描述
Santoprene 281-64MED is a natural medical-grade thermoplastic vulcanizate from Celanese designed for medical, healthcare, pharmaceutical and drug-delivery applications.
The grade combines elastomeric flexibility with thermoplastic processability and is specifically included in Celanese’s dedicated Santoprene MED medical-grade portfolio. Celanese describes the material as a soft, colorable specialty TPV with biocompatibility testing corresponding to USP Class VI and ISO 10993.
Current typical properties include:
- 71 Shore A hardness
- 0.950 g/cm³ density
- 6.1 MPa tensile stress at break
- 432% elongation at break
- 2.7 MPa tensile stress at 100% elongation
- 23.7% compression set at 23°C / 168 h
- 27% compression set at 70°C / 24 h
- 34% compression set at 125°C / 24 h
- 44% compression set at 125°C / 70 h
This balance makes Santoprene 281-64MED useful for medical components that require more firmness than very soft elastomers while still needing substantial flexibility and elastic recovery.
Celanese also specifically promotes Santoprene 281-64MED for peristaltic pump tubing, where the material’s resiliency, flex-fatigue performance, elasticity and sterilizability are important.
The grade can be processed on conventional thermoplastic equipment by injection molding and extrusion, and current Celanese data also lists multi-injection molding, sheet extrusion and coextrusion.
For more TPV products, visit our TPV Thermoplastic Vulcanizates Product Category →.
For the current Santoprene portfolio, see the Official Celanese Santoprene & Geolast Product Finder →.
Key Features of Santoprene 281-64MED
| Feature | Engineering Benefit |
|---|---|
| 71 Shore A Hardness | Provides a medium-soft medical elastomer with useful mechanical support |
| Medical-Grade TPV | Developed specifically for healthcare and medical applications |
| USP Class VI Testing | Supports medical biocompatibility evaluation |
| ISO 10993 Testing | Supports biological evaluation requirements |
| FDA Drug Master File | Regulatory documentation available for the Santoprene 181/281 MED family |
| 432% Elongation at Break | Provides substantial flexibility and deformation capability |
| 6.1 MPa Tensile Strength | Provides useful mechanical durability |
| 2.7 MPa Stress at 100% Elongation | Provides a controlled elastomeric response |
| 27% Compression Set @ 70°C / 24 h | Provides useful compression-recovery performance |
| Excellent Flex-Fatigue Resistance | Important for repeatedly flexed medical components |
| Steam Sterilizable | Supports selected steam-sterilized medical applications |
| Gamma Sterilizable | Supports selected gamma-sterilized applications |
| ETO Sterilizable | Supports ethylene-oxide sterilization |
| Injection Moldable | Suitable for complex molded medical components |
| Extrudable | Suitable for tubing and continuous medical profiles |
| Polyolefin Bonding | Suitable for selected overmolding and multi-material designs |
Celanese specifically identifies Santoprene 281-64MED as a natural medical grade suitable for steam, gamma and ETO sterilization, with injection and extrusion processing and polyolefin bonding capability.
Typical Applications for Santoprene 281-64MED
Santoprene 281-64MED is especially relevant to medical applications requiring durability, repeated flexing and elastic recovery.
| Application Area | Typical Use |
|---|---|
| Peristaltic Pump Tubing | Flexible tubing exposed to repeated compression and recovery |
| Medical Seals | Flexible sealing components |
| Medical Gaskets | Elastomeric interfaces requiring repeated compression |
| Drug-Delivery Devices | Flexible functional and sealing components |
| Syringe Components | Flexible seals and interfaces |
| Pharmaceutical Closures | Elastomeric closure components |
| Medical Tubing Components | Flexible tubing, connectors and interfaces |
| Medical Connectors | Flexible connector components |
| Diagnostic Equipment | Molded healthcare components |
| Pump Components | Flexible parts exposed to cyclic deformation |
| Healthcare Equipment | Flexible seals, covers and interfaces |
| Medical Packaging Components | Selected pharmaceutical and healthcare components |
Celanese’s dedicated peristaltic-pump material guide describes Santoprene 281-64MED as providing high resiliency, excellent flex fatigue, biocompatibility, sterilizability, low permeation and high elasticity for pump-tubing applications.
Typical Properties of Santoprene 281-64MED
Physical Properties
| Property | Typical Value | Test Method |
|---|---|---|
| Density | 950 kg/m³ / 0.950 g/cm³ | ISO 1183 |
| Shore A Hardness, 15 s | 71 | ISO 48-4 / ISO 868 |
| Appearance | Natural | Manufacturer information |
| Product Form | Pellets | Manufacturer information |
| Resin Identification | TPV | ISO 1043 |
| Part Marking Code | >TPV< | ISO 11469 |
| Polymer Base | Polyolefin-based TPV | Manufacturer information |
The current Celanese Materials Database sheet revised April 21, 2025 lists 71 Shore A hardness and 950 kg/m³ density.
Mechanical Properties
| Property | Typical Value | Test Method |
|---|---|---|
| Tensile Stress at 100% Elongation | 2.7 MPa | ISO 37 |
| Tensile Stress at Break | 6.1 MPa | ISO 527-1/-2 or ISO 37 |
| Elongation at Break | 432% | ISO 527-1/-2 or ISO 37 |
| Compression Set, 23°C / 168 h | 23.7% | ISO 815 |
| Compression Set, 70°C / 24 h | 27% | ISO 815 |
| Compression Set, 125°C / 24 h | 34% | ISO 815 |
| Compression Set, 125°C / 70 h | 44% | ISO 815 |
| Shore A Hardness | 71 | ISO 48-4 / ISO 868 |
These current grade-specific values make Santoprene 281-64MED especially relevant to flexible medical parts where repeated deformation and compression recovery matter.
Medical Biocompatibility of Santoprene 281-64MED
A major advantage of Santoprene 281-64MED is the medical biocompatibility program behind the material.
Celanese lists Santoprene 281-64MED in its medical biocompatibility testing matrix with testing corresponding to:
| Biological / Medical Test | Standard |
|---|---|
| Cytotoxicity | ISO 10993-5 |
| Muscle Implantation | USP Class VI / ISO 10993-6 |
| Intracutaneous Testing | USP Class VI / ISO 10993-10 |
| Maximization Sensitization | ISO 10993-10 |
| Systemic Toxicity | USP Class VI / ISO 10993-11 |
| Heavy Metals | USP 381 |
| Extractable Heavy Metals | EP Monograph 3.2.9 |
Celanese notes that ISO 10993 and USP Class VI testing is conducted on representative MED grades, while cytotoxicity and heavy-metal testing is performed annually on representative grades.
USP Class VI & ISO 10993 Support
Santoprene 281-64MED is part of Celanese’s medical TPV family supported by biocompatibility testing corresponding to USP Class VI and ISO 10993.
This makes the grade relevant for medical-device manufacturers developing:
- Drug-delivery equipment
- Pump systems
- Medical seals
- Pharmaceutical components
- Flexible tubing
- Connectors
- Diagnostic equipment
- Healthcare components
The regulatory support is one of the major reasons to use a dedicated MED grade rather than a general-purpose Santoprene TPV.
FDA Drug Master File Support
Celanese lists active U.S. FDA Drug Master File 17690 for the Santoprene 181 / 281 MED grades.
For customers developing pharmaceutical or drug-delivery products, this can support regulatory submissions by allowing confidential material information to be referenced through the manufacturer’s Drug Master File.
This is especially relevant to:
- Drug-delivery systems
- Pharmaceutical packaging
- Syringe components
- Medical closures
- Pump components
- Combination products
Sterilization Compatibility
Celanese lists Santoprene 281-64MED as compatible with the three major sterilization routes shown in its medical-grade portfolio:
| Sterilization Method | Santoprene 281-64MED |
|---|---|
| Steam | Compatible |
| Gamma Radiation | Compatible |
| Ethylene Oxide (ETO) | Compatible |
Celanese also reports broader Santoprene medical-grade testing involving steam at 134°C, ethylene oxide and gamma radiation up to 50 kGy for relevant medical materials.
Actual finished-part sterilization conditions should be selected according to device design, exposure duration, number of cycles and regulatory requirements.
Peristaltic Pump Tubing
Santoprene 281-64MED has a particularly strong application story in peristaltic pump tubing.
Celanese specifically highlights this grade for flexible pump tubing because of:
- High resiliency
- Excellent flex-fatigue resistance
- Biocompatibility
- Sterilizability
- Low permeation
- High elasticity
- Good performance with barbed fittings
Peristaltic pump tubing is repeatedly compressed by rollers during operation, so a material must recover its shape consistently over a large number of cycles.
Celanese’s published compression-stress-relaxation work for Santoprene 281-64MED evaluates force retention over extended time using ISO 3384 testing, reinforcing its positioning for cyclic pump-tubing applications.
Polyolefin Bonding
Celanese lists Polyolefin as the compatible bonding substrate for Santoprene 281-64MED.
This can be useful for:
- Two-component injection molding
- Overmolded medical components
- Integrated seals
- Medical-device housings
- Flexible interfaces molded onto polyolefin parts
Actual adhesion depends on the specific substrate, component design and processing conditions.
Why Choose Santoprene 281-64MED?
The main reason to select Santoprene 281-64MED is its balance of medical regulatory support, mechanical durability and elastomeric flexibility.
At approximately 71 Shore A, the material provides more mechanical support than very soft TPVs while remaining sufficiently flexible for tubing, seals, gaskets and repeated-flex medical components.
Its approximately 432% elongation at break supports substantial deformation, while 6.1 MPa tensile strength provides useful mechanical durability.
Compression-set values of approximately 23.7% at 23°C / 168 h and 27% at 70°C / 24 h are particularly relevant to sealing and pump applications.
More importantly, the grade combines:
- Medical-grade TPV formulation
- USP Class VI / ISO 10993 biocompatibility support
- FDA Drug Master File support
- Steam sterilization compatibility
- Gamma sterilization compatibility
- ETO sterilization compatibility
- Excellent flex-fatigue resistance
- Injection and extrusion processability
For customers requiring a 71A medical-grade TPV for peristaltic pump tubing, medical seals, drug-delivery components or healthcare equipment, Santoprene 281-64MED is a particularly relevant grade to evaluate.
Processing Guidelines for Santoprene 281-64MED
Santoprene 281-64MED is shear dependent and can be processed on conventional thermoplastic equipment.
Current Celanese data lists:
- Injection molding
- Multi-injection molding
- Extrusion
- Sheet extrusion
- Coextrusion
Current Grade-Specific Injection Conditions
| Processing Parameter | Celanese Guidance |
|---|---|
| Drying Recommended | Yes |
| Drying Temperature | 80°C |
| Drying Time | ≥3 hours |
| Processing Moisture Content | ≤0.08% |
| Optimum Melt Temperature | 210°C |
| Minimum Melt Temperature | 190°C |
| Maximum Melt Temperature | 230°C |
| Optimum Mold Temperature | 30°C |
| Minimum Mold Temperature | 10°C |
| Maximum Mold Temperature | 50°C |
These values come from the Celanese Materials Database sheet revised April 21, 2025.
Injection Molding Notes
For injection molding, processors should optimize:
- Melt temperature
- Injection speed
- Screw speed
- Holding pressure
- Back pressure
- Gate dimensions
- Runner design
- Mold temperature
- Venting
- Cooling time
Because Santoprene 281-64MED is shear dependent, higher shear can reduce apparent melt viscosity and improve mold filling.
Extrusion Processing
Santoprene 281-64MED is also specifically designed for extrusion applications.
Important variables include:
- Barrel temperature profile
- Screw geometry
- Screw speed
- Adapter temperature
- Die temperature
- Melt pressure
- Draw-down ratio
- Cooling conditions
- Tubing dimensions
- Wall-thickness control
- Surface finish
For medical and pharmaceutical production, cleanliness, material handling and manufacturing controls should be aligned with the customer’s quality system.
Related Products
We supply Santoprene TPV grades for different medical, healthcare, pharmaceutical, hardness and processing requirements.
Typical Santoprene medical product families include:
- Santoprene 281 MED Series
- Santoprene 181 MED Series
- Santoprene 8281 MED Series
- Santoprene 8181 MED Series
- Santoprene medical tubing grades
- Santoprene medical sealing grades
- Santoprene drug-delivery grades
- Santoprene pharmaceutical grades
- Santoprene healthcare TPV grades
View More TPV Thermoplastic Vulcanizates →
For grade-selection support, send us your required hardness, sterilization method, biological evaluation requirements, application and processing method.
Technical Documents for Santoprene 281-64MED
| Document Type | Description |
|---|---|
| TDS | Current physical, mechanical and processing data |
| SDS | Safety Data Sheet |
| USP Class VI Information | Medical biocompatibility testing information |
| ISO 10993 Information | Biological evaluation information |
| FDA DMF Information | Drug Master File 17690 support |
| Sterilization Information | Steam, gamma and ETO compatibility |
| Peristaltic Pump Information | Pump-tubing application and compression-relaxation data |
| Processing Guide | Injection molding and extrusion guidance |
| Medical Product Guide | Santoprene MED portfolio information |
| COA | Batch-specific quality information where available |
Need technical documents for Santoprene 281-64MED?
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Please state Santoprene 281-64MED and specify whether you require TDS, SDS, USP Class VI, ISO 10993, FDA DMF, sterilization or peristaltic-pump information.
FAQ About Santoprene 281-64MED
Q1: What is Santoprene 281-64MED?
Santoprene 281-64MED is a natural medical-grade thermoplastic vulcanizate from Celanese developed for healthcare, medical-device, pharmaceutical and drug-delivery applications.
Q2: What is the hardness of Santoprene 281-64MED?
The current Celanese medical-grade data lists approximately 71 Shore A.
Q3: What is the density?
The typical density is approximately 0.950 g/cm³.
Q4: What is the tensile strength?
Typical tensile stress at break is approximately 6.1 MPa.
Q5: What is the elongation at break?
Typical elongation at break is approximately 432%.
Q6: What is the tensile stress at 100% elongation?
The typical value is approximately 2.7 MPa.
Q7: What is the compression set?
Current Celanese data lists approximately 23.7% at 23°C / 168 h, 27% at 70°C / 24 h, 34% at 125°C / 24 h and 44% at 125°C / 70 h.
Q8: Does Santoprene 281-64MED have USP Class VI support?
Yes. Celanese includes Santoprene 281-64MED in its MED biocompatibility testing matrix corresponding to USP Class VI and ISO 10993.
Q9: Is Santoprene 281-64MED ISO 10993 tested?
Yes. Celanese lists testing covering cytotoxicity, implantation, intracutaneous response, sensitization and systemic toxicity for the MED medical-grade program.
Q10: Does it have an FDA Drug Master File?
Celanese lists active U.S. FDA DMF 17690 for the Santoprene 181/281 MED family.
Q11: Is Santoprene 281-64MED suitable for peristaltic pump tubing?
Yes. Celanese specifically publishes Santoprene 281-64MED as a material solution for peristaltic pump tubing, highlighting resiliency, flex-fatigue resistance and elasticity.
Q12: Can Santoprene 281-64MED be steam sterilized?
Yes. Steam sterilization is listed for the grade in Celanese’s medical portfolio.
Q13: Is it compatible with gamma radiation sterilization?
Yes. Gamma sterilization is listed as compatible for Santoprene 281-64MED.
Q14: Can Santoprene 281-64MED be sterilized with ETO?
Yes. Ethylene oxide (ETO) is also listed as a compatible sterilization method.
Q15: Can Santoprene 281-64MED be injection molded and extruded?
Yes. Current Celanese information lists injection molding, multi-injection molding, extrusion, sheet extrusion and coextrusion.
Q16: What processing temperatures are recommended?
Current Celanese guidance lists an optimum melt temperature of approximately 210°C, with a range of 190–230°C, and an optimum mold temperature of about 30°C, with a range of 10–50°C.
Request Santoprene 281-64MED Price & Technical Support
For pricing, availability, technical documents or application support for Santoprene 281-64MED, please provide:
- Required quantity
- Destination country or port
- Medical-device, pump-tubing or pharmaceutical application
- Required Shore hardness
- Patient-contact or fluid-contact condition
- Required ISO 10993 testing
- USP Class VI requirement
- FDA DMF documentation requirement
- Sterilization method: steam / gamma / ETO
- Repeated-flex or peristaltic-pump requirement
- Operating temperature
- Injection-molding or extrusion process
- Bonding / overmolding substrate
- TDS / SDS requirement
- COA requirement
- Sample requirement, if applicable
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