PureSperm®40 and PureSperm®80 are sterile (autoclaved SAL-10-3) colloidal silica suspensions in isotonic salt solutions. They are optimised for the preparation of density gradients for the separation and purification of human sperm for use in Assisted Reproduction Technologies. PureSperm®40 should be used with PureSperm®80 to form a two-layer density discontinuous gradient system which effectively separates normal sperm from lymphocytes, epithelial cells, abnormal or immature sperm, cell debris, bacteria and seminal fluid.
Components Silane-coated silica
Performance Characteristics pH: 7.4 - 7.8 Osmolality (mOsm/kg H2O) : 300 - 310 Endotoxin levels : <1.0 EU/mL Sperm survival 18 hours after density gradient separation: >70% Contents are tested by human sperm survival only Bottles and stoppers are 2-cell M.E.A. tested
Storage and Stability Store unopened bottles at 2 to 40ºC and avoid temperatures above or below these values. Under these conditions PureSperm® 40 and PureSperm® 80 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® 40 and PureSperm® 80.
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®40/80 causes floors and benches to be extremely slippery • PureSperm®40/80 does not represent any kind of fire or combustion hazard. A material safety data sheet is available from the distributor or manufacturer(see nidacon.com) • 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
Ordering Information Article No. Name Volume PSK-020 PureSperm® 40/80 2 × 20 mL
PS40-100 PureSperm® 40 100 mL PS80-100 PureSperm® 80 100 mL
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