Views: 0 Author: Peter Cui Publish Time: 2023-07-19 Origin: Mitour Silicone
Table of Contents
In the world of advanced materials, few substances combine the breadth of beneficial properties found in platinum silicone rubber. From life-saving medical implants and infant feeding products to aerospace seals and precision electronics, platinum-cured silicone has become the material of choice wherever purity, performance, and safety are non-negotiable.
Yet despite its widespread use, platinum silicone rubber remains poorly understood outside of manufacturing and engineering circles. What exactly makes platinum curing superior to other methods? Why do medical device manufacturers, baby product brands, and food-grade kitchenware producers specifically demand platinum-cured silicone? And how do you identify a manufacturer capable of delivering the genuine article?
At Mitour Silicone, we have manufactured platinum-cured, food-grade silicone products for global clients across medical, consumer, and industrial markets for over 18 years. This ultimate guide answers every essential question about platinum silicone rubber — from the chemistry of the curing process through applications, performance properties, environmental considerations, and manufacturer selection criteria.
Platinum silicone rubber is a type of silicone elastomer that uses a platinum-based catalyst to drive the curing (vulcanization) process — the chemical reaction that transforms liquid or uncured silicone compounds into a solid, elastic, high-performance rubber.
The base material — silicone — is a synthetic polymer built on an alternating silicon-oxygen backbone:
$$-[\text{Si}(\text{R}_2) - \text{O}]_n-$$
Where R represents organic side groups (typically methyl, vinyl, or phenyl groups) that determine the material's specific properties. The curing process crosslinks these polymer chains into a three-dimensional network, creating the elastic solid we recognize as silicone rubber.
Platinum curing (also called addition curing or hydrosilylation) works through a fundamentally different mechanism than other silicone curing systems:
The Hydrosilylation Reaction:
$$\text{Si-H} + \text{CH}_2=\text{CH-Si} \xrightarrow{\text{Pt catalyst}} \text{Si-CH}_2\text{-CH}_2\text{-Si}$$
In this reaction:
Vinyl-functional silicone (one component) provides reactive vinyl groups
Hydride-functional silicone (second component) provides Si-H groups
Platinum catalyst facilitates the addition reaction between these groups
Result: Carbon-carbon bonds form between polymer chains — creating a pure, stable crosslinked network
What makes this chemistry exceptional:
The reaction produces no byproducts — no volatile organic compounds (VOCs), no acids, no peroxides
The platinum catalyst is consumed in trace amounts and remains locked in the cured matrix
The resulting crosslinks are purely carbon-carbon bonds — chemically stable and inert
No post-cure degassing is required (unlike peroxide systems)
Platinum silicone rubber is supplied as a two-part system:
Component | Designation | Contains | Function |
Part A | Base | Vinyl-terminated silicone polymer + platinum catalyst | Provides reactive sites and catalyst |
Part B | Crosslinker/Curative | Hydride-functional silicone crosslinker | Provides crosslinking agent |
Mix ratio | Typically 1:1 or 10:1 by weight | Per manufacturer specification | Critical for complete cure |
Critical Note: The mix ratio must be followed precisely. Incorrect ratios result in incomplete curing — producing a tacky, under-cured product with compromised properties.
Understanding what distinguishes platinum curing from alternative systems is essential for appreciating why it commands premium status across demanding applications.
Property | Platinum (Addition) Cure | Peroxide Cure | Condensation Cure |
Curing mechanism | Hydrosilylation (addition) | Free radical crosslinking | Moisture-activated condensation |
Byproducts | ✅ None | ❌ Peroxide decomposition products | ❌ Alcohol or acetic acid |
Post-cure required | ✅ Not required | ❌ Required (removes byproducts) | ❌ Not applicable |
Shrinkage | ✅ Very low (<0.1%) | ⚠️ Low-moderate | ❌ Moderate-high |
Purity | ✅ Highest | ⚠️ Good (after post-cure) | ⚠️ Moderate |
Biocompatibility | ✅ Excellent (USP Class VI) | ⚠️ Good (requires post-cure) | ⚠️ Limited |
Food safety | ✅ FDA/LFGB certified | ⚠️ Possible with post-cure | ⚠️ Limited |
Mechanical properties | ✅ Superior | ✅ Good | ⚠️ Moderate |
Tear resistance | ✅ Excellent | ✅ Good | ⚠️ Moderate |
Transparency | ✅ Excellent (water-clear) | ⚠️ Good | ⚠️ Moderate |
Odor | ✅ Odorless | ⚠️ Slight odor possible | ⚠️ Possible odor |
Inhibition sensitivity | ⚠️ Sensitive to inhibitors | ✅ Less sensitive | ✅ Less sensitive |
Shelf life | ✅ Good (2 years typical) | ✅ Good | ✅ Good |
Cost | Higher (platinum cost) | Lower | Lowest |
Best for | Medical, food, baby products | Industrial, general purpose | Sealants, mold making |
The absence of byproducts is the defining advantage of platinum curing. In peroxide-cured systems, the decomposition of organic peroxides during curing generates volatile byproducts that must be removed through a secondary post-cure oven process. If this post-cure is incomplete or skipped, residual byproducts remain in the silicone — potentially migrating into food or body contact applications.
Platinum curing eliminates this risk entirely. The addition reaction is clean, complete, and leaves no residual compounds to migrate. This is why:
Medical device manufacturers specify platinum-cured silicone for implants and body-contact devices
Baby product brands require platinum curing for pacifiers, bottle nipples, and teethers
Food-grade kitchenware manufacturers use platinum curing for products that contact food at high temperatures
Pharmaceutical companies use platinum-cured silicone for drug delivery systems and packaging
Property | Typical Range | Test Standard | Significance |
Hardness | Shore A 0–80 (formulation-dependent) | ASTM D2240 | Determines feel and application suitability |
Tensile strength | 4–12 MPa | ASTM D412 | Resistance to tearing under tension |
Elongation at break | 200–800% | ASTM D412 | Flexibility and stretch capability |
Tear resistance | 10–50 kN/m | ASTM D624 | Resistance to tear propagation |
Compression set | 5–25% | ASTM D395 | Seal recovery after sustained compression |
Shrinkage | < 0.1% | Dimensional measurement | Dimensional precision in molded parts |
Density | 1.1–1.3 g/cm³ | ASTM D792 | Weight characteristics |
Rebound resilience | 50–70% | ASTM D1054 | Energy return after compression |
Property | Value | Significance |
Operating temperature range | -60°C to +250°C (-76°F to +482°F) | Widest temperature range of any elastomer |
Short-term peak temperature | Up to 300°C (572°F) | Brief high-heat exposure tolerance |
Low-temperature flexibility | Remains flexible to -60°C | No brittleness in freezing conditions |
Thermal conductivity | 0.2–0.3 W/m·K | Moderate heat transfer |
Coefficient of thermal expansion | ~300 × 10⁻⁶/°C | Important for precision applications |
Autoclave resistance | 121°C, 15 psi, repeated cycles | Critical for medical sterilization |
Chemical Environment | Resistance Level | Notes |
Dilute acids | ✅ Excellent | Safe for acidic food contact |
Dilute alkalis | ✅ Excellent | Dishwasher and cleaning agent resistant |
Water and steam | ✅ Excellent | Steam sterilization compatible |
Alcohols | ✅ Good | Suitable for alcohol-based sanitizers |
Oils and fats | ✅ Good | Food-safe with fatty foods |
Oxidizing agents | ✅ Good | Ozone and UV resistant |
Concentrated acids | ⚠️ Moderate | Check specific formulation |
Aromatic hydrocarbons | ⚠️ Limited | May cause swelling |
Chlorinated solvents | ⚠️ Limited | Specialized formulations available |
Property | Value | Application |
Dielectric strength | 15–25 kV/mm | Electrical insulation |
Volume resistivity | 10¹⁴–10¹⁵ Ω·cm | Insulation applications |
Dielectric constant | 2.7–3.0 at 1 MHz | Electronic applications |
Dissipation factor | 0.001 at 1 MHz | Low electrical loss |
Property | Platinum Silicone | Significance |
Transparency | Water-clear (unfilled) | Allows visual inspection of contents |
Light transmission | >90% (thin sections) | Optical applications |
UV stability | Excellent | No yellowing with UV exposure |
Colorability | Full Pantone range | Unlimited color options |
Biocompatibility refers to a material's ability to perform its intended function without eliciting harmful local or systemic effects in the body. For implanted or body-contact medical devices, biocompatibility is not optional — it is a regulatory requirement.
Biocompatibility Test | Platinum Silicone Result | Standard |
Cytotoxicity | ✅ Non-cytotoxic | ISO 10993-5 |
Sensitization | ✅ Non-sensitizing | ISO 10993-10 |
Irritation | ✅ Non-irritating | ISO 10993-10 |
Systemic toxicity (acute) | ✅ Non-toxic | ISO 10993-11 |
Implantation | ✅ Biocompatible | ISO 10993-6 |
Genotoxicity | ✅ Non-genotoxic | ISO 10993-3 |
Hemocompatibility | ✅ Hemocompatible | ISO 10993-4 |
USP Class VI | ✅ Passes | USP <88> |
The biocompatibility advantage of platinum-cured silicone over peroxide-cured alternatives stems directly from its chemistry:
Factor | Platinum Cure | Peroxide Cure |
Residual catalyst | Platinum — inert, non-toxic | Peroxide decomposition products — potentially irritating |
Byproduct migration | None | Possible if post-cure incomplete |
Extractables | Minimal | Higher (requires extraction testing) |
Leachables | Minimal | Higher potential |
Long-term stability | Excellent | Good (with proper post-cure) |
The medical industry represents the most demanding and highest-value application domain for platinum silicone rubber. Its combination of biocompatibility, sterilization resistance, chemical inertness, and mechanical performance makes it irreplaceable in numerous medical applications.
Application Category | Specific Products | Key Requirements Met |
Implantable devices | Breast implant shells, tissue expanders, cochlear implant components | USP Class VI, ISO 10993, long-term biocompatibility |
Fluid management | IV tubing, drainage catheters, feeding tubes, peristaltic pump tubing | Chemical inertness, flexibility, sterilization resistance |
Respiratory | Ventilator masks, breathing circuits, oxygen masks, anesthesia components | Airtight seal, biocompatibility, sterilization resistance |
Wound care | Wound dressings, scar management sheets, negative pressure wound therapy | Biocompatibility, moisture management |
Prosthetics | Facial prosthetics, limb socket liners, finger prosthetics | Skin-like feel, durability, colorability |
Drug delivery | Controlled-release implants, transdermal patches, infusion ports | Controlled permeability, biocompatibility |
Diagnostic equipment | Gaskets, seals, diaphragms in diagnostic instruments | Chemical resistance, dimensional stability |
Dental | Impression materials, mouth guards, dental prosthetic components | Biocompatibility, dimensional accuracy |
Certification/Standard | Requirement | Significance |
ISO 10993 series | Biocompatibility evaluation | International medical device standard |
USP Class VI | Biological reactivity testing | US pharmacopeia standard for implantables |
FDA 21 CFR 177.2600 | Food contact (for medical nutrition) | FDA material compliance |
ISO 13485 | Quality management for medical devices | Manufacturing quality standard |
CE Marking (EU MDR) | European medical device regulation | EU market access |
Sterility assurance | SAL 10⁻⁶ | Sterility standard for implantables |
Platinum silicone's food-grade properties — zero byproducts, chemical inertness, temperature stability, and certified safety — make it the preferred material for food-contact applications where safety and performance are paramount.
Application | Products | Why Platinum Silicone |
Bakeware | Baking mats, molds, cake pans, muffin trays | Heat resistance to 230°C+; non-stick; easy release |
Kitchen tools | Spatulas, whisks, tongs, pastry brushes | Food-safe; heat-resistant handles; flexible |
Food storage | Reusable bags, lids, stretch covers, containers | Airtight seal; freezer to oven safe |
Beverage equipment | Coffee machine seals, water filter gaskets, bottle seals | Chemical inertness; flavor neutrality |
Food processing | Conveyor belts, gaskets, seals, tubing | FDA compliance; chemical resistance |
Baby feeding | Bottle nipples, pacifiers, teethers, spoons | Maximum purity; biocompatibility |
Brewing and winemaking | Tubing, gaskets, bungs, stoppers | Flavor neutrality; chemical resistance |
Dairy processing | Milking equipment seals, tubing | Hygienic design; easy cleaning |
Certification | Standard | Market |
FDA 21 CFR 177.2600 | Food contact material compliance | USA |
LFGB §30/31 | Food contact testing (migration) | Germany/EU |
EU Regulation 10/2011 | Plastic materials food contact | European Union |
GB 4806.11 | Food contact silicone standard | China |
JHOSPA | Food contact standard | Japan |
Health Canada | Food contact material | Canada |
Baby products represent one of the most safety-critical consumer applications — and platinum silicone has become the industry standard for premium infant products precisely because of its unmatched purity profile.
Product | Hardness Range | Key Safety Requirement |
Pacifier nipples | Shore A 25–35 | USP Class VI; LFGB; EN 1400 |
Bottle nipples/teats | Shore A 30–40 | FDA; LFGB; anti-colic design |
Teething toys | Shore A 35–50 | EN 71; LFGB; no sharp edges |
Baby spoons | Shore A 40–55 | FDA; LFGB; soft tip |
Breast pump parts | Shore A 35–50 | FDA; skin contact biocompatibility |
Baby bibs | Shore A 45–55 | FDA; LFGB; adjustable closure |
Feeding bowls | Shore A 50–65 | FDA; LFGB; suction base |
Baby toothbrushes | Shore A 30–45 | FDA; LFGB; ultra-soft bristles |
Concern | Peroxide Silicone Risk | Platinum Silicone Solution |
Residual chemicals | Peroxide byproducts if post-cure incomplete | Zero byproducts — no risk |
Odor | Possible residual odor | Completely odorless |
Extractables | Higher extractable content | Minimal extractables |
Regulatory compliance | Requires additional testing | Passes strictest standards inherently |
Parent confidence | Requires explanation | Recognized as gold standard |
Application | Products | Key Properties Required |
Wearables | Smartwatch bands, fitness tracker straps, earbuds | Skin compatibility, flexibility, sweat resistance |
Device protection | Phone cases, tablet covers, laptop sleeves | Impact absorption, flexibility, grip |
Audio | Earphone tips, headphone cushions, microphone covers | Acoustic properties, skin comfort |
Keyboards and input | Keyboard covers, button seals, trackpad protectors | Tactile feel, durability, chemical resistance |
Connectors and seals | Waterproofing gaskets, connector boots, cable management | IP rating compliance, dimensional stability |
Thermal management | Thermal interface pads, heat sink gaskets | Thermal conductivity, compression properties |
Category | Products | Platinum Silicone Advantage |
Personal care | Facial cleansing brushes, massage tools, hair accessories | Skin biocompatibility, easy cleaning |
Sports and fitness | Swim goggles, mouthguards, grip accessories | Skin comfort, chemical resistance |
Home goods | Pot holders, trivets, jar openers, ice cube trays | Heat resistance, non-slip properties |
Pet products | Food bowls, toys, grooming tools | Non-toxic, easy to clean, durable |
Travel accessories | Collapsible bottles, travel containers, luggage tags | Durability, flexibility, chemical resistance |
Industry | Applications | Key Requirements |
Aerospace | Seals, gaskets, vibration dampers, cable insulation | Extreme temperature range, outgassing requirements |
Automotive | Engine seals, spark plug boots, sensor gaskets | High-temperature resistance, chemical resistance |
Semiconductor | Wafer handling components, cleanroom seals | Ultra-low outgassing, particle contamination control |
Optical | Lens seals, optical fiber coatings, display gaskets | Optical clarity, dimensional stability |
Energy | Solar panel encapsulants, fuel cell seals | UV stability, long-term durability |
Textile | Waterproof coatings, elastic applications | Flexibility, washability |
LSR injection molding is the most advanced and widely used manufacturing process for platinum-cured silicone products:
Process Parameter | Specification | Significance |
Material form | Two-component liquid (Part A + Part B) | Automated metering and mixing |
Mix ratio | 1:1 (typical) | Precise ratio critical for full cure |
Injection temperature | 5–25°C (cold runner) | Prevents premature curing in runner |
Mold temperature | 150–200°C | Drives rapid curing in mold cavity |
Cycle time | 15–90 seconds | Highly efficient for high-volume production |
Shrinkage | < 0.1% | Exceptional dimensional accuracy |
Flash | Minimal | Reduced post-processing |
LSR Injection Molding Advantages:
Advantage | Detail |
Automation | Fully automated process; minimal human intervention |
Consistency | Machine-controlled parameters ensure batch-to-batch uniformity |
Efficiency | Short cycle times enable high-volume production |
Cleanliness | Closed system prevents contamination |
Complex geometry | High injection pressure fills intricate mold details |
Multi-cavity | Multiple parts per cycle increases productivity |
Overmolding | Can bond to substrates (plastics, metals) in single operation |
Process Parameter | Specification | Application |
Material form | Solid gum compound or pre-mixed liquid | Versatile; suits various product types |
Mold temperature | 150–180°C | Drives curing reaction |
Cure time | 3–10 minutes | Longer than LSR injection |
Pressure | 50–200 bar | Ensures complete mold fill |
Best for | Medium complexity parts; lower volumes | Cost-effective tooling |
Characteristic | Detail |
Process | Pre-measured compound transferred from pot through runners into cavities |
Advantages | Better dimensional control than compression; lower tooling cost than injection |
Best for | Medium complexity; medium volumes |
Typical applications | Seals, gaskets, medical components |
Characteristic | Detail |
Process | Continuous silicone profile pushed through shaped die |
Products | Tubing, profiles, cords, strips |
Cure method | Hot air vulcanization (HAV) or salt bath cure |
Best for | Continuous lengths; uniform cross-section profiles |
Understanding the key formulation variables helps specify the right platinum silicone for your application:
Shore A Range | Characteristics | Typical Applications |
Shore A 0–10 | Gel-like; maximum conformability | Prosthetics, cushioning, special effects |
Shore A 10–25 | Very soft; skin-like | Medical prosthetics, breast forms |
Shore A 25–45 | Soft; flexible | Baby products, pacifiers, medical tubing |
Shore A 45–65 | Medium; balanced | Kitchenware, consumer products, seals |
Shore A 65–80 | Firm; shape-retaining | Industrial seals, structural components |
Formulation Type | Key Additive/Modification | Application |
High-transparency | Optimized polymer purity | Optical applications, medical visualization |
High-tear strength | Reinforcing fillers | Demanding mechanical applications |
Thermally conductive | Ceramic or metallic fillers | Thermal management |
Electrically conductive | Carbon black or silver fillers | EMI shielding, antistatic |
Flame retardant | Halogen-free FR additives | Electronics, aerospace |
Self-lubricating | PTFE or silicone oil additives | Moving parts, reduced friction |
Fluorosilicone | Fluorine-modified polymer | Enhanced chemical resistance |
High-consistency (HCR) | Solid gum form | Compression molding applications |
Liquid (LSR) | Low-viscosity two-part system | Injection molding |
Environmental Factor | Assessment | Detail |
Longevity | ✅ Positive | Long product lifespan reduces replacement frequency |
Microplastics | ✅ Positive | Does not generate microplastics during use or degradation |
Chemical leaching | ✅ Positive | Minimal migration; does not contaminate soil or water |
Energy in production | ⚠️ Neutral | Energy-intensive manufacturing; offset by long lifespan |
Raw material source | ⚠️ Neutral | Silicon from abundant silica; platinum from mining |
Recyclability | ⚠️ Developing | Not standard recyclable; specialist programs emerging |
Biodegradability | ❌ Limitation | Does not biodegrade; incineration produces inert silica ash |
End-of-life | ⚠️ Developing | Pyrolysis and specialist recycling options advancing |
Stage | Platinum Silicone | Single-Use Plastic | Standard Rubber |
Raw material | Silicon (abundant) + platinum (scarce) | Petroleum (finite) | Natural rubber (renewable) |
Production energy | Moderate-high | Moderate | Moderate |
Use phase | ✅ Long life; no leaching | ❌ Short life; potential leaching | ⚠️ Moderate life |
End of life | Specialist recycling; inert ash | Landfill; microplastics | Landfill; some recycling |
Overall LCA | ✅ Favorable for long-use applications | ❌ Poor for single-use | ⚠️ Application-dependent |
Development | Status | Potential Impact |
Silicone pyrolysis recycling | Commercial scale emerging | Recovers silicone oil for reuse |
Manufacturer take-back programs | Pilot programs active | Circular economy model |
Bio-based silicone research | Early-stage R&D | Reduced petroleum dependency |
Reduced platinum loading | Ongoing optimization | Lower precious metal consumption |
Renewable energy in production | Increasing adoption | Reduced carbon footprint |
Application | Primary Certifications | Secondary/Regional |
Medical implants | ISO 10993, USP Class VI, ISO 13485 | FDA 510(k), CE MDR |
Food contact | FDA 21 CFR 177.2600, LFGB §30/31 | REACH, EU 10/2011 |
Baby products | FDA, LFGB, EN 1400 (pacifiers), EN 71 | CPSC, ASTM F963 |
Consumer electronics | REACH, RoHS | CE, FCC |
Aerospace | AS9100, outgassing per ASTM E595 | MIL-spec standards |
Pharmaceutical | USP Class VI, ISO 10993, FDA DMF | ICH Q3C |
FDA 21 CFR 177.2600 — Rubber Articles Intended for Repeated Use:
Covers silicone rubber for repeated food contact
Tests for extractables under specified conditions
Required for US market food-contact applications
LFGB §30/31 (Germany/EU):
Considered the world's most stringent food contact silicone standard
Tests migration of substances into food simulants
Covers both aqueous and fatty food simulants
Widely accepted as the global gold standard for food-grade silicone
USP Class VI:
United States Pharmacopeia biological reactivity standard
Tests for systemic injection toxicity, intracutaneous reactivity, and implantation
Required for pharmaceutical and medical device applications
ISO 10993 Series:
International standard for biological evaluation of medical devices
20+ parts covering different aspects of biocompatibility
Required for all medical device market access globally
The first and most critical question: Is the silicone genuinely platinum-cured?
Verification Method | How to Execute | What to Look For |
Request material data sheet | Ask for TDS (Technical Data Sheet) | Should specify "addition cure" or "platinum catalyst" |
Request certification | Ask for FDA/LFGB test reports | Reports should specify platinum-cured silicone |
Third-party testing | Commission SGS/Intertek testing | Independent verification of material composition |
Odor test | Smell cured samples | Platinum silicone is completely odorless |
Extractables test | Request extraction test data | Platinum silicone shows minimal extractables |
Certification | What It Confirms | Importance |
ISO 9001 | Quality management system | Fundamental quality assurance |
ISO 13485 | Medical device quality management | Required for medical applications |
IATF 16949 | Automotive quality management | Required for automotive applications |
BSCI / Sedex | Social compliance audit | Required by major retailers |
GMP (cGMP) | Good Manufacturing Practice | Required for pharmaceutical/medical |
ISO 14001 | Environmental management | Sustainability commitment |
Capability | Questions to Ask | Why It Matters |
LSR injection molding | Do you have LSR injection machines? What brands/tonnages? | Essential for high-volume, consistent production |
Mold design | Do you design molds in-house? What CAD software? | Mold quality determines product quality |
Material formulation | Can you adjust hardness, color, and properties? | Customization capability |
Cleanroom capability | Do you have ISO-classified cleanrooms? | Required for medical and electronic applications |
Post-processing | What trimming, printing, and assembly capabilities? | Complete product delivery |
Testing equipment | What in-house testing do you perform? | Quality assurance capability |
Support Capability | Detail | Importance |
Existing certifications | FDA, LFGB, ISO 10993, USP Class VI | Reduces your time-to-market |
New certification support | Can they support new certification applications? | Critical for novel applications |
Documentation | Complete, organized certification documentation | Regulatory submission support |
Regulatory expertise | Knowledge of target market requirements | Prevents costly compliance errors |
Test report provision | SGS/Intertek reports provided with orders | Buyer confidence; retailer requirements |
Experience Factor | Minimum Standard | Premium Standard |
Years in operation | 10+ years | 15+ years |
Platinum silicone experience | 5+ years dedicated | 10+ years |
Industry experience | Your specific industry | Multiple demanding industries |
Client references | 3+ verifiable references | Major brand references |
Export experience | Your target markets | Global export capability |
Factor | Consideration | Questions to Ask |
MOQ | Minimum order quantity | What is MOQ for your product type? |
Lead time | Sample and production lead times | What are standard and rush lead times? |
Pricing | Competitive but not suspiciously low | Request detailed cost breakdown |
Payment terms | Standard international terms | T/T, LC, payment schedule |
IP protection | NDA and design protection | Will they sign NDA? |
Communication | Responsiveness and English capability | Test with detailed technical inquiry |
Red Flag | What It Indicates | Action |
Cannot provide FDA/LFGB certificates | Material may not be genuine platinum-cured | Disqualify for food/medical applications |
Unusually low pricing | Possible material substitution (peroxide for platinum) | Request material verification testing |
No ISO certification | Inadequate quality management | Proceed with extreme caution |
Refuses factory visit | May be trading company or has something to hide | Disqualify |
Cannot answer technical questions | Lacks genuine manufacturing expertise | Disqualify for technical applications |
No cleanroom for medical products | Cannot meet medical manufacturing requirements | Disqualify for medical applications |
Strong odor in samples | Possible peroxide curing or low-quality materials | Request material data sheet; test independently |
Capability | Detail |
Experience | 18+ years manufacturing platinum-cured silicone products |
Processing methods | LSR injection molding, compression molding, transfer molding, extrusion |
Hardness range | Shore A 0–80 (custom formulation available) |
Certifications | FDA 21 CFR, LFGB §30/31, ISO 10993, USP Class VI, REACH, RoHS |
Quality management | ISO 9001 certified; BSCI and Sedex audited |
Cleanroom | ISO Class 7 cleanroom for medical and sensitive applications |
Testing | In-house physical testing; third-party chemical testing via SGS/Intertek |
Design support | In-house engineering and design team |
Industries served | Medical, food, baby products, consumer electronics, industrial |
Industry | Products | Certifications Available |
Medical | Tubing, gaskets, prosthetic components, device seals | ISO 10993, USP Class VI, ISO 13485 |
Baby products | Pacifiers, bottle nipples, teethers, bibs, spoons | FDA, LFGB, EN 1400, EN 71 |
Food/kitchen | Baking mats, molds, spatulas, storage products | FDA, LFGB |
Consumer | Watch bands, phone cases, earphone tips | REACH, RoHS |
Industrial | Seals, gaskets, tubing, vibration dampers | Application-specific |
Platinum silicone rubber stands in a class of its own among elastomeric materials — combining the inherent advantages of silicone (temperature range, chemical resistance, flexibility, longevity) with the superior purity, biocompatibility, and performance that only platinum-catalyzed addition curing can deliver.
Its zero-byproduct curing chemistry, exceptional biocompatibility profile, and ability to meet the world's most stringent food and medical safety certifications make it the definitive choice for any application where material purity is critical — from life-saving medical implants and infant feeding products to precision food processing equipment and advanced electronics.
The essential principles for working with platinum silicone:
✅ Specify platinum (addition) cure explicitly — not just "food-grade silicone"
✅ Require FDA and/or LFGB certification documentation for food and baby applications
✅ Require ISO 10993 and USP Class VI for medical applications
✅ Verify material authenticity through third-party testing for critical applications
✅ Choose manufacturers with demonstrated platinum silicone expertise and relevant certifications
✅ Respect mix ratios and processing parameters for optimal cured properties
At Mitour Silicone, platinum-cured silicone is not just a material we work with — it is the foundation of our commitment to manufacturing products that meet the highest standards of safety, performance, and quality that our global clients and their end users deserve.
Q: What is the difference between platinum silicone and regular silicone?
A: "Regular silicone" typically refers to peroxide-cured silicone. The key difference is the curing chemistry: platinum curing (addition cure) produces no byproducts and results in higher purity, better biocompatibility, lower shrinkage, and superior mechanical properties. Platinum silicone is required for medical implants, baby products, and premium food-contact applications where purity is critical.
Q: Is platinum silicone safe for babies?
A: Yes — platinum-cured, food-grade silicone is the safest material available for baby products. It is completely free from BPA, phthalates, latex, and curing byproducts. It meets FDA, LFGB, and EN 1400 standards. The absence of curing byproducts (unique to platinum curing) makes it the preferred material for pacifiers, bottle nipples, and teethers worldwide.
Q: How can I verify that a silicone product is genuinely platinum-cured?
A: Request the material's Technical Data Sheet (TDS) specifying "addition cure" or "platinum catalyst." Request FDA 21 CFR or LFGB test reports — these specify the curing system. Commission independent SGS or Intertek testing. A genuine platinum-cured product will be completely odorless and show minimal extractables in migration testing.
Q: Can platinum silicone be used for medical implants?
A: Yes — platinum-cured silicone is the standard material for many medical implants, including breast implants, cochlear implant components, and various soft tissue implants. It must meet ISO 10993 biocompatibility standards and USP Class VI requirements, and be manufactured under ISO 13485 quality management systems.
Q: What temperature range can platinum silicone withstand?
A: High-quality platinum-cured silicone maintains its properties from -60°C (-76°F) to +250°C (+482°F) continuously, with short-term peak exposure tolerance up to 300°C (572°F). It remains flexible at freezing temperatures and stable at oven temperatures — making it suitable for applications ranging from cryogenic storage to high-heat cooking.
Q: Does platinum silicone contain platinum that could be harmful?
A: No. The platinum catalyst used in the curing process is present in trace amounts (typically 5–20 ppm) and becomes chemically bound within the cured silicone matrix. It does not leach or migrate under normal use conditions. Platinum is biocompatible and non-toxic — its use in medical implants and pharmaceutical applications confirms its safety profile.
Q: What is the minimum order quantity for custom platinum silicone products from Mitour Silicone?
A: MOQ varies by product type and complexity. For standard products with custom colors or printing, MOQ typically starts at 500 units. For custom designs requiring new tooling, MOQ starts at 1,000 units. Contact us with your specific requirements for a tailored MOQ and pricing proposal.
For brands and manufacturers that demand the highest standard of silicone purity, safety, and performance, Mitour Silicone delivers 18 years of platinum-cured silicone manufacturing expertise — backed by complete FDA, LFGB, ISO 10993, and USP Class VI certification capability.
[Contact Us Today →] Share your platinum silicone product requirements, request certified material samples, or consult with our engineering team about the optimal formulation for your application!
