PureSperm 100

For the preparation of density gradients

PureSperm 100 is a sterile colloidal silica suspension in an isotonic salt solution. It is optimized for the preparation of density gradients used to separate and purify human sperm from semen for use in Assisted Reproduction Technologies (ART). This system effectively separates normal sperm from lymphocytes, epithelial cells, abnormal, immature and senescent sperm, cell debris, bacteria and seminal fluid.

Features:

  • Increases sperm survival time.
  • Removes sources of ROS.
  • Removes bacteria.
  • Removes sperm with abnormal DNA.
  • Improves cryo-survival.
  • Improves yield and recovery compared to swim-up techniques

Safety and Quality:

  • 2 years shelf life.
  • Pharmaceutical grade packaging to maintain product quality.
  • Terminal sterilization by autoclaving.
  • Cleared by regulatory authorities around the world.
  • Produced according to cGMP and ISO standards.

PureSperm 100 stock suspension should be diluted with PureSperm Buffer to provide layers of different densities required for the gradient. For optimal results, the sperm pellet should be washed subsequently in PureSperm Wash. These three products together form an optimized system for the preparation of sperm for ART.


Components:

  • Silane-coated silica
  • Calcium chloride
  • Potassium chloride
  • Sodium chloride
  • Purified water
  • HEPES
  • EDTA
  • Glucose

Performance Characteristics:

  • pH: 7.4-7.8.
  • Osmolality (mOsm/kg H2O): 300-310.
  • Endotoxin transfer during treatment : <1.0 EU/mL.
  • Sperm survival 18 hours after density gradient separation: >70%.


Storage and Stability:

  • Store at 2 to 27ºC and avoid temperatures above or below these values. Under these conditions PureSperm 100 has a shelf-life of 24 months. The expiry date is shown on both bottles and cartons.
  • Open and close bottles under aseptic conditions. After opening, store at 2 to 8ºC when not in use. Shelf-life on the product label applies when the product is stored according to manufacturer’s recommendations.
  • No antibiotics, unstable additives or preservatives have been added by the manufacturer to PureSperm 100.


Precautions and Warnings:

  • When retrieving the sperm pellet, follow the instructions given in the pack insert to avoid inadvertent contamination.
  • Use aseptic procedures at all times.
  • If available, use sealed buckets during centrifugation to avoid creation of aerosols.
  • Clean accidental spills using a dampened cloth or paper. PureSperm 100 causes floors and benches to be extremely slippery.
  • PureSperm 100 does not represent any kind of fire or combustion hazard. A material safety data sheet is available from the distributor or manufacturer.
  • Do not use any solution which shows evidence of bacterial contamination.
  • Do not use contents if tamper-evident seal is broken.
  • Federal Law (USA) restricts this device to sale by or on the order of a physician.
  • Please check for regulatory compliance governing the use of ART products in your country.

Contact us to order at:

Ireland Head Office: +353 (0)52 74428964­5

4-5 The Square , Cahir Co. Tipperary Ireland

E-mail: info@biotipp.com