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Fetal Bovine Serum (FBS) is derived from coagulated whole blood, collected from the fetus by cardiac puncture. The blood is immediately centrifuged and the serum is frozen for transfer to our treatment facilities. Upon receipt at the processing plant, the serum is thawed, tested for acceptability, collected and passed through three sterilization filters of 100 nm (0.1 μm). The serum is bottled by an asceptic filling process.
Complete Traceability
For all our batches, we have complete traceability. The labeling system is computerized and designed for clarity from batch to batch. Each batch is monitored throughout processing and production to final packaging. The geographical origin is indicated on the Certificate of Analysis which accompanies each delivery of fetal bovine serum.
Quality Control Tests
All sera are rigorously tested for sterility, mycoplasmas, viruses (BVD, IBR and PI3). Each batch is also tested for its ability to withstand cell growth in vitro, plating efficiency and cloning efficiency on the following cell lines: HeLa, L929, SP2 / O-AG14, MRC-5. Certified and specially certified sera are subjected to a battery of additional tests including endotoxin, chemical components, protein electrophoresis and radial immunodiffusion.
BSE
Donors of European origin are tested for BSE before treatment in accordance with European Regulation 999/2001. All animals tested are BSE negative.
原材料的溯源
當(dāng)科學(xué)家選擇他們所用的血清時,考慮到的一個重要的因素就是它的來源。因此,血清的可溯源性變得極其的重要。Biosera的胎牛血清來自于心臟穿刺無菌采集胎牛心臟的凝塊全血。生產(chǎn)的每批產(chǎn)品,從血清的采集到貫穿整個生產(chǎn)過程的每一步,直至 包裝,都嚴格按照我們的標(biāo)準(zhǔn)進行。所有產(chǎn)品運送到世界各地的顧客手中之前均經(jīng)過Biosera分析,分類和測試。我們的質(zhì)量體系可追蹤到原材料的供應(yīng)商和收集血清的屠宰場。Biosera的縱向一體化體系能確保胎牛血清(FBS)真正原產(chǎn)地和可追溯性。
Biosera的質(zhì)量
用我們的血清對特定的細胞系生長的促進作用來衡量FBS的質(zhì)量。適用于一種細胞系的血清可能不完全適用于另一種細胞系。Biosera的顧客可以先做樣品的生長性能的測試再進行購買。有成千上萬的不同細胞系,沒有兩批FBS產(chǎn)品是完全相同的,因此我們提供非常寬廣的樣品和儲備政策.
血清的批次留存
在60天的測試期間內(nèi),Biosera很高興為您提供不同批次保存產(chǎn)品的免費試樣,一般FBS的試樣大小是50ml/批次。如果需要,Biowest可以適當(dāng)調(diào)整以適應(yīng)客戶的要求。試用過后,Biosera可以為沒有充足的儲存設(shè)備的客戶保存24個月,在這種情況下,將按計劃交貨給客戶。
技術(shù)支持
Biosera經(jīng)驗豐富的技術(shù)服務(wù)員工能夠解決所有關(guān)于Biosera質(zhì)量控制和產(chǎn)品的問題。我們致力于提供即時、禮貌、專業(yè)的服務(wù)。