Abstract
The sensitivity, reliability, reproducibility and ease of use of the WILCO LFC package integrity test method was evaluated by preparing and testing a series of rubber-stoppered glass vials which were modified by affixing a glass micropipette through the vial side wall. The test units contained water, 50% aqueous ethanol, 20% lithium chloride or 20% aqueous glycerol. Leakage measurement obtained by LFC testing were compared to helium leak rate measurements. The LFC methods detected all leak >0.0014 standard cubic centimeters per second (sccs), which represents a sensitivity about fourteen-fold greater than standard vacuum decay methods. The minimum detectable leak corresponded to a nominal micropipette internal diameter of between 1 and 2 microns. The effective detection range corresponded to a leak size associated with a 40 to 100% probability of microbial ingress based on a previously reported logistical regression model between helium leak rate and microbial immersion. The sensitivity did not vary with solvent or testing duration in range of 5 to 10 seconds. The coefficient of variation was about 3%. The LFC operation was rapid and without apparent mechanical or electronic problems over the two day testing period used in these studies.
Footnotes
- Received April 28, 1999.
- Accepted June 1, 1999.
- Copyright © Parenteral Drug Association. All rights reserved.
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