Too Much by Half: Misapplication of the Half-Cycle Approach to Sterilization

November 15, 2016
James P. Agalloco

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

Pharmaceutical Technology, Pharmaceutical Technology-11-15-2016, Volume 2016 eBook, Issue 3
Pages: s21–s26

The half-cycle method for validating sterilization can have adverse effects on materials if used for steam sterilization.

The half-cycle method for validating sterilization, although necessary in its original context of ethylene oxide sterilization, can have adverse effects on materials if used for steam sterilization.

The author describes some of these potential results and reviews historical and current thinking on validation of sterilization processes.

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