ABSTRACT
Viruses are commonplace in human-source proteins; large plasma pools from which clotting factors, immunoglobulins, and serum albumin are prepared often contain several hepatitis viruses and the human immunodeficiency virus (HIV). The preferred strategies detailed in the chapter impart viral safety to proteins for injections. In the first half of the 1980s, shortly after acquired immunodeficiency syndrome (AIDS) had surfaced as a menace, the Hyland Division of Baxter Healthcare developed methods for the dry heat inactivation of HIV and other viruses. The basic techniques for viral inactivation and elimination may be categorized as follows: Decontamination of materials not intended for injections are moist heat sterilization, dry heat sterilization, exposure to strong oxidizers, gamma sterilization. Decontamination of materials intended for injections are exclusion of virus-containing material by prior testing, dry heating of freeze-dried material, moist heating of freeze-dried material, pasteurization of material in solution, virus removal by hydrophobic interaction, gamma sterilization, cold ethanol fractionation, and virus removal by ultrafiltration.
