[Monitoring of sterilization procedures for plasma derivatives using bacteriophages]

Since 1968 the combination of beta-propiolactone (beta-PL) plus UV-inactivation for the sterilization of plasma derivatives is in use at Biotest. In 1981, a bacteriophage test system was established for routine monitoring of the efficacy of this sterilization procedure, using the bacteriophages phi x 174, phi e, Kappa and f2. In the period of 1981 to 1986, 88 control experiments were performed under production conditions demonstrating a mean inactivation of these test viruses of greater than or equal to 6.7 log10. This constant and high efficacy of the beta-PL/UV sterilization procedure guarantees the longstanding safety of beta-PL/UV sterilized blood derivatives. Bacteriophages are also useful experimental viruses for monitoring the efficacy of pasteurization processes.