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Fluorosilicone Rubber: Made in USA, Full COA with Each Batch

ElastaPro makes fluorosilicone rubber at our Made in USA manufacturing facility in Santa Fe Springs, California. Domestic sourcing can help you to reduce supply chain risk, but that’s not the only reason to buy high-performance materials from us. ElastaPro manufactures fluorosilicone rubber as solid sheets and uncured compound in accordance with our ISO 9001:2015 and AS9100D certified quality management system. Moreover, we offer a full Certificate of Analysis (COA) with each batch.

Why Choose Domestic Fluorosilicone Rubber?

Domestic sourcing reduces your supply chain risk by shortening shipping distances, minimizing transportation touchpoints, and allowing for quicker responses to disruptions such as geopolitical disputes, natural disasters, and pandemics. Along with shorter lead times and greater visibility, the benefits include reduced exposure to international trade issues such as tariffs, border closings, and shipping delays. It’s also easier to coordinate and collaborate with a Made in USA manufacturer.

Even if you can’t visit us in California to meet face-to-face, ElastaPro makes communications easy. Whether you pick up the phone, send us an email, or use the chatbot or contact form on our website, we pride ourselves on quick and responsive service. We’re also available for Teams or Zoom calls and regularly update our website with technical content and descriptions. For example, the fluorosilicone page on our website let you download technical data sheets.

Why Ask for a Fluorosilicone COA?

A Certificate of Analysis (COA) is a document that provides the test results for a specific batch of a material. By contrast, a Certificate of Conformance (COC) simply attests that a material meets requirements. In other words, a COC does not provide batch-level test data. That’s a key distinction in industries like aerospace and defense, both of which use fluorosilicone rubber because of its wide temperature range, superior resistance to fuels and solvents, and ability to meet standards.

ElastaPro provides a full COA with each batch and includes key specifications such as tensile strength, elongation, compression set, hardness, and temperature range testing. Importantly, our COAs demonstrate that our flurosilicone rubber complies with standards such as AMSR-25988, which was published by SAE International and supersedes MIL-DTL-25988. Older prints may still reference MIL-R-25988, which is sometimes written as MILR-25988 instead.

What If There’s a Spec Change or Substitution? 

Fluorosilicone specs are subject to change, and suppliers sometimes change the ingredients in their products. That’s why ElastaPro performs a full qualification whenever there’s a spec change or we update a raw material. We also conduct full lot-to-lot verification in accordance with the spec, which contains a table for testing during lot-to-lot qualification work. In the AMSR-25988 specification, Table IV outlines material property requirements.

Ask ElastaPro for Flurosilicone Rubber

Do you need spec-grade fluorosilicone rubber with a full COA for traceability? Have you considered how partnering with a Made in USA materials manufacturer can help you to reduce supply chain uncertainty while ensuring quality? For fluorosilicone solid sheet and uncured compound, the name you can trust is ElastaPro. Contact us for proven materials you can depend upon.

Low Outgassing Silicones: Materials, Standards, and Applications

ElastaPro makes low outgassing silicones that meet ASTM E595 requirements and are specially formulated and processed to minimize the release of volatile compounds under vacuum conditions and/or heat. In addition to spacecraft, applications include aerospace, defense, electronics, optics, and medical devices.

ElastaPro produces low outgassing silicones at our Made in USA manufacturing facility in Santa Fe Springs, California and offers these specification grade materials as solid silicone sheet and uncured silicone compound. Choose ASTM E595 silicone in following durometers (hardness) on the Shore A scale: 40, 50, 60, and 70.

Keep reading to learn more and contact us for a quote.

What is Outgassing?

Outgassing refers to the release of volatile organic compounds (VOCs) from a material, typically at reduced pressure (vacuum) or elevated temperatures. Volatiles include residual solvents from processing, unreacted monomers, plasticizers and additives, and degradation products from thermal or environmental stress. Sometimes, outgassing is called off-gassing instead.

In vacuum conditions such as space, the released vapors from outgassing can condense on sensitive surfaces such as optical lenses, sensors, or electronics. This can cause contamination, but it can also degrade performance or result in mission failure. Silicone elastomers are chemically stable and heat resistant, but they can contain low-molecular-weight siloxanes that are prone to volatilization.

What is ASTM E595?

ASTM E595 defines a standard test method for Total Mass Loss and Condensable Volatile Materials from outgassing in a vacuum environment. ASTM International developed this test standard in cooperation with NASA, and it simulates the conditions that materials such as silicones may face when used aboard spacecraft.

Importantly, ASTM E595 provides a consistent, repeatable way to measure how much mass a material loses in avacuum due to outgassing, and how much of that lost mass condenses on nearby surfaces. There are three key metrics.

• Total Mass Loss (TML) is the percentage of initial mass lost by the specimen during the test. This measurement is important, but TML alone does not indicate contamination risk. Some volatiles may not condense on cold surfaces but dissipate harmlessly.

• Collected Volatile Condensable Material (CVCM) is the percentage of material that condenses on a cooled collector plate. CVCM is critical measurement for optical and thermal systems since even a small amount of condensable material can fog lenses, degrade solar panels, or alter thermal emissivity.
• Water Vapor Recovered (WVR) is an optional measurement for materials, such as silicones, that absorb and release water vapor. WVR is less critical in space environments, but it’s important for applications (such as electronic assembly) that may occur in humid conditions.

ASTM E595 provides the framework for measuring these values, but NASA’s own standards define acceptable limits for spacecraft. For example, NASA-STD-6016 specifies that a material must meet the following criteria to be considered low outgassing.

• TML ≤ 1.0%
• CVCM ≤ 0.10%

This dual structure of ASTM providing the test method and NASA providing the acceptance criteria ensures consistency and practical usability across the aerospace sector.

Where are Low Outgassing Silicones Used?

Low outgassing is important for spaceflight and aerospace applications, but engineers also need low outgassing silicones for electronics and semiconductors, medical devices and pharmaceuticals, and optical and precision instruments.

Aerospace and Spaceflight

Outgassed volatiles can condense on telescope mirrors, star trackers, and camera lenses, reducing transmission and resolution. These substances can also condense on thermal control surfaces such as radiators or solar arrays and alter emissivity and absorptivity. In crewed spacecraft, outgassed volatiles may pose toxicity or odor concerns.

Electronics and Semiconductors

In microelectronics, outgassed siloxanes can deposit on contacts or printed circuit boards, leading to insulation failure or corrosion. The low outgassing silicones that ElastaPro provides are used for enclosure sealing, but the electronics industry also needs materials with low levels of outgassing for potting compounds, conformal coatings, and encapsulants.

Medical Devices and Pharmaceuticals

ASTM E595 does not apply to medical devices or pharmaceuticals; however, these industries are also concerned about the migration of volatile compounds that could interfere with sterile environments or analytical equipment. Low outgassing silicones can help improve biocompatibility and analytical purity, but other standards and requirements also apply.

Optical and Precision Instruments

Microscopes, laser systems, and satellites all require pristine optical surfaces. Even trace condensation can cause scattering or absorption, degrading performance. Silicones with low outgassing may be required for these applications.

Ask Elasto Proxy for Low Outgassing Silicones

ElastaPro makes ASTM E595 silicone and supplies these specification grade materials as solid silicone sheet and uncured silicone compound. Solid silicone sheets arrive ready for die cutting and come in thicknesses ranging from .010” to .500” and widths up to 60”. Uncured silicone compound can be molded, extruded, or calendered.

At ElastaPro, we manufacture materials in accordance with our ISO 9001:2015 and AS9100D Certified Quality Management system (QMS) and provide a Certificate of Analysis (COA) with each batch for traceability.  Contact us to request a quote, discuss your applications, or receive additional information about how we serve your industry.

Aerospace Silicones

ElastaPro makes aerospace silicones that meet customer callouts and military, civilian, and industry standards. These specification grade silicones are available as solid silicone sheet and uncured silicone compound. Solid silicone sheets arrive ready for die cutting and come in thicknesses ranging from .010” to .500” and widths up to 60”. Uncured silicone compound can be molded, extruded, or calendered.

ElastaPro manufactures aerospace silicones in accordance with our AS9100D and ISO 9001:2015 certified quality management system (QMS) at our Made in USA manufacturing facility in Santa Fe Springs, California. We are committed to meeting the highest quality standards and to supplying high-performance materials with the speed and value you deserve.

What are Aerospace Silicones?

Aerospace silicones are formulated to withstand the extreme conditions of aviation, aeronautics, and space. They differ from commercial grade and general purpose silicones in their enhanced properties such as high and low temperature resistance, durability, and low outgassing characteristics.

There are other silicone materials that can meet the rigors of extreme environments, but aerospace silicones also meet specifications from the U.S. military, civilian standards organizations, and/or original equipment manufacturers (OEMs). Some aerospace silicones are also military silicones, but not all military silicones are used in aerospace applications.

Types of Aerospace Silicones

ElastaPro makes aerospace silicones that meet the following specifications.

• A-A-55759
• A-A-59588
• AMS
• ASTM E595
• BMS
• DMS
• LMA
• MIL-DTL-25988
• MIL-PRF-81322
• MIL-SD-417
• PWA
• SAE
• WS14644

A-A-55759 Silicones

A-A-55759 silicones meet the requirements of alphanumeric classes within A-A-595750, a defense and aerospace specification from the U.S. General Services Administration (GSA) that is sometimes written as AA 59759, AA55759, or A A 55759.  A-A-55759 has replaced ZZR765 (ZZ-R-75), which is still found on some part drawings.

ElastaPro makes the following types of A-A-55759 silicones.

• A-A-55759 1A
• A-A-55759 1B
• A-A-55759 3A
• A-A-55759 3B

A-A-59588 Silicones

A-A-59588 silicones meet the requirements of alphanumeric classes within A-A-59588, a defense and aerospace specification published by the U.S. General Services Administration (GSA) that is sometimes written as MIL SPEC AA-59588, AA 59588, AA59588, or A A 59588. This standard has replaced ZZR765 (ZZ-R-75), which is still found on some part drawings.

ElastaPro makes the following types of A-A-59588 silicones.

• A-A-59588 1A
• A-A-59588 1B
• A-A-59588 2A/2B
• A-A-59588 3A
• A-A-59588 3B

AMS Silicones

AMS silicones meet Aerospace Material Specifications (AMS) from SAE International. AMS standards are not military standards, but some military applications reference these civilian aerospace standards. In addition to material properties, AMS specifications cover manufacturing processes and testing procedures. They also include requirements for material selection and quality control.

ElastaPro makes the following types of AMS silicones.

• AMS3325
• AMS3326
• AMS3327
• AMS3332
• AMS3334
• AMS3335
• AMS3336
• AMS3337
• AMS 3338
• AMS3345
• AMS3348
• AMS3349
• AMS 3356
• AMS3357
• AMS3301
• AMS3302
• AMS3303
• AMS3304
• AMS3315

ASTM E595 Silicones

ASTM E595 silicones meet the low outgassing requirements in ASTM E595, which forms the basis of NASA’s low outgassing standard. These specification grade silicones have a total mass loss (TML) of ≤1.00% and a Collected Volatile Condensable Material (CVCM) of ≤0.10%. ElastaPro makes ASTM E595 silicones in 40, 50, 60, and 70 durometer (Shore A).

BMS Silicones

BMS silicones meet requirements in Boeing Material Specifications (BMS). The Boeing Company developed this set of standards to ensure that silicones and other materials meet specific performance and quality requirements for Boeing aircraft.

ElastaPro supplies BMS silicones that meet these specific standards.

• BMS 1-52
• BMS 1-53
• BMS 1-57
• BMS 1-62
• BMS 1-71
• BMS 1-72
• BMS 1-74

DMS Silicones

DMS silicones meet Douglas Material Specification (DMS) requirements, which are now managed by The Boeing Company. Douglas developed these requirements to achieve efficient and cost-effective aircraft production through integrated processes, supplier compliance, quality management, and supply chain management. 

Contact ElastaPro for DMS silicones.

LMA Silicones

LMA silicones meet Lockheed Martin Aeronautics (LMA) requirements. Lockheed Martin Aeronautics is a division of Lockheed Martin Corporation that focuses on the design, development, production, and sustainment of military aircraft. LMA maintains detailed specifications that define the required properties, testing methods, and quality control procedures for each material used.

ElastaPro makes silicones that meet LMA-ME025 and LMA-STM requirements.

MIL-DTL-25988 Fluorosilicones (AMSR-25988)

MIL-DTL-25988 fluorosilicones meet the requirements of a U.S. military detail (DTL) specification for fluorosilicone (FVMQ) elastomers that resist fuel and oil and are used in aerospace applications. MIL-DTL-25988 classifies materials into types, classes and grades based on properties such as tensile strength, elongation, and hardness.

AMSR-25988, an SAE International specification, supercedes MIL-DTL-25988; however, MIL-DTL-25988 is still found on part drawings. AMSR-25988 and MIL-DTL-25988 both supercede the MILR-25988 standard, which is sometimes written as MIL-R-25988. Applications for MIL-DTL-25988 fluorosilicones include O-rings, molded parts, sheets, strips, and extruded shapes.

Contact ElastaPro for MIL-DTL-25988 fluorosilicones.

MIL-PRF-81322 Silicones

MIL-PRF-81322 silicones conform to a U.S. Department of Defense performance specification (PRF) for aircraft turbine engine lubricating oils. MIL-PRF-81322 does not focus specifically on silicone, but some lubricants contain silicone-based additives. Silicones contribute to a lubricant’s ability to withstand the high temperatures from turbine engines.

Contact ElastaPro for MIL-PRF-81322 silicones.

MIL-STD-417 Silicones

MIL-STD-417 silicones conform to a U.S. Department of Defense standard (STD) that defines a classification system and test standard for solid elastomeric materials (vulcanized rubber compounds). Material designations under this standard begin with the letter TA and are followed by a three-digit numeric identifier.

ElastaPro makes MIL-STD-417 silicones rangng from TA 405 to TA 810.

PWA Silicones

PWA silicones meet Pratt & Whitney requirements. Pratt Whitney, a division of RTX, designs and builds engines that are used aboard military and civilian aircraft. Compliant silicones must conform to AMS standards, military specifications, and other industry standards in addition to Pratt & Whitney’s internal requirements.

Contact ElastaPro for PWA silicones.

SAE Silicones

SAE silicones meet specific standards from SAE International. AMS silicones and AMSR-25988 silicones meet SAE standards, but there are other standards that affect silicones as well. For example, SAE-J20 covers silicone rubber that’s used in coolant hoses. TS147 covers silicone that used in loop-style clamp assemblies.

In addition to AMS and AMSR-25988 silicones, ElastaPro makes SAE-J20 and TS147 silicones.

WS14644 Silicones

WS14644 silicones are used in but not limited to aerospace applications. They meet the requirements of a U.S. Department of Navy specification that establishes requirements for vulcanized electrically conductive rubber compounds. WS14644 contains three types of materials and is sometimes listed on older part drawings.

ElastaPro makes Type III WS14644 silicones that are filled with carbon black and provide high conductivity.

Ask ElastaPro for Aerospace Silicones

ElastaPro makes specification grade aerospace silicones and supplies these materials as solid silicone sheet and uncured silicone compound. We provide a Certificate of Analysis (COA) with each batch for traceability.  Contact us to request a quote, discuss your applications, or receive additional information about how we serve the aerospace industry.

USP Class VI Sealing Products: Seven Types

USP Class VI sealing products encompass a broad spectrum of geometries, materials, and manufacturing approaches. From simple O-rings and gaskets to complex diaphragms, valve seats, and custom molded parts, these seals play a critical role in ensuring product safety, regulatory compliance, and reliable performance in high-purity environments. Engineers selecting these seals must carefully evaluate sterilization resistance, chemical compatibility, and extractables, all while aligning with industry-specific regulatory frameworks.

ElastaPro makes USP Class VI silicone materials as solid silicone sheet and uncured silicone compound. For service, quality, value and speed, contact ElastaPro.

Types of USP Class VI Sealing Products

There are seven major types of USP Class VI sealing products.

• O-rings
• Gaskets
• Diaphragms
• Sealing Profiles and Extrusions
• Sanitary Seals and Tri-Clamp Gaskets
• Custom Molded Sheets
• Valve Seats and Sealing Components

The following sections describe them.

1. O-Rings

O-rings are the most common and versatile USP Class VI sealing products used in biomedical and pharmaceutical equipment.

• Materials: USP Class VI–certified elastomers such as silicone, fluorosilicone, EPDM (ethylene propylene diene monomer), and FKM (fluoroelastomer). Silicone and EPDM are especially common due to their chemical resistance and cleanroom compatibility.

• Applications: O-rings are used in syringe pumps, bioreactors, peristaltic pumps, chromatography systems, and aseptic connectors. Their circular geometry provides uniform compression and reliable sealing even under pressure cycling.

• Key Benefits: Ease of installation, broad chemical compatibility, and resistance to sterilization methods such as autoclaving, gamma irradiation, and ethylene oxide (EtO) treatment.

2. Gaskets

Gaskets provide flat sealing between two rigid surfaces, typically flanges.

• Materials: USP Class VI silicone sheets, PTFE (polytetrafluoroethylene) composites, and perfluoroelastomers (FFKM). PTFE-encapsulated silicone gaskets are often specified when chemical resistance and biocompatibility are both required.

• Applications: Sterile process piping, pharmaceutical mixing tanks, bioprocessing skids, and clean-in-place (CIP) systems. In these environments, gaskets prevent contamination and maintain sterile boundaries.

• Key Benefits: Large sealing surface, customizable geometry, and high resistance to process fluids ranging from solvents to biological media.

3. Diaphragms

Diaphragms are flexible membranes that separate two environments while allowing pressure or mechanical force to be transmitted.

• Materials: USP Class VI–approved silicone, EPDM, or PTFE-lined elastomers. Some diaphragms are multilayer composites that combine flexibility with chemical inertness.

• Applications: Diaphragm valves, pump heads, and pressure regulators in biopharmaceutical systems. They are especially critical in applications where sterility and purity must be maintained without direct fluid leakage.

• Key Benefits: Smooth, crevice-free geometry that reduces bacterial entrapment; compatibility with sterilization; and long fatigue life under cyclic loading.

4. Sealing Profiles and Extrusions

Custom sealing profiles, sometimes referred to as extruded seals, are widely used in pharmaceutical isolators, medical enclosures, and sterile filling equipment.

• Materials: USP Class VI silicone rubber is the dominant choice due to its flexibility, clarity (in translucent grades), and resistance to repeated sterilization. Thermoplastic elastomers (TPEs) are also used in some extrusion profiles.

• Applications: Door seals in cleanrooms, chamber gaskets for lyophilizers, and perimeter seals for glove boxes. They maintain controlled atmospheres and prevent ingress of contaminants.

• Key Benefits: Continuous lengths with minimal splicing, availability in bulb, U-channel, and custom geometries, and low compression set for long-term sealing.

5. Sanitary Seals and Tri-Clamp Gaskets

Sanitary seals are standardized USP Class VI sealing products used with hygienic fittings in biopharma and food processing.

• Materials: USP Class VI silicone, EPDM, FKM, and PTFE. Some manufacturers also provide platinum-cured silicone versions, which reduce extractables compared to peroxide-cured variants.

• Applications: Tri-clamp gaskets seal the joints in stainless-steel sanitary tubing systems. They are indispensable in dairy processing, vaccine production, and parenteral drug manufacturing.

• Key Benefits: Easy assembly and disassembly for cleaning, compliance with both USP Class VI and FDA CFR 21, and surface finishes optimized for cleanability.

6. Custom Molded Seals

Not all sealing requirements can be met with standard geometries. Custom molded USP Class VI sealing products allow engineers to create shapes tailored to specific equipment.

• Materials: USP Class VI elastomers including silicone, EPDM, and perfluoroelastomers. These can be compounded to balance mechanical properties with biocompatibility.

• Applications: Seals for implantable devices, diagnostic cartridges, microfluidic platforms, and drug delivery systems. Custom seals often support innovations in life sciences where unique geometries are required.

• Key Benefits: Optimized sealing performance, integration with device architecture, and scalability for high-volume production.

7. Valve Seats and Sealing Components

Beyond diaphragms, valve systems often require additional USP Class VI–compliant sealing parts such as valve seats, poppets, and bellows.

• Materials: PTFE, perfluoroelastomers, or high-purity silicone. Material selection depends on chemical exposure and mechanical requirements.

• Applications: Aseptic sampling valves, pinch valves, and dosing systems in sterile pharmaceutical manufacturing.

• Key Benefits: High wear resistance, low extractables, and reliable sealing under dynamic movement and pressure cycling.

Do you need USP Class VI silicones to fabricate products like these ? Contact ElastaPro.

Silicone Colors: The Most Popular Choices for Silicone Sheet

White Silicone Sheet

Blue Silicone Sheet

Orange Silicone Sheet

Gray Silicone Sheet

Clear Silicone Sheet

Harnessing the Power of Electrically Conductive Silicone in Advanced Electronics

Electrically conductive silicone is a specialized material designed to transmit electrical currents while maintaining the flexibility and durability of traditional silicone. This unique combination makes it indispensable in modern electronics and engineering, where it serves crucial roles in shielding, dissipation, and ensuring reliable connections in circuits. As technology advances, it emerges as a vital material due to its resilience.

This article explores the role of this conductive silicone in modern electronics and its crucial applications in enhancing device efficiency.

Essential Role of Electrically Conductive Silicone in Electronic Devices

Electrically conductive silicone enhances the performance and reliability of electronic devices due to its unique properties. Here are some of its key roles:

EMI and RFI Shielding

Conductive silicone is often used to shield electronic devices from electromagnetic interference (EMI) and radio frequency interference (RFI). This is essential in preventing interference between different components within a device, which can cause malfunctions. The silicone’s conductive fillers (silver or carbon particles) create a barrier that absorbs and reflects electromagnetic waves to protect sensitive components.

Thermal Shielding

Some conductive silicones are designed to effectively dissipate heat. Such dual functionality can protect components from electrical and thermal stresses, improving the device’s overall durability and lifespan.

Static Discharge Protection

This silicone can safely dissipate static electricity and is particularly important in environments where static buildup can damage delicate electronic components. By providing a reliable path to ground, conductive silicone helps prevent electrostatic discharge (ESD), which can cause sudden and catastrophic failure of electronic circuits.

Reliable Electrical Connections

Electrically conductive silicone can create secure and consistent electrical pathways between device parts. It guarantees that grounding is effective and reliable over long periods, even under varying environmental conditions.

Flexible Circuitry and Connections

Conductive silicone is often used in flexible circuits and wearable electronics where traditional metallic connections are impractical. Its ability to maintain conductivity while stretched, compressed, or bent allows for innovative designs in modern electronics.

Sealing and Bonding

This type of silicone can seal and bond components while providing an electrical connection. Such dual-purpose functionality is especially valuable in compact devices with limited space.

Key Applications

The following applications demonstrate how conductive silicone is crucial in advancing modern electronics and engineering:

• Thermal interface materials (TIMs): Conductive silicone can be used in thermal pads and gap fillers to enhance heat dissipation between electronic components and heat sinks to ensure proper cooling.
• Printed circuits and flexible conductors: This material is used in flexible printed circuit boards (PCBs) and other flexible electronics, which enables the development of bendable and stretchable electronic devices.
• Pressure and touch sensors: Conductive silicone is used in sensors that detect pressure or touch, making it useful in touchscreens and wearable electronics.
• Conductive keypads: The material is often utilized to construct keypads and switches, where its conductive properties allow the closing of electrical circuits when pressed.
• Electrical contacts and seals: In batteries and fuel cells, conductive silicone creates seals and connections that maintain electrical conductivity while withstanding harsh environmental conditions.
• Biomedical sensors: Conductive silicone is used in medical devices for sensors and electrodes due to its biocompatibility, which allows the devices to conform to the body’s shape.
• Flexible wearable electronics: This material is essential in wearable devices like smartwatches and fitness trackers, providing electrical connectivity while maintaining comfort.

Choose ElastaPro Silicone Sheeting for Top-Notch Conductive Solutions!

At ElastaPro Silicone Sheeting, we provide electrically conductive silicone with unmatched precision. Our advanced solid silicone materials are also engineered into elastomeric shielding, offering exceptional resistance against EMI and RFI. With our superior components, you can ensure reliable electrical grounding, effective shielding, and enhanced conductivity!

Contact us today for innovative conductive silicones that bring reliability and excellence to your projects.

FDA Silicone: The Gold Standard in Health and Safety Compliance

FDA silicone refers to products that comply with the regulations set forth by the United States Food and Drug Administration (FDA). These regulations govern the safe use of silicone-based items in medical, pharmaceutical, food, and beverage applications. They also guarantee that the materials are non-toxic, chemically inert, and do not impart harmful substances into the products.

This article will explore the importance of FDA-approved silicone in various industries and the specific regulations and standards it must meet.

Significance of FDA Silicone Across Industries

FDA-approved silicone is pivotal across various industries due to its exceptional properties and adherence to stringent regulatory standards. In the food and beverage industry, this material is important to ensure the safety and quality of products. Its non-toxic nature prevents contamination and maintains the integrity of various food items, from processing equipment to packaging materials.

Using FDA silicone is also imperative in the pharmaceutical and medical sectors to uphold patient safety and regulatory compliance. Its exceptional biocompatibility, sterility, and resistance to chemical degradation make it indispensable in implants, catheters, and tubing. They are designed to be in direct contact with the human body for prolonged periods.

Furthermore, FDA silicone finds applications in various consumer products, from personal care items to industrial machinery. Its versatility and safety profile make it preferable for goods like baby bottle tubes, kitchen utensils, and automotive components. Manufacturers can instill consumer confidence regarding product safety by selecting this material for such applications.

FDA Regulations and Standards for Silicone Products

Compliance with the following regulations and standards is essential for silicone product manufacturers to ensure safety, effectiveness, and regulatory approval:

21 CFR Part 177

This regulation outlines the requirements for polymers including silicone intended for use in contact with food. It specifies permissible additives, maximum extractable levels, and overall safety criteria to prevent the migration of harmful substances into food.

USP Class VI

The United States Pharmacopeia (USP) Class VI standard applies to materials used in medical and pharmaceutical devices. Silicone products must meet cytotoxicity, sensitization, and systemic toxicity assessments to ensure they are safe for medical use.

ISO 10993

This international standard provides guidelines for evaluating the biological safety of medical devices, including silicone-based components. It encompasses various tests such as irritation, genotoxicity, and implantation tests to assess the compatibility of silicone materials with the human body.

ISO 9001 and ISO 13485

While not specific to silicone products, these quality management standards are relevant for producers of medical devices and pharmaceutical products incorporating silicone. Compliance with ISO 9001 ensures consistent quality control processes, whereas ISO 13485 focuses on meeting regulatory requirements for medical device manufacturing.

ISO 14971

This standard specifies requirements for risk management of medical devices, including those containing silicone. It entails identifying and mitigating hazards associated with silicone components, ensuring that risks are minimized.

FDA 510(k) Clearance

This process evaluates the safety and effectiveness of new medical devices compared to existing products. It ensures that silicone components meet regulatory requirements before being marketed in the United States.

FDA Master Files

Manufacturers may submit Master Files to the FDA containing confidential information about silicone materials’ safety, composition, and processing. These documents can streamline the regulatory review process for companies utilizing silicone product components.

Partner With ElastaPro Silicone Sheeting for Your Silicone Needs

At ElastaPro Silicone Sheeting, we offer high-quality silicone products and services tailored to meet global clients’ diverse needs! Our extensive portfolio spans industries including healthcare, automotive, electronics, and beyond catering to a wide array of applications and requirements. We also adhere to stringent quality control measures throughout our manufacturing process.

Contact us today to learn more about our solutions!

Calendered Silicone: The Process, Benefits, and Its Multitude of Uses

There are three primary methods to fabric silicone rubber products; molding, extrusion and calendering. Calendering plays a pivotal role in creating high-quality silicone products for gaskets, seals, o-rings and a variety of other products with various geometries and configurations. This manufacturing process involves passing raw silicone through a series of rollers under high pressure with a specific gap to establish the thickness of the sheet. The result is a silicone sheet with uniform thickness and smooth surface finish, suitable for various applications.

This blog will delve into the intricacies of calendered silicone, from its production process to its many applications.

The Process of Calendering Silicone

The process begins with raw silicone polymer, typically in the form of a gum or compound where additional ingredients are added to the material to meet key specifications . The silicone is performed for loading into the calendar.

Next, the silicone is fed into a calendering machine, where it passes through multiple rollers to control the thickness and surface characteristics of the silicone. Once the calendering process is complete, the silicone sheet may undergo a curing and post cure process or be supplied to fabricators in an uncured format. Cured silicone sheet may receive further treatment such as Pressure Sensitive Adhesive Application and slitting or cutting into specific dimensions based on customer requirements.

Quality control measures are implemented throughout the calendering process to monitor thickness, surface finish, and other relevant parameters. This ensures that the resulting silicone sheets meet the required specifications and quality standards. The silicone sheets are then packaged and prepared for distribution.

Benefits of Calendered Silicone

Here are some of the advantages of this silicone material:

• Flexible: Calendered silicone can bend, stretch, and adapt to various shapes without losing its integrity.
• Temperature-resilient: This silicone material maintains its properties across a wide temperature range from extreme cold to high heat making it suitable for diverse environments.
• Chemical-resistant: Calendered silicone exhibits resistance to various chemicals, oils, and solvents. This is why it is often used in applications where exposure to these substances is common.
• Weatherproof: Resisting weathering and UV radiation makes this silicone ideal for outdoor applications. It can endure exposure to sunlight and weather conditions without significant degradation.
• Biocompatible: This type of silicone is well-tolerated by the human body, making it suitable for various applications in the medical field.
• Customizable: Manufacturers can tailor calendered silicone sheets to meet specific requirements. This enhances its applicability in various industries and niche applications.

Versatile Uses of Calendered Silicone

Thanks to its unique properties and benefits, calendered silicone finds diverse applications across various industries:

• Automotive seals and gaskets: This type of silicone is ideal for seals and gaskets in vehicle components due to its resistance to heat and chemicals, or for thermal management in Electric Vehicles.
• Electrical insulation: Thanks to its excellent dielectric properties, calendered silicone insulates wires, cables, and electronic components.
• Flexible printed circuit boards (PCBs): This material can be used for flexible PCBs for electronic devices, allowing for versatile and bendable electronic components.
• Medical devices: Calendered silicone is utilized in medical equipment and devices for its biocompatibility, flexibility, and resistance to sterilization methods.
• Solar panel encapsulation: This silicone material is commonly applied in the encapsulation of solar panels to protect them from environmental factors and enhance their durability.
• Textile coating:Calendered silicone can be applied as a coating on textiles to make them resistant to water, heat, and chemicals.
• Weatherstripping: This material is typically used to manufacture weather stripping for doors and windows, providing insulation and protection against the elements.

ElastaPro: Your First Choice in Silicone Sheet Solutions

ElastaPro Silicone Sheeting is your go-to source for premium silicone products! Our company is founded by seasoned veterans in the silicone industry. Moreover, we boast decades of experience, high precision equipment, and proprietary manufacturing techniques. We offer US-made, high-quality products from calendered silicone sheets to uncured silicone compounds in standard and customized options.

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Specs of Silicone and Their Respective Applications

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Silicone is a versatile synthetic material composed primarily of silicon, oxygen, carbon, and hydrogen. Its non-reactive nature makes it suitable for diverse applications, including sealants, lubricants, and medical implants. Moreover, its exceptional thermal stability allows it to withstand temperature variations, from freezing to high-temperature industrial processes.

Due to its versatility, silicone comes in different specifications tailored to meet diverse industry requirements. These variations in material formulations allow for customization based on hardness, flexibility, and chemical resistance. Below are some of its most common specifications and their respective applications:

Military Specifications

Here are examples of widely-used silicone mil-specifications:

MIL-DTL-25988

The MIL-DTL-25988 specification is structured to define the parameters and characteristics of fluorosilicone (FVMQ) materials, emphasizing their intended use in aerospace applications. It classifies the materials into various classes, considering factors like tensile strength, elongation, and durometer hardness. It also guarantees that the fluorosilicone meets stringent standards, providing reliability, durability, and performance across military conditions.

MIL-DTL-83528

The MIL-DTL-83528 criterion outlines the specifications for electrically conductive rubber and fluorosilicone gaskets. These products are intended to offer protection against electromagnetic interference (EMI) and radio frequency interference (RFI). They are essential components in instances where shielding against such disruption is required to ensure electronic systems’ integrity and effective operation.

Aviation Specifications

While no specific overarching aviation specifications exist exclusively for silicone, various standards may reference or incorporate silicone-based materials. Here are a few examples:

Lockheed STM23

Lockheed STM23 specifications cover a wide range of silicone chemistry for various mission-critical requirements. Materials such as high-strength VMQ, PVMQ, and FVMQ are used with the Lockhead STM23 specifications. ElastaPro has many materials that meet these requirements.

MIL-PRF-81322

The MIL-PRF-81322 specification outlines general requirements for aircraft turbine engine lubricating oils. It does not specifically focus on silicone, but some lubricants that meet this specification may contain silicone-based additives. These compounds known for their thermal stability and oxidation resistance contribute to the lubricants ability to withstand high temperatures within turbine engines.

AMS

The AMS criterion specifies silicone rubber for use in high-temperature aviation engine seals and gaskets. The material is designed to withstand the extreme conditions encountered in aircraft engines, like elevated temperatures and exposure to aviation fuels. In addition, silicone rubber in various aerospace applications contributes to effective sealing and long-term durability. ElastaPro offers certified materials meeting stringent standards, including 3302, 3303, 3304, 3305, 3315, 3320, 33345, 3337, 3346, 3325, 3332, 3326, 3348, and 3348.

Boeing Material Specifications

Boeing typically employs various industry and international standards for materials. ElastaPro works with key requests such as BMS 1-52, 1-76, 1-57, 1-73 and 1-73.

BMS Solid Silicone Sheet

BMS solid silicone sheets are engineered to meet stringent standards for flexibility, durability, and high resistance to environmental factors. This makes them suitable for diverse aircraft components. They are also utilized in gaskets, seals, and insulation applications, providing reliable performance in challenging aerospace environments.

At ElastaPro Silicone Sheeting, these sheets arrive ready for die-cutting. They are between 0.010” and 0.500” thick and available in widths of up to 60”.

BMS Uncured Silicone Compound

The BMS sets stringent standards for uncured silicone compounds’ right chemical composition and physical properties. This ensures that they meet the specific requirements for aerospace use. By adhering to BMS, manufacturers guarantee that the compounds contribute to producing high-quality and durable aviation components.

Choose ElastaPro Silicone Sheeting for Your Silicone Needs

ElastaPro Silicone Sheeting delivers high-quality silicone products and components to clients across the globe! Our product range spans various solutions, each crafted to meet stringent industry standards and specific application needs. From sheets and gaskets to seals and custom products, we offer versatile options that find applications in numerous industries.

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Medical Grade Silicone: What Sets It Apart and Why It Matters

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Medical grade silicone is a type of silicone that meets specific quality and safety standards suitable for healthcare applications. These materials are often required to meet USP Class VI or ISO 10993 requirements for biocompatibility. It is made using highly purified compounds for biocompatibility, meaning it is unlikely to cause adverse reactions when in contact with the human body. It is also well-known for its durability and resistance to extreme temperatures, making it ideal for medical devices and implants.

Unlike other types, medical grade silicone is subjected to stringent quality control and testing procedures to guarantee it meets the highest purity standards. This article will explore the properties of this synthetic polymer, highlighting why it is exceptionally valuable in the medical industry.

Unique Properties of Medical Grade Silicone

The following features make this component essential in the healthcare industry, ensuring patient safety and well-being:

Biocompatibility

This property is extremely critical in the medical field, as it ensures that the human body has well-tolerated silicone devices and implants. Whether employed in pacemakers, joint replacements, or catheters, the material’s biocompatibility contributes to the overall success of medical interventions.

Chemical and Fluid Resistance

Medical grade silicone is highly resistant to bodily fluids, chemicals, and the sterilization processes commonly performed in healthcare settings. This resistance ensures the tool remains stable and maintains its structural integrity over extended periods. Moreover, its tolerance to various chemicals means it can withstand exposure to disinfectants and medications without deteriorating.

Electrical Insulation

This feature is useful in medical equipment with electronic components. Silicone can efficiently separate and shield delicate circuitry from moisture and external factors, guaranteeing devices’ safe and dependable operation. Examples include defibrillators, infusion pumps, pacemakers, and other diagnostic machines.

Flexibility and Durability

One of silicone’s characteristics is its capacity to be customized to varying levels of flexibility while keeping structural integrity. This feature enables it to resemble the softness of human tissue in medical procedures like breast implants. Its flexibility is also beneficial in prosthetics and tubing, where it needs to conform to the body’s contours or undergo repeated bending.

Hypoallergenic Nature

Because this silicone is hypoallergenic, it is less likely to cause allergic responses when it comes into contact with the skin. This is critical in situations where the material is near the patient, such as wound dressings or skin-contacting medical devices. Patients can be confident that the equipment is compatible with their bodies, lowering the chance of skin irritations or allergies.

Resistance to Bacteria Growth

The silicone’s resistance to bacteria growth is critical in preventing infections when used in medical devices or prosthetics. Its properties make it less conducive to the attachment and proliferation of harmful microorganisms, reducing the risk of device-related diseases. This is particularly essential in implants like urinary catheters or long-term indwelling instruments.

Thermal Stability

Medical grade silicone can withstand extreme temperature fluctuations without losing its qualities. This is especially important in hospitals where sterilization keeps medical devices clean. Autoclaving is a popular disinfection method that involves subjecting instruments and equipment to high-pressure steam at elevated temperatures.

Transparency and Clarity

Some silicone formulations provide optical clarity and transparency. This unique feature benefits ophthalmic applications such as intraocular and contact lenses. The material’s clearness allows for optimal light transmission, improving the quality of vision correction and minimizing distortion.

Choose ElastaPro Silicone Sheeting for Your Silicone Needs

At ElastaPro Silicone Sheeting, we offer high-quality silicone products and services to clients across the globe! Our portfolio encompasses various components, catering to the specific needs of industries such as healthcare, automotive, electronics, and more. We also employ rigorous quality control measures to ensure everything we do meets and exceeds industry standards.

Contact us today to learn more about our solutions!