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Parameter |
Specification |
| 1 |
Pack
size |
100
mL and 500 mL in PETG ‘Nalgene Bottles’ |
| 2 |
Overpack
configuration |
To
meet customer requirements |
| 3 |
Expiry
date |
Not
stated |
| 4 |
Filteration |
Sterile
filtered to Triple 0.1µm |
| 5 |
Sterility |
No
growth after 14 days incubation (BP Appendix XVIa) |
| 6 |
Mycoplasma |
Not
detected |
| 7 |
Virus |
BVD |
Not
detected |
| IBR |
| P13 |
| 8 |
Endotoxin |
Less
than 5 EU/mL |
| 9 |
Functionality |
Supports
cell growth (BHK cell line) to a level of at least
90% of a nominated reference Fetal Bovine Serum |
| 10 |
pH |
6.9
to 7.9 |
| 11 |
Osmoiality |
280
to 340 mOsm/Kg |
| 12 |
Haemoglobin |
Less
that 18 mg/dL |
| 13 |
Total
Protein |
25
to 55 g/L |
| 14 |
Electrophoresis |
Albumin |
Greater
than 65% w/v |
| Alpha
Globulin |
Greater
than 5% w/v |
| Gamma
Globulin |
Less
than 2% w/v |
Raw
Fetal Bovine Serum is obtained from animals which
were of New Zealand origin and were processed in premises
pursuant to the Meat Act 1981 or approved by the Food
Safety Authority. It is produced in accordance with
New Zealand law. The cows from which the co-products
were derived passed ante- and post-mortem FSA Verification
Agency veterinary inspection.
African horse sickness, African swine fever, anthrax,
avian influenza (fowl plague), bluetongue disease,
bovine spongiform encephalopathy (BSE), Brucella abortus,
Brucella melitensis, Brucella suis, classical swine
fever (hog cholera), contagious bovine pleuropneumonia,
foot and mouth disease, glanders, lumpy skin disease,
Newcastle disease (with the exception of an asymptomatic
lentogenic strain), peste des petites ruminants, rabies,
Rift Valley fever, rinderpest, scrapie, sheep and
goat pox, swine vesicular disease and vesicular stomatitis
do not occur in New Zealand.
The importation into New Zealand of ruminant meat,
bone meal and blood meal for use in stock foods is
prohibited.
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