Summary

PureSperm®100 is a sterile (autoclaved SAL-10-3) colloidal silica suspension in an isotonic salt solution. It is optimised for the preparation of density gradients for the separation and purification of human sperm for use in Assisted Reproduction Technologies (ART). This system effectively separates normal sperm from lymfocytes, epithelital cells, abnormal or immature sperm, cell debris, bacteria and seminal fluid.

Features of PureSperm® Gradients:

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:

Longest shelf life of commercially available gradients
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 optimum results, the sperm pellet should be washed in PureSperm® Wash. These three products together form an optimized system for preparation of sperm for ART.

Components

– Silane-coated silica
– Calcium ions
– Chloride ions
– Potassium ions
– Sodium ions
– 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 40ºC 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

Recommendations

Prepare two PureSperm® gradients for each semen sample. This reduces the risk of overloading a single gradient, provides security when handling tubes or recovering sperm pellets and provides two tubes to balance the centrifuge rotor.

Ordering Information

Article No. / Name / Volume
PS100-100 / PureSperm® 100 / 100 mL
PS100-250 / PureSperm® 100 / 250 mL
PS100-1000 / PureSperm® 100 / 1000 mL

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