描述
Santoprene 181-55MED is a soft black medical-grade thermoplastic vulcanizate (TPV) from Celanese developed for medical, healthcare, pharmaceutical and drug-delivery applications that require elastomeric flexibility, sealing performance and thermoplastic processing.
The grade is part of the Santoprene MED medical-grade portfolio. Celanese currently positions Santoprene medical grades for applications including medical devices, drug-delivery systems, syringe components, soft-touch grips, seals, gaskets, diaphragms, tubing, electrical cable components and healthcare packaging.
Santoprene TPV was designed to provide rubber-like elasticity while processing like a thermoplastic. For medical-component manufacturers, this can simplify production compared with traditional thermoset elastomers because the material can be injection molded or extruded without a separate vulcanization step.
Santoprene 181-55MED is a black grade with a Shore A hardness of approximately 59. This puts it in a medium-soft elastomer range that can provide a useful balance between sealing compliance and dimensional support.
Current Celanese medical-grade data lists a specific gravity of approximately 0.98, tensile strength of approximately 6.1 MPa, elongation at break of approximately 440%, tensile stress at 100% elongation of approximately 2.1 MPa, and compression set of approximately 19% after 168 hours at 23°C.
The relatively low compression-set value is especially relevant to seals, gaskets and drug-delivery components because long-term elastic recovery helps maintain sealing force after prolonged deformation.
The grade can be processed by both injection molding and extrusion. Historical grade-level processing documentation also lists multi-injection molding, profile extrusion, sheet extrusion and coextrusion.
A major reason to select Santoprene 181-55MED is its medical regulatory and biocompatibility support.
Celanese states that Santoprene MED grades are supported by USP Class VI testing, ISO 10993 biocompatibility testing and FDA Drug Master Files. The company also states that production takes place at Good Manufacturing Practices (GMP) sites.
For the 181/281 MED family, Celanese identifies an active U.S. FDA Drug Master File: DMF 17690.
Celanese’s medical-grade testing table specifically includes Santoprene 181-55MED in a biocompatibility matrix covering cytotoxicity, implantation, intracutaneous testing, sensitization, systemic toxicity and heavy-metals-related evaluations.
The current medical-grade solution data also identifies steam, gamma and ethylene oxide (ETO) as sterilization methods compatible with this grade.
This combination makes Santoprene 181-55MED particularly suitable for medical components where material flexibility, sealing performance, sterilization capability and documented medical-grade support are all important.
For more TPV materials, visit our TPV Thermoplastic Vulcanizates Product Category →.
For current manufacturer information, see the Celanese Santoprene TPV Medical Grades page →.
Key Features of Santoprene 181-55MED
| Feature | Engineering Benefit |
|---|---|
| Medical-Grade TPV | Developed for medical, healthcare and pharmaceutical applications |
| Black Appearance | Suitable for black medical-device components, seals and grips |
| Shore A 59 | Medium-soft elastomeric behavior for sealing and flexible parts |
| USP Class VI Positioning | Supports medical-material qualification programs |
| ISO 10993 Testing | Celanese provides biocompatibility testing support for MED grades |
| FDA Drug Master File Support | Celanese lists active DMF 17690 for 181/281 MED grades |
| Steam Sterilization Compatibility | Suitable for device designs using steam sterilization |
| Gamma Sterilization Compatibility | Supports gamma-sterilized medical components |
| ETO Sterilization Compatibility | Supports ethylene-oxide sterilization processes |
| 440% Elongation at Break | High flexibility and deformability |
| 19% Compression Set at 23°C / 168 h | Supports long-term sealing performance |
| Injection Molding & Extrusion | Enables efficient high-volume thermoplastic processing |
| Polyolefin Bonding Compatibility | Celanese lists polyolefin as the bonding substrate for this grade |
| Manufacturing Scrap Recyclability | Santoprene TPV can offer in-process recycling opportunities |
The core value of Santoprene 181-55MED is not simply its hardness. It combines medical-grade regulatory support, sterilization capability and elastomeric sealing performance in a processable TPV platform.
Typical Applications for Santoprene 181-55MED
Celanese positions Santoprene medical TPV for a broad range of medical and healthcare components.
| Application Area | Typical Use |
|---|---|
| Medical Seals | Flexible sealing components requiring long-term elastic recovery |
| Medical Gaskets | Gaskets in devices, equipment and packaging systems |
| Soft-Touch Grips | Comfortable grip surfaces on medical devices |
| Diaphragms | Flexible moving components |
| Drug-Delivery Components | Elastomeric sealing parts in delivery systems |
| Syringe Components | Plunger seals and sealing interfaces where the selected grade is validated for the device |
| Medical Equipment Components | Bumpers, liners, caps and strain-relief parts |
| Electrical Cable Components | Jacketing, insulation and connector-related components |
| Healthcare Packaging | Bumpers, tube gaskets, caps and closures |
| Flexible Medical Parts | Components requiring soft touch and elastic recovery |
Celanese also highlights Santoprene TPV for peristaltic-pump tubing, wearable-device grips and seals, medical-equipment parts, syringe seals and packaging components across its medical portfolio.
Grade selection should be based on the final device design, sterilization route, contact conditions and regulatory requirements.
Typical Properties of Santoprene 181-55MED
Physical Properties
| Property | Typical Value | Test Method |
|---|---|---|
| Specific Gravity | 0.98 | ISO 1183 / ASTM D792 |
| Density | 0.98 g/cm³ | ISO 1183 |
| Shore A Hardness | 59 | ISO 868 |
| Color | Black | Manufacturer information |
| Product Form | Pellets | Manufacturer information |
| Material Family | TPV / TPE | Manufacturer information |
The relatively low density is useful for lightweight medical-device and healthcare components.
Mechanical Properties
| Property | Typical Value | Test Method |
|---|---|---|
| Tensile Stress at 100% Elongation | 2.1 MPa | ISO 37 / ASTM D412 |
| Tensile Strength at Break | 6.1 MPa | ISO 37 / ASTM D412 |
| Elongation at Break | 440% | ISO 37 / ASTM D412 |
| Compression Set, 23°C / 168 h | 19% | ISO 815 / ASTM D395B |
These properties show that Santoprene 181-55MED combines high extensibility with good elastic recovery.
The 440% elongation supports flexible component design, while the 19% compression set is valuable for seals that remain under compression for extended periods.
Medical & Regulatory Support
USP Class VI
Celanese identifies Santoprene 181-55MED as a medical grade with USP Class VI support in its current medical portfolio and product literature.
ISO 10993 Biocompatibility Testing
Celanese’s published medical-grade testing matrix includes Santoprene 181-55MED in testing categories covering:
- Cytotoxicity
- Muscle implantation
- Intracutaneous response
- Sensitization
- Systemic toxicity
- Heavy-metals-related testing
The Celanese table references standards including ISO 10993-5, ISO 10993-6, ISO 10993-10 and ISO 10993-11, together with relevant USP tests.
FDA Drug Master File
Celanese identifies the following active U.S. FDA Drug Master File for this family:
DMF 17690 – Santoprene TPV 181 / 281 MED grades
A Drug Master File can support regulatory submissions by allowing the manufacturer to provide confidential material information directly to the FDA.
GMP Production
Celanese states that Santoprene MED grades are produced at Good Manufacturing Practices (GMP) sites as part of the medical-grade supply framework.
Sterilization Compatibility of Santoprene 181-55MED
Celanese’s current medical-grade data identifies the following sterilization methods for Santoprene 181-55MED:
| Sterilization Method | Celanese Medical-Grade Table |
|---|---|
| Steam | Supported |
| Gamma Radiation | Supported |
| Ethylene Oxide (ETO) | Supported |
This broad sterilization compatibility is useful when designing medical-device components intended for different sterilization routes.
Actual component performance can depend on sterilization dose, temperature, number of cycles, geometry, stress state and the presence of other materials in the assembly. Device-level validation should therefore be based on the intended finished-product conditions.
Why Choose Santoprene 181-55MED?
The main reason to select Santoprene 181-55MED is the combination of medical-grade support and high-performance TPV behavior.
Traditional thermoset rubbers such as silicone, butyl rubber or EPDM can provide excellent elastomeric performance, but they often require mixing, curing, trimming or additional processing steps.
Santoprene TPV processes as a thermoplastic.
This can enable:
- Faster molding cycles
- Precision injection molding
- Reduced finishing operations
- Extrusion and coextrusion
- Multi-material processing
- In-process scrap recycling opportunities
- Complex part integration
For medical seals and gaskets, long-term compression performance is especially important.
The current 19% compression set after 168 hours at 23°C provides a strong indication of elastic recovery under room-temperature compression.
For soft-touch and flexible parts, Shore A 59 offers a useful balance between softness and structural support.
For components that must stretch or deform during use or assembly, the 440% elongation at break provides significant flexibility.
The material also provides a documented medical framework: USP Class VI positioning, ISO 10993 testing, FDA Drug Master File support and multiple sterilization routes.
For black medical components where a natural or colorable appearance is not required, Santoprene 181-55MED is a highly targeted grade.
Processing Guidelines for Santoprene 181-55MED
Santoprene 181-55MED can be processed on conventional thermoplastic equipment.
Published grade-level methods include:
- Injection molding
- Multi-injection molding
- Extrusion
- Profile extrusion
- Sheet extrusion
- Coextrusion
Drying & Processing Window
Historical grade-level Santoprene documentation recommends:
| Processing Parameter | Guidance |
|---|---|
| Drying Temperature | 80°C |
| Drying Time | 3 hours |
| Processing Temperature Window | 175–230°C |
Desiccant drying for approximately 3 hours at 80°C is recommended.
Santoprene TPV is a shear-dependent material. As shear rate increases, apparent melt viscosity decreases.
This means that processing performance can be influenced strongly by:
- Screw speed
- Injection speed
- Gate dimensions
- Melt temperature
- Back pressure
- Mold temperature
- Extrusion die geometry
- Draw-down
- Cooling conditions
Injection Molding
For injection-molded medical components, evaluate gate position and size, filling balance, venting, mold temperature, injection speed, holding pressure, cooling time, part shrinkage and surface requirements.
Extrusion
For medical profiles, tubing or jacketing applications, optimize barrel temperatures, adapter temperature, die temperature, screw speed, melt pressure, draw-down ratio, cooling and dimensional stability.
Material Compatibility During Processing
Published Santoprene processing information states that Santoprene TPV is incompatible with acetal (POM) and PVC in the molten state.
Processing equipment should therefore be properly purged when switching between these materials and Santoprene 181-55MED.
Sterilization, Sealing & Medical Design Advantages
Medical-device elastomers often need to perform several jobs simultaneously.
A component may need to seal against a mating surface, recover after prolonged compression, flex repeatedly, resist sterilization, maintain dimensional consistency, provide soft touch, process economically and meet medical-material documentation requirements.
Santoprene 181-55MED is designed around this combination.
Celanese describes Santoprene medical TPV as offering long-term sealing performance, chemical and high-temperature resistance, sterilizability, soft-touch options and simplified thermoplastic processing.
The material can therefore be considered for applications where conventional rubber processing would add manufacturing complexity.
Related Products
Santoprene 281-55MED – Natural medical-grade TPV with approximately Shore A 60 hardness, intended for medical and healthcare applications.
Santoprene 8281-55MED – Natural medical-grade TPV with approximately Shore A 59 hardness and medical regulatory support.
Santoprene 8181-55B1MED – Black medical bonding grade designed for adhesion to selected engineering thermoplastics such as PC, ABS and COPE.
View More TPV Thermoplastic Vulcanizates →
Technical Documents for Santoprene 181-55MED
| Document Type | Description |
|---|---|
| TDS | Grade-specific physical and mechanical properties |
| SDS | Safety Data Sheet |
| Medical Compliance Information | USP Class VI and ISO 10993 testing information |
| Drug Master File Information | FDA DMF 17690 reference for 181 / 281 MED grades |
| Sterilization Information | Steam, gamma and ETO compatibility information |
| Processing Guide | Injection molding and extrusion recommendations |
| COA | Batch-specific quality documentation where available |
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FAQ About Santoprene 181-55MED
Q1: What is Santoprene 181-55MED?
Santoprene 181-55MED is a black medical-grade TPV from Celanese designed for medical, healthcare and pharmaceutical applications requiring flexibility and sealing performance.
Q2: What is the hardness of Santoprene 181-55MED?
The current Celanese medical-grade table lists approximately Shore A 59.
Q3: Does Santoprene 181-55MED meet USP Class VI requirements?
Celanese identifies Santoprene 181-55MED as a medical grade with USP Class VI support.
Q4: Does Santoprene 181-55MED have ISO 10993 testing?
Yes. Celanese includes this grade in its medical biocompatibility testing matrix covering multiple ISO 10993 test categories.
Q5: Is there an FDA Drug Master File?
Yes. Celanese identifies DMF 17690 for the Santoprene 181 / 281 MED grade family.
Q6: What sterilization methods are supported?
Celanese’s medical-grade table lists steam, gamma and ETO sterilization for Santoprene 181-55MED.
Q7: What is the tensile strength?
The current medical-grade data lists approximately 6.1 MPa tensile strength at break.
Q8: What is the elongation at break?
Current Celanese data lists approximately 440% elongation at break.
Q9: What is the compression set?
The published value is approximately 19% after 168 hours at 23°C.
Q10: Can Santoprene 181-55MED be injection molded and extruded?
Yes. Celanese identifies both injection molding and extrusion for this medical grade, with additional grade-level documentation listing profile extrusion, sheet extrusion, coextrusion and multi-injection molding.
Request Santoprene 181-55MED Price & Technical Support
For pricing, availability, medical documentation or application support for Santoprene 181-55MED, please provide:
- Required quantity
- Destination country or port
- Medical-device or healthcare application
- Seal, gasket, grip, diaphragm, tube or other component type
- Required hardness
- Sterilization method: steam, gamma or ETO
- Number of sterilization cycles
- Contact duration and contact type
- Operating temperature
- Chemical or drug exposure
- Injection-molding or extrusion process
- USP / ISO 10993 documentation requirements
- FDA DMF support requirement
- TDS, SDS or COA requirement
- Sample requirement, if applicable
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