血清生產過程在一個可控的條件下進行。SIP滅菌、無菌過濾和分裝作為關鍵的滅菌過程證實是有效的。產品生產符合質量管理標準ISO9001。血清生產過程遵循IVDD78/79/EC。適用于常規(guī)細胞的培養(yǎng)。

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.