Medical-Grade Polydimethylsiloxane (PDMS / Dimethicone)
Silico® Medical-Grade Polydimethylsiloxane (PDMS) is a high-purity silicone fluid designed for use in medical, pharmaceutical, and healthcare applications. With excellent chemical stability, low volatility, and verified biocompatibility, it serves as an ideal material for lubricious coatings, device components, drug delivery systems, and topical formulations.
Introduction
Silico® Medical-Grade Polydimethylsiloxane (PDMS) is an ultra-pure silicone fluid engineered for medical devices, pharmaceutical formulations, and healthcare applications. This dimethicone-based silicone oil is refined through advanced purification and distillation processes to achieve exceptional chemical purity, minimal volatility, and proven biocompatibility.
Silico® medical-grade PDMS offers reliable performance as a lubricious coating material, device assembly aid, drug-delivery carrier, or pharmaceutical excipient.
Typical Physical Properties
| Parameter | Typical Range / Value | Test Method / Notes |
|---|---|---|
| Appearance | Clear, colorless, viscous liquid | Visual |
| Chemical Name / INCI | Polydimethylsiloxane (Dimethicone) | — |
| Viscosity (25 °C) | 350 / 1,000 / 12,500 cSt (other grades: 50–100,000 cSt) | ASTM D445 |
| Specific Gravity (25 °C) | 0.965 – 0.975 g/cm³ | ASTM D1475 |
| Refractive Index (25 °C) | 1.402 – 1.406 | ASTM D1218 |
| Flash Point (Closed Cup) | > 300 °C (non-flammable) | ASTM D93 |
| Volatile Content / Loss on Drying | ≤ 0.2 % | Gravimetric |
| Unsaturation / Vinyl Content | < 0.1 % (non-reactive grade) | FTIR |
| Purity (Organic Content) | ≥ 99.0 % PDMS | GC / GC-MS |
| Heavy Metals (Pb, Cd, Hg, As) | ≤ 10 ppm total | ICP-MS |
| Endotoxin Level (on request) | ≤ specified EU/mL or EU/g | LAL test |
| Biocompatibility Status | ISO 10993 data available (cytotoxicity, irritation, sensitization) | ISO 10993-1 |
| USP / NF Compliance | Dimethicone NF or equivalent, where applicable | USP monograph |
| Packaging Options | 1 kg bottle / 25 kg drum / 200 kg drum / 1000 kg IBC | Standard & custom sizes |
| Shelf Life | 24 months (sealed, 5 – 35 °C) | — |
Key Benefits & Technical Advantages
| Feature | Description |
|---|---|
| Medical and Pharmaceutical Suitability | Produced under controlled manufacturing conditions to meet USP / NF Dimethicone and medical-grade silicone standards. Supports applications requiring GMP-style documentation and pharmacopeial traceability. |
| High Purity and Low Volatility | Multi-step vacuum distillation and filtration eliminate low-boiling residues and metal catalysts. Low extractables and leachables ensure compatibility with sensitive drug-contact or implantable applications. |
| Wide Viscosity Range | Offered in viscosities from 50 cSt to 100,000 cSt, covering low-lubricity fluids to high-consistency formulations. Popular grades include 350 cSt, 1,000 cSt, and 12,500 cSt for device and coating applications. |
| Excellent Biocompatibility | Formulated for downstream ISO 10993 and USP Class VI biocompatibility testing. Historical data available for cytotoxicity, sensitization, irritation, and hemocompatibility. |
| Thermal & Chemical Stability | PDMS maintains structural integrity under sterilization (EO, γ-irradiation, autoclave) and resists degradation in a wide range of medical environments. |
| Low Surface Energy / High Lubricity | Enables smooth device insertion, reduces tissue friction, and minimizes residue build-up on coated surfaces. |
Typical Applications
Lubricious coatings for catheters, guidewires, and syringes
Medical device assembly fluids and mold-release agents
Pharmaceutical excipient or processing aid where dimethicone is listed in pharmacopeias (e.g., topical or oral preparations)
Microfluidic and lab-on-chip systems requiring inert silicone interfaces
Cosmetic and dermatological formulations demanding medical-grade safety and purity
Regulatory & Biocompatibility Guidance
ISO 10993 Compliance: Silico® supports full biological evaluation per ISO 10993-1 (cytotoxicity, sensitization, irritation, systemic toxicity).
Pharmacopeial Compatibility: Selected grades comply with Dimethicone NF / USP monographs for pharmaceutical use.
Regulatory Support: Product SDS, REACH, and RoHS declarations available upon request.
Testing Data Access: Certificates of Analysis (CoA), Extractables & Leachables reports, and ISO 10993 summary sheets available to assist in regulatory submissions.
Selection Guidance (By Application Type)
| Application | Recommended Viscosity Grade | Notes |
|---|---|---|
| Catheter / guidewire coating | 350 – 1,000 cSt | Ensures lubricity and clean film formation |
| Elastomer processing aid | 1,000 – 12,500 cSt | Improves mold release and flow properties |
| Microfluidic / chip devices | < 350 cSt | Enables precision flow and optical clarity |
| Topical / cosmetic formulations | 100 – 1,000 cSt | Provides smooth texture, low irritation |
Handling & Storage
Store sealed in original containers between 5 °C and 35 °C.
Avoid moisture, direct sunlight, and strong oxidizers.
Use protective gloves and goggles during handling.
Do not aerosolize; ensure adequate ventilation if spraying or coating.
Quality Assurance & Support
Silico® provides the following technical and regulatory support services:
-
Full Certificate of Analysis (CoA) for each production lot
-
GMP-style documentation for pharmaceutical customers
-
Extractables & Leachables testing support
-
ISO 10993 biocompatibility data (historical or customized testing)
- Technical consultation for sterilization and compatibility studies
Procurement & Contact
For technical datasheets, CoA, ISO 10993 summary reports, or to request a product sample, please contact:
Silico® Technical Sales — info@rissochem.com
Visit: www.silicore.com
Please specify your intended medical application and desired viscosity grade for accurate recommendations.
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