GM501 SpermActive
GM501 SpermActive is a ready-to- use medium designed for all human sperm preparation, sperm washing and swim up techniques like density-gradient centrifugation as well as for testicular tissue.
Rev03_00
| Product description | Product code | Unit |
|---|---|---|
| GM501 SpermActive | 4 GM 501SA-020 | 20 ml |
| GM501 SpermActive | 4 GM 501SA-050 | 50 ml |
Product facts and notices
- Composition
- Product specifications and quality control
- Instructions for use
- Precautions and warnings
- Storage instructions and stability
Composition:
- NaCl, KCl, KH2PO4, MgSO4.7H2O, NaHCO3, CaCl2.2H2O, D(+)-Glucose anhydrous, Na-Lactate, Na-Pyruvate, EDTA, Alanyl-Glutamine, water, non-essential and essential Amino Acids, 15 mM HEPES, human serum albumin (5.00 g/liter), Gentamicin (10.00 mg/liter), Phenolred.
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 SpermActive is available upon re-quest and can also be downloaded from our website.
- GM501 SpermActive is manufactured and tested according to the following specifications:
:
| pH (at 37°C, 6 % CO2) | 7.20-7.50 |
| Osmolality (mOsm/kg) | 270-290 |
| Sterility | sterile – SAL 10-3 (Sterility Assurance Level) |
| Endotoxins (EU/ml) | < 0,25 |
| MEA (Blastocysts after 96 Std in %) | ≥ 80 after 60 min of exposure (zygote stage) |
Instructions for use:
- The intended users are IVF professionals (lab technicians, embryologists or medical doctors).
- GM501 SpermActive must be equilibrate over night in a humidified CO2-incubator (at 5-7 % CO2, 37°C).
Precautions and warnings:
- GM501 SpermActive contains the antibiotic: Gentamicin Sulfate. 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, even when GM501 SpermActive 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 defect when the product is delivered.
- Do not use the product if it becomes discoloured, cloudy or shows any evidence of microbial contamination.
Aufbewahrungshinweise und Haltbarkeit:
- The shelf life is 6 months from time of manufacture.
- Store between 2-8°C.
- Do not freeze before use.
- Keep away from (sun) light.
- After opening the container do not use the product longer than 7 days.
- Do not use after expiry date.