compatible with disinfectants, fluids, and extreme temperatures

Using high-quality elastomers is critical, but the manufacturing process, extrusion, molding, and finishing ultimately determines component performance. SantopSeal’s expertise ensures that medical-grade materials are formed into precise, functional, and reliable parts.

Materials used by SantopSeal for Custom Medical Extrusions

Santoprene® TPV (Thermoplastic Vulcanizate)

SantopSeal works with a broad range of Santoprene® medical grades optimized for extrusion and molding, including:

• Santoprene® 181-55MED – Injection molding & coextrusion
• Santoprene® 281-55MED / 281-64MED – Coextrusion and small tubing extrusion
• Santoprene® 8281 Series (35, 45, 55, 65, 75MED) – Multi-injection molding, blow molding, small tubing extrusion

Technical Highlight: Santoprene® 8281-75MED

A commonly used grade for medical extrusions, Santoprene® 8281-75MED is:

• Soft, colorable, non-hygroscopic TPV in the TPE family
• Biocompatible (USP Class VI / ISO 10993) with annual testing for cytotoxicity and heavy metals
• Maintained Drug Master File (DMF) with the FDA
• Processing methods: Extrusion (small tubing), blow molding, injection molding
• Mechanical Properties:
  • Shore A hardness: 79
  • Tensile stress at 100% elongation: 3.6 MPa
  • Tensile stress at break: 7.8 MPa
  • Elongation at break: 510%
  • Compression set: 34% at 23°C, 35% at 70°C, 48% at 125°C
• Density: 920 kg/m³

This combination of properties makes it ideal for medical tubing, seals, and extrusions that require durability, flexibility, and sterilization resistance.

TPE (Thermoplastic Elastomers) : Medical-grade TPEs provide excellent flexibility and soft-touch properties while remaining processable via extrusion and injection molding.

Key Advantages:

• Customizable in durometer (45–80A) and color
• Excellent compression set and elongation
• Can mimic silicone feel with simpler processing
• Ideal for overmolded components, cords, and soft-touch extrusions

Applications: Tubing, gaskets, seals, cords, and soft grips for medical devices.

Medical-Grade Silicone: Silicone remains the gold standard for high-performance medical extrusions:

• High elongation and low compression set
• Heat and chemical resistant
• Sterilizable via autoclave, EtO, or gamma methods
• Available in multiple colors and durometers

Applications: Tubing, seals, gaskets, diaphragms, and flexible extruded profiles in fluid-handling, diagnostic, and respiratory devices.

Custom Extrusions & Tubing: SantopSeal Expertise

SantopSeal specializes in custom extrusions for medical devices, including:

• Tubing: IV lines, catheters, fluid transport systems
• Seals & Gaskets: Leak-proof device closures, diaphragms
• Cords & Profiles: Protective grips, connectors, and custom cross-sections

Capabilities:

• Multiple durometers: 35–80A for soft or firm applications
• Custom colors: For device coding or branding
• Production flexibility: From 50 ft prototypes to millions of feet
• Short lead times: Typically 2 weeks for prototypes or small runs
• Precision extrusion: Tight dimensional tolerances and complex cross-sections

SantopSeal’s experience with Santoprene® TPV grades ensures that extruded tubing, seals, and gaskets are dimensionally stable, biocompatible, and ready for sterilization, regardless of volume.

Comparison of Santoprene® TPV Grades for Extrusion

Grade	Processing	Applications	Durometer	Notes
181-55MED	Coextrusion, Injection Molding	Tubing, seals, gaskets	55A	Standard medical applications
281-55MED	Coextrusion, Injection Molding	Tubing, cords	55A	Flexible extrusion option
281-64MED	Coextrusion, Small Tubing Extrusion	Small-diameter tubing	64A	Tight-tolerance tubing
8281-35MED	Multi Injection Molding	Seals, gaskets	35A	Soft, flexible profiles
8281-45MED	Multi Injection Molding	Tubing, grips	45A	Balanced flexibility
8281-55MED	Multi Injection Molding	Tubing, extrusions	55A	Medium durometer, general purpose
8281-65MED	Blow Molding, Small Tubing Extrusion	Tubing, seals	65A	Firmer extrusion needs
8281-75MED	Blow Molding, Small Tubing Extrusion	Tubing, gaskets	79A	High strength, USP Class VI certified

 

Applications Across Medical Devices

SantopSeal produces extrusions, tubing, seals, and gaskets for commercial medical applications:

• Tubing: IV, catheters, fluid-handling systems
• Seals & Gaskets: Leak-proof device closures, diaphragms, membranes
• Cords & Custom Profiles: Protective grips, connectors, cross-sectional profiles
• Soft-touch or overmolded parts: Flexible device grips and handles

The combination of SantopSeal’s manufacturing expertise and high-quality medical-grade materials ensures performance, compliance, and reliability.

Why Choose SantopSeal for Medical Extrusions?

• Expert Manufacturing: Precision extrusion, molding, and finishing
• Custom Shapes & Sizes: Tubing, cords, gaskets, and seals
• Multiple Durometers & Colors: 45–80A
• USP Class VI Certified Materials: Biocompatible and FDA-compliant
• Short Lead Times: 2 weeks for prototypes or small runs
• Production Flexibility: 50 ft to millions of ft
• Engineering Support: Design, prototyping, and material selection

SantopSeal is a trusted partner for medical device manufacturers who need custom extrusions, tubing, and seals using proven medical-grade elastomers.

Request a Quote or Download Datasheets

• Request a Quote for custom tubing, seals, gaskets, or extrusions
• Download Technical Datasheets for Santoprene® TPV grades and processing properties
• Talk to a Specialist to discuss your application and specifications

SantopSeal Corporation ensures that your medical devices have high-quality, custom extrusions, tubing, seals, and gaskets – manufactured to precision tolerances, compliance standards, and fast turnaround requirements. From prototype to high-volume production, we help you bring reliable, compliant, and flexible medical components to market.