Sil-Select StockTM

Intended use

Sil-Select StockTM is a stock solution for semen preparation. It is an isotonic gradient for semen preparation with a density of approximately 1.12g/ml.

Sil-Select StockTM can be used for semen preparation for Intra Uterine Insemination (IUI), In Vitro Fertilization (IVF) and IntraCytoplasmatic Sperm Injection (ICSI).

Composition

Sil-Select StockTM consists of silane-coated colloidal silica particles suspended in HEPES-buffered EBSS (Earle’s balanced salt solution).
Some product codes are supplemented with 10mg/l gentamicin (medicinal substance).

Further information on the composition of the medium can be found in the material safety data sheet.

Regulatory

  • Europe: CE-marked (MDR, Notified Body number 2797)
  • USA: US FDA Cleared
  • Canada: Health Canada License
  • Brazil: Registered
  • Other regions: Information available upon request

Product order codes
SIS100: 1 x 100ml – Sil-Select Stock™
SIS100_32G: 1 x 100ml – Sil-Select Stock™
SIS500: 1 x 500ml – Sil-Select Stock™
SIS100G: 1 x 100ml – Sil-Select Stock™ with gentamicin
SIS100_32G: 1 x 100ml – Sil-Select Stock™ with gentamicin
SIS500G: 1 x 500ml – Sil-Select Stock™ with gentamicin

pH 7.20-7.90 (7.20-7.60 at product release)
Osmolality 300-330mOsm/kg
Sterility test by the current Ph. Eur. 2.6.1./ USP <71> No growth
Endotoxin < 0.5 EU/mL
Human sperm survival assay (% motility compared with control after 4 hours exposure to test medium) ≥ 80%
Human sperm survival assay (% motility compared with control after 24 hours exposure to test medium) ≥ 75%
Density 1.1150-1.1250g/mL
Shelf life 18 months from date of production

Sperm Processing

Sil-Select Stock is a stock solution for the preparation of density gradients for sperm selection

Instructions For Use
Summary of safety and clinical performance
Material Safety Data Sheet