Silbione Oil 70047 V 100
SILBIONE FLD 70047V 100 — Medical-grade PDMS silicone oil for condom lubrication, catheter lubrication, and pharmaceutical applications. Complies with the European Pharmacopoeia.
SILBIONE FLD 70047V 100 — medical-grade linear polydimethylsiloxane.
Viskosität 100 mm²/s bei 25 °C. Europäische Pharmakopöe konform, FDA-Lebensmittelkontakt, Schwermetalle < 0,0005 ppm. Hauptanwendung: Kondom-Schmierstoff, daneben Katheter-Lubrikation, Pharma-Hilfsstoffe und Lebensmittel-Release. Ab Schweizer Lager.
documents
HS code:
39100000
SILBIONE FLD 70047V 100 – Medical-grade PDMS silicone oil
SILBIONE FLD 70047V 100 is a medical-grade linear polydimethylsiloxane (PDMS). Unlike the industrial Bluesil FLD 47V series, Silbione undergoes the rigorous testing required by the European Pharmacopoeia (Ph. Eur.) and meets the requirements for food contact and medical devices.
Typische Anwendungen sind Kondom-Schmierstoff (Hauptanwendung!), Rohstoffe für medizinische Katheter und Schläuche, Hautpflege-Formulierungen und Arzneimittel-Hilfsstoffe. Die umfangreichen Qualitätsprüfungen umfassen: IR-Spektrum nach Europäischer Pharmakopöe, Schwermetalle < 0,0005 ppm, Phenyl-Verbindungen < 0,2 %, Fluoreszenz für Mineralöl-Kontamination < 0,1 mg/kg.
Main areas of application
- Condom lubricant – the most important single use
- Raw materials for medical devices: catheter lubrication, tubing lubrication, syringe lubricants
- Food contact: Non-stick coatings for baking pans, food conveyor belts
- Pharmaceutical excipients in ointments, creams, and sprays
- Skin care formulations with a long-lasting lubricating film
Specifications (according to the European Pharmacopoeia)
| Viscosity @ 25 °C | 100 mm²/s (±10%) |
| Color | clear liquid, Hazen ≤ 30 |
| smell | odorless to faint |
| Volatile substances (2 hours at 150°C) | ≤ 0.3% |
| Turbidity | ≤ 4 NTU |
| Foreign substances | none |
| Acidity (0.01 N NaOH/2 g) | ≤ 0.15 |
| Phenyl compounds | ≤ 0.2% |
| Heavy metals (as Pb) | ≤ 0.0005 ppm |
| Fluorescence for mineral oil | ≤ 0.1 mg/kg |
| IR spectrum | In the European Pharmacopoeia |
| Shelf Life | 36 months |
Solubility
Soluble in: halogenated solvents (dichloromethane, chloroform, trichloroethane), ketones (MEK), esters (ethyl/butyl acetate, isopropyl palmitate/myristate), ethers (ethyl ether, isopropyl ether), higher alcohols (lauryl alcohol, 2-ethylhexanol). Insoluble in: water, lower alcohols (methanol, ethanol), vegetable/animal oils and fatty acids, glycols, glycerin.
Regulatory status
SILBIONE FLD 70047V 100 meets the requirements of the European Pharmacopoeia, FDA regulations for food contact, and various national pharmacopoeias. Use in specific medical devices or drug formulations requires individual approval—the suitability for a specific application is the responsibility of the user (Elkem offers the raw material in compliance with pharmacopoeias, but does not provide medical device approval).
SILBIONE FLD 70047V 100 is supplied by SILITECH AG with technical consultation, a batch certificate, pharmacopoeia compliance documentation, and shipping from a Swiss warehouse within 24 hours.
Frequently Asked Questions About SILBIONE FLD 70047V 100
Questions about Medical-Grade Silicone Oil 100 cSt
Both are linear PDMS silicone oils with the same chemical structure. The difference lies in quality testing and regulatory compliance: Silbione is tested according to the European Pharmacopoeia (IR spectrum, heavy metals, phenyl compounds, fluorescence, turbidity, acidity) and is approved for medical devices and food contact. Bluesil 47V is industrial grade without a pharmaceutical certificate.
Yes, condom lubricant is the primary application. Silbione FLD 70047V is purchased as a raw material by leading condom manufacturers and incorporated into their final products. Its low levels of heavy metal and phenyl contamination, low surface tension, and good skin compatibility make the material ideal for direct contact with mucous membranes.
Depending on the application: V100 for low-viscosity coatings (liquid waterproofing, pharmaceutical sprays), V350 as a standard medical oil (condom lubricant, catheter lubrication, standard skin care), V12,500 for thick-film coatings and viscous pharmaceuticals. For condom applications, V350 is the industry-standard viscosity.
Store at −20 to +50 °C in the unopened original packaging for up to 36 months. PDMS does not age significantly, but reseal the container after opening to prevent dust contamination. The expiration date must be strictly observed for medical device applications; the same applies to food contact applications.
product specifications
| Physical properties | |
|---|---|
| Paint cured | Transparent |
| Self-leveling | Yes |
| consistency | Flowable |
| product information | |
|---|---|
| container | 1 kg or 5 kg or 200 kg |
| brand | silbione |
| manufacturer | Elkem Silicones |
| Number of components | 1K (single-component) |
| mixing ratio | Single-component |
| Additional features | |
|---|---|
| UV resistance | Yes |
| product approvals | |
|---|---|
| food contact | Yes |
| Suitable for medical use | Yes |
| Areas of application | |
|---|---|
| Main application | Protective coating (conformal) |
| Electrical Properties | |
|---|---|
| Electrical insulation | Yes |
| keywords | |
|---|---|
| keywords | |
| processing | |
|---|---|
| Viscosity of the mixture | 100 mPa·s |
| Physical & Thermal | |
|---|---|
| Density (23°C) | 0.97 g/cm³ |
| Refractive index n (20°C) | 1.403 |
| Temperature resistance (duration) | -50 to 200 °C |
| Peak temperature (short-term) | 200 °C |
| thermal conductivity | 0.16 W/(m·K) |
| storage | |
|---|---|
| Shelf life in original packaging | 36 months |
| Storage temperature | -20 to 50 °C |