RUMEX Silicone Oil Smartsil 1000/5000

Consumables / RUMEX Silicone Oil Smartsil 1000/5000

Silicone Oil is administered with Silicone Oil infusion systems and cannulas

Ultra purified silicone oil for the endo-tamponade after vitrectomy.

RUMEX silicone oil has proven an excellent stability and optimal transparency because of its exclusive vacuum molecular distillation purification which avoids any emulsification risk. Our exclusive solvent free purification process is extracted low molecular weight oligomers and potentially toxic low molecular weight and residual volatile components (water, ethanol) which are lead to emulsification. This is why we guarantee that our silicone oil is one of the purest available on the market.

No emulsification shall occur, if the recommendation mentioned in the Instructions for use is followed.

Each feature of SmartSil 1000/5000 is prominent; the choice of viscosity offers an optimal balance between easy injection and a stable temporary tamponade. In 2013 we are pleased to report the highest and the lowest scores (as compared to similar products worldwide).

  • the highest interfacial tension
  • the lowest rate of interactions
  • the lowest index of polydispersity
  • the lowest value of toxicity
  • the lowest risk of diffusion or absorption
  • an excellent stability and optimal transparency

SMARTSIL 1000/5000
Purified Silicone Oil for Vitreoretinal Surgery

  • Maximum interfacial tension and minimum interactions between tissues, cells and endo-tamponades media
  • Optimal combination of specific gravity, refractive index and surface tension
  • The choice of viscosity for a balance between easy injection and a stable temporary tamponade

Physico-chemical properties

Interfacial tension
≥ 40 mNm-1 at 37°C
Density
0.97
Viscosity
1000/5000 cSt
Refractive index
1.40
Volatility
< 1%
Polydispersity
< 2.8
Volume of oil
10 ml
Syringe
20 ml

Purification

  • Vacuum molecular distillation solvent free purification
  • Potentially toxic low molecular weight oligomers (D4 to D20) extraction
  • Residual volatile components extraction (water, ethanol, etc.)

Post-purification controls

  • Gel permeation chromatography (GPC)
  • Gaseous chromatography (GC)

Sterilization

  • Silicone oils are dry heat sterilized
  • Syringes are steam sterilized

Packaging

Syringes are supplied sterile under double pouch.

Indication

SmartSil 1000/5000 is used for prolonged tamponade after surgical treatment for severe retinal detachment (RD), especially:

  • RD with proliferative vitreal retinopathy
  • RD with diabetic retinopathy complications
  • RD with giant tears
  • Traumatic RD
  • Secondary RD with viral retinitis

Note:

Internal tamponade with purified silicone oil is not recommended for patients with intraocular silicone lenses.