GM501 SpermAir
GM501 SpermAir is a ready-to-use medium designed for all human sperm-preparation (e.g. density gradient centrifugation), sperm-washing and swim-up techniques as well as for testicular tissue.
Rev03_00
| Product description | Product code | Unit |
|---|---|---|
| GM501 SpermAir | 4 GM 501AIR+PR+G-02 | 2 ml |
| GM501 SpermAir | 4 GM 501AIR+PR+G-20 | 20 ml |
| GM501 SpermAir | 4 GM 501AIR+PR+G-50 | 50 ml |
Product facts and notices
- Composition
- Product specifications and quality control
- Instructions for use
- Precautions and warnings
- Storage instructions and stability
Composition:
- NaCl, KCI, KH2PO4, MgSO4.7H2O, NaHCO3, CaCl2.2H2O, D(+)-Glucose anhydrous, Na-Lactate (50 % solution), Na-Pyruvate, EDTA, Alanyl-Glutamine, 21 mM HEPES, water, non-essential and essential Amino Acids, human serum albumin (5.00 g/Liter), Gentamicin (10 mg/Liter), Phenol Red.
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Product specifications and quality control:
- All raw materials are of highest available purity (European Pharmacopoeia and/or USP standard) if applicable.
- A certificate of analysis is available for each batch upon request from our website with respective lot number.
- The MSDS for GM501 SpermAir is available upon request and can also be downloaded from our website.
- GM501 SpermAir is manufactured according to the following specifications:
| pH (at 37°C) | 7,20-7,50 |
| Osmolality (mOsm/kg) | 270-290 |
| Sterility | sterile – SAL 10-3 (Sterility Assurance Level) |
| Endotoxins (EU/ml) | < 0,25 |
|
MEA (Blastocysts in %) (after 5 days of culture in the product covered by mineral oil, starting from zygote stage) |
≥ 80 |
Instructions for use:
- The intended users are IVF professionals (lab technicians, embryologists or medical doctors).
- Do not equilibrate GM501 SpermAir in a CO2-incubator, just warm it up to 37°C. GM501 SpermAir is HEPES-buffered. Incubation in a CO2-incubator will lower the pH.
Precautions and warnings:
- GM501 SpermAir contains the antibiotic Gentamicin Sulphate. Appropriate precautions should be taken to ensure that the patient is not sensitized to this antibiotic.
- Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot totally be excluded. This also applies to unknown or emerging viruses and other pathogens. There are no reports of proven virus transmissions with albumin, manufactured to European Pharmacopoeia specifications by established processes.
Therefore, handle all specimens as if capable of transmitting HIV or hepatitis. Always wear protective clothing when handling specimens. - Always work under strict hygienic conditions (ISO 5 environment, e.g. LAF-bench) to avoid possible contamination, eventhough GM501 SpermAir medium contains Gentamicin.
- Only for the intended use.
Pre-use checks:
- Do not use the product if bottle, seal of the container or package is opened or defective when the product is delivered.
- Do not use the product if it becomes discoloured, cloudy or shows any evidence of microbial contamination.
Storage instructions and stability:
- The shelf life is 6 month from time of manufacture.
- Store between 2-8°C.
- Do not freeze before use.
- Keep away from (sun)light.
- The product can be used safely up to 7 days after opening, when sterile conditions are maintained.
- Do not use after expiry date.