Bromelain in Dulbecco´s PBS
Bromelain in Dulbecco‘s PBS is designed for liquefaction of viscous semen samples prior to semen analysis and preparation for further IVF treatment.
Rev03_00
| Produktbeschreibung | Artikelnummer | Einheit |
|---|---|---|
| Bromelain in Dulbecco´s PBS | 4 GM 501BROM10 | 10 ml |
Product facts and notices
- Composition
- Product specifications and quality control:
- Instructions for use:
- Precautions and warnings:
- Storage instructions and stability:
Composition:
- Bromelain solved in Dulbecco’s PBS
Bromelain in Dulbecco’s PBS is an enzyme preparation and has a specific activity of 10 IU/ml.
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 Bromelain in Dulbecco´s PBS is available upon request and can also be downloaded from our website.
- Bromelain in Dulbecco´s PBS is manufactured and tested 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) | < 0,5 |
| Mouse Embryo Assay (MEA)
(1-cell assay, blastocysts after 96 h in %)
|
≥ 80
|
| Sperm Survival test
(survival after 4 hours exposure of density selected spermatozoa to the test medium in %) |
≥ 80
|
Instructions for use:
- Warm the Bromelain in Dulbecco‘s PBS to 37°C.
- Dilute the semen sample with the same volume of Bromelain (for highly viscous, tenacious ejaculate we recommend to previously grind the ejaculate roughly!)
- Swing the semen solution carefully.
- Incubate the ejaculate for approx. 10 minutes at 37°C.
- Use the liquefied semen sample for evaluation. Attention: To calculate the sperm concentration the dilution 1+1 (1:2) of semen with Bromelaine must be accounted.
Precautions and warnings:
- 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.
- Only for the intended use.
- The long term safety of ICSI, including the use of Bromelain, on children born following this procedure is unknown.
- Since the device in its intended use does not come into direct contact with the patient, toxicity as well as sensitization is highly unlikely. However, caution may be advised with ejaculates from patients with known latex and associated food allergies, since Bromelain shares possibly antigen epitopes (Levy and Leynadier, 1997).
- The user facility of this device is responsible for maintaining traceability of the product and must comply with national regulations regarding traceability, where applicable.
Pre-use checks:
- Do not use the product if it becomes discoloured, cloudy, or shows any evidence of microbial contamination.
- Do not use the product if seal of the container is opened or defective when the product is delivered.
Storage instructions and stability:
- The shelf life is 9 month from time of manufacture.
- Store between 2-8°C.
- Do not freeze before use.
- The product can be used safely up to 7 days after opening, when sterile conditions are maintained and the products are stored at 2-8°C.
- Stable after transport (max. 5 days) at elevated temperature (≤ 37°C).
- Do not use after expiry date.