Collected at government approved abattoirs in the United States.
True pooled and triple 0.1 micron sterile filtered that passes sterility, mycoplasma, and 9CFR viral testing requirements
Granted a Certificate of Suitability, R0-CEP 2018-271, by the European Directorate for the Quality of Medicines (EDQM).
Validated process used to heath inactivate serum at 56°C ± 2°C for 30 minutes via bulk inactivation of entire lot in the pooling tank or individual bottles in a water bath.
Validated process used to gamma irradiate serum within one of two separate dose ranges: 25-40 kGy and 30-45 kGy.