Too Much by Half: Misapplication of the Half-Cycle Approach to Sterilization
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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Full Tolerance Coverage Method for Assessing Uniformity of Dosage Units with Large Sample Sizes
March 10th 2025The ‘full tolerance coverage method’ is introduced as a coverage estimation approach for assessing the uniformity of dosage units from large sample sizes, ensuring that no dosage unit exceeds the specification range.
