Sil-Select Stock – FertiPro

Sil-Select Stock^TM

Intended use

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

Composition

Sil-Select Stock^TM 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™
SIS500: 1 x 500ml – Sil-Select Stock™
SIS100_32G: 1 x 100ml – Sil-Select Stock™ with gentamicin

Product specifications

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