Extruded Silicone rubber for pharmaceutical industry use is trusted for its stability, purity, and non-toxic nature. It is widely used in drug manufacturing, tubing, seals, and medical components due to its ability to tolerate heat, chemicals, and sterilization.
Silicone Rubber seals are valued across industries for their flexibility and durability; however, when safety is a concern, only the highest-grade silicone will meet the requirements. In pharmaceutical and medical applications, silicone must meet strict standards for biocompatibility and cleanliness.
In this blog, we’ll explain what makes medical-grade silicone unique, explore the certifications associated with it, and show you where to purchase safe, FDA-compliant silicone rubber in the USA. Choosing the right silicone means protecting both your products and your patients.
Table of Contents
What are the Types of Silicone Grades?
Silicone comes in different grades, each customised for specific industries and performance needs.
- Food Grade Silicone
- FDA-compliant and safe for food contact
- Non-toxic, odorless, and resistant to bacteria
- Maintains stability during cooking, freezing, or processing
- Common in beverage lines, baking molds, and sanitary seals
- FDA-compliant and safe for food contact
- Biocompatible Silicone
- Designed for medical and pharmaceutical applications
- Meets USP Class VI and ISO 10993 standards
- Hypoallergenic, non-reactive, and safe for body contact
- Used in implants, catheters, and medical tubing
- Designed for medical and pharmaceutical applications
- Heat Resistant Silicone
- Performs in extreme temperatures from –60°C to over 230°C
- Remains flexible without cracking or degrading
- Ideal for automotive, aerospace, and high-heat sealing
- Offers long-term durability in demanding conditions
- Performs in extreme temperatures from –60°C to over 230°C
Silicone is manufactured in various grades, depending on its intended use and application.
| Silicone Grade | Key Features | Common Uses |
| Food Grade Silicone | Safe for body contact- Meets medical safety standards (USP Class VI)- Non-toxic and hypoallergenic. | Food machines, baking molds, beverage lines |
| Biocompatible Silicone | Automotive, aerospace, and high-temperature sealing | Automotive, aerospace, and high-temperature sealing |
| Heat Resistant Silicone | Medical tubing, implants, and surgical parts | Automotive, aerospace, high-temperature sealing |
What Is the Highest Grade Silicone?
Some types of silicone are specifically designed for critical applications that require the highest level of purity and safety. These are often used in the medical, pharmaceutical, and food industries.
- Platinum Cured Silicone
Platinum-cured silicone is considered the highest grade available. It offers ultra-high purity, contains no toxic by-products, and is ideal for cleanroom, food contact, and medical use. - USP Class VI Silicone
USP Class VI silicone meets strict medical and biocompatibility standards. It is approved for use inside the human body, including in implants, surgical tubing, and diagnostic devices. - Premium Silicone Rubber
Premium silicone rubber is built for high performance. It is strong, flexible, heat-resistant, and long-lasting, and is used in advanced industries like aerospace, pharmaceuticals, and medical device manufacturing.
These top-grade materials are chosen when only the safest, cleanest, and most reliable silicone will do.
Read More: ASTM D2000 Specifications for Rubber Materials
How to Identify Premium Quality Silicone?
When selecting silicone for critical applications, it’s essential to understand what distinguishes high-quality material from others. Premium silicone is clean, safe, and made to meet strict quality industry standards.
- Medical silicone rubber is specifically designed for healthcare applications. It’s biocompatible, non-toxic, and meets certifications like USP Class VI. This type is trusted for medical tubing, devices, and surgical components.
- Silicone for implants must be highly pure and safe for long-term contact with the human body. It’s usually platinum-cured and thoroughly tested for use within the body.
- When comparing platinum silicone to standard silicone, always opt for platinum-cured silicone for medical, food, or cleanroom use. It’s safer, cleaner, and more stable than peroxide-cured types.
Choosing certified, high-quality silicone ensures your product is safe, reliable, and ready for demanding environments.
Read More– Is 100% Medical-Grade Silicone Safe?
What are the Applications of the Highest Grade Silicone?
The highest-grade silicone is utilized in various industries where safety, cleanliness, and performance are of paramount importance. It is trusted for both medical and high-temperature environments.
- Medical Silicone Tubing
Medical-grade silicone tubing is widely used in healthcare settings to transport fluids, air, or medication due to its flexibility and biocompatibility. - Silicone for Medical Use
Found in devices like syringes, valves, connectors, and masks. It is used because it is non-toxic and easy to sterilize. - Surgical Grade Silicone
Used for implants, prosthetics, and tools that touch or go inside the body. It must be very pure and fully tested. - Pharmaceutical Processing
Used in clean environments for the production of medicine. It helps safely move liquids without contamination. - Food and Beverage Equipment
Food-grade silicone is used in baking, drink lines, and dairy machines. It does not affect taste and is easy to clean. - Cleanroom Applications
Platinum-cured silicone is used in biotech and electronics where cleanliness is critical. - Aerospace and Automotive
Used in engines and machines that operate at extremely high temperatures. It can handle high temperatures and pressure without breaking.
The highest grade silicone is chosen when products must be clean, strong, and safe for people or sensitive environments.
Read More: What is Solid Silicone ZZ-R-765/A-A-59588 Grade?
Why U.S.-Made Silicone Is Superior?
When quality, safety, and reliability matter, silicone made in the USA is a better choice. It meets higher standards and offers better support compared to many imported materials.
- High Temperature Silicone
U.S.-made silicone is tested for extreme heat resistance. It performs well in industries such as aerospace, automotive, and manufacturing, where parts must withstand high temperatures without failing. - Custom Silicone Manufacturing
American manufacturers offer custom silicone manufacturing, giving you the exact shape, size, and performance you need. This helps speed up production and improve product quality. - FDA Compliant Silicone
U.S. silicone products are more likely to meet strict safety rules, such as FDA-compliant silicone for food and medical use. You get full traceability, documentation, and peace of mind.
In short, U.S.-made silicone offers better quality, faster delivery, easier communication, and stronger compliance, making it the preferred choice for critical applications.
Elastostar’s Rubber Corporation Role in Supplying Top-Grade Silicone
Elastostar Rubber Corporation is a trusted silicone extrusion manufacturer providing high-performance solutions for medical, food, and industrial use. We specialize in platinum-cured medical-grade silicone, renowned for its purity, safety, and durability. All materials are made from US-made silicone rubber, thoroughly tested to meet USP Class VI standards, including Sections 88 and 87.
From reverse engineering to prototype and full production runs, we support customers with design help and custom manufacturing. We also offer some of the shortest lead times in the industry. Whether you need tubing, gaskets, or custom profiles, Elastostar delivers FDA-compliant, high-grade silicone customised to your exact needs.
Recommended Reads
- What’s the Difference Between Medical Grade Silicone and Regular Silicone?
- Is Silicone Used in Medical Devices?
- USP CL VI Platinum Cured Silicone for Pharmaceutical and Medical Devices
Conclusion
At Elastostar Rubber Corporation, we provide certified silicone materials, including medical-grade and food-safe silicone, as well as high-performance silicone rubber designed for demanding environments. Our platinum-cured medical silicone is FDA-compliant, meeting USP Class VI standards, and passes testing for biocompatibility under Sections 87 and 88.
Made in the USA, our products offer outstanding purity, heat resistance, and durability for critical applications. Whether you need tubing, seals, or custom parts, we deliver reliable and safe solutions customised to your specific needs. Contact us today to discuss your project and receive a fast, personalized quote.
Read More: Solid Silicone Fibreglass Reinforced Grade
FAQs
What is the highest quality silicone available?
Platinum‑cured silicone is considered the highest quality. It offers ultra-high purity with no harmful byproducts, maintaining reliable performance in medical, food, and cleanroom environments.
What is platinum-cured silicone, and why is it better?
Silicone cured using a platinum catalyst avoids the residual chemicals found in peroxide-cured versions. This results in a cleaner, stronger material with superior tensile and elongation properties ideal for critical applications such as medical devices and food contact components. For more information or to find the right material for your needs, contact us today.
Is medical-grade silicone the same as food-grade silicone?
No. Medical-grade silicone must meet stricter biocompatibility standards, such as those outlined in USP Class VI, whereas food-grade silicone is approved under FDA food-contact guidelines (CFR 177.2600). Both may be platinum-cured, but medical-grade silicone undergoes additional testing.
How can I identify FDA-approved silicone rubber?
Why is platinum-cured silicone used in medical devices?
Because it is extremely pure and free of harmful residues. It also tolerates sterilization methods such as autoclaving, gamma, and ethylene oxide, making it safe and durable for implants, surgical tubing, seals, and diagnostic tools.
What certifications should high-grade silicone meet?
Top-grade silicone should meet FDA CFR 177.2600, USP Class VI, and often RoHS standards. These certifications verify safety for food contact, body contact, and compliance with international regulations.
What are the benefits of choosing U.S.-made silicone?
Silicone produced in the U.S. offers tighter quality control, complete traceability, faster production and delivery times, and substantial compliance with FDA, USP, and international standards essential for regulated applications.
What type of silicone is safe for use in implants or direct body contact?
Use USP Class VI silicone, preferably platinum-cured and thoroughly tested (Sections 87 and 88). This grade is certified for long-term body contact applications, such as implants and medical tubing.
