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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.

 

 

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