Collection of blood-raw material- is only performed in Companies approved by the SENASA under strict quality standards from traced animals and health certificated from the herd of origin.
SAB is obtained from a selective precipitation carried out on Bovine Serum, consisting of a controlled termic-protection and termic-coagulation of serum proteins. Protein decantation is helped with diatomaceous earths which diminish endotoxin content.
Supernatant is submitted to successive filtrations steps up to 0.1µm, in maximum asepsis conditions. Afterwards, concentration and purification through hollow-fiber cartridges is performed using dedicated ultra-filtration equipment. Product sterilization is performed in a filtration train using certified absolute filters of first quality, ending in a double sterilizing filtration up to 0.1µm.
With the purpose of assuring the quality and consistency from our products lot to lot, they are carried out physiochemical and biological controls in each one of the parts of the process and envelope the finished product.
|
DETERMINATION |
SPECIFICATIONS |
MÉTHODOLOGY |
|
Total Proteins: |
10 g% |
Colorimétric - BIURET. |
|
Albúmin: |
10 g% |
Colorimétric - BCF |
|
PH: |
6.7 – 7,5 |
Potentiometry |
|
pureza: |
> 95% |
Relacion % Albumina / Proteinas totales |
| Bacterial and fungal sterility | Sterile | Thioglycollate, Soy and Saboraud broth |
|
Electrophoretic profile |
Normal Profile alb:95-100% |
Electrophoresis on Cellulose Acetate against reference serum. |
Flasks for 1000 cm3, 500 cm3, 250 cm3, 125 cm3 y 60 cm3.
The SAB must be stored at temperature (2-8°C), the usefulness of this serum preserved in these conditions is at least 3 years. The traceability of the products is guaranteed from the origin to the end, accompanied by the certifications of the competent Agency of Argentina (SENASA) and irradiation certificate, highlighting that our country has been declared free of Bovine Spongiform Encephalopathy (BSE) by the World Organization of Health (WHO).
