Sil-Select Plus – FertiPro

Sil-Select Plus^TM

Intended use

Sil-Select Plus^TM is a gradient system for semen preparation. The following gradients are available:

Sil-Select Plus^TM Upper layer (45%)
Sil-Select Plus^TM 80%
Sil-Select Plus^TM Lower layer (90%)

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

Sil-Select Plus Sperm Washing/Insemination medium is intended for use in Assisted Reproductive Technologies, more specifi cally for sperm washing/holding and for the production of density gradients. The medium can be used for IUI.

Sil-Select Plus is ready-to-use.

Composition

Sil-Select Plus^TM gradients consist of silane-coated colloidal silica particles suspended in HEPES-buffered EBSS (Earle’s balanced salt solution) supplemented with 0.4-2.2g/l human serum albumin (medicinal substance derived from human blood plasma).

Some product codes are supplemented with phenol red or 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)
Canada: Health Canada License
Brazil: Registered
Other regions: Information available upon request

Product order codes

SIP008 (8 preparations):

8 x 2.5ml – Sil-Select Plus^TM Lower layer
8 x 2.5ml – Sil-Select Plus^TM Upper layer
8 x 5ml – Sil-Select Plus^TM Sperm Washing/Insemination medium

SIP016 (16 preparations):

2 x 20ml – Sil-Select Plus^TM Lower layer
2 x 20ml – Sil-Select Plus^TM Upper layer
5 x 20ml – Sil-Select Plus^TM Sperm Washing/Insemination medium

SIP050:

1 x 50ml – Sil-Select Plus^TM Lower layer
1 x 50ml – Sil-Select Plus^TM Upper layer

SIP100:

1 x 100ml – Sil-Select Plus^TM Lower layer
1 x 100ml – Sil-Select Plus^TM Upper layer

SIP020LO: 5 x 20ml – Sil-Select Plus^TM Lower layer
SIP020UP: 5 x 20ml – Sil-Select Plus^TM Upper layer

SIP025LO: 25 x 2.5ml – Sil-Select Plus^TM Lower layer
SIP025UP: 25 x 2.5ml – Sil-Select Plus^TM Upper layer

SIP80_100: 1 x 100ml – Sil-Select Plus^TM 80%

Product specifications

pH	7.20-7.90 (7.20-7.60 at product release)
Osmolality	280-310mOsm/kg (Upper Layer) 290-330mOsm/kg (Lower Layer) 290-330mOsm/kg (80%)
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	1.0500-1.0700 g/ml (Upper layer) 1.1050-1.1150 g/ml (Lower layer) 1.097-1.107 g/ml (80%)
Shelf life	18 months from date of production
View product specifications washing/insemination medium