Nobimpex FBS
Australian Origin FBS
Australian origin Fetal Bovine Serum is highly sought after due to Australia's freedom from all major epidemic diseases of livestock, including Foot and Mouth Disease. This status is collectively administered by The World Organisation for Animal Health (OIE), the Food and Agricultural Organisation of the United Nations (FAO) and the World Health Organisation (WHO), who are responsible for monitoring the international epidemiology of livestock diseases.
Filtration is carried out using a two-tank system to ensure complete homogeneity. Pooled serum is transferred via pre-filters to a Raw Serum Tank. This pool is stirred constantly by a magnetic stirrer. Final filtration is by triple 0.1 micron filters for Fetal Bovine Serum.
The finished sterile serum is held in the Sterile Serum tank until the filtration is complete. The serum is constantly moved by a magnetic stirred to ensure complete homogeneity before dispensing. The entire filtration and dispensing system including both tanks are sterilized using pure steam.
Finished sterile FBS is blast frozen and stored at -20°C.
Sterile Fetal Bovine Serum is finished in a laboratory area operated to cGMP standard. All production processes are performed and recorded to an ISO 9001:2008 system.
Dispensing is done within a ISO 14644 Class 5 workstation placed in a Class 7 clean room. This air supply is pressurised with presures descending from the Class 7 clean room outwards.
Environment monitoring is performed during the filling operation. The atmosphere is monitored for viable and non-viable particles. Both workstation surfaces as well as personnel are checked for bacterial levels.
All operations are performed and recorded according to ISO 9001-2008 Quality Systems.
