Silbione™ medical fluids
for Lubrication and coatings
Medical Grade Silicone Fluids for Lubrication and coatings
Elkem Silicones has designed a range of medical grade fluids in order to meet the demand of lubrication or hydrophobic coatings and demolding applications. Our product offering includes polydimethylsiloxanes fluids, emulsions and RTV lubricants.
Silbione™ DM GMP are linear polydimethylsiloxanes fluids available as a range with three viscosities. They comply with:
- European pharmacopoeia requirements for Dimethicone.
- Production complies with the principles and guidelines of Good Manufacturing Practice laid down in Directive 2003/94/EC.
- European Drug Master File available
User has sole responsibility to determine product suitability for intended uses and applications.
Silbione™ Medical Fluids Selector Table
Silbione™ FLD 70047
| Silbione™ Products | Ph. Eur. 3.1.8 on "silicone oil used as lubricant" | Monography Ph. Eur. Dimeticone | Manufactured according to selected GMP principles* | Viscosity (mPa.s) | Shelf life (months) | |
| Silbione™ FLD 70047 are linear polydimethylsiloxanes | FLD 70047 v 100 | - | - | - | 100 | 36 |
| FLD 70047 v 200 | - | - | - | 200 | 36 | |
| FLD 70047 v 350 | - | - | - | 350 | 36 | |
| FLD 70047 v12 500 | ♦ | - | - | 12 500 | 36 | |
| FLD 70047 v30 000 | ♦ | - | - | 30 000 | 36 |
*Production complies with the principles and guidelines of Good Manufacturing Practice laid down in Directive 2003/94/EC
Silbione™ Emulsion
| Silbione™ Product | Ph. Eur. 3.1.8 on "silicone oil used as lubricant" | Monography Ph. Eur. Dimeticone** | Manufactured according to selected GMP principles* | Solid content (%) | Viscosity (mPa.s) | Shelf life (months) | |
| Silbione™ EMULSION is a water-based emulsion of PDMS | EMUL 70001 SP | - | ♦ | - | 35 (Dimeticone oil) | 300 | 24 |
*Production complies with the principles and guidelines of Good Manufacturing Practice laid down in Directive 2003/94/EC
**The silicone fluid in Silbione™ EMULSION is tested according to European Pharmacopeia (EP) requirements.
Silbione™ DM
| Silbione™ Products | Monography Ph. Eur. Dimeticone | Manufactured according to selected GMP principles* | Viscosity (mPa.s) | Shelf life (months) | |
| Silbione™ DM are linear polydimethylsiloxanes | DM 300 GMP | ♦ | ♦ | 300 | 36 |
| DM 500 GMP | - | ♦ | 500 | 36 | |
| DM 1000 GMP | ♦ | ♦ | 1 000 | 36 |
*Production complies with the principles and guidelines of Good Manufacturing Practice laid down in Directive 2003/94/EC
Silbione™ RTV Lubricant
| Silbione™ Products | Monography Ph. Eur. Dimeticone | Solid content (%) | Solvent | Viscosity (mPa.s) | Shelf life (months) | |
| Silbione™ RTV LUBRICANT is an aminofunctional silicone in solvent | RTV Lubricant | ♦ | 30 (Aminofunctional dimethylsiloxane copolymer) | mixed aliphatic and isopropanol | 30 | 24 |