| ANIMAL SERUM (FBS) PROCESSING
Collection and processing are undertaken by trained employees ensuring
compliance with cGMP procedures in USDA inspected abattoirs and
our FDA licensed manufacturing facility. No additives are used and
temperatures are carefully monitored at all times. Fetal
Bovine Serum (FBS) or Fetal Calf Serum is collected aseptically by cardiac puncture
closed system. Standing donor herds are bled by aseptic venous puncture
closed system. After collection the blood is refrigerated and within
24 hours the clotted blood undergoes refrigerated centrifugation.
Prior to final pooling, each 3.5 L jug is subjected to numerous
tests to ensure compliance with raw product specifications. Each
is tested for: Endotoxin, pH, Osmolality, Protein and Hemoglobin.
Approved serum is pooled in a 1000 L refrigerated tank prior to
filtration, to facilitate pool uniformity.
Fetal bovine Serum is triple 0.1µ filtered
in a validated class 100 environment in our new class 10,000 clean
room and aseptically filtered into pre-sterilized PETG bottles.
The finished product is then quick frozen at or below -20° C.