The collection of blood-raw material- is only in Companies approved by the SENASA under strict quality standards from traced animals and health certificated from the herd of origin.
The serum is packaged in sanitized drums, maintaining aseptic conditions and cold throughout the process. Product sterilization is performed in filtration train using certified absolute filters of first quality, ending in a double sterilizing filtration up to 0.1µm. Serum is gamma irradiated at 25Ky through a validate procedure, thus ensuring adventitious virus and mycoplasma inactivation without affecting product integrity.
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 : |
5,0 - 8,0 g% |
Colorimétric - BIURET. |
|
Albúmin: |
3.0 – 4.5 g% |
Colorimétric - BCF |
|
PH: |
7,0 – 8.2 |
Potentiometry |
|
Electrophoretic profile: |
Normal Profile |
Electrophoresis on Cellulose Acetate against reference serum. |
| Bacterial and fungal sterility: | Sterile | Thioglycollate, Soy and Saboraud broth |
Nalgene bottles per 1000 cm3.
The SEA must be stored at freezer temperature, 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).
Liquid, frozen at -20ºC in 5 liters drums. store between -14ºC to -20ºC.
