Fetal Bovine Serum is derived from the blood of fetuses of slaughtered dams which have passed ante and post mortem veterinary inspection in government supervised slaughter-houses and are passed as fit for human consumption. The blood is obtained by cardiac puncture utilising a single-use needle, tube and bag.
The blood is allowed to clot naturally and is then centrifuged to obtain the liquid fraction of the blood which is now regarded as semi-processed serum. No other additions or deletions of material are permitted.
STERILE FILTERED: Semi-processed Raw Fetal Bovine Serum, is thawed, pooled and filtered through a series of sterile membranes down to 0.1 microns before being finally packaged, usually in 500ml or 1L bottles. No further processing, additions or deletions are performed. However, subsequent treatment, including gamma irradiation or heat inactivation, may be carried out and the bottles labelled accordingly.
SPECIFICATION - FETAL BOVINE SERUM - STERILE FILTERED (FBSF) |
Product | Fetal Bovine Serum - Sterile Filtered |
Catalogue No. | FBSF |
Certificate of Suitability | Australia: R1-CEP 2000-187-Rev 00 New Zealand: R1-CEP 2000-188-Rev 00 |
Source | Bovine blood from fetuses of healthy cows which have been inspected ante and post mortem by Australian or New Zealand Government veterinarians and passed as fit for human consumption. |
Collection/Processing Method | Blood is collected via cardiac puncture into sterile bags. Blood is separated by cup centrifugation and double spun. Serum is subsequently passed through a series of filters terminating with triple 0.1 µm pore size filters. Product is dispensed in IS0 14644 Class 5 Laminar Flow Workstation via a closed system. It is then immediately frozen. |
Description | A clear amber viscous liquid with a characteristic odour. |
Pack Size | 500ml & 1000ml sterile PET & PETG square media bottles |
Storage | -20 degrees Centigrade |
Expiry Date | Six years from the date of manufacture |
TEST | METHOD | SPECIFICATION |
Visual Examination | Visual Examination | Satisfactory |
Specificity | Species I.D. | Bovine |
Sterility | Millipore Steritest Broth Culture 14 Day Incubation | Sterile |
Mycoplasma | Broth Culture 35 Day Incubation | Not Detected |
Viruses: | 9CFR (113-53c) |
|
Bovine Respiratory Syncytial Virus | Fluorescent Antibody | Not Detected | Bovine Viral Diarrhea Virus | Fluorescent Antibody | Not Detected | Bovine Parvovirus | Fluorescent Antibody | Not Detected | Bluetongue Virus | Fluorescent Antibody | Not Detected | Bovine Adenovirus | Fluorescent Antibody | Not Detected | Rabies Virus | Fluorescent Antibody | Not Detected | Reovirus | Fluorescent Antibody | Not Detected | Infectious Bovine Rhinotracheitis | Cytopathic Agents | Not Detected | Para Influenza 3 (PI3) | Haemadsorbing Agent | Not Detected |
|
EMA/CHMP/BWP |
|
|
7.3.2 Test for specified viruses |
| Not Detected | 7.3.3 BVDV |
| Not Detected | 7.3.4 Serum Neutralization Assay |
| As Reported |
|
Antibodies: |
|
|
BVD | VNT | As Reported | IBR | VNT | As Reported | PI3 | Elisa | As Reported | BT (Australia) | Elisa | As Reported | Akabane (Australia) | Elisa | As Reported | EBL | Elisa | As Reported |
|
pH | pH Meter | 6.9 - 7.6 |
Osmolatlity | Osmometer | 280-0365 mOsmol/kg |
Total Protein | Beckman Coulter Synchron Clinical Systems | 30 - 45 mg/m |
Albumin | Electrophoresis | As Reported % |
Total Globulins: |
|
|
Alpha | Electrophoresis | As Reported % | Beta | Electrophoresis | As Reported % | Gamma | Electrophoresis | As Reported % |
|
IgG | ELISA | ≤ 400 mg/l |
Electrophoresis pattern | Agarose Gel Plate | Typical |
Haemoglobin | UV/VIS Spectrophotometer | ≤ 0.18 mg/ml |
Endotoxin | Kinetic Turbidimetric | ≤ 5 IU/ml |
FUNCTIONALITY TEST |
Cell Line Used |
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|
MDBK: | Cell Culture | ≥ 85% of FCS Control | Hybridoma: | Cell Culture | ≥ 85% of FCS Control | MRC-5: | Cell Culture | ≥ 85% of FCS Control | Vero: | Cell Culture | ≥ 85% of FCS Control |
|
BIOCHEMICAL PROFILE - BECKMAN DXC 800 ANALYSER |
Sodium |
| As Reported mmol/l |
Potassium |
| As Reported mmol/l |
Chloride |
| As Reported mmol/l |
Bicarbonate |
| As Reported mmol/l |
Anion Gap |
| As Reported mmol/l |
Glucose |
| As Reported mmol/l |
Urea |
| As Reported mmol/l |
Creatinine |
| As Reported µmol/l |
Urea/Creatinine |
| As Reported (ratio) |
Urate |
| As Reported mmol/l |
Bilirubin total |
| As Reported µmol/l |
Calcium |
| As Reported mmol/l |
Alkaline Phosphatase |
| As Reported U/l |
Gamma Glutamyl Transferase |
| As Reported U/l |
Alanine Transaminase (Glutamic Pyruvic Transaminase) |
| As Reported U/l |
Aspartate Transaminase (Glutamic Oxaloacetic Transaminase) |
| As Reported U/l |
Lactate Dehydrogenase |
| As Reported U/l |
Cholesterol |
| ≤ 1.2 mmol/l |
Triglyceride |
| As Reported mmol/l |