血清生產(chǎn)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(guān)鍵的滅菌過程證實是有效的。產(chǎn)品生產(chǎn)符合質(zhì)量管理標準ISO9001。血清生產(chǎn)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.
關(guān)鍵字： 新生牛血清
博升生物是一家專注于生命科學技術(shù)領(lǐng)域的高科技企業(yè)。專業(yè)代理進口實驗室試劑、化工產(chǎn)品、實驗室消耗品。產(chǎn)品涉及細胞生物學、免疫學、新藥研發(fā)、體外診斷、免疫治療和臨床應用等相關(guān)產(chǎn)品。公司擁有獨立的進出口權(quán)，在海關(guān)、檢疫局、質(zhì)監(jiān)局、外匯局都有備案；可以為客戶提供生物制品的代理申報、清關(guān)、物流和付匯等專業(yè)服務。