Silbione™ medical 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.

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Silbione™ DM

Refer to the regulatory attestation for the conformance to any regulated applications.

Silbione™ product	Monography Ph. Eur. Dimeticone	Manufacturing Practice laid down in Directive 2003/94/EC.*	Viscosity mPa.s	Volatile content	Color Hazen	Turnidity NTU	Acidity index	Mineral oils ppm	Phenyl compounds %	Heavy metals (Pb) ppm
DM 300 GMP	♦	♦	300	≤ 0,3 %	≤ 30	≤ 4	≤ 0.15	≤ 0.1	≤ 0.2	≤ 5
DM 500 GMP	♦	♦	500	≤ 0,3 %	≤ 30	≤ 4	≤ 0.15	≤ 0.1	≤ 0.2	≤ 5
DM 1000 GMP	♦	♦	1000	≤ 0,3 %	≤ 30	≤ 4	≤ 0.15	≤ 0.1	≤ 0.2	≤ 5

* Production complies with the principles and guidelines of Good Manufacturing Practice laid down in Directive 2003/94/EC

Silbione™ FLD 70047

Silbione™ FLD 70047 are linear polydimethylsiloxanes. Refer to the regulatory attestation for the conformance to any regulated applications.

Silbione™ product	Monography Ph. Eur. Dimeticone	Manufacturing Practice laid down in Directive 2003/94/EC.*	Viscosity mPa.s	Volatile content	Color Hazen	Turnidity NTU	Acidity index	Mineral oils ppm	Phenyl compounds %	Heavy metals (Pb) ppm
FLD 70047 v 100	♦		100	≤ 0,3 %	≤ 30	≤ 4	≤ 0.15	≤ 0.1	≤ 0.2	≤ 5
FLD 70047 v 200	♦		200	≤ 0,3 %	≤ 30	≤ 4	≤ 0.15	≤ 0.1	≤ 0.2	≤ 5
FLD 70047 v 350	♦		350	≤ 0,3 %	≤ 30	≤ 4	≤ 0.15	≤ 0.1	≤ 0.2	≤ 5
FLD 70047 v12 500		♦	12 500	≤ 2 %	≤ 30	≤ 4	≤ 0.15			≤ 5
FLD 70047 v30 000		♦	30 000	≤ 2 %	≤ 30	≤ 4	≤ 0.15			≤ 5

* Production complies with the principles and guidelines of Good Manufacturing Practice laid down in Directive 2003/94/EC

Silbione™ EMULSION 70001 SP is used as hydrophobic lubricant for medical devices.

Silbione™ EMULSION

The silicone fluid in Silbione™ EMULSION 70001 SP is tested according to European Pharmacopeia (EP) requirements.

Silbione™ product	Dimeticone oil	Solvent	Emulsifier	pH	Heavy metals (Pb) ppm
EMUL 70001 SP	35%	Water	non-ionic	2.5 to 4.5	≤ 10

Silbione™ RTV LUBRICANT

Silbione™ RTV LUBRICANT can be used on razor blades, scalpels, hypodermic needles and other applications where a partially cured cohesive silicone coating is required. The polar nature of the aminofunctional group and the air cure of the silicone cause thin films to deposit and adhere to metal and plastics for lubricity on surfaces.

Silbione™ product	Aminofunctional dimethylsiloxane copolymer	Solvent	Viscosity mPa.s	Flash point	Density
RTV Lubricant	30%	mixed aliphatic and isopropanol	30	58 °C	0.87

The typical properties listed above are not intended for use in preparing specifications. For test methods and specifications, please contact an Elkem representative.