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Silicone Requalification: Know the Risks and Costs

Buying silicone sheeting and uncured compound might seem like a low-risk activity, even when you’re purchasing spec-grade materials. A silicone that’s “qualified” meets mechanical, chemical and regulatory requirements and can remain in the same bill of materials (BOM) for years. In an age of global sourcing, however, believing that a compound won’t change is risky.

Silicone Compounds and Silicone Ingredients

Silicone compounds contain numerous ingredients. Examples include fillers, colorants, and flame retardants – just to name a few. Changing one key ingredient can affect an entire compound’s mechanical properties, thermal stability, compression set, and cure profile. Ingredient substitution can also negate a compound’s compliance with a standard or regulation.

Even if you’re buying domestically manufactured silicones, those compounds probably contain ingredients that come from nations where there’s a risk of a supply chain shut-off. If a key ingredient suddenly becomes unavailable, your compounder will look for another source. Failure to find a replacement isn’t the only threat to your supply chain, however. 

This article from ElastaPro examines the risks and costs associated with silicone requalification, a lengthy and expensive process that could become necessary because of ingredients. As you continue reading, remember that supply chain resilience isn’t just about where a silicone compound is made. It’s also about where its ingredients come from.

Medical Silicone Example

Imagine that you’ve been buying a U.S.-made medical grade silicone that contains a key ingredient from a nation with which the United States has serious disputes. The ingredient suddenly becomes unavailable because of a geopolitical disruption, a trade war, or because of a plant shutdown caused by a personnel issue.

The compounder substitutes a chemically similar ingredient and tells you that the new material is equivalent. There’s a problem, however. Medical-grade silicones must comply with standards such as ISO 10993, USP Class VI, and FDA 21 CFR 177.2600. Because of the substitution, there’s a risk that the compound that you’ve been buying is no longer biocompatible.

The way to address this risk isn’t by reviewing your supplier’s internal testing data. You’ll need to requalify the entire compound, a process that’s especially demanding in regulated industries like medical device manufacturing. In addition to mechanical and physical testing, there’s chemical, analytical, and standards-specific testing to perform.

Depending on the medical device’s class, you may need to update FDA Master File references, the Design History File (DHF), and the Device Master Record (DMR). There’s also risk management documentation to compile and supplier qualification records to review. 

Military Silicone Example 

Military silicones offer another example of where an ingredient substitution can put projects, your business, and potentially national security at risk. Imagine that you’re a buyer for a defense contractor that needs A-A-59588 silicones. More specifically, you need a Class 3B silicone. You find a vendor that supplies this material and offers a Certificate of Conformance (COC).  

That type of cert is useful, but it simply states that a product meets standards or specifications. In other words, it doesn’t contain test-level data for your specific batch of materials. This is a problem because, at some point, the supplier made an ingredient substitution that reduced the compound’s flex resistance or heat age so that it no longer meets A-A-59588 Class 3B requirements.    

When the compound fails during testing, you raise the issue with your supplier. That’s when you learn that the compounder had switched sources for a key ingredient. The new ingredient was less expensive, but the supplier is located in a country that’s not authorized to supply U.S. defense projects. The status of your project just went from bad to worse.   

How to Reduce Costs and Risks

Silicone compounders that buy ingredients from risky sources can put more than just your supply chain at risk. In the medical, food processing, aerospace, and defense industries, it’s critical to use compounds that meet industry standards or regulatory requirements. And buying a “cheap silicone” won’t prevent you from having to pay for expenses like requalification. 

At ElastaPro, we work closely with buyers so that they understand not just what they’re specifying, but where it comes from and how secure that supply chain really is. We also provide a full Certificate of Analysis (COA) with every batch and welcome your questions about the origins of our raw materials, which come from friendly sources rather than risky ones. 

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Fluorosilicone Chemical Compatibility Charts

ElastaPro makes fluorosilicone materials resist petroleum oils and hydrocarbon fluids. For full specifications and product availability, visit our Fluorosilicone pillar page.

Although fluorosilicones resist many aggressive chemicals, they do not resist all chemicals. Use the fluorosilicone chemical compatibility charts below for information about resistance to:

• Fuels
• Oils and lubricants
• Solvents
• Water and coolants
• Chemicals and industrial chemicals
• Aerospace and specialty chemicals
• Food and pharmaceutical chemicals

Each of these fluorosilicone chemical compatibility charts uses this rating system.

• Excellent (A): Fully compatible, very low swelling, maintains physical properties
• Good (B): Minor swelling or property change; generally acceptable
• Fair (C): Significant swelling or degradation; use caution
• Poor (D): Not compatible; severe degradation
• NR: Not recommended / data insufficient

Important: These are typical values. It is the responsibility of the user to ensure a fluorosilicone’s compatibility with the specific fuel, oil, solvent, or chemical in your application under the expected service conditions.

Fluorosilicone Fuel Resistance

Fluorosilicone Resistance to Oils and Lubricants

Fluorosilicone Solvent Resistance

Fluorosilicone Resistance to Water and Coolants

Fluorosilicone Resistance to Chemicals and Industrial Fluids

Aerospace and Specialty Chemicals

Food and Pharmaceutical Chemicals

Summary Table (Condensed)

Do Your Spec-Grade Silicones Contain Risky Raw Materials?

Material specifications are a matter of mission assurance in defense, aerospace, nuclear, and healthcare applications. Engineers diligently call out ASTM standards, AMS specs, and approved suppliers – and rightfully so.

But there’s a critical question that often goes unasked. Where do the raw materials that make up your spec-grade materials come from?  

Do You Know What’s in Your Silicone?

Silicone is a perfect example. The finished compound might be manufactured by a reputable U.S. based company, but what about key ingredients like these?

• Polydimethylsiloxane (PDMS) from which silicone bases are made
• Additives like heat stabilizers, flame retardants, and colorants
• Catalysts like peroxides and platinum system

Today, the raw materials in silicones are heavily sourced from overseas suppliers. China controls almost 75% of global silicon metal production and more than 55% of PDMS supply – and they’re still investing.   

That’s not a minor dependency. It’s a strategic vulnerability embedded in your bill of materials.

Which Questions Do You Need to Ask?

Reshoring efforts are gaining momentum, and some silicone producers are making real investments in supply chain transparency and domestic or allied-nation sourcing. But the burden shouldn’t fall solely on manufacturers. 

End users and procurement teams need to ask tougher questions.

• What are the countries of origin for the base polymer and key ingredients?
•  Are there geopolitical risks in the upstream supply chain?
• What happens to lead times and pricing if trade conditions change overnight?  

How Secure is Your Supply Chain?

At ElastaPro, we believe that supply chain literacy and friendly nation sourcing are part of the job. That’s why we work closely with customers in critical industries to help them understand not just what they’re specifying, but where it comes from and how secure that supply chain really is.

“Made in the USA” on a datasheet is a starting point. It’s not the full story.

If your application can’t afford supply chain disruptions, it’s time to have a supplier conversation that goes deeper than the spec sheet. Let’s talk about what’s in your materials – and whether those ingredients come from nations you can count on.       

Contact ElastaPro 

Silicone Company: ElastaPro is Made in USA

Choosing the right silicone company is critical for engineers, fabricators, and OEMs who depend on consistent performance, reliable supply, and application‑specific material expertise. In the United States, the silicone industry includes dozens of suppliers — but only a select few combine technical depth, grade diversity, and customer‑focused service at a level that supports demanding aerospace, medical, food‑processing, automotive, and industrial applications.

ElastaPro is the silicone company that stands out. With decades of formulation and manufacturing experience, we deliver high‑performance silicone sheets, sponge, foam, and uncured compounds engineered for precision and reliability.

What a Leading Silicone Company Provides

A true silicone company does more than sell material. It must offer:

• Multiple silicone grades for different regulatory and performance needs
• Consistent physical properties across batches
• Customization options for durometer, thickness, width, and color
• Fast lead times and responsive technical support
• Compliance with FDA, USP Class VI, aerospace, and industrial standards

ElastaPro meets — and exceeds — these expectations.

Why ElastaPro Is the Silicone Company Engineers Trust

As a U.S.‑based silicone company headquartered in Santa Fe Springs, California, ElastaPro manufactures both solid silicone sheet and uncured silicone compound with tight quality control and repeatable performance.

What sets our silicone company apart?

Extensive Grade Selection

We offer one of the broadest portfolios in the industry, including:

• Commercial & general‑purpose silicone
• FDA‑compliant silicone (CFR 177.2600)
• Medical‑grade silicone (USP Class VI)
• Fuel‑ and solvent‑resistant fluorosilicone (FVMQ)
• Electrically conductive silicone
• Fiberglass‑reinforced silicone
• Extreme‑temperature silicone
• Flame‑retardant silicone
• Metal‑detectable silicone

Customization Capabilities

As a flexible silicone company, we tailor:

• Durometer (20–90 Shore A)
• Thickness and width
• Cure system (peroxide or platinum)
• Color and translucency
• Physical property targets

Proven Performance

Our materials withstand –65°F to +500°F, resist chemicals, and maintain mechanical integrity under stress — essential for aerospace, defense, medical, and industrial environments.

Customer‑First Service

Engineers choose us because we deliver:

• Fast quotes
• Reliable lead times
• Technical guidance
• Consistent quality
• U.S.‑based manufacturing stability

ElastaPro isn’t just a silicone supplier — we’re a full‑service silicone company committed to long‑term customer success.

How Our Silicone Company Compares to Others

ElastaPro supports manufacturers across:

• Aerospace & Defense
• Medical & Pharmaceutical
• Food & Beverage Processing
• Automotive & EV
• Electronics & Sensors
• Industrial Manufacturing

Our silicone sheets, sponge, foam, and compounds are engineered for gaskets, seals, diaphragms, pads, molded parts, extrusions, and die‑cut components.

Why Engineers Searching for a Silicone Company Choose ElastaPro

If you’re evaluating silicone companies in the USA, ElastaPro delivers the combination of:

• Material expertise
• Regulatory compliance
• Customization
• Performance consistency
• Responsive support

…that modern manufacturing requires.

In a crowded market, ElastaPro remains the silicone company trusted for mission‑critical applications.

Request a Quote from a Leading Silicone Company

Whether you need solid silicone sheet, uncured silicone compound, or a custom‑engineered formulation, ElastaPro is ready to support your project.

Contact us today to request a quote or discuss your application.

Medical Silicone Sheeting: Engineered Materials for Healthcare

Medical silicone sheeting plays a critical role in healthcare applications that require performance, stability, and biocompatibility under demanding conditions. Unlike general purpose grade silicone, medical grade silicone is engineered to meet stringent regulatory, mechanical, and environmental requirements. That’s what makes medical silicones safe for contact with human skin, blood and fluids, or living tissue. It’s also why these biocompatible materials can withstand repeated sterilization cycles.  

Medical Silicone Sheeting: Durometers, Widths, and Thicknesses

ElastaPro produces medical silicone sheeting in controlled formulations and to durometers, widths, and thicknesses that medical OEMs need. At our Made in USA manufacturing facility, we calendar medical grade silicones into solid sheets that arrive ready for die cutting or other fabrication methods. These materials are easy to cut or convert and provide a superior gasket and sealing solution.

• Durometers range from 10 to 70 Shore A.
• Widths up to 60” wide are available
• Thicknesses range from .007” to .500”

ElastaPro’s medical silicone sheeting is typically translucent, but various colors (including custom color matching) are achievable. We can also supply silicone rolls that are slit-to-width for automated cutting operations. No matter what you order, you’ll receive medical silicones that are free from unpleasant smells and odors, organic plasticizers, and phthalates.   

Platinum Curing vs. Peroxide Curing

ElastaPro’s medical silicone sheeting is platinum-cured instead of peroxide-cured to minimize extractables and leachables, eliminate peroxide by-products, and provide the stability that FDA Title 21 CFR 177.2600 requires. Platinum-cured silicones also exhibit low volatility and consistent mechanical behavior across a wide temperature range. In addition, they have excellent clarity in translucent grades. ElastaPro can provide peroxide-cured materials for healthcare applications, but post-curing is required.

Biocompatibility and Compliance

Biocompatibility is a key characteristic of ElastaPro’s medical silicone sheeting. In addition to FDA Title 21 CFR 177.2600 requirements, these materials are engineered to comply with USP Class VI, ISO 10993, and Ph. Eur Monograph 3.19 from the European Pharmacopoeia. As our Healthcare Grade Silicone Sheeting Certification shows, USP Class VI and ISO 10993 studies were performed for test items ranging from 10 to 70 durometer (Shore A) and showed no relevant biological effects.  

• USP Class VI studies include acute system toxicity, intracutaneous toxicity, and short-term implantation (less than 29 days).
• ISO 10993 studies include cytotoxicity, hemolysis, pyrogenicity, sensitization, dermal irritation, and implantation (90 days).

Mechanical Performance

Mechanical performance is another key characteristic of ElastaPro’s medical silicone sheeting. These materials maintain their elasticity, tear strength, and tensile properties even after repeated sterilization by autoclave, gamma, or ethylene oxide (EtO) methods. They also retain their modulus and compression set characteristics for reliable sealing and cushioning in medical devices that undergo repeated use.

In sealing and fluid management applications, silicone’s low compression set and resistance to swelling are essential. Parts cut from medical silicone sheets can form reliable seals under low pressure for use in lightweight housings and compact devices. Because silicone is inherently inert and hydrophobic, it resists swelling in aqueous environments and maintains dimensional stability when exposed to biological fluids, such as in diagnostic and therapeutic systems.

Thermal Stability and Environmental Resistance

ElastaPro’s medical silicone sheeting also provides excellent thermal and environmental resistance. These materials remain functional from approximately −80°F to +450°F, supporting their use in sterilization chambers, heated fluid paths, and outdoor or transport‑exposed medical equipment. At intermittent temperatures, ElastaPro’s medical silicone sheets resist heat up to 500°F. Medical silicone sheets also resist UV, ozone, and oxidation for long‑term reliability in portable devices and emergency equipment.

Choose High-Quality Medical Silicone Sheeting

ElastaPro makes medical silicone sheeting from high-quality raw materials and provides a Certificate of Analysis (COA) with every batch. Our precision calendaring ensures uniform thickness and a consistent surface finish, attributes that support efficient cutting and conversion processes. To request a quote or discuss your healthcare application, contact ElastaPro.

Medical Grade Silicones from ElastaPro

Medical grade silicones from ElastaPro are used for sealing and gasketing in medical devices and equipment. These platinum-cured materials meet FDA Title 21 CFR 177.2600, USP Class VI, ISO 10993, and European Pharmacopoeia requirements. ElastaPro manufactures medical silicones in the United States and supplies them as solid sheets, continuous rolls, and uncured compounds.

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Silicone Product Manufacturers USA

Looking for silicone product manufacturers USA? ElastaPro stands out among U.S. silicone product manufacturers by combining technical expertise, diverse product grades, and customer-focused service, making it the best choice for engineers and manufacturers. Contact us to request a quote or to discuss your application.

USA Silicone Product Manufacturers

The United States hosts a competitive landscape of silicone manufacturers, supplying industries from aerospace and automotive to healthcare and food processing. These companies produce silicone in various forms—solid sheets, sponge, foam, and uncured compounds—each tailored to specific applications. Engineers rely on silicone for its temperature resistance, chemical stability, and flexibility, making it indispensable for seals, gaskets, medical devices, and high-performance components.

While many suppliers offer silicone materials, the differentiating factors often come down to grade variety, compliance with standards, and responsiveness to customer needs. This is where ElastaPro excels.

Why ElastaPro is the Best Choice Among U.S. Silicone Product Manufacturers

ElastaPro, headquartered in Santa Fe Springs, California, is a Made-in-USA silicone supplier specializing in solid and cellular sheets as well as uncured compounds. Founded by industry veterans, our company leverages decades of experience to deliver materials that meet stringent specifications across multiple sectors.

Key advantages include:

• Extensive Grade Options: ElastaPro offers commercial, general purpose, FDA-compliant, medical (USP Class VI), fuel- and solvent-resistant, electrically conductive, fiberglass-reinforced, extreme temperature, flame-retardant, and metal-detectable grades.
• Customization: Customers can specify durometer (20–90 Shore A), thickness, width, and even color, ensuring materials fit exact design requirements.
• Performance: Products withstand temperatures from -65°F to +500°F, resist chemicals, and maintain mechanical integrity under stress.
• Customer Experience: ElastaPro emphasizes speed, quality, and trust, with on-time deliveries and responsive service.

This combination of technical breadth and customer-centric values positions ElastaPro as more than a supplier. We’re a partner for engineers seeking reliable silicone solutions.

Silicone Manufacturers USA = ElastaPro

For engineers and manufacturers evaluating silicone suppliers in the USA, ElastaPro offers unmatched versatility, compliance, and service. Its transparent silicone sheets, sponge materials, and uncured compounds are engineered to meet demanding applications, while its customer-first approach ensures projects stay on track. In a crowded market, ElastaPro’s combination of technical excellence and trustworthiness makes it the best choice for sourcing silicone materials.

Food Grade Silicones from ElastaPro

Food grade silicones from ElastaPro are used by the food, beverage, and dairy industries. These high-purity elastomers are non-toxic, tasteless, odorless, and resistant to microbial growth. They’re also stable at high and low temperatures and easy to sterilize. Importantly, our food grade silicones comply with specific requirements and guidelines for food contact materials. Applications range from seals, gaskets, and diaphragms to tubing, baking mats, and conveyor belt covers.

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Silicone Manufacturers USA

Looking for silicone manufacturers USA? ElastaPro stands out among U.S. silicone manufacturers by combining technical expertise, diverse product grades, and customer-focused service, making it the best choice for engineers and manufacturers. Contact us to request a quote or to discuss your application.

Silicone Manufacturers in the USA

The United States hosts a competitive landscape of silicone manufacturers, supplying industries from aerospace and automotive to healthcare and food processing. These companies produce silicone in various forms—solid sheets, sponge, foam, and uncured compounds—each tailored to specific applications. Engineers rely on silicone for its temperature resistance, chemical stability, and flexibility, making it indispensable for seals, gaskets, medical devices, and high-performance components.

While many suppliers offer silicone materials, the differentiating factors among silicone manufacturing companies often come down to grade variety, compliance with standards, and responsiveness to customer needs. This is where ElastaPro excels.

Why ElastaPro is the Best Choice Among Silicone Manufacturing Companies

ElastaPro, headquartered in Santa Fe Springs, California, is a Made-in-USA silicone manufacturer specializing in solid and cellular sheets as well as uncured compounds. Founded by industry veterans, we leverage decades of experience to deliver materials that meet stringent specifications across multiple sectors.

Compared to other silicone manufacturers, our key advantages include:

• Extensive Grade Options: ElastaPro offers commercial, general purpose, FDA-compliant, medical (USP Class VI), fuel- and solvent-resistant, electrically conductive, fiberglass-reinforced, extreme temperature, flame-retardant, and metal-detectable grades.
• Customization: Customers can specify durometer (20–90 Shore A), thickness, width, and even color, ensuring materials fit exact design requirements.
• Performance: Products withstand temperatures from -65°F to +500°F, resist chemicals, and maintain mechanical integrity under stress.
• Customer Experience: ElastaPro emphasizes speed, quality, and trust, with on-time deliveries and responsive service.

This combination of technical breadth and customer-centric values positions ElastaPro as more than a supplier. Among silicone manufacturing companies, we’re a value-added partner.

Silicone Manufacturers USA = ElastaPro

For engineers and manufacturers evaluating silicone suppliers in the USA, ElastaPro offers unmatched versatility, compliance, and service. Its transparent silicone sheets, sponge materials, and uncured compounds are engineered to meet demanding applications, while its customer-first approach ensures projects stay on track. In a crowded market, ElastaPro’s combination of technical excellence and trustworthiness makes it the best choice for sourcing silicone materials.

Military Silicones and Fluorosilicones

ElastaPro makes military silicones and fluorosilicones that meet U.S. military specifications and standards. Collectively, these high-performance materials are sometimes referred to as MIL-SPEC silicones. ElastaPro supplies them as silicone sheets or uncured silicone compound. They’re proudly Made in America and come with a full Certificate of Analysis (COA) for traceability.

• Silicone sheets arrive ready for die cutting and are available with pressure-sensitive adhesives (PSAs). ElastaPro makes both solid silicone sheet and cellular silicone sheet.

• Uncured silicone compound arrives ready for curing and can be molded, extruded, or calendered.

ElastaPro produces military silicones and fluorosilcones in accordance with our AS9100D and ISO 9001:2015 certified quality management system (QMS). As North America’s largest manufacturer of solid silicone sheet, we’re committed to meeting the highest quality standards while supplying the MIL-SPEC silicones you need with the speed and value you deserve.

What are Military Silicones and Fluorosilicones? 

Military Silicones (VMQ), Phenyl Silicones (PVMQ) and Fluorosilicones (FVMQ) are formulated and manufactured to meet U.S. military specifications and standards for products such as seals, gaskets, O-rings, electrical insulation, and vibration damping. They can meet military detail specifications (MIL-DTL) or military standards for rubber products (MIL-R).

The main difference between military silicones and fluorosilicones is that military fluorosilicones contain fluorine additions that maintain silicone’s excellent high-temperature stability and mechanical properties while offering greater resistance to fuel, oil, and other chemicals. Fluorosilicones tend to be more expensive, but they’re required for some applications.

Military silicones and fluorosilicones also include materials that meet related specifications and standards. For example, some aerospace silicones and SAE International silicones have military applications because of their excellent material properties. Examples include AMS silicones and AMSR25988 fluorosilicones. ElastaPro makes these and other spec-grade rubber materials.

Types of Military Silicones and Fluorosilicones

ElastaPro makes MIL-SPEC silicones that meet the following specifications.

• MIL-DTL-25988
• MIL-R-25988
• MIL-R-46089
• MIL-R-6130
• MIL-STD-417 TA
• MIL-STD-670 TE12
• WS14644

MIL-DTL-25988

MIL-DTL-25988 fluorosilicones meet the requirements of a U.S. military detail specification for a fluorosilicone rubber (FVMQ) that resists fuels, oils, and high temperature. Materials are categorized by types, classes, and grades.  AMSR25988, an SAE International Standard, superseded MIL-DTL-25988 and is equivalent to the MIL-DTL-25988C, which still appears on some part drawings.

MIL-R-25988

MIL-R-25988 fluorosilicone meets the requirements of U.S. military specification for rubber materials that provide oil and fuel resistance, especially in aerospace applications. It contains two types and two classes. MIL-DTL-25988 superseded MIL-R-25988 and was in turn superseded by AMSR25988. Some part drawings still refer to MIL-R-25988, however.

MIL-R-46089

MIL-R-46089 silicone meets the requirements of a U.S. military specification for a closed-cell sponge silicone. It categorizes materials by grades, forms, and sheet sizes. ElastaPro makes medium-grade silicone sponge sheet in all three MIL-R-46089 sizes (codes): 12” x 12” (1), 24” x 24” (2), and 36” x 36” (3). ASTM D1056 superseded MIL-R-46089, but it’s still referenced on older part drawings.

MIL-R-6130

MIL-R-6130 silicone meets the requirements of a U.S. military specification for a chemically blown cellular rubber, a group of materials more commonly known as sponge rubber and foam rubber. This MIL-SPEC divides materials into types, grades, and conditions (firmness). ElastaPro makes Type II (closed-cell) silicones with medium firmness.

MIL-STD-417 TA

MIL-STD-417 TA silicone meets the requirements of a U.S. military standard for solid elastomer materials. The “TA” designation refers to silicones and is followed by a three-digit number. ElastaPro makes MIL-STD-417 TA silicones that range from TA 405 to TA810. Note that ASTM D2000 superseded this military standard and uses FC, FS, FE, or GE instead of TA.

MIL-STD-670 TE12

MIL-STD-670 TE12 silicone foam meets the requirements of a U.S. military standard for a closed-cell medium-density silicone foam for seals and gaskets. The TE12 designation indicates a specific firmness and density within the larger standard. This soft, compressible material is used to absorb shock and maintain a seal under harsh conditions.

WS14644

WS14655 silicone meets the requirements of a U.S. Navy specification for electrically conductive silicone rubber compounds. It’s divided into types and classes. ElastaPro makes Type III high conductivity, carbon black filled materials. Applications include EMI gaskets, anti-static components, and conductive pads and seals.

Ask ElastaPro for Military Silicones and Fluorosilicones

Do you need military silicones and fluorosilicones in high or low volumes? Whether you need a 2-lb. lab sample or 200,000 pounds of production material, we’re ready to help. That’s not all either. In addition to adhesive lamination, ElastaPro offers roll slitting and product development services. Thank you for learning more about us, and we invite you to contact ElastaPro for more information.