新生牛血清

血清生产过程在一个可控的条件下进行。SIP灭菌、无菌过滤和分装作为关键的灭菌过程证实是有效的。产品生产符合质量管理标准ISO9001。血清生产过程遵循IVDD78/79/EC。适用于常规细胞的培养。

Biosera New Born Calf Serum

FOR IN VITRO LABORATORY USE ONLY, NOT FOR DRUG, HUMAN

VETERINARY USE

Collected from the source:

When searchers choose their serum, an important factor that should be taken into consideration is the source, which also emphasises the traceability of the serum.

Our system of vertical integration allows us to be certain of the origin and traceability of our serum.Each batch is rigorously controlled, from the collection of serum and in all the stages of its treatment and production on our premises through to final packaging.Biosera’s New Born Calf Serum is derived from clotted whole blood aseptically collected from New Born Calves via the vein. The serum is imported in agreement with the french legislation.

Filtration:

Final Filter Size: 0.2μm, x 2

Sterility:

All sera are tested for the absence of aerobic and anaerobic bacteria, fungi, yeast and Mycoplasma.The sterility test is based on the European Pharmacopeia requirements.

The sera are tested for the absence of Mycoplasma after 21 days of culture.

Virus Tested:

All of our serum is tested for:

- Bovine Viral Diarrhoea (BVD)

- Infectious Bovine Rhinotracheitis (lBR)

- Parainfluenza Type 3 (Pl3)

Sera are tested for the absence of the indicated viruses by inoculation to GBK cells. The revelation is made by indirect immunofluorescence.The antibodies are tested by an Elisa method.

Endotoxin:

All sera are tested to determine the levels of endotoxins. BioWest carries out a chromokinetic

(quantitative test) test.The endotoxin reagent is standardized against the US reference endotoxin. The method is based on "the bacterial endotoxins test", US pharmacopeia 23rd revision.

Osmolarity:

Determined by a lowered freezing temperature. The osmometer is calibrated against standard

solutions

Haemoglobin:

The haemoglobin level is measured by spectrophotometer.

Total Protein:

Determined by Electrophoresis.