Plasma Protein Fraction (Human)

Plasma Protein Fraction, USP (PPF) has largely replaced preparations of pooled plasma as a plasma expander. Three commercial lots of PPF (Plasmanate ®‐Cutter) prepared in 1959 were subjected to a planned stability study extending over a nine year period with the following findings: 1. Motion lability was not adversely affected by storage for periods up to 7 years at temperatures of 25° or below. 2. With extended time, there was a small gradual decrease in the albumin component and a corresponding increase in a component with an electrophoretic mobility of alpha‐globulin but with a sedimentation rate equivalent to that of albumin; this rate of change was greatly accelerated at 40°. 3. Viscosity increased at a rate of approximately 0.3% per year at 5° and 25°; at 40° viscosity increased sharply with extended time. 4. Turbidity was little affected by time and temperature except for periods in excess of 2 years at 40°. 5. No antigenic changes were detectable after 2 years at 40° or 8 years at 25°. 6. Clinical studies in normal volunteers with PPF stored 9 years at 25°, and in ill patients with PPF stored 2 years at 40° and 9 years at 25° showed no adverse reactions. It is concluded that Plasma Protein Fraction can be safely used after storage for 5 years at temperatures not exceeding 30°.