Sepal Reproductive Devices | Sperm CryoProtec

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Sperm CryoProtec

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Sperm CryoProtec

Intended Use: Summary and Explanation

Sperm CryoProtec™ is supplied as a yellowish, sterile salt solution containing glycerol, optimised for freezing human sperm.

Performance Characteristics

pH:	7.5 - 8.5
Endotoxin levels	< 1.0 EU/mL
Sperm survival	>50%.

Contents tested by human sperm survival only.
Bottles and stoppers are 2-cell MEA tested.

Components

Sodium chloride	potassium chloride
Magnesium sulphate	glucose
Potassium dihydrogen phosphate
Glycerol	lactate
Sodium bicarbonate	pyruvate
HSA (human serum albumin)	EDTA
WFI quality water	HEPES

Protein Supplementation

Sperm CryoProtec™ contains the component human serum albumin. (hSA). The hSA is manufactured from blood donated in the United States. The blood donors who supply the plasma are tested for various viruses before being allowed to donate blood for this purpose. Each plasma donation is individually tested for ALT, HBs antigen, HIV-1/2 antibody and HCV antibody by ELISA. Only those plasma donations found non-reactive for those antibodies have been used for the manufacture of the hSA component. The plasma pool is tested again before manufacture of the hSA product. The hSA product is heated at 60°C for 10 hours as a final precaution.

Sperm CryoProtec™ can be filter sterilised, if required, using a 0.22 mm or 0.45 mm filter (e.g. Millipore Millex-GV). Do not use filters containing extractables or wetting agents as these may be toxic to sperm.

Storage and Stability

Store unopened bottles at 2 to 30ºC and avoid temperatures above or below these values. Under these conditions Sperm CryoProtec™ has a shelf-life of 12 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.

No antibiotics, unstable additives or preservatives have been included in Sperm CryoProtec™.

Precautions and Warnings

Use aseptic procedures at all times.
Use sealed buckets during centrifugation to avoid creation of aerosols.
Sperm CryoProtec™ contains glycerol which is combustible. A material safety data sheet is available from the manufacturer or distributor.
Do not use vial contents if tamper-evident seal is broken.
Do not use any solution which shows evidence of bacterial contamination.
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 products for ART in your country.

Ordering Information

product #	product name	order multiple
SCP-020	SpermCryoProtec™	2 x 20 ml