Tests are performed according to the guidelines listed in the Code of Federal Regulations (CFR) issued by the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA). An overview of the tests routinely performed are as follows:

Endotoxin

Level of Endotoxin is determined by using the Limulus Amebocyte Lysate (LAL) gel clot method.

pH

Measurement is done using standard methods for determining hydrogen ion concentration.

Hemoglobin

Determined hy colorimetric assay.

Mycoplasma

All serum is tested for the absence of mycoplasma based on the large volume method of Barile and Kern, CFR Title 9, Part 113.28. All sera are tested by the fluorescent DNA staining technique for cell cultures (from the growth test) after the second and fourth passage (Hoechst bisbenzamide test).

Bacteriophage

Contamination is determined by plaque assay using host sensitive strains of E.Coli.

Virus Testing

All batches of serum are carefully tested for virus contamination in accordance with modified CFR Title 9 Part 113.53. Virus testing is species. Serum of bovine origin is tested for the presence of Bovine Viral Diarrhea virus (BVD), Infectious Bovine Rhinotracheitis virus (IBR) and Parainfluenza virus Type 3 (Pl-3).

Protein Electrophoresis Identity Profile

Provides a profile characteristic for age. This test is quantified for albumin and globulin fractions as percentages of total protein.

Total protein

Determined spectrophotometrically at 540nm by the Biuret calorimetric assays. 

Sterility

Blood agar, Fluid Thioglycollate, Trypticase soy broth (soy-bean casein) at 30o-35oC and 20o-25oC aerobically and anerobically for 14 days USP XXIII <71> and CFR Title 9 Part 113.26.

Chemistries

Characteristic profile of all serum batches.

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