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.
关键字: 新生牛血清
博升生物是一家专注于生命科学技术领域的高科技企业。专业代理进口实验室试剂、化工产品、实验室消耗品。产品涉及细胞生物学、免疫学、新药研发、体外诊断、免疫治疗和临床应用等相关产品。公司拥有独立的进出口权,在海关、检疫局、质监局、外汇局都有备案;可以为客户提供生物制品的代理申报、清关、物流和付汇等专业服务。