Fig. 1

Schematic overview of general steps involved in the industrial production of spray-dried plasma. Critical control points for quality assurance and quality control. Manufacturers following good manufacturing practices collect blood from animals inspected and determined fit for slaughter for human consumption. Blood flows into an enclosed system, separated into plasma and blood cell fractions, rapidly chilled to 4 °C and held in insulated holding tanks. Then plasma is transported in cleaned, sealed dedicated tankers to a remote spray drying facility where it is held in insulated tanks. Alternatively, the whole blood is chilled to 4 °C in the slaughterhouse and transported to remote spray drying facility where it is split into plasma and blood cells fractions. At abattoirs, collection systems and holding tanks are cleaned and sanitized by standard operating procedures specific for each plant. Holding tanks at abattoirs or spray drying plants are cleaned and sanitized when emptied. Filtration and concentration systems are cleaned per standard operating procedures. Standard operating procedures are in place for continual monitoring and recording of computer controlled spray drying process. Each lot of spray dried product is identified at packaging and must pass quality control and assurance testing before release for sale. Product lot number allows traceability of distribution to customers